(86 days)
The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.
The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).
The provided text is a 510(k) Summary for the VMAT PRO device, seeking substantial equivalence to a predicate device (D-Actor 200 Vibration Massage System). It focuses on demonstrating that the new device is as safe and effective as the legally marketed predicate. However, this document does not describe a study involving human readers, AI assistance, or the establishment of ground truth by multiple experts for a test set.
The closest information provided is about performance testing to establish that the VMAT PRO control unit performs as intended, and a comparison of its technological characteristics with the predicate device.
Therefore, I cannot fully address all the points in your request as the information is not present in the provided document. I will fill in what can be inferred and explicitly state where information is missing.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a threshold that must be met. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing various technical specifications. The acceptance criterion is implicit: the device's performance characteristics must be sufficiently similar to the predicate device, or any differences must not impact safety or efficacy.
| Characteristic | Predicate Device (D-ACTOR® 200 K173692) | VMAT PRO (K243488) | Comparison / Reported Performance vs. Implicit Acceptance Criteria (Similarity to Predicate) |
|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pains, temporary increase in local blood circulation, activation of connective tissue. | Relief of minor muscle aches and pains, temporary increase in local blood circulation, activation of connective tissue. | Identical. Meets implicit acceptance criteria. |
| Modes of action | Radial pressure waves, or extracorporeal pulse activation respectively | HP-AT pressure pulse handpiece | Same. Meets implicit acceptance criteria. |
| Mechanism of action | Pneumatically generated vibrations | Pneumatically generated vibrations | Same. Meets implicit acceptance criteria. |
| Type of acoustic wave generation | Pneumatic/ballistic | Pneumatic/ballistic | Same. Meets implicit acceptance criteria. |
| Pulse repeat rate (1/s) | 1-21 Hz | 1-21 Hz | Same. Meets implicit acceptance criteria. |
| Maximum & Minimum Intensity setting | 1-5 bar | 0.5-5.0 bar | Very similar. VMAT PRO goes slightly lower (0.5 bar vs 1 bar), but this is stated to make it more comfortable for patients and not impact safety. Meets implicit acceptance criteria. |
| Type of application | Continuous vibration at a fixed frequency | Continuous vibration at a fixed frequency | Same. Meets implicit acceptance criteria. |
| Driving power | 1-5 bar | 1-5 bar | Same. Meets implicit acceptance criteria. |
| Projectile Mass (g) | 3.0 g | 3.1 g | Same. Meets implicit acceptance criteria. |
| Pulse repeat rate | 1-21Hz | 1-21Hz | Same. Meets implicit acceptance criteria. |
| Number of pulses | variable | Variable | Same. Meets implicit acceptance criteria. |
| Max & Min displacement of applicator heads | 0.6 – 2.0 mm | VAT220: Max: 1.230 mm / Min: 0.350 mmVAT215: Max: 0.320 mm / Min: 0.120 mmVAT120: Max: 1.300 mm / Min: 0.700 mmVAT 135: Max: 0.760 mm / Min: 0.300 mm | Different. However, the document states measurements were taken differently (ultrasound in laboratory) and the difference is minimal and does not pose a risk. Meets implicit acceptance criteria. |
| Pressure | 1-5 bar | 0.5-5.0 bar (7.25 psi - 72.5psi) | Very similar. Same justification as for intensity setting. Meets implicit acceptance criteria. |
| Beam Pressure Maximum (BPM) | According to modified protocols from IEC 61846 N/A | According to IEC 63045 (at 5 bar)VAT 220: 45.8 mJVAT 215: 34 mJVAT 120: 24 mJVAT 135: 34 mJ | Different measurements. Due to different standards (IEC 61846 vs IEC 63045). Document explains term "derived focal acoustic pulse energy" is not applicable as device has no focus. VMAT PRO values are within usual range for pressure pulse devices. Implicitly meets acceptance criteria via explanation. |
| Total Derived focal acoustic pulse energy | 5bar/6.5mJ3bar/2.4mJ | N/A (term not applicable) | Different measurements/terminology. Explained by standard differences and device nature (no focus). Implicitly meets acceptance criteria via explanation. |
| Positive derived acoustic pulse energy | Not explicitly stated for predicate in this format | According to IEC 63045 (measured for VAT220 at 5bar)VAT 220: 39.9 mJVAT 215: 23 mJVAT 120: 17 mJVAT 135: 32 mJ | Explained by standard differences allowing for comparison via BPM. Implicitly meets acceptance criteria via explanation. |
| Positive peak pressure | Values of ultrasonic pulse:5bar/18.5MPa3bar/13.4MPa | VAT220: 5 bar: 8.1 MPa / 3 bar: 6.7 MPaVAT215: 5 bar: 11.3 MPa / 3 bar: 8.1 MPaVAT120: 5 bar: 6.3 MPa / 3 bar: 4.9 MPaVAT 135: 5 bar: 3.8 MPa / 3 bar: 2.8 MPa | Different. Due to different testing methodology. Implicitly meets acceptance criteria via explanation. |
| Negative peak pressure | Values of ultrasonic pulse:5bar: 6.8MPa3bar: 5.0MPa | VAT220: 5 bar: 6.5 MPa / 3 bar: 5.1 MPa | Same as VAT220. (Predicate transmitter not specified). Implicitly meets acceptance criteria. |
| Derived pulse-intensity integral (Energy Flux Density) | Values of ultrasonic pulse according to modified protocols from IEC 61846:5bar: .284 mJ/mm23bar: .176 mJ/mm2 | VAT220: 5 bar: 0.267 mJ/mm2 / 3 bar: 0.152 mJ/mm2VAT215: 5 bar: 0.224 mJ/mm2 / 3 bar: 0.135 mJ/mm2VAT120: 5 bar: 0.252 mJ/mm2 / 3 bar: 0.187 mJ/mm2VAT 135: 5 bar: 0.207 mJ/mm2 / 3 bar: 0.129 mJ/mm2 | Different but very close. Stated as nearly identical and "key specification to compare." Implicitly meets acceptance criteria. |
| Maximum penetration depth | Not explicitly stated for predicate | VAT 220: 33.1 mmVAT 215: 23.1 mmVAT 120: 32 mmVAT 135: 35 mm | Different. Stated that differences are within 1mm of predicates (implying predicate data was known but not fully listed here) and do not impact safety or efficacy. Implicitly meets acceptance criteria. |
| Working mode | Continuous | Continuous | Same. Meets implicit acceptance criteria. |
| Rise time (measured at 5bar (10%-90%) (μs)) | Not explicitly stated for predicate | VAT220: 4.97 μsVAT215: 2.41 μsVAT 120: 4.28 μsVAT 135: 4.16 μs | Similar. Within standard range for pressure pulse devices. Implicitly meets acceptance criteria. |
| Compressional pulse duration (measured at 5 bar in μs) | Ultrasonic pulse: 5 μs | VAT220: 6.6 μsVAT215: 2.93 μsVAT120: 4.78 μsVAT 135: 6.96 μs | Similar. Within standard range for pressure pulse devices. Implicitly meets acceptance criteria. |
| Power Supply | Not explicitly stated for predicate | 230 VAC 50 Hz115 VAC 60 Hz (optional with reference M93AF) | No direct comparison to predicate possible from provided table. Assumed to be compatible or safe. |
| Maximum operating Temperature | 10-40c | 18-30C | Within predicate's range. Meets implicit acceptance criteria. |
| Treatment heads | 4: 6mmOD, 15mmOD, 20mmOD, 35mmOD | 4: 20mm, 20mm, 35mm, 15mm | Similar sizes. Meets implicit acceptance criteria. |
| Patient Contacting Materials | Steel | Titanium, Stainless Steel, Polyoxymethylene | Similar for transmitters, different for transmitter casing. All materials tested for biocompatibility and found biocompatible. Meets implicit acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes technical and performance testing of the device itself (e.g., electrical safety, EMC, acoustic characteristics), not a clinical study or a study involving a "test set" of patient data for AI evaluation. Therefore, this information is not applicable to this 510(k) summary. The testing refers to the device unit's performance, not a dataset.
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. This document does not concern an AI/clinical diagnostic device requiring expert adjudicated ground truth. The "ground truth" for the device's technical specifications is established through engineering and physical measurements according to international standards (IEC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As no diagnostic test set is used, no adjudication method is relevant.
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
No. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission." Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm but a physical therapeutic device. The "performance testing" described refers to the device's physical and electrical characteristics as per IEC standards, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical characteristics comparison, the "ground truth" is derived from:
- Engineering measurements and specifications of the VMAT PRO device itself, conducted in a laboratory setting (e.g., "measured in a laboratory, using ultrasound" for applicator displacement).
- Published specifications of the predicate device (D-Actor 200) from its own 510(k) submission or technical documentation.
- Adherence to international standards such as IEC 60601-1, IEC 60601-1-2, and IEC 63045:2020 for safety, EMC, and ultrasonic characteristics.
- Biocompatibility testing according to ISO 10993-1:2018.
For the purpose of this 510(k) submission, the "ground truth" is primarily device-centric technical specifications and compliance with recognized standards, not clinical diagnostic outcomes or human expert interpretations of patient data.
8. The sample size for the training set
Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
February 6, 2025
TermoSalud % Aubrey Thompson Regulatory Consultant Hoy and Associates Regulatory Consultants 1830 Bonnie Way Sacramento, California 95825
Re: K243488
Trade/Device Name: Vmat Pro Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: October 31, 2024 Received: November 12, 2024
Dear Aubrey Thompson:
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 (the 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/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.
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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).
Your device is also subject to, among other requirements, the Quality System (OS) 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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
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assistance/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,
Heather L. Dean -S
for Amber Ballard, PhD Assistant Director 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
Submission Number (if known)
Device Name
VMAT PRO
Indications for Use (Describe)
The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.
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 VMAT PRO K243488
| Applicant | TermoSalud |
|---|---|
| Address | Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain |
| Applicant Contact | Cristina Cifuentes Pantoja |
| Correspondent Contact | Aubrey Thompson, Regulatory ConsultantAubreyThompson@hoyregulatory.com |
| Preparation Date | February 6, 2025 |
| Device Trade Name | VMAT PRO (K243488) |
| Device Classification Name | Massager, Therapeutic, Electric |
| Common Name | Therapeutic electric massager |
| Regulation Number | 21 CFR 890.5660 |
| Product Code | ISA |
| Regulatory Class | I |
| Legally Marketed PredicateDevice | D-Actor 200 Vibration Massage System (K173692) |
Device Description:
The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).
Indications for use:
The VMAT PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue.
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510(K) Summary VMAT PRO K243488
Substantial Equivalence—Technological Characteristics:
| Subject Device | Predicate Device | Comparison |
|---|---|---|
| The VMAT PRO is intended for relief ofminor muscle aches and pains, temporaryincrease in local blood circulation, andactivation of connective tissue | The D-ACTOR® 200 Vibration Massage System is intended for: Relief of minormuscle aches and pains, temporaryincrease in local blood circulation,activation of connective tissue | Identical. |
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| Technical Comparison | VMAT PRO | D-ACTOR® 200 VibrationMassage System(K173692) | Comparison |
|---|---|---|---|
| Modes of action | HP-AT pressure pulse handpiece | Radial pressure waves, orextracorporeal pulseactivation respectively | Same |
| Mechanism of action | Pneumatically generatedvibrations | Pneumatically generatedvibrations | Same |
| Type of acoustic wavegeneration | Pneumatic/ballistic | Pneumatic/ballistic | Same |
| Pulse repeat rate (1/s) | 1-21 Hz | 1-21 Hz | Same |
| Maximum andMinimum intensitysetting | 0.5-5.0 bar | 1-5 bar | Very similar- thepressure on the VMATPRO goes slightlylower than thepredicate device, butit does not impact thesafety of the device.Treatment pressure isadjusted for patientcomfort, so a slightlylower pressure can bemore comfortable forpatients. |
| Type of application | Continuous vibration at a fixedfrequency | Continuous vibration at afixed frequency | Same |
| Driving power | 1-5 bar | 1-5 bar | Same |
| Projectile Mass (g) | 3.1 g | 3.0 g | Same |
| Pulse repeat rate | 1-21Hz | 1-21Hz | Same |
| Number of pulses | Variable | variable | Same |
| Max and Mindisplacement ofapplicator heads | VAT220:Max: 1.230 mmMin: 0.350 mmVAT215:Max: 0.320 mmMin: 0.120 mmVAT120:Max: 1.300 mmMin: 0.700 mmVAT 135:Max: 0.760 mmMin: 0.300 mm | 0.6 – 2.0 mm | Different. There aredifferent ways ofmeasuring thisvariable and that notall of them are equallyaccurate. In our case,it has been measuredin a laboratory, usingultrasound.The difference invalues is minimal anddoes not pose a risk tothe safety of theequipment and theuser. |
| Pressure | 0.5-5.0 bar (7.25 psi - 72.5psi) | 1-5 bar | Very similar- thepressure on the VMATPRO goes slightlylower than thepredicate device, butit does not impact thesafety of the device.Treatment pressure isadjusted for patientcomfort, so a slightlylower pressure can bemore comfortable forpatients. |
| Beam PressureMaximum (BPM) | According to IEC 63045 (at 5bar)VAT 220: 45.8 mJVAT 215: 34 mJ | According to modifiedprotocols from IEC 61846N/A | The measurementstaken are different |
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510(K) Summary VMAT PRO
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510(K) Summary VMAT PRO K243488 VAT 120: 24 mJ VAT 135: 34 mJ
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510(K) Summary VMAT PRO
| Total Derived focalacoustic pulse energy | N/A | 5bar/6.5mJ3bar/2.4mJ | because themeasurement for theacoustic pulse wasconducted per IEC63045 standards,which requires BeamPressure Maximummeasurements.The energy values ofthe VMAT PRO arewell within the usualrange for pressurepulse devices. thedifference betweenthe values of ourVMAT PRO and thevalues of D-Actor 200is due to the termsused in the standard.See furtherexplanation of thedifference inspecifications below. |
|---|---|---|---|
| Positive derivedacoustic pulseenergy | According to IEC 63045(measured for VAT220 at 5bar)VAT 220: 39.9 mJVAT 215: 23 mJVAT 120: 17 mJVAT 135: 32 mJ | ||
| Positive peak pressure | VAT220:5 bar: 8.1 MPa3 bar: 6.7 MPaVAT215: | Values of ultrasonic pulse:5bar/18.5MPa3bar/13.4MPa | The difference in thesevalues is due todifference in testingmethodology. Seediscussion below. |
| 5 bar: 11.3 MPa3 bar: 8.1 MPaVAT120:5 bar: 6.3 MPa3 bar: 4.9 MPaVAT 135:5 bar: 3.8 MPa3 bar: 2.8 MPa | |||
| Negative peakpressure | VAT220:5 bar: 6.5 MPa3 bar: 5.1 MPa | Values of ultrasonic pulse:5bar: 6.8MPa3bar: 5.0MPa | Same as VAT220. The510K summary of thepredicate device doesnot state whichtransmitter was testedfor these values. |
| Derived pulse-intensity integral(Energy Flux Density) | VAT220:5 bar: 0.267 mJ/mm23 bar: 0.152 mJ/mm2VAT215:5 bar: 0.224 mJ/mm23 bar: 0.135 mJ/mm2 | Values of ultrasonic pulseaccording to modifiedprotocols from IEC 61846:5bar: .284 mJ/mm23bar: .176 mJ/mm2 | Different. While thevalues are notidentical, they are veryclose in to one anotherfor the VAT220 andthe remainingtransmitters all have |
| VAT120:5 bar: 0.252 mJ/mm23 bar: 0.187 mJ/mm2VAT 135:5 bar: 0.207 mJ/mm23 bar: 0.129 mJ/mm2 | lower values than theypredicate. | ||
| Maximum penetrationdepth | VAT 220: 33.1 mmVAT 215: 23.1 mmVAT 120: 32 mmVAT 135: 35 mm | Different. Thedifferences are within1 mm of thepredicates, which doesnot impact the safetyor efficacy. | |
| Working mode | Continuous | Same | |
| Rise time (measuredat 5bar (10%-90%)(μs) | VAT220Ultrasonic pulse: 4.97 μsVAT215 | Similar. These risetimes are all within thestandard range forpressure pulse devices. | |
| Ultrasonic pulse: 2.41 µsVAT 120:Ultrasonic pulse: 4.28 µs | See further discussionbelow. | ||
| VAT 135:Ultrasonic pulse: 4.16 µs | |||
| Compressional pulseduration (measured at5 bar in µs ) | VAT220Ultrasonic pulse: 6.6 µsVAT215Ultrasonic pulse: 2.93 μsVAT120:Ultrasonic pulse: 4.78 µsVAT 135:Ultrasonic pulse: 6.96 us | Ultrasonic pulse: 5 µs | Similar. These pulsedurations are all withinthe standard range forpressure pulse devices.See further discussionbelow. |
| Power Supply | 230 VAC 50 Hz115 VAC 60 Hz (optional withreference M93AF) | 500 VA | |
| Maximum operatingTemperature | 18-30C | 10-40c | The VMAT operatingtemperature is withinthe range of thepredicate's |
| Treatment heads | 4: 20mm, 20mm, 35mm, 15mm | 4: 6mmOD, 15mmOD,20mmOD, 35mmOD | Similar sizes |
| Patient ContactingMaterials | Titanium, Stainless Steel,Polyoxymethylene | Steel | Similar for transmitters,different fortransmitter casing. |
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510(K) Summary VMAT PRO
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Performance Testing
Verification and validation activities were successfully completed and establish that the VMAT PRO control unit performs as intended. Testing included the following:
IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility Requirements and tests
IEC 63045:2020 Ultrasonics -Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields.
Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
Biocompatibility
All tissue contacting materials were tested for biocompatibility according to ISO 10993-1:2018 and found to be biocompatible.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Substantial Equivalence Discussion
Though the measurements in the substantial equivalence table above some differences between the VMAT PRO and the predicate device, the differences are due to different measuring methods. A key parameter to compare is the derived pulse-intensity integral (energy flux density, measured in mJ/mm²). This parameter demonstrates efficacy because the therapeutic effectiveness of pressure pulses depends on whether the energy of the pressure pulse is distributed over a large area or focused on a locally confined treatment zone (focal zone). The measure of energy concentration is obtained by calculating the energy per area (derived pulse-intensity integral) and is obtained after the pulse has stabilized, not at the first impulse or shot.
Test Methods
The performance testing for the predicate device was conducted using modified protocols from the IEC 61846 standard. Testing for the VMAT Pro was conducted to the standard IEC 63045. This resulted in several differences in the measurements taken.
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510(K) Summary VMAT PRO K243488
Devices such as the VMAT PRO do not have a focus, so the term derived focal acoustic pulse energy is not applicable in this case. The term is also not used in IEC 63045, the focus has been replaced by the beam pressure maximum (BPM).
The derived pulse-intensity integral values of the VMAT PRO are within the usual range for pneumatic pressure pulse devices. Therefore, the difference between the values of our VMAT PRO and the values of D-Actor 200 is due to the terms used in the regulations.
Conclusion
The VMAT PRO and D-Actor 200 are identical in their indications for use and similar in their overall design. The key specification to compare, the derived pulse-intensity integral, is nearly identical between the devices. Differences that exist are due to either differences in the method of pressure wave generation, or differences in the test methods used. The differences do not impact the safety or efficacy of the VMAT PRO device and the key comparisons show that the VMAT PRO is substantially equivalent to the predicate device.
§ 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.