OW100S (model OW100S-US)

K213120 · Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · ISA · Oct 12, 2022 · Physical Medicine

Device Facts

• Record ID: K213120
• Device Name: OW100S (model OW100S-US)
• Applicant: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
• Product Code: ISA · Physical Medicine
• Decision Date: Oct 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase in local blood circulation - Activation of connective tissue

Device Story

OW100S is a pulsed acoustic wave device; uses electrically powered generator to create high-voltage spark in water; spark generates acoustic waves; waves propagate through water-filled hand-held applicator; applicator uses silicone membrane and ultrasound transmission gel to reflect waves toward treatment area. Device used in clinical settings by healthcare providers. Output consists of unfocused pressure pulses; used for muscle aches, circulation, and connective tissue activation. Modification from predicate (OrthoGold 100) includes 'break circuit' in generator to increase pulse capacity per applicator/electrode (up to 500K pulses) and modified water cartridge solution (potassium bromide). Device provides therapeutic benefit via extracorporeally induced acoustic pulses.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed the device meets design specifications. Performance testing compared acoustic field characteristics (pressure, intensity, pulse duration) between OW100S and predicate, showing statistical similarity. Software validated to Moderate level of concern; hazard analysis confirmed risks mitigated.

Technological Characteristics

Pulsed acoustic wave device; electro-hydraulic spark gap generation; 115 VAC power; hand-held applicator (OP155S) with silicone membrane; potassium bromide cartridge solution (2300μS/cm). Standards: IEC 61846, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 60601-1-6, IEC 63045, IEC 62304.

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

• OrthoGold 100 (OW100) (K210451)

Submission Summary (Full Text)

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October 12, 2022

Tissue Regeneration Technologies, LLC DBA as SoftWave TRT % Cherita James Regulatory Consultant M Squared Associates. Inc 127 West 30th Street, 9th Floor New York, New York 10001

Re: K213120

Trade/Device Name: OW100S (model OW100S-US) Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: September 12, 2022 Received: September 13, 2022

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/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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tushar Bansal, PhD Acting 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) K213120

Device Name OW100S (model OW100S-US)

Indications for Use (Describe)

The OW100S (model OW100S-US) 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X 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.

| Sponsor: | SoftWave TRT, LLC |
|----------|--------------------------|
| | 195 Chastain Meadows CT. |
| | Suite 109 |
| | Kennesaw, GA 30144 |

Contact: Cherita James M Squared Associates, Inc. 127 West 30th Street 9th Floor New York, New York 10001 Ph: 347-536-1463 Fax: [phone] Email: CJames(@MSquaredAssociates.com

| Date of Submission: | September 12, 2022 |
|----------------------|---------------------------------------|
| Proposed Class: | I |
| Proprietary Name: | OW100S (model OW100S-US) |
| Common Name: | Acoustic wave device |
| Classification Name: | Therapeutic massager |
| Regulation Number: | Section 890.5660 Therapeutic massager |
| Product Codes: | ISA |
| Predicate Device: | TRT, OrthoGold 100 (OW100) K21045 |

## Device Description

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. 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 modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.

There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.

### Indications for Use

The OW100S is intended for:

- -Relief of minor muscles aches and pains
-Temporary increase in local blood circulation

-Activation of connective tissue.

### Performance Data

The same verification and validation testing was performed for the current device design as the predicate and demonstrated that the OW100S 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 OW100S 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 performance testing demonstrated that the OW100S is substantially equivalent to the predicate device, OW100.

| The OW100S conforms to the following standards: |
|-------------------------------------------------|
|-------------------------------------------------|

| Standard | Recognition Number |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| IEC 61846 First edition 1998-04, ultrasonics - pressure pulse lithotripters -<br>characteristics of fields | 9-7 |
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and<br>a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general<br>requirements for basic safety and essential performance | 19-4 |
| IEC 60601-1-2:2014 Edition 4, Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and | 19-8 |

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| Standard | Recognition Number |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| tests | |
| 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 |
| IEC 60601-1-6 Edition 3.1 2013-10<br>Medical electrical equipment - Part 1-6: General requirements for basic safety and<br>essential performance - Collateral standard: Usability | 5-89 |
| IEC 63045-2020: Ultrasonics - Non-focusing short pressure pulse sources including<br>ballistic pressure pulse sources - Characteristics of fields | N/A |
| IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes<br>[Including Amendment 1 (2016)] | 13-79 |

# Substantial Equivalence

The modified OrthoGold 100, identified as OW100S, has the following similarities to those which

previously received 510(k) concurrence:

- . has the same indicated use,
- uses the same operating principle, .
- incorporates the same materials .
- incorporates the same basic device design, with the addition of the "break circuit" and minor . changes to the applicator, water cartridge, and software

The table below compares the OW100S characteristics to the predicate device.

| Product Characteristic | Subject Device<br>OW100S | Predicate Device<br>OrthoGold 100 (OW100) | Comparison |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K213120 | K210451 | NA |
| Indications for Use | The OW100S is intended for:<br>-Relief of minor muscles aches<br>and pains<br>-Temporary increase in local blood<br>circulation<br>-Activation of connective tissue. | The OrthoGold 100 is intended for:<br>-Relief of minor muscles aches and<br>pains<br>-Temporary increase in local blood<br>circulation<br>-Activation of connective tissue. | OW100S has the<br>same indications<br>and intended use<br>as the OW100 |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | identical, no<br>change |
| Mechanisms of Action | Extracorporeally induced<br>unfocused pressure pulses | Extracorporeally induced unfocused<br>pressure pulses | identical, no<br>change |
| Maximum and Minimum<br>intensity settings | 1 to 16 | 1 to 16 | identical, no<br>change |
| Number and size of<br>treatment applicator heads | OP155S<br>Size: 230 x Ø 70 mm | OP155<br>Size: 230 x Ø 70 mm | identical, no<br>change |
| Product Characteristic | Subject Device<br>OW100S | Predicate Device<br>OrthoGold 100 (OW100) | Comparison |
| Electrode lifetime | E1-E10: 500K sw<br>E11-E16: 350K sw | E1-E10: 100K sw<br>E-11-E16: 70K sw | Break circuit<br>and modified<br>water cartridge<br>solution reduce<br>the wear of<br>electrodes over<br>time, but there is<br>no change to<br>device outputs at<br>selected energy<br>level, and<br>therefore no<br>change to<br>safety/effectiven<br>ess in treatment |
| Cartridge solution and<br>conductivity | Potassium bromide solution<br>2300μS/cm | Silver chloride solution 600μS/cm | Modified<br>solution to<br>support<br>extended<br>electrode life.<br>no change to<br>device outputs at<br>selected energy<br>level, and<br>therefore no<br>change to<br>safety/effectiven<br>ess in treatment |
| Type of application (e.g.,<br>continuous vibration at a<br>fixed frequency); | Continuous at various frequencies | Continuous at various frequencies | identical, no<br>change |
| Maximum and minimum<br>vibration frequency | Frequency of 1 - 8 Hz in steps of<br>0.5 Hz | Frequency of 1 - 8 Hz in steps of<br>0.5 Hz | identical, no<br>change |
| Driving Power | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | identical, no<br>change |
| Power Supply | 115 VAC | 115 VAC | identical, no<br>change |
| Maximum penetration<br>depth | 37.4 mm at energy level 16 | 25.4 mm at energy level 16 | similar, higher<br>max.penetration<br>depth due to<br>tolerances and<br>several<br>statistical<br>effects.<br>Geometry of<br>reflector in<br>applicator,<br>which defines<br>acoustic field,<br>remained<br>unchanged |
| Product Characteristic | Subject Device<br>OW100S | Predicate Device<br>OrthoGold 100 (OW100) | Comparison |
| Energy flow density<br>PIIT [mJ/mm2] | 0.00020 - 0.04900<br>at energy level 1 - 16 | 0.00017 - 0.04403<br>at energy level 1 - 16 | similar, values<br>of energy flow<br>density slightly<br>higher due to<br>tolerances and<br>several<br>statistical effects |
| Operating mode | Continuous | Continuous | identical, no<br>change |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | identical, no<br>change |
| Number of pulses (min<br>and max) | 500-2000/ session | 500-2000/ session | identical, no<br>change |
| Maximum operating<br>temperature | Room temperature | Room temperature | identical, no<br>change |
| Type of acoustic wave<br>generation | Electro hydraulic, spark gap under<br>water caused by discharge of high<br>voltage condensers | Electro hydraulic, spark gap under<br>water caused by discharge of high<br>voltage condensers | identical |
| Peak compressional<br>acoustic pressure<br>pc [Mpa] | 11.20 at energy level 16 | 9.27<br>at energy level 16 | similar, values<br>of peak<br>compressioneal<br>acoustic<br>pressure slightly<br>higher due to<br>tolerances and<br>several<br>statistical effects |
| Peak rarefactional acoustic<br>pressure<br>pcr[Mpa] | 1.22 at energy level 16 | -1.52 at energy level 16 | similar, values<br>of rarefractional<br>acoustic<br>pressure slightly<br>lower due to<br>tolerances and<br>several<br>statistical effects |
| Description of the spatial<br>distribution of the acoustic<br>pressure and intensity | Unfocused acoustic pressure field,<br>see pressure measurements | Unfocused acoustic pressure field,<br>see pressure measurements | Similar, no<br>change |
| Positive peak pressure<br>amplitude (MPa)<br>pc [Mpa] | 0.61 - 11.20at energy level 1 - 16 | 0.43 - 9.27<br>at energy level 1 - 16 | similar, values<br>of positive peak<br>pressure<br>amplitude<br>slightly higher<br>due to tolerances<br>and several<br>statistical effects |
| Negative peak pressure<br>amplitude (MPa)<br>pcr[Mpa] | -0.17 to - 1.22MPa<br>at energy level 1 - 16 | -0.17 to -1.52 MPa<br>at energy level 1 - 16 | similar, values<br>of negative peak<br>pressure<br>amplitude<br>slightly lower<br>due to tolerances and<br>several<br>statistical effects |
| Product Characteristic | Subject Device<br>OW100S | Predicate Device<br>OrthoGold 100 (OW100) | Comparison |
| | | | due to tolerances<br>and several<br>statistical effects |
| Derived focal acoustic<br>pulse energy (mJ)<br>EbT [mJ] | 0.020- 3.370 at energy level 1 - 16 | 0.022 - 2.278<br>at energy level 1 - 16 | similar values of<br>derived focal<br>acoustic pulse<br>energy differ<br>due to tolerances<br>and several<br>statistical effects |
| Derived pulse -intensity<br>integral, integrated over<br>total temporal integration<br>limits<br>PIIT [mJ/mm2] | 0.00020-0.04900 mJ/mm2<br>at energy level 1 - 16 | 0.00017 - 0.04403 mJ/mm2<br>at energy level 1 - 16 | similar, values<br>of derived pulse-<br>intensity integtal<br>slightly higher<br>due to tolerances<br>and several<br>statistical effects |
| Rise time (ns)<br>(10% - 90%) tr [us] | 1.08 - 0.18 at energy level 1 - 16 | 1.89 - 0.28 at energy level 1 - 16 | similar, values<br>of rise time<br>differ due to<br>tolerances and<br>several<br>statistical effects |
| Compressional pulse<br>duration (us)<br>tFWHMpc [uS] | 0.79 - 0.82 us at energy level 1 -<br>16 | 1.23 - 0.77 us at energy level 1 - 16 | similar, values<br>of<br>compressional<br>pulse duration<br>differ due to<br>tolerances and<br>several<br>statistical effects |

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# Clinical Information

Not applicable. Bench and performance testing support the substantial equivale in this submission.

# Conclusion

The OW100S has the same indications for use and similar design features as compared with the predicate device system. The OW100S described in this submission is, in our opinion, substantially equivalent to the predicate, OrthoGold 100 (OW100). The proposed device performs as well as the legally marketed predicate device. 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.