(81 days)
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).
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 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.
The provided text is a 510(k) summary for the OW100S device, which is an extracorporeal shock wave device. It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.
However, the document does not contain information about:
- Acceptance criteria for an AI/device performance study (as it's not an AI device in the context of the prompt's implied AI/imaging study)
- Reported device performance against such criteria
- Sample size used for a test set or data provenance
- Number of experts or their qualifications for establishing ground truth
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size for a training set
- How ground truth for a training set was established
The document explicitly states "Clinical Information: Not applicable. Bench and performance testing support the substantial equivalence in this submission." This indicates that no clinical studies (like those typically associated with AI/ML device performance or human-in-the-loop studies) were conducted or are being presented here for the purpose of demonstrating substantial equivalence. Instead, the equivalence is based on technical specifications and performance characteristics compared to a previously cleared predicate device.
The "Performance Data" section solely refers to:
- Verification and validation testing.
- Software validation (Moderate level of concern).
- Hazard analysis/risk management.
- Conformance to various IEC and AAMI standards (e.g., IEC 61846 for ultrasonics, AAMI/ANSI ES60601-1 for medical electrical equipment, IEC 62304 for medical device software).
The table provided compares the OW100S (subject device) to its predicate device (OrthoGold 100/OW100) and a reference device (OW100S, K213120). This comparison focuses on physical and technical characteristics, not clinical performance metrics or AI/ML model performance.
Therefore, based on the provided document, I cannot answer the questions related to acceptance criteria and an AI/ML performance study because the submission is for a physical medical device (extracorporeal shock wave device) and relies on technical equivalence, not AI/ML-based clinical performance data.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
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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: 703-562-9797 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 K200926Reference 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 -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 |
| 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 sourcesincluding ballistic 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 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.
| ProductCharacteristic | Subject DeviceOW100S | Reference deviceOW100S | Predicate DeviceOrthoGold 100(OW100) | Comparison |
|---|---|---|---|---|
| 510(k)Number | To be assigned | K213120 | K191961, K200926 | NA |
| Indications forUse | The OrthoGold 100OW100S is indicated toprovide acoustic pressureshockwaves in thetreatment of chronic, full-thickness diabetic footulcers with wound areasmeasuring no larger than | The OW100S isintended for:-Relief of minormuscles aches andpains-Temporaryincrease in localblood circulation | K191961: TheOrthoGold 100 isindicated to provideacoustic pressureshockwaves in thetreatment of chronic,full-thickness diabeticfoot ulcers with wound | OW100S has thesame indicationsand intended use asthe OW100 inK191961,K200926 |
| ProductCharacteristic | Subject DeviceOW100S | Reference deviceOW100S | Predicate DeviceOrthoGold 100(OW100) | Comparison |
| 16 cm2, which extendthrough the epidermis,dermis, tendon, orcapsule, but without boneexposure. The OrthoGold100 OW100S is indicatedfor adult (22 years andolder), diabetic patientspresenting with diabeticfoot ulcers greater than 30days in duration and isindicated for use inconjunction with standarddiabetic ulcer care.The OrthoGold 100OW100S is indicated toprovide acoustic pressureshockwaves in thetreatment of superficialpartial thickness seconddegree burns in adults (22years or older). TheOrthoGold 100 OW100Sis indicated for use inconjunction with standardof care burn treatment(s). | -Activation ofconnective tissue. | areas measuring nolarger than 16 cm2,which extend throughthe epidermis, dermis,tendon, or capsule, butwithout bone exposure.The OrthoGold 100 isindicated for adult (22years and older),diabetic patientspresenting with diabeticfoot ulcers greater than30 days in duration andis indicated for use inconjunction withstandard diabetic ulcercare.K200926:TheOrthoGold 100 isindicated to provideacoustic pressureshockwaves in thetreatment of superficialpartial thickness seconddegree burns in adults(22 years or older). TheOrthoGold 100 isindicated for use inconjunction withstandard of care burntreatment(s). | ||
| Modes ofAction | Unfocused pressurepulses | Unfocused pressurepulses | Unfocused pressurepulses | identical, nochange |
| Mechanisms ofAction | Extracorporeally inducedunfocused pressure pulses | Extracorporeallyinduced unfocusedpressure pulses | Extracorporeallyinduced unfocusedpressure pulses | identical, nochange |
| Maximum andMinimumintensitysettings | 1 to 16 | 1 to 16 | 1 to 16 | identical, nochange |
| Number andsize oftreatmentapplicatorheads | OP155SSize: 230 x Ø 70 mm | OP155SSize: 230 x Ø 70mm | OP155Size: 230 x Ø 70 mm | identical, nochange |
| Electrodelifetime | E1-E10: 500K swE11-E16: 350K sw | E1-E10: 500K swE11-E16: 350K sw | E1-E10: 100K swE11-E16: 70K sw | Break circuit andmodified watercartridge solutionreduce the wear ofelectrodes over |
| ProductCharacteristic | Subject DeviceOW100S | Reference deviceOW100S | Predicate DeviceOrthoGold 100(OW100) | Comparison |
| time, but there isno change todevice outputs atselected energylevel, and thereforeno change tosafety/effectivenessin treatment | ||||
| Cartridgesolution andconductivity | Potassium bromidesolution 2300μS/cm | Potassium bromidesolution 2300μS/cm | Silver chloride solution600μS/cm | Modified solutionto supportextended electrodelife. no change todevice outputs atselected energylevel, and thereforeno change tosafety/effectivenessin treatment |
| Type ofapplication(e.g.,continuousvibration at afixedfrequency); | Continuous at variousfrequencies | Continuous atvarious frequencies | Continuous at variousfrequencies | identical, nochange |
| Maximum andminimumvibrationfrequency | Frequency of 1 - 8 Hz insteps of 0.5 Hz | Frequency of 1 - 8Hz in steps of 0.5Hz | Frequency of 1 - 8 Hz inidentical, nosteps of 0.5 Hz | change |
| Driving Power | High voltage 2 - 7 kVCapacitor: 0,2 uF | High voltage 2 - 7kVCapacitor: 0,2 uF | High voltage 2 - 7 kVCapacitor: 0,2 uF | identical, nochange |
| Power Supply | 115 VAC | 115 VAC | 115 VAC | identical, nochange |
| Maximumpenetrationdepth | 37.4 mm at energy level16 | 37.4 mm at energylevel 16 | 25.4 mm at energy level16 | similar, highermax.penetrationdepth due totolerances andseveral statisticaleffects. Geometryof reflector inapplicator, whichdefines acousticfield, remainedunchanged |
| Energy flowdensityPIIT [mJ/mm2] | 0.00020 - 0.04900 atenergy level 1 - 16 | 0.00020 - 0.04900at energy level 1 -16 | 0.00017 - 0.04403at energy level 1 - 16 | similar, values ofenergy flowdensity slightlyhigher due totolerances andseveral statistical |
| ProductCharacteristic | Subject DeviceOW100S | Reference deviceOW100S | Predicate DeviceOrthoGold 100(OW100) | Comparison |
| effects | ||||
| Operating mode | Continuous | Continuous | Continuous | identical, nochange |
| Pulse repeatrate (1/s) | 1 - 8 Hz | 1 - 8 Hz | 1 - 8 Hz | identical, nochange |
| Number ofpulses (min andmax) | 500-2000/ session | 500-2000/ session | 500 - 2000 | identical, nochange |
| Maximumoperatingtemperature | Room temperature | Room temperature | Room temperature | identical, nochange |
| Type ofacoustic wavegeneration | Electro hydraulic, sparkgap under water causedby discharge of highvoltage condensers | Electro hydraulic,spark gap underwater caused bydischarge of highvoltage condensers | Electro hydraulic, sparkgap under water causedby discharge of highvoltage condensers | identical |
| Peakcompressionalacousticpressurepc [Mpa] | 11.20 at energy level 16 | 11.20 at energylevel 16 | 9.27at energy level 16 | similar, values ofpeakcompressionealacoustic pressureslightly higher dueto tolerances andseveral statisticaleffects |
| Peakrarefactionalacousticpressurepcr[Mpa] | 1.22 at energy level 16 | 1.22 at energy level16 | -1.52 at energy level 16 | similar, values ofrarefractionalacoustic pressureslightly lower dueto tolerances andseveral statisticaleffects |
| Description ofthe spatialdistribution ofthe acousticpressure andintensity | Unfocused acousticpressure field, seepressure measurements | Unfocused acousticpressure field, seepressuremeasurements | Unfocused acousticpressure field, seepressure measurements | Similar, no change |
| Positive peakpressureamplitude(MPa)pc [Mpa] | 0.61 - 11.20 at energylevel 1 - 16 | 0.61 - 11.20 atenergy level 1 - 16 | 0.43 - 9.27at energy level 1 - 16 | similar, values ofpositive peakpressure amplitudeslightly higher dueto tolerances andseveral statisticaleffects |
| Negative peakpressureamplitude(MPa)pcr[Mpa] | -0.17 to 1.22MPa atenergy level 1 - 16 | -0.17 to 1.22MPaat energy level 1 -16 | -0.17 to -1.52 MPaat energy level 1 - 16 | similar, values ofnegative peakpressure amplitudeslightly lower dueto tolerances andseveral statistical |
| ProductCharacteristic | Subject DeviceOW100S | Reference deviceOW100S | Predicate DeviceOrthoGold 100(OW100) | Comparison |
| effects | ||||
| Derived focalacoustic pulseenergy (mJ)EbT [mJ] | 0.020- 3.370 at energylevel 1 - 16 | 0.020- 3.370 atenergy level 1 - 16 | 0.022 - 2.278at energy level 1 - 16 | similar values ofderived focalacoustic pulseenergy differ dueto tolerances andseveral statisticaleffects |
| Derived pulse -intensityintegral,integrated overtotal temporalintegrationlimitsPIIT [mJ/mm2] | 0.00020-0.04900mJ/mm2 | 0.00020-0.04900mJ/mm2 | 0.00017 - 0.04403mJ/mm2at energy level 1 - 16 | similar, values ofderived pulse-intensity integtalslightly higher dueto tolerances andseveral statisticaleffects |
| Rise time (ns)(10% - 90%) tr[us] | 1.08 - 0.18 at energylevel 1 - 16 | 1.08 - 0.18 atenergy level 1 - 16 | 1.89 - 0.28 at energylevel 1 - 16 | similar, values ofrise time differ dueto tolerances andseveral statisticaleffects |
| Compressionalpulse duration(μs)tFWHMpc [μs] | 0.79 - 0.82 μs at energylevel 1 - 16 | 0.79 - 0.82 μs atenergy level 1 - 16 | 1.23 - 0.77 μs at energylevel 1 - 16 | similar, values ofcompressionalpulse durationdiffer due totolerances andseveral statisticaleffects |
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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 similar design features as compared with the Primary predicate device system. The OW100S described in this submission is substantially equivalent to the predicate, OrthoGold 100 (OW100). The proposed device performs as well as the legally marketed predicate devices. Any differences between the subject and predicate devices would not affect the safety or effectiveness, or raise different questions of safety and effectiveness.
§ 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.