OrthoGold 100TM
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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December 21, 2018
Tissue Regeneration Technologies, LLC
o Jennifer Daudelin, MSJ
Regulatory Consultant III
M Squared Associates, Inc.
575 Eighth Avenue, Suite 1212
New York, New York 10018
Re: K182682
Trade/Device Name: OrthoGold 100TM
Regulation Number: 21 CFR 890.5660
Regulation Name: Therapeutic Massager
Regulatory Class: Class I
Product Code: ISA
Dated: September 26, 2018
Received: September 26, 2018
Dear Jennifer Daudelin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
Silver Spring, MD 20993
K182682 – Jennifer Daudelin Page 2
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (https://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director
Division of Neurological
and Physical Medicine Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K182682
Device Name
OrthoGold 100
Indications for Use (Describe)
The OrthoGold 100 is intended for the activation of connective tissue.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
510(k) Summary
Tissue Regeneration Technologies, LLC OrthoGold 100™
The following information is provided as required by 21 CFR § 807.87 for the Tissue Regeneration Technologies, LLC 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
Sponsor: Tissue Regeneration Technologies, LLC
251 Heritage Walk
Woodstock, GA 30188
Contact: Jennifer A. Daudelin, M.S.J.
M Squared Associates, Inc.
575 Eighth Avenue, Suite 1212
New York, NY 10018
Ph: 703-562-9800 x251
Fax: 703-562-9797
Email: jdaudelin@msquaredassociates.com
Date Prepared: September 24, 2018
Proposed Class: I
Proprietary Name: OrthoGold 100™
Common Name: Therapeutic Massager
Classification Name: Massager, Therapeutic, Electric
Regulation Number: 21 CFR 890.5660
Product Codes: ISA
Predicate Device(s):
|
Manufacturer Device Name |
510(k) Number |
Procode |
Class |
|
Asclepion Laser Technologies GmbH Dermablate Effect |
K081541 |
ISA |
I |
Indications for Use
The OrthoGold 100™ is intended for the activation of connective tissue.
Tissue Regeneration Technologies, LLC 510(k) Summary
OrthoGold100™ Page 1 of 4
000001
Device Description
The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
Performance Data
Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005; as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36. In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the Dermablate predicate device. In addition, probe cover testing and transport verification and validation was also conducted. The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device.
The table below compares the OrthoGold 100 characteristics to the predicate device.
|
Product Characteristic |
Subject Device OrthoGold 100™ |
Predicate Device Dermablate Effect |
Comparison |
|
510(k) Number |
To be assigned |
K081541 |
NA |
|
Indications for Use |
Activation of connective tissue |
Activation of connective tissue |
Identical |
|
Modes of Action |
Unfocused pressure pulses |
Radial (unfocused) pressure waves, or extracorporeal pulse activation respectively |
Similar |
|
Mechanisms of Action |
Extracorporeally induced unfocused pressure pulses |
Pneumatically generated vibrations + unfocused pressure pulses |
Equivalent |
|
Maximum and Minimum intensity settings |
1 to 16 |
Specific Value Not Available |
Similar |
Tissue Regeneration Technologies, LLC 510(k) Summary
OrthoGold100™ Page 2 of 4
000002
|
Product Characteristic |
Subject Device OrthoGold 100™ |
Predicate Device Dermablate Effect |
Comparison |
|
Number and size of treatment applicator heads |
OP155 Size: 230 x ø 70 mm |
Specific Value Not Available |
Similar |
|
Maximum and minimum displacements of applicator heads |
Not Applicable |
Specific Value Not Available |
NA |
|
Type of application (e.g., continuous vibration at a fixed frequency); |
Continuous at various frequencies |
Specific Value Not Available |
Similar |
|
Maximum and minimum vibration frequency |
Frequency of 1 – 8 Hz in steps of 0.5 Hz |
Specific Value Not Available |
Similar |
|
Driving Power |
High voltage 2 – 7 kV Capacitor: 0,2 uF |
Specific Value Not Available |
Similar |
|
Power Supply |
115 VAC |
Specific Value Not Available |
Similar |
|
Maximum applicator force |
Not Applicable |
Specific Value Not Available |
NA |
|
Maximum applicator displacement |
Not Applicable |
Specific Value Not Available |
NA |
|
Maximum penetration depth |
25.4 mm at energy level 16 |
30mm (3cm) |
Similar |
|
Energy flow density PIIT [mJ/mm2] |
0.00017 – 0.04403 at energy level 1 – 16 |
0.018-0.25 |
Similar |
|
Operating mode |
Continuous |
Specific Value Not Available |
Similar |
|
Projectile mass (g) |
Not Applicable |
Specific Value Not Available |
NA |
|
Pulse repeat rate (1/s) |
1 – 8 Hz |
1-11 Hz |
Similar |
|
Number of pulses (min and max) |
500 – 2000 |
Specific Value Not Available |
Similar |
|
Maximum operating temperature |
Room temperature |
Specific Value Not Available |
Similar |
|
Type of acoustic wave generation |
Electro hydraulic, spark gap under water caused by discharge of high voltage condensers |
Ballistic technology, pressurized air pulses accelerate a projectile within a guiding tube |
Similar |
|
Peak compressional acoustic pressure pc [Mpa] |
9.27 at energy level 16 |
13.4 |
Similar |
|
Peak rarefactional acoustic pressure pcr[Mpa] |
-1.52 at energy level 16 |
Specific Value Not Available |
Similar |
|
Description of the spatial distribution of the acoustic pressure and intensity |
Unfocused acoustic pressure field, see pressure measurements |
Specific Value Not Available |
Similar |
|
Positive peak pressure amplitude (MPa) pc [Mpa] |
0.43 – 9.27 at energy level 1 – 16 |
13.4 |
Similar |
Tissue Regeneration Technologies, LLC 510(k) Summary
OrthoGold100™ Page 3 of 4
000003
|
Product Characteristic |
Subject Device OrthoGold 100™ |
Predicate Device Dermablate Effect |
Comparison |
|
Negative peak pressure amplitude (MPa) pcr[Mpa] |
-0.17 to -1.52 at energy level 1 – 16 |
Specific Value Not Available |
Similar |
|
Derived focal acoustic pulse energy (mJ) EbT [mJ] |
0.022 – 2.278 at energy level 1 – 16 |
Specific Value Not Available |
Similar |
|
Derived pulse ‐intensity integral, integrated over total temporal integration limits PIIT [mJ/mm2] |
0.00017 – 0.04403 at energy level 1 – 16 |
Specific Value Not Available |
Similar |
|
Rise time (ns) (10% – 90%) tr [us] |
1.89 – 0.28 at energy level 1 – 16 |
Specific Value Not Available |
Similar |
|
Compressional pulse duration (μs) tFWHMpc [uS] |
1.23 – 0.77 at energy level 1 – 16 |
Specific Value Not Available |
Similar |
Technological Characteristics and Substantial Equivalence
The OrthoGold 100™ has the same indications for use and similar design features as compared with the predicate system. The bench testing demonstrates that the performance characteristics of the OrthoGold 100™ are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
Tissue Regeneration Technologies, LLC 510(k) Summary
OrthoGold100™ Page 4 of 4
000004