(380 days)
The OW100S (model OW100S-US) is intended for:
-
Relief of minor muscle aches and pains
-
Temporary increase in local blood circulation
-
Activation of connective tissue
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.
There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
The provided documents describe the medical device OW100S (model OW100S-US), a therapeutic massager, and its substantial equivalence to a predicate device, the TRT, OrthoGold 100 (OW100). The submission does not contain information about a study with acceptance criteria and device performance results as typically described for software or AI-enabled medical devices.
Instead, this submission is a 510(k) premarket notification that demonstrates substantial equivalence to a legally marketed predicate device. The core of the submission relies on:
- Identical Indications for Use.
- Similar technological characteristics, with minor modifications to improve durability (e.g., increased electrode lifetime).
- Performance and bench testing to ensure the modified device meets design specifications and relevant safety standards.
Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies, are not applicable or not provided within this type of submission for a non-software/AI device.
However, I can extract the information that is available about performance and the basis for equivalence.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance is based on demonstrating that the subject device (OW100S) is substantially equivalent to the predicate device (OrthoGold 100) and meets applicable safety and performance standards. The "reported device performance" is essentially a comparison of the OW100S's physical and operational characteristics to those of the predicate device, showing that any differences do not impact safety or effectiveness.
Here's a table based on the comparison provided in the submission:
| Product Characteristic | Acceptance Criteria (Implied by Predicate) | Reported OW100S Performance | Comparison / Outcome |
|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pains; Temporary increase in local blood circulation; Activation of connective tissue. | Same as predicate. | Identical: Indicates the same clinical utility. |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | Identical |
| Mechanisms of Action | Extracorporeally induced unfocused pressure pulses | Extracorporeally induced unfocused pressure pulses | Identical |
| Maximum and Minimum Intensity Settings | 1 to 16 | 1 to 16 | Identical |
| Number and Size of Treatment Applicator Heads | OP155, Size: 230 x Ø 70 mm | OP155S, Size: 230 x Ø 70 mm | Identical in size and fundamental design (minor upgrade indicated by 'S' suffix). |
| Electrode Lifetime | E1-E10: 100K sw; E-11-E16: 70K sw | E1-E10: 500K sw; E11-E16: 350K sw | Improved: Break circuit and modified water cartridge solution reduce wear over time, but no change to device outputs at selected energy level, therefore no change to safety/effectiveness. |
| Cartridge Solution and Conductivity | Silver chloride solution 600μS/cm | Potassium bromide solution 2300μS/cm | Modified: To support extended electrode life. No change to device outputs at selected energy level, therefore no change to safety/effectiveness. |
| Maximum Penetration Depth | 25.4 mm at energy level 16 | 37.4 mm at energy level 16 | Similar/Slightly Higher: Due to tolerances and statistical effects. Geometry of reflector (defines acoustic field) remained unchanged, implying fundamental safety/effectiveness is maintained. |
| Energy Flow Density PII | 0.00017 - 0.04403 mJ/mm2 at energy level 1-16 | 0.00020 - 0.04900 mJ/mm2 at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Peak Compressional Acoustic Pressure (pc) | 9.27 at energy level 16 | 11.20 at energy level 16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Peak Rarefactional Acoustic Pressure (pcr) | -1.52 at energy level 16 | 1.22 at energy level 16 (Note: text states -1.22 in table lower down) | Similar/Slightly Lower: Due to tolerances and statistical effects, despite discrepancy between text and explicit table value. Implies values are within acceptable variation for clinical equivalence. |
| Positive Peak Pressure Amplitude (pc) | 0.43 - 9.27 MPa at energy level 1-16 | 0.61 - 11.20 MPa at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Negative Peak Pressure Amplitude (pcr) | -0.17 to -1.52 MPa at energy level 1-16 | -0.17 to -1.22 MPa at energy level 1-16 | Similar/Slightly Lower: Due to tolerances and statistical effects. |
| Derived Focal Acoustic Pulse Energy (EbT) | 0.022 - 2.278 mJ at energy level 1-16 | 0.020 - 3.370 mJ at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Derived Pulse-Intensity Integral (PIIT) | 0.00017 - 0.04403 mJ/mm2 at energy level 1-16 | 0.00020 - 0.04900 mJ/mm2 at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Risetime (tr) | 1.89 - 0.28 µs at energy level 1-16 | 1.08 - 0.18 µs at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Compressional Pulse Duration (tFWHMpc) | 1.23 - 0.77 µs at energy level 1-16 | 0.79 - 0.82 µs at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Compliance with Standards | Compliance with relevant IEC standards (listed in document) | Compliance demonstrated in performance testing. | Met: Certification to recognized international standards for medical electrical equipment, lithotripters, usability, and software lifecycle. |
| Hazard Analysis / Risk Management | Risks mitigated to an acceptable level (for predicate) | Performed, and all risks demonstrated to be mitigated to an acceptable level. | Met: Ensures device safety. |
| Software Validation | Software validated (for predicate) | Software validated and demonstrated to be of a Moderate level of concern. | Met: Appropriate validation for the software's risk level. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not discuss a clinical "test set" in the context of patient data. The performance evaluation was based on bench testing and verification and validation (V&V) testing of the device's engineering specifications. Therefore, data provenance from a patient population (country, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The submission focuses on hardware modifications and engineering performance, not on diagnostic accuracy requiring expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device, and no MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. Performance was demonstrated through V&V and bench testing of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the engineering specifications and demonstrated performance of the predicate device, alongside international consensus standards (e.g., IEC 61846, AAMI / ANSI ES60601-1, IEC 60601-1-2) for safety and performance testing. The "truth" is that the device, after modifications, still operates safely and effectively within expected parameters compared to the predicate and standard requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
October 12, 2022
Tissue Regeneration Technologies, LLC DBA as SoftWave TRT % Cherita James Regulatory Consultant M Squared Associates. Inc 127 West 30th Street, 9th Floor New York, New York 10001
Re: K213120
Trade/Device Name: OW100S (model OW100S-US) Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: September 12, 2022 Received: September 13, 2022
Dear Cherita James:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213120
Device Name OW100S (model OW100S-US)
Indications for Use (Describe)
The OW100S (model OW100S-US) is intended for:
-
Relief of minor muscle aches and pains
-
Temporary increase in local blood circulation
-
Activation of connective tissue
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for Tissue Regeneration Technologies, LLC 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | SoftWave TRT, LLC |
|---|---|
| 195 Chastain Meadows CT. | |
| Suite 109 | |
| Kennesaw, GA 30144 |
Contact: Cherita James M Squared Associates, Inc. 127 West 30th Street 9th Floor New York, New York 10001 Ph: 347-536-1463 Fax: 703-562-9797 Email: CJames(@MSquaredAssociates.com
| Date of Submission: | September 12, 2022 |
|---|---|
| Proposed Class: | I |
| Proprietary Name: | OW100S (model OW100S-US) |
| Common Name: | Acoustic wave device |
| Classification Name: | Therapeutic massager |
| Regulation Number: | Section 890.5660 Therapeutic massager |
| Product Codes: | ISA |
| Predicate Device: | TRT, OrthoGold 100 (OW100) K21045 |
Device Description
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
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The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.
There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
Indications for Use
The OW100S is intended for:
- -Relief of minor muscles aches and pains
-Temporary increase in local blood circulation
-Activation of connective tissue.
Performance Data
The same verification and validation testing was performed for the current device design as the predicate and demonstrated that the OW100S meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The OW100S software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. The performance testing demonstrated that the OW100S is substantially equivalent to the predicate device, OW100.
| The OW100S conforms to the following standards: |
|---|
| ------------------------------------------------- |
| Standard | Recognition Number |
|---|---|
| IEC 61846 First edition 1998-04, ultrasonics - pressure pulse lithotripters -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 and | 19-8 |
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| Standard | Recognition Number |
|---|---|
| tests | |
| 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 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 modified OrthoGold 100, identified as OW100S, has the following similarities to those which
previously received 510(k) concurrence:
- . has the same indicated use,
- uses the same operating principle, .
- incorporates the same materials .
- incorporates the same basic device design, with the addition of the "break circuit" and minor . changes to the applicator, water cartridge, and software
The table below compares the OW100S characteristics to the predicate device.
| Product Characteristic | Subject DeviceOW100S | Predicate DeviceOrthoGold 100 (OW100) | Comparison |
|---|---|---|---|
| 510(k) Number | K213120 | K210451 | NA |
| Indications for Use | The OW100S is intended for:-Relief of minor muscles achesand pains-Temporary increase in local bloodcirculation-Activation of connective tissue. | The OrthoGold 100 is intended for:-Relief of minor muscles aches andpains-Temporary increase in local bloodcirculation-Activation of connective tissue. | OW100S has thesame indicationsand intended useas the OW100 |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | identical, nochange |
| Mechanisms of Action | Extracorporeally inducedunfocused pressure pulses | Extracorporeally induced unfocusedpressure pulses | identical, nochange |
| Maximum and Minimumintensity settings | 1 to 16 | 1 to 16 | identical, nochange |
| Number and size oftreatment applicator heads | OP155SSize: 230 x Ø 70 mm | OP155Size: 230 x Ø 70 mm | identical, nochange |
| Product Characteristic | Subject DeviceOW100S | Predicate DeviceOrthoGold 100 (OW100) | Comparison |
| Electrode lifetime | E1-E10: 500K swE11-E16: 350K sw | E1-E10: 100K swE-11-E16: 70K sw | Break circuitand modifiedwater cartridgesolution reducethe wear ofelectrodes overtime, but there isno change todevice outputs atselected energylevel, andtherefore nochange tosafety/effectiveness in treatment |
| Cartridge solution andconductivity | Potassium bromide solution2300μS/cm | Silver chloride solution 600μS/cm | Modifiedsolution tosupportextendedelectrode life.no change todevice outputs atselected energylevel, andtherefore nochange tosafety/effectiveness in treatment |
| Type of application (e.g.,continuous vibration at afixed frequency); | Continuous at various frequencies | Continuous at various frequencies | identical, nochange |
| Maximum and minimumvibration frequency | Frequency of 1 - 8 Hz in steps of0.5 Hz | Frequency of 1 - 8 Hz in steps of0.5 Hz | identical, nochange |
| Driving Power | High voltage 2 - 7 kVCapacitor: 0,2 uF | High voltage 2 - 7 kVCapacitor: 0,2 uF | identical, nochange |
| Power Supply | 115 VAC | 115 VAC | identical, nochange |
| Maximum penetrationdepth | 37.4 mm at energy level 16 | 25.4 mm at energy level 16 | similar, highermax.penetrationdepth due totolerances andseveralstatisticaleffects.Geometry ofreflector inapplicator,which definesacoustic field,remainedunchanged |
| Product Characteristic | Subject DeviceOW100S | Predicate DeviceOrthoGold 100 (OW100) | Comparison |
| Energy flow densityPIIT [mJ/mm2] | 0.00020 - 0.04900at energy level 1 - 16 | 0.00017 - 0.04403at energy level 1 - 16 | similar, valuesof energy flowdensity slightlyhigher due totolerances andseveralstatistical effects |
| Operating mode | Continuous | Continuous | identical, nochange |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1 - 8 Hz | identical, nochange |
| Number of pulses (minand max) | 500-2000/ session | 500-2000/ session | identical, nochange |
| Maximum operatingtemperature | Room temperature | Room temperature | identical, nochange |
| Type of acoustic wavegeneration | Electro hydraulic, spark gap underwater caused by discharge of highvoltage condensers | Electro hydraulic, spark gap underwater caused by discharge of highvoltage condensers | identical |
| Peak compressionalacoustic pressurepc [Mpa] | 11.20 at energy level 16 | 9.27at energy level 16 | similar, valuesof peakcompressionealacousticpressure slightlyhigher due totolerances andseveralstatistical effects |
| Peak rarefactional acousticpressurepcr[Mpa] | 1.22 at energy level 16 | -1.52 at energy level 16 | similar, valuesof rarefractionalacousticpressure slightlylower due totolerances andseveralstatistical effects |
| Description of the spatialdistribution of the acousticpressure and intensity | Unfocused acoustic pressure field,see pressure measurements | Unfocused acoustic pressure field,see pressure measurements | Similar, nochange |
| Positive peak pressureamplitude (MPa)pc [Mpa] | 0.61 - 11.20at energy level 1 - 16 | 0.43 - 9.27at energy level 1 - 16 | similar, valuesof positive peakpressureamplitudeslightly higherdue to tolerancesand severalstatistical effects |
| Negative peak pressureamplitude (MPa)pcr[Mpa] | -0.17 to - 1.22MPaat energy level 1 - 16 | -0.17 to -1.52 MPaat energy level 1 - 16 | similar, valuesof negative peakpressureamplitudeslightly lowerdue to tolerances andseveralstatistical effects |
| Product Characteristic | Subject DeviceOW100S | Predicate DeviceOrthoGold 100 (OW100) | Comparison |
| due to tolerancesand severalstatistical effects | |||
| Derived focal acousticpulse energy (mJ)EbT [mJ] | 0.020- 3.370 at energy level 1 - 16 | 0.022 - 2.278at energy level 1 - 16 | similar values ofderived focalacoustic pulseenergy differdue to tolerancesand severalstatistical effects |
| Derived pulse -intensityintegral, integrated overtotal temporal integrationlimitsPIIT [mJ/mm2] | 0.00020-0.04900 mJ/mm2at energy level 1 - 16 | 0.00017 - 0.04403 mJ/mm2at energy level 1 - 16 | similar, valuesof derived pulse-intensity integtalslightly higherdue to tolerancesand severalstatistical effects |
| Rise time (ns)(10% - 90%) tr [us] | 1.08 - 0.18 at energy level 1 - 16 | 1.89 - 0.28 at energy level 1 - 16 | similar, valuesof rise timediffer due totolerances andseveralstatistical effects |
| Compressional pulseduration (us)tFWHMpc [uS] | 0.79 - 0.82 us at energy level 1 -16 | 1.23 - 0.77 us at energy level 1 - 16 | similar, valuesofcompressionalpulse durationdiffer due totolerances andseveralstatistical effects |
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Clinical Information
Not applicable. Bench and performance testing support the substantial equivale in this submission.
Conclusion
The OW100S has the same indications for use and similar design features as compared with the predicate device system. The OW100S described in this submission is, in our opinion, substantially equivalent to the predicate, OrthoGold 100 (OW100). The proposed device performs as well as the legally marketed predicate device. Any differences between the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.