OW100S

K233937 · Softwave/Trt, LLC · PZL · Jul 9, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233937
• Device Name: OW100S
• Applicant: Softwave/Trt, LLC
• Product Code: PZL · General, Plastic Surgery
• Decision Date: Jul 9, 2024
• 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, fullthickness 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 dearee burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

Device Story

OW100S is a pulsed acoustic wave device; generates high-voltage sparks in water to create acoustic waves; waves propagated through water-filled coupling membrane and silicone membrane applicator; applied via ultrasound transmission gel. Used in clinical settings by healthcare providers to treat chronic diabetic foot ulcers and second-degree burns. Device includes a 'break circuit' in the generator to increase pulse capacity per applicator. Output is unfocused pressure pulses; used alongside standard wound/burn care. Benefits include non-invasive acoustic stimulation of tissue to support healing. No changes to power output, geometry, or energy flux density compared to predicate.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed the device meets design specifications and is safe/effective. Software validated to Moderate level of concern; hazard analysis/risk management confirmed all risks mitigated.

Technological Characteristics

Electro-hydraulic spark gap generator; high voltage (2-7 kV); unfocused pressure pulses; 1-8 Hz frequency; 115 VAC power. Applicator (OP155S) uses silicone membrane and potassium bromide solution (2300µS/cm). Software-controlled; Moderate level of concern. 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+ years) 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+ years) with superficial partial-thickness second-degree burns. Used in conjunction with standard 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

• TRT, OW100S (K231710)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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.

July 9, 2024

Softwave/TRT LLC Cherita James Regulatory Consultant 3330 Highway 136 West Woodstock, Georgia 30175

Re: K233937

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 11, 2024 Received: June 11, 2024

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 [phone] or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen -Long H. Chen-S

Date: 2024.07.09 11:52:38 -04'00"

Long Chen, 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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# Indications for Use

Submission Number (if known)

K233937

Device Name

OW100S

Indications for Use (Describe)

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness 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 dearee 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

The following information is provided as required by 21 CFR § 807.87 for SoftWaveTRT 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.

- SoftWaveTRT LLC Sponsor: 3330 Highway 136 West Woodstock, GA 30175
- Contact: Cherita James M Squared Associates/a PPG Company 1129 20th St. NW Suite 600 Washington, DC 20036 Ph: 347-536-1463 Email: Cherita.James(@ProPharmaGroup.com

Submitted date: July 8, 2024

| 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, OW100S K231710 |

### 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 applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

Model OW100S and applicator OP155S includes a "break circuit" in the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses at low energy flux density in the device. Updates to labeling of the OW 100S includes revisions to

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# K233937

contraindications/warnings/ cautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use. 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, fullthickness 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 is applicable 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 OW100s cleared for Class II indications.

| 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 |

The OW100S conforms to the following standards:

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| Standard | Recognition Number |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| 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 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. .

The table below compares the OW100S characteristics to the predicate and reference device. Updates to labeling of the OW100S include revisions to contraindications/warnings/ precautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use.

| Product<br>Characteristic | Subject Device<br>OW100S | Primary Predicate<br>device<br>OW100S | Comparison |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k) Number | TBD | K231710 | NA |
| Product code | PZL | PZL | Same |
| Indications for 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<br>16 cm2, which extend<br>through the epidermis,<br>dermis, tendon, or capsule,<br>but without bone exposure.<br>The OrthoGold 100<br>OW100S is indicated for<br>adult (22 years and older),<br>diabetic patients presenting<br>with diabetic foot ulcers<br>greater than 30 days in<br>duration and is indicated<br>for use in conjunction with | 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<br>16 cm2, which extend<br>through the epidermis,<br>dermis, tendon, or capsule,<br>but without bone exposure.<br>The OrthoGold 100<br>OW100S is indicated for<br>adult (22 years and older),<br>diabetic patients presenting<br>with diabetic foot ulcers<br>greater than 30 days in<br>duration and is indicated<br>for use in conjunction with | OW100S has the same<br>indications and intended use<br>as the OW100S in K231710 |
| Product<br>Characteristic | Subject Device<br>OW100S | Primary Predicate<br>device<br>OW100S | Comparison |
| | standard diabetic ulcer<br>care. | standard diabetic ulcer<br>care. | |
| | The OrthoGold 100 OW100S<br>is indicated to provide<br>acoustic pressure shockwaves<br>in the treatment of superficial<br>partial thickness second<br>degree burns in adults (22<br>years or older). The<br>OrthoGold 100 OW100S is<br>indicated for use in<br>conjunction with standard of<br>care burn treatment(s). | The OrthoGold 100 OW100S<br>is indicated to provide<br>acoustic pressure shockwaves<br>in the treatment of superficial<br>partial thickness second<br>degree burns in adults (22<br>years or older). The<br>OrthoGold 100 OW100S is<br>indicated for use in<br>conjunction with standard of<br>care burn treatment(s). | |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | identical to primary predicate<br>OW100S, no change |
| Mechanisms of Action | Extracorporeally induced<br>unfocused pressure pulses | Extracorporeally induced<br>unfocused pressure pulses | identical to primary predicate<br>OW100S, no change |
| Maximum and<br>Minimum intensity<br>settings | 1 to 16 | 1 to 16 | identical to primary predicate<br>OW100S, no change |
| Number and size of<br>treatment applicator<br>heads | OP155S<br>Size: 230 x Ø 70 mm | OP155S<br>Size: 230 x Ø 70 mm | identical to primary predicate<br>OW100S, no change |
| Electrode lifetime | E1-E10: 500K sw<br>E11-E16: 350K sw | E1-E10: 500K sw<br>E11-E16: 350K sw | identical to primary predicate<br>OW100S, no change |
| Cartridge solution and<br>conductivity | Potassium bromide solution<br>2300µS/cm | Potassium bromide solution<br>2300µS/cm | identical to primary predicate<br>OW100S, no change |
| Type of application<br>(e.g., continuous<br>vibration at a fixed<br>frequency); | Continuous at various<br>frequencies | Continuous at various<br>frequencies | identical to primary predicate<br>OW100S, no change |
| Maximum and<br>minimum vibration<br>frequency | Frequency of 1 - 8 Hz in steps<br>of 0.5 Hz | Frequency of 1 - 8 Hz in steps<br>of 0.5 Hz | identical to primary predicate<br>OW100S, no change |
| Driving Power | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | High voltage 2 - 7 kV<br>Capacitor: 0,2 uF | identical to primary predicate<br>OW100S, no change |
| Power Supply | 115 VAC | 115 VAC | identical to primary predicate<br>OW100S, no change |
| Maximum penetration<br>depth | 37.4 mm at energy level 16 | 37.4 mm at energy level 16 | identical to primary predicate<br>OW100S, no change |
| Energy flow density<br>PIIT [mJ/mm2] | 0.00020 - 0.04900 at energy<br>level 1 - 16 | 0.00020 - 0.04900 at energy<br>level 1 - 16 | identical to primary predicate<br>OW100S, no change |
| Operating mode | Continuous | Continuous | identical to primary predicate<br>OW100S, no change |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | identical to primary predicate<br>OW100S, no change |
| Product<br>Characteristic | Subject Device<br>OW100S | Primary Predicate<br>device<br>OW100S | Comparison |
| Number of pulses (min<br>and max) | 500-2000/ session | 500-2000/ session | identical to primary predicate<br>OW100S, no change |
| Maximum operating<br>temperature | Room temperature | Room temperature | identical to primary predicate<br>OW100S, no change |
| Type of acoustic wave<br>generation | Electro hydraulic, spark gap<br>under water caused by<br>discharge of high voltage<br>condensers | Electro hydraulic, spark gap<br>under water caused by<br>discharge of high voltage<br>condensers | identical to primary predicate<br>OW100S, no change |
| Peak compressional<br>acoustic pressure<br>pc [Mpa] | 11.20 at energy level 16 | 11.20 at energy level 16 | identical to primary predicate<br>OW100S, no change |
| Peak rarefactional<br>acoustic pressure<br>pcr[Mpa] | 1.22 at energy level 16 | 1.22 at energy level 16 | identical to primary predicate<br>OW100S, no change |
| Description of the<br>spatial distribution of<br>the acoustic pressure<br>and intensity | Unfocused acoustic pressure<br>field, see pressure<br>measurements | Unfocused acoustic pressure<br>field, see pressure<br>measurements | identical to primary predicate<br>OW100S, no change |
| Positive peak pressure<br>amplitude (MPa)<br>pc [Mpa] | 0.61 - 11.20 at energy level<br>1 - 16 | 0.61 - 11.20 at energy level<br>1 - 16 | identical to primary predicate<br>OW100S, no change |
| Negative peak pressure<br>amplitude (MPa)<br>pcr[Mpa] | -0.17 to – 1.22MPa at energy<br>level 1 - 16 | -0.17 to – 1.22MPa at energy<br>level 1 - 16 | identical to primary predicate<br>OW100S, no change |
| Derived focal acoustic<br>pulse energy (mJ)<br>EbT [mJ] | 0.020- 3.370 at energy level 1 - 16 | 0.020- 3.370 at energy level 1 - 16 | identical to primary predicate<br>OW100S, no change |
| Derived pulse -intensity<br>integral, integrated over<br>total temporal<br>integration limits<br>PIIT [mJ/mm2] | 0.00020-0.04900 mJ/mm2 | 0.00020-0.04900 mJ/mm2 | identical to primary predicate<br>OW100S, no change |
| Rise time (ns)<br>(10% - 90%) tr [us] | 1.08 – 0.18 at energy level 1 - 16 | 1.08 – 0.18 at energy level 1 - 16 | identical to primary predicate<br>OW100S, no change |
| Compressional pulse<br>duration (us)<br>tFWHMpc [uS] | 0.79 - 0.82 us at energy level<br>1 - 16 | 0.79 - 0.82 us at energy level<br>1 - 16 | identical to primary predicate<br>OW100S, no change |

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# Similarities

The OW100S is identical to the previously cleared OW100S previously cleared under K231710. There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or wave penetration as a result of these changes.

User interactions with the device are the same. The change requires no revisions to the recommended treatment parameters when compared to prior submissions.

# Differences

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# K233937

## Labeling changes to contraindications, warnings, and precautions

This submission concerns revisions and clarifications in labeling contraindications, warnings, and precautions. The changes are implemented to align the labeling with currently marketed acoustic wave devices for the identical indications for use, as well as to clarify and omit information that was duplicated in these sections in prior submissions. In some instances, text is revised to clarify the intent of the statement, or to present statements more appropriately for instance as a warning rather than precaution.

#### Clinical Information

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

### Conclusion

The OW100S has the same indications for use and identical design features as compared with the Primary predicate device system. The OW100S described in this submission is, in our opinion, substantially equivalent to the predicate. 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.