(360 days)
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
The provided text describes a 510(k) submission for the H-Wave® Sport, a powered muscle stimulator. The regulatory pathway for this device is based on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria and performance metrics typically associated with AI/ML-based devices or therapies requiring more rigorous clinical evidence.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this specific 510(k) summary. The "study" referenced is largely laboratory bench testing to ensure the device functions as intended and supports the use of low-frequency stimulation for endurance and active recovery, rather than a clinical trial proving specific performance metrics against a defined ground truth.
Here's a breakdown of the applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance | The H-Wave® Sport functioned as intended in all instances during laboratory bench testing. |
| Expected Results | The results observed were as expected for all tests. |
| Support for Intended Use | Performance data supports the use of low-frequency stimulation for endurance and active recovery. |
| Safety and Effectiveness (Substantial Equivalence) | The H-Wave® Sport is as safe and effective as the cleared H-Wave® (K915230) and the cleared Compex® Sport (K011880). The minor technological differences raise no new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The text refers to "laboratory bench testing" without specifying the number of devices tested or the specific test parameters.
- Data Provenance: The testing was "laboratory bench testing," implying an engineered environment rather than a human subject study. The country of origin for the data is not specified, but the applicant (Electronic Waveform Lab, Inc.) is based in Huntington Beach, CA, USA.
- Retrospective or Prospective: Not applicable as it was bench testing, not a human study.
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)
- Number of Experts: Not applicable. Ground truth in this context refers to engineering specifications and functional performance metrics, not clinical interpretation by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication is typically used for resolving discrepancies in expert interpretations in clinical studies.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This device is not AI-driven and does not involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (muscle stimulator), not an algorithm or AI. The "performance" refers to the device's electrical and mechanical functioning.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for the bench testing would be the device's design specifications and established engineering principles for powered muscle stimulators. Functional performance was assessed against these expected outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in the AI/ML sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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K08/998
JUL - 9 2009
510(k) Summary
Electronic Waveform Lab Inc.'s H-Wave® Sport
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Electronic Waveform Lab, Inc. 16168 Beach Boulevard Suite 232 Huntington Beach, CA 92647
Phone: (800) 874-9283 Facsimile: (714) 316-2833
Contact Person: Ryan P. Heaney, President
Date Prepared: February 3, 2009
Name of Device
H-Wave® Sport
Common or Usual Name/Classification Name
Powered muscle stimulator
Predicate Devices
H-Wave®, Electronic Waveform Lab, Inc. (K915230) Compex® Sport, Compex S.A. (K011880)
Intended Use / Indications for Use
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions ..
Technological Characteristics
The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
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Performance Data
The company performed laboratory bench testing to evaluate the H-Wave Sport device. In all instances, the H-Wave® Sport functioned as intended and the results observed were as expected. Performance data supports the use of low-frequency stimulation for endurance and active recovery.
Substantial Equivalence
The H-Wave® Sport is as safe and effective as the cleared H-Wave® and the cleared Compex® Sport. The H-Wave® Sport has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the H-Wave® Sport and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the H-Wave Sport is as safe and effective as the predicate devices. Thus, the H-Wave® Sport is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Electronic Waveform Lab, Inc. % Mr. Ryan P. Heaney, President 16168 Beach Boulevard Suite 232 Huntington Beach, California 92647
JUL - 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K081998
Trade/Device Name: H-Wave® Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: June 17, 2009 Received: June 17, 2009
Dear Mr. Heaney:
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 Amendmounts, 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. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration.
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ryan P. Heaney
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K081998
Device Name: H-Wave® Sport
Indications for Use:
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KO81948
(Division Sign-Off) (Division Signical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
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