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 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 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.

AI/ML Overview

The provided text does NOT include acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the OW100S device, which is an extracorporeal shock wave device. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also named OW100S, K231710), rather than providing performance data against novel acceptance criteria.

Here's what the document indicates regarding performance:

No specific acceptance criteria are listed.
No new clinical study was conducted to demonstrate performance against acceptance criteria.
The manufacturer states: "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." (Page 4)
The "Performance Data" section (Page 4) lists standards to which the device conforms, such as IEC 61846 (ultrasonics - pressure pulse lithotripters - characteristics of fields), AAMI/ANSI ES60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-36 (particular requirements for extracorporeally induced lithotripsy), IEC 60601-1-6 (usability), IEC 63045 (non-focusing short pressure pulse sources), and IEC 62304 (medical device software - software life cycle processes). Conformance to these standards implies certain performance characteristics, but the specific acceptance criteria derived from these standards or the results against those criteria are not detailed.
The document largely relies on comparing the technical characteristics of the new OW100S device to its predicate (K231710), finding them to be identical across various parameters like indications for use, modes of action, intensity settings, applicator characteristics, power, penetration depth, energy flow density, and acoustic pressure metrics (pages 5-7). This comparison suggests that since the characteristics are identical to a previously cleared device, the performance is also considered identical and therefore "substantially equivalent."

Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (beyond being "identical" to the predicate's specifications) are provided.
Sample size used for the test set and the data provenance: No test set from an independent study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical test set with ground truth is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical acoustic wave device, not an algorithm. Performance validation relates to physical specifications and safety standards.
The type of ground truth used: Not applicable as no diagnostic ground truth for a test set is described.
The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
How the ground truth for the training set was established: Not applicable.

The document clearly states under "Clinical Information": "Not applicable. Bench and performance testing support the substantial equivalence in this submission." This explicitly indicates that no clinical study with acceptance criteria and results was part of this submission for demonstrating substantial equivalence. The "performance testing" referenced is likely limited to verification and validation against the device's design specifications and conformance to listed standards, as opposed to a clinical efficacy study.

Summary

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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 (1-800-638-2041 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)

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

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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 -characteristics of fields	9-7
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 anda2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: generalrequirements for basic safety and essential performance	19-4
IEC 60601-1-2:2014 Edition 4, Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements andtests	19-8
IEC 60601-2-36 Edition 2.0: 2014-04,Medical electrical equipment - Part 2-36: Particular requirements for the safety ofequipment 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 2013-10Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance - Collateral standard: Usability	5-89
IEC 63045-2020: Ultrasonics - Non-focusing short pressure pulse sources includingballistic pressure pulse sources - Characteristics of fields	N/A
IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes[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.

ProductCharacteristic	Subject DeviceOW100S	Primary PredicatedeviceOW100S	Comparison
510(k) Number	TBD	K231710	NA
Product code	PZL	PZL	Same
Indications for Use	The OrthoGold 100OW100S is indicated toprovide acoustic pressureshockwaves in thetreatment of chronic, full-thickness diabetic footulcers with wound areasmeasuring no larger than16 cm2, which extendthrough the epidermis,dermis, tendon, or capsule,but without bone exposure.The OrthoGold 100OW100S is indicated foradult (22 years and older),diabetic patients presentingwith diabetic foot ulcersgreater than 30 days induration and is indicatedfor use in conjunction with	The OrthoGold 100OW100S is indicated toprovide acoustic pressureshockwaves in thetreatment of chronic, full-thickness diabetic footulcers with wound areasmeasuring no larger than16 cm2, which extendthrough the epidermis,dermis, tendon, or capsule,but without bone exposure.The OrthoGold 100OW100S is indicated foradult (22 years and older),diabetic patients presentingwith diabetic foot ulcersgreater than 30 days induration and is indicatedfor use in conjunction with	OW100S has the sameindications and intended useas the OW100S in K231710
ProductCharacteristic	Subject DeviceOW100S	Primary PredicatedeviceOW100S	Comparison
	standard diabetic ulcercare.	standard diabetic ulcercare.
	The OrthoGold 100 OW100Sis indicated to provideacoustic pressure shockwavesin the treatment of superficialpartial thickness seconddegree burns in adults (22years or older). TheOrthoGold 100 OW100S isindicated for use inconjunction with standard ofcare burn treatment(s).	The OrthoGold 100 OW100Sis indicated to provideacoustic pressure shockwavesin the treatment of superficialpartial thickness seconddegree burns in adults (22years or older). TheOrthoGold 100 OW100S isindicated for use inconjunction with standard ofcare burn treatment(s).
Modes of Action	Unfocused pressure pulses	Unfocused pressure pulses	identical to primary predicateOW100S, no change
Mechanisms of Action	Extracorporeally inducedunfocused pressure pulses	Extracorporeally inducedunfocused pressure pulses	identical to primary predicateOW100S, no change
Maximum andMinimum intensitysettings	1 to 16	1 to 16	identical to primary predicateOW100S, no change
Number and size oftreatment applicatorheads	OP155SSize: 230 x Ø 70 mm	OP155SSize: 230 x Ø 70 mm	identical to primary predicateOW100S, no change
Electrode lifetime	E1-E10: 500K swE11-E16: 350K sw	E1-E10: 500K swE11-E16: 350K sw	identical to primary predicateOW100S, no change
Cartridge solution andconductivity	Potassium bromide solution2300µS/cm	Potassium bromide solution2300µS/cm	identical to primary predicateOW100S, no change
Type of application(e.g., continuousvibration at a fixedfrequency);	Continuous at variousfrequencies	Continuous at variousfrequencies	identical to primary predicateOW100S, no change
Maximum andminimum vibrationfrequency	Frequency of 1 - 8 Hz in stepsof 0.5 Hz	Frequency of 1 - 8 Hz in stepsof 0.5 Hz	identical to primary predicateOW100S, no change
Driving Power	High voltage 2 - 7 kVCapacitor: 0,2 uF	High voltage 2 - 7 kVCapacitor: 0,2 uF	identical to primary predicateOW100S, no change
Power Supply	115 VAC	115 VAC	identical to primary predicateOW100S, no change
Maximum penetrationdepth	37.4 mm at energy level 16	37.4 mm at energy level 16	identical to primary predicateOW100S, no change
Energy flow densityPIIT [mJ/mm2]	0.00020 - 0.04900 at energylevel 1 - 16	0.00020 - 0.04900 at energylevel 1 - 16	identical to primary predicateOW100S, no change
Operating mode	Continuous	Continuous	identical to primary predicateOW100S, no change
Pulse repeat rate (1/s)	1 - 8 Hz	1 - 8 Hz	identical to primary predicateOW100S, no change
ProductCharacteristic	Subject DeviceOW100S	Primary PredicatedeviceOW100S	Comparison
Number of pulses (minand max)	500-2000/ session	500-2000/ session	identical to primary predicateOW100S, no change
Maximum operatingtemperature	Room temperature	Room temperature	identical to primary predicateOW100S, no change
Type of acoustic wavegeneration	Electro hydraulic, spark gapunder water caused bydischarge of high voltagecondensers	Electro hydraulic, spark gapunder water caused bydischarge of high voltagecondensers	identical to primary predicateOW100S, no change
Peak compressionalacoustic pressurepc [Mpa]	11.20 at energy level 16	11.20 at energy level 16	identical to primary predicateOW100S, no change
Peak rarefactionalacoustic pressurepcr[Mpa]	1.22 at energy level 16	1.22 at energy level 16	identical to primary predicateOW100S, no change
Description of thespatial distribution ofthe acoustic pressureand intensity	Unfocused acoustic pressurefield, see pressuremeasurements	Unfocused acoustic pressurefield, see pressuremeasurements	identical to primary predicateOW100S, no change
Positive peak pressureamplitude (MPa)pc [Mpa]	0.61 - 11.20 at energy level1 - 16	0.61 - 11.20 at energy level1 - 16	identical to primary predicateOW100S, no change
Negative peak pressureamplitude (MPa)pcr[Mpa]	-0.17 to – 1.22MPa at energylevel 1 - 16	-0.17 to – 1.22MPa at energylevel 1 - 16	identical to primary predicateOW100S, no change
Derived focal acousticpulse energy (mJ)EbT [mJ]	0.020- 3.370 at energy level 1 - 16	0.020- 3.370 at energy level 1 - 16	identical to primary predicateOW100S, no change
Derived pulse -intensityintegral, integrated overtotal temporalintegration limitsPIIT [mJ/mm2]	0.00020-0.04900 mJ/mm2	0.00020-0.04900 mJ/mm2	identical to primary predicateOW100S, no change
Rise time (ns)(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 predicateOW100S, no change
Compressional pulseduration (us)tFWHMpc [uS]	0.79 - 0.82 us at energy level1 - 16	0.79 - 0.82 us at energy level1 - 16	identical to primary predicateOW100S, 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.

Regulation Number and Section

§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.

(a)
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.(b)
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.