OrthoGold 100
Device Facts
| Record ID | K210451 |
|---|---|
| Device Name | OrthoGold 100 |
| Applicant | Tissue Regeneration Technologies, LLC |
| Product Code | ISA · Physical Medicine |
| Decision Date | May 5, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5660 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The OrthoGold 100 is intended for: - Relief of minor muscle aches and pains - · Temporary increase in local blood circulation - · Activation of connective tissue
Device Story
OrthoGold 100 is a pulsed acoustic wave device for therapeutic massage. It uses an electrically powered generator to create high-voltage (2-7 kV) discharges, causing spark-gap-induced expansion of water to generate transient acoustic waves. These waves propagate through a water-filled coupling membrane in a hand-held applicator, applied to the patient's skin via a silicone membrane and ultrasound transmission gel. Operated by clinicians in a clinic setting, the device delivers unfocused pressure pulses to the treatment area. The provider selects intensity levels (1-16) and frequencies (1-8 Hz) to manage muscle aches, circulation, and connective tissue activation. The output is mechanical acoustic energy, which provides therapeutic massage effects. The device is intended to provide relief of minor muscle aches and pains, increase local blood circulation, and activate connective tissue, potentially benefiting patients through non-invasive physical therapy.
Clinical Evidence
No clinical data was relied upon. Substantial equivalence is supported by bench testing, including verification and validation of design specifications, hazard analysis, and risk management. The device conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-36. In vitro testing demonstrated that applicator displacement, force, and penetration depth are equivalent to the predicate device.
Technological Characteristics
Pulsed acoustic wave device; electro-hydraulic spark-gap generation; high voltage (2-7 kV) power supply; hand-held applicator with water-filled coupling membrane and silicone interface. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, and IEC 61846. Operates at 1-8 Hz frequency and 1-16 intensity levels. Standalone device.
Indications for Use
Indicated for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue in patients requiring therapeutic massage.
Regulatory Classification
Identification
A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
Predicate Devices
- Storz Medical D-Actor 200 Vibration Massage System (K173692)
Submission Summary (Full Text)
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May 5, 2021
Tissue Regeneration Technologies, LLC % Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St Floor 9 New York, New York 10001
Re: K210451
Trade/Device Name: OrthoGold 100 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic massager Regulatory Class: Class I Product Code: ISA Dated: February 12, 2021 Received: February 16, 2021
Dear Cherita James:
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/cdrl/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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K210451
Device Name
OrthoGold 100
Indications for Use (Describe)
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
Type of Use (Select one or both, as applicable) y Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for 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 information upon which the substantial equivalence determination is based.
The safety and effectiveness of the OrthoGold 100™ is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).
| Sponsor: | Tissue Regeneration Technologies, LLC<br>251 Heritage Walk<br>Woodstock, GA 30188<br>Ph: 1-404-402-6844 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cherita James<br>M Squared Associates, Inc.<br>127 West 30th Street<br>9th Floor<br>New York, New York 10001<br>Ph: 347-536-1463<br>Fax: 703-562-9797<br>Email: CJames@MSquaredAssociates.com |
| Date prepared: | May 4, 2021 |
| Proposed Class: | I |
| Proprietary Name: | OrthoGold 100™ |
| Proprietary Name: | OrthoGold 100™ |
|----------------------|------------------------------------------------------------|
| Common Name: | Therapeutic Massager |
| Classification Name: | Massager, Therapeutic, Electric |
| Regulation Number: | 21 CFR 890.5660 |
| Product Codes: | ISA |
| Predicate Device: | Storz Medical D-Actor 200 Vibration Massage System K173692 |
#### 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.
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The technology and performance testing of the OrthoGold 100™ have been cleared previously (K182682). There are no changes to the OrthoGold 100™ regarding device characteristics, software, and device performance since the previous clearance.
#### Indications for Use
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
#### 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. Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 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 OrthoGold 100 is compliant with the following standards:
| Standard | Recognition Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| IEC 61846 First edition 1998-04, ultrasonics - pressure pulse lithotripters - characteristics of<br>fields | 9-7 |
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012<br>(consolidated text) medical electrical equipment - part 1: general requirements for basic safety<br>and essential performance | 19-4 |
| IEC 60601-1-2:2014 Edition 4, Medical electrical equipment - Part 1-2: General requirements<br>for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances<br>- Requirements and<br>tests | 19-8 |
| IEC 60601-2-36 Edition 2.0: 2014-04,<br>Medical electrical equipment - Part 2-36: Particular requirements for the safety of<br>equipment for extracorporeally induced lithotripsy | 9-119 |
| DRAFT IEC 63045 ED1, Ultrasonics - Non-focusing pressure pulse sources - Characteristics of<br>fields | N/A |
There are no changes to the standards referenced in the previous submission present no changes to the previously cleared OrthoGold 100.
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## Clinical Data
Clinical performance data is not relied upon to eastanblish the substantial equivalence of the subject and predicate device.
| Product Characteristic | Subject Device<br>OrthoGold 100™ | Predicate Device<br>D-Actor 200 | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K210451 | K173692 | NA |
| Indications for Use | Relief of minor muscle aches<br>and pains<br>Temporary increase in local<br>blood circulation<br>Activation of connective tissue | Relief of minor muscle aches<br>and pains<br>Temporary increase in local<br>blood circulation<br>Activation of connective tissue | Equivalent |
| Modes of Action | Unfocused pressure pulses | Radial (unfocused) pressure<br>waves, or extracorporeal pulse<br>activation respectively | Similar |
| Mechanisms of Action | Extracorporeally induced<br>unfocused pressure pulses | Pneumatically generated<br>vibrations + unfocused pressure<br>pulses | Equivalent |
| Maximum and<br>Minimum intensity<br>settings | 1 to 16 | 1-5 bar | Similar |
| Number and size of<br>treatment applicator<br>heads | OP155<br>Size: 230 x Ø 70 mm | 4: 6mmOD, 15mmOD,<br>20mmOD, 35mmOD | Similar |
| Maximum and<br>minimum displacements<br>of applicator heads | Not Applicable | 0.6 - 2.0 mm | NA |
| Type of application<br>(e.g., continuous<br>vibration at a fixed<br>frequency); | Continuous at various<br>frequencies | Continuous at various<br>frequencies | Similar |
| Product Characteristic | Subject Device<br>OrthoGold 100TM | Predicate Device<br>D-Actor 200 | Comparison |
| Maximum and<br>minimum vibration<br>frequency | Frequency of 1 - 8 Hz in steps<br>of 0.5 Hz | 1-21 Hz | Similar |
| Driving Power | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | 1-5 bar | Similar |
| Power Supply | 115 VAC | 500 VA | Similar |
| Maximum penetration<br>depth | 25.4 mm at energy level 16 | 32mm | Similar |
| Energy flow density<br>PIIT [mJ/mm2] | 0.00017 - 0.04403<br>at energy level 1 - 16 | Values of ultrasonic pulse:<br>5bar/0.284mJ/mm2<br>3bar/0.176mJ/mm2 | Similar |
| Operating mode | Continuous | Continuous | Similar |
| Projectile mass (g) | Not Applicable | 3 | NA |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1-21 Hz | Similar |
| Number of pulses (min<br>and max) | 500 - 2000 | Variable | Similar |
| Maximum operating<br>temperature | Room temperature | 10-40C | Similar |
| Type of acoustic wave<br>generation | Electro hydraulic, spark gap<br>under water caused by<br>discharge of high voltage<br>condensers | Pneumatic/ballistic | Similar |
| Peak compressional<br>acoustic pressure<br>pc [MPa] | 9.27<br>at energy level 16 | 18.5 | Similar |
| Peak rarefactional<br>acoustic pressure<br>pcr[MPa] | -1.52 at energy level 16 | 6.8MPa at 5 bar | Similar |
| Product Characteristic | Subject Device | Predicate Device | |
| | OrthoGold 100TM | D-Actor 200 | Comparison |
| Description of the<br>spatial distribution of<br>the acoustic pressure<br>and intensity | Unfocused acoustic pressure<br>field, see pressure<br>measurements | Specific Value Not Available | Similar |
| Positive peak pressure<br>amplitude (MPa)<br>pc [MPa] | 0.43 - 9.27<br>at energy level 1 - 16 | 5 bar/18.5MPa<br>3bar/13.4MPa | Similar |
| Negative peak pressure<br>amplitude (MPa)<br>pcr[MPa] | -0.17 to -1.52 MPa<br>at energy level 1 - 16 | Values of ultrasonic pulse:<br>5bar/6.8MPa 3bar/5.0MPa | Similar |
| Derived focal acoustic<br>pulse energy (mJ)<br>EbT [mJ] | 0.022 - 2.278<br>at energy level 1 - 16 | Values of ultrasonic pulse:<br>5bar/6.5mJ<br>3bar/2.4mJ | Similar |
| Derived pulse -intensity<br>integral, integrated over 0.00017 - 0.04403 mJ/mm2<br>total temporal<br>integration limits<br>PIIT [mJ/mm2] | at energy level 1 - 16 | Values of ultrasonic pulse<br>5bar/0.284mJ/mm2<br>3bar/0.176mJ/mm2 | Similar |
| Rise time (ns)<br>(10% - 90%) tr [µs] | 1.89 - 0.28 at energy level 1 -<br>16 | Ultrasonic pulse: 2.5µs<br>Sonic pulse: 25µs – 2.5ms | Similar |
| Compressional pulse<br>duration (µs)<br>tFWHMpc [µS] | 1.23 - 0.77 µs at energy level 1<br>- 16 | Ultrasonic pulse: 5.0µs<br>Sonic pulse: 50µs – 5.0ms | Similar |
The table below compares the OrthoGold 100 characteristics to the predicate device.
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### 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
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## K210451
the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
