OW100S

K231710 · Softwave/Trt, LLC · PZL · Sep 1, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231710
• Device Name: OW100S
• Applicant: Softwave/Trt, LLC
• Product Code: PZL · General, Plastic Surgery
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4685
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

Device Story

Pulsed acoustic wave device; generates high-voltage spark in water to create acoustic waves; propagated through water-filled coupling membrane and silicone membrane/ultrasound gel. Used in clinical settings by healthcare providers. Modification adds 'break circuit' to generator to increase electrode pulse capacity (100K to 500K pulses). Output is unfocused acoustic pressure pulses. Affects clinical decision-making by providing adjunctive treatment for chronic wounds and burns. Benefits include extended electrode life and reduced maintenance while maintaining therapeutic performance.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing demonstrated the device meets design specifications and is safe and effective for its intended use.

Technological Characteristics

Electro-hydraulic spark gap generator; water-filled coupling; silicone membrane; 115 VAC power; 1-8 Hz frequency; 1-16 intensity settings. Conforms to IEC 61846, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 60601-1-6, IEC 63045, and IEC 62304.

Indications for Use

Indicated for adult (22+) diabetic patients with chronic, full-thickness diabetic foot ulcers (≤16 cm2, extending through epidermis/dermis/tendon/capsule, no bone exposure, >30 days duration) and adults (22+) with superficial partial-thickness second-degree burns. Used with standard ulcer/burn care.

Regulatory Classification

Identification

An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use. (4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life. (7) Physician labeling must include: (i) Information on how the device operates and the typical course of treatment; (ii) A detailed summary of the device's technical parameters; (iii) Validated methods and instructions for reprocessing of any reusable components; and (iv) Instructions for preventing hearing loss by use of hearing protection. (8) Patient labeling must include: (i) Relevant contraindications, warnings, precautions, adverse effects, and complications; (ii) Information on how the device operates and the typical course of treatment; (iii) The probable risks and benefits associated with the use of the device; (iv) Post-procedure care instructions; and (v) Alternative treatments.

Predicate Devices

• OrthoGold 100 (OW 100) (K191961, K200926)

Reference Devices

• OW100S (K213120)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 1, 2023

Softwave./TRT LLC % Cherita James Regulatory Consultant M Squared Associates/a PPG Company 1129 20th St NW, Suite 600 Washington, District of Columbia 20036

Re: K231710

Trade/Device Name: Ow100s Regulation Number: 21 CFR 878.4685 Regulation Name: Extracorporeal Shock Wave Device For Treatment Of Chronic Wounds Regulatory Class: Class II Product Code: PZL Dated: June 12, 2023 Received: June 12, 2023

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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.09.01 07:59:58 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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K231710

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

Device Name OW100S

#### Indications for Use (Describe)

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

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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#### 510(K) SUMMARY 5

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: Tissue Regeneration Technologies, LLC 251 Heritage Walk Woodstock, GA 30188
- Cherita James Contact: M Squared Associates/a PPG Company 1129 20th St. NW Suite 600 Washington, DC 20036 Ph: 347-536-1463 Fax: [phone] Email: Cherita.James(@ProPharmaGroup.com

| Date of Submission: | June 12, 2023 |
|----------------------|-------------------------------------------------------------------------------------|
| Proposed Class: | II |
| Proprietary Name: | OW100S (model OW100S-US) |
| Common Name: | Acoustic wave device |
| Classification Name: | Extracorporeal shock wave device for treatment of chronic wounds |
| Regulation Number: | Section 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. |
| Product Codes: | PZL |
| Predicate Device: | TRT, OrthoGold 100 (OW 100) K191961 and K200926<br>Reference Device: OW100S K213120 |

## Device Description

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water 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.

The modification to the OrthoGold 100 (OW100) is identified as model OW100S and applicator OP155S includes the addition of a "break circuit" added to the acoustic wave generator which

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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 high 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.

## Indications for Use

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm², which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

## 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.

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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<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 |
| 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<br>including 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 (OW100), 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, ●
- o 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 and reference device.

| Product<br>Characteristic | Subject Device<br>OW100S | Reference device<br>OW100S | Predicate Device<br>OrthoGold 100<br>(OW100) | Comparison |
|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | To be assigned | K213120 | K191961, K200926 | NA |
| Indications for<br>Use | The OrthoGold 100<br>OW100S is indicated to<br>provide acoustic pressure<br>shockwaves in the<br>treatment of chronic, full-<br>thickness diabetic foot<br>ulcers with wound areas<br>measuring no larger than | The OW100S is<br>intended for:<br>-Relief of minor<br>muscles aches and<br>pains<br>-Temporary<br>increase in local<br>blood circulation | K191961: The<br>OrthoGold 100 is<br>indicated to provide<br>acoustic pressure<br>shockwaves in the<br>treatment of chronic,<br>full-thickness diabetic<br>foot ulcers with wound | OW100S has the<br>same indications<br>and intended use as<br>the OW100 in<br>K191961,<br>K200926 |
| Product<br>Characteristic | Subject Device<br>OW100S | Reference device<br>OW100S | Predicate Device<br>OrthoGold 100<br>(OW100) | Comparison |
| | 16 cm2, which extend<br>through the epidermis,<br>dermis, tendon, or<br>capsule, but without bone<br>exposure. The OrthoGold<br>100 OW100S is indicated<br>for adult (22 years and<br>older), diabetic patients<br>presenting with diabetic<br>foot ulcers greater than 30<br>days in duration and is<br>indicated for use in<br>conjunction with standard<br>diabetic ulcer care.<br>The OrthoGold 100<br>OW100S is indicated to<br>provide acoustic pressure<br>shockwaves in the<br>treatment of superficial<br>partial thickness second<br>degree burns in adults (22<br>years or older). The<br>OrthoGold 100 OW100S<br>is indicated for use in<br>conjunction with standard<br>of care burn treatment(s). | -Activation of<br>connective tissue. | areas measuring no<br>larger than 16 cm2,<br>which extend through<br>the epidermis, dermis,<br>tendon, or capsule, but<br>without bone exposure.<br>The OrthoGold 100 is<br>indicated for adult (22<br>years and older),<br>diabetic patients<br>presenting with diabetic<br>foot ulcers greater than<br>30 days in duration and<br>is indicated for use in<br>conjunction with<br>standard diabetic ulcer<br>care.<br>K200926:The<br>OrthoGold 100 is<br>indicated to provide<br>acoustic pressure<br>shockwaves in the<br>treatment of superficial<br>partial thickness second<br>degree burns in adults<br>(22 years or older). The<br>OrthoGold 100 is<br>indicated for use in<br>conjunction with<br>standard of care burn<br>treatment(s). | |
| Modes of<br>Action | Unfocused pressure<br>pulses | Unfocused pressure<br>pulses | Unfocused pressure<br>pulses | identical, no<br>change |
| Mechanisms of<br>Action | Extracorporeally induced<br>unfocused pressure pulses | Extracorporeally<br>induced unfocused<br>pressure pulses | Extracorporeally<br>induced unfocused<br>pressure pulses | identical, no<br>change |
| Maximum and<br>Minimum<br>intensity<br>settings | 1 to 16 | 1 to 16 | 1 to 16 | identical, no<br>change |
| Number and<br>size of<br>treatment<br>applicator<br>heads | OP155S<br>Size: 230 x Ø 70 mm | OP155S<br>Size: 230 x Ø 70<br>mm | OP155<br>Size: 230 x Ø 70 mm | identical, no<br>change |
| Electrode<br>lifetime | E1-E10: 500K sw<br>E11-E16: 350K sw | E1-E10: 500K sw<br>E11-E16: 350K sw | E1-E10: 100K sw<br>E11-E16: 70K sw | Break circuit and<br>modified water<br>cartridge solution<br>reduce the wear of<br>electrodes over |
| Product<br>Characteristic | Subject Device<br>OW100S | Reference device<br>OW100S | Predicate Device<br>OrthoGold 100<br>(OW100) | Comparison |
| | | | | time, but there is<br>no change to<br>device outputs at<br>selected energy<br>level, and therefore<br>no change to<br>safety/effectiveness<br>in treatment |
| Cartridge<br>solution and<br>conductivity | Potassium bromide<br>solution 2300μS/cm | Potassium bromide<br>solution 2300μS/cm | Silver chloride solution<br>600μS/cm | Modified solution<br>to support<br>extended electrode<br>life. no change to<br>device outputs at<br>selected energy<br>level, and therefore<br>no change to<br>safety/effectiveness<br>in treatment |
| Type of<br>application<br>(e.g.,<br>continuous<br>vibration at a<br>fixed<br>frequency); | Continuous at various<br>frequencies | Continuous at<br>various frequencies | Continuous at various<br>frequencies | identical, no<br>change |
| Maximum and<br>minimum<br>vibration<br>frequency | Frequency of 1 - 8 Hz in<br>steps of 0.5 Hz | Frequency of 1 - 8<br>Hz in steps of 0.5<br>Hz | Frequency of 1 - 8 Hz inidentical, no<br>steps of 0.5 Hz | change |
| Driving Power | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | High voltage 2 - 7<br>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 | 115 VAC | identical, no<br>change |
| Maximum<br>penetration<br>depth | 37.4 mm at energy level<br>16 | 37.4 mm at energy<br>level 16 | 25.4 mm at energy level<br>16 | similar, higher<br>max.penetration<br>depth due to<br>tolerances and<br>several statistical<br>effects. Geometry<br>of reflector in<br>applicator, which<br>defines acoustic<br>field, remained<br>unchanged |
| Energy flow<br>density<br>PIIT [mJ/mm2] | 0.00020 - 0.04900 at<br>energy level 1 - 16 | 0.00020 - 0.04900<br>at energy level 1 -<br>16 | 0.00017 - 0.04403<br>at energy level 1 - 16 | similar, values of<br>energy flow<br>density slightly<br>higher due to<br>tolerances and<br>several statistical |
| Product<br>Characteristic | Subject Device<br>OW100S | Reference device<br>OW100S | Predicate Device<br>OrthoGold 100<br>(OW100) | Comparison |
| | | | | effects |
| Operating mode | Continuous | Continuous | Continuous | identical, no<br>change |
| Pulse repeat<br>rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | 1 - 8 Hz | identical, no<br>change |
| Number of<br>pulses (min and<br>max) | 500-2000/ session | 500-2000/ session | 500 - 2000 | identical, no<br>change |
| Maximum<br>operating<br>temperature | Room temperature | Room temperature | Room temperature | identical, no<br>change |
| Type of<br>acoustic wave<br>generation | Electro hydraulic, spark<br>gap under water caused<br>by discharge of high<br>voltage condensers | Electro hydraulic,<br>spark gap under<br>water caused by<br>discharge of high<br>voltage condensers | Electro hydraulic, spark<br>gap under water caused<br>by discharge of high<br>voltage condensers | identical |
| Peak<br>compressional<br>acoustic<br>pressure<br>pc [Mpa] | 11.20 at energy level 16 | 11.20 at energy<br>level 16 | 9.27<br>at energy level 16 | similar, values of<br>peak<br>compressioneal<br>acoustic pressure<br>slightly higher due<br>to tolerances and<br>several statistical<br>effects |
| Peak<br>rarefactional<br>acoustic<br>pressure<br>pcr[Mpa] | 1.22 at energy level 16 | 1.22 at energy level<br>16 | -1.52 at energy level 16 | similar, values of<br>rarefractional<br>acoustic pressure<br>slightly lower due<br>to tolerances and<br>several statistical<br>effects |
| Description of<br>the spatial<br>distribution of<br>the acoustic<br>pressure and<br>intensity | Unfocused acoustic<br>pressure field, see<br>pressure measurements | Unfocused acoustic<br>pressure field, see<br>pressure<br>measurements | Unfocused acoustic<br>pressure field, see<br>pressure measurements | Similar, no change |
| Positive peak<br>pressure<br>amplitude<br>(MPa)<br>pc [Mpa] | 0.61 - 11.20 at energy<br>level 1 - 16 | 0.61 - 11.20 at<br>energy level 1 - 16 | 0.43 - 9.27<br>at energy level 1 - 16 | similar, values of<br>positive peak<br>pressure amplitude<br>slightly higher due<br>to tolerances and<br>several statistical<br>effects |
| Negative peak<br>pressure<br>amplitude<br>(MPa)<br>pcr[Mpa] | -0.17 to 1.22MPa at<br>energy level 1 - 16 | -0.17 to 1.22MPa<br>at energy level 1 -<br>16 | -0.17 to -1.52 MPa<br>at energy level 1 - 16 | similar, values of<br>negative peak<br>pressure amplitude<br>slightly lower due<br>to tolerances and<br>several statistical |
| Product<br>Characteristic | Subject Device<br>OW100S | Reference device<br>OW100S | Predicate Device<br>OrthoGold 100<br>(OW100) | Comparison |
| | | | | effects |
| Derived focal<br>acoustic pulse<br>energy (mJ)<br>EbT [mJ] | 0.020- 3.370 at energy<br>level 1 - 16 | 0.020- 3.370 at<br>energy level 1 - 16 | 0.022 - 2.278<br>at energy level 1 - 16…