Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
Symptomatic relief of post-traumatic acute pain .
Symptomatic relief of post-operative pain .

Device Description

The Biowave Corporation Neuromodulation Pain Therapy Device is a battery-powered device intended to provide clinicians with the flexibility to prescribe powered muscle stimulation and TENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller electrode pad ("Pain Site Pad") placed directly over the source of the pain (the treatment site).

AI/ML Overview

The provided text for K052289, "Deepwave Neuromodulation Pain Therapy Device," is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the following information:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or training set.
Data provenance (country of origin, retrospective/prospective).
Number or qualifications of experts used for ground truth.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
Details about a standalone (algorithm only) performance study.
How ground truth was established for either test or training sets.

Instead, the submission focuses on comparing the proposed device's indications for use, design, and function to a predicate device to establish substantial equivalence. The key information provided is:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics in a table. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or substantially equivalent indications for use and similar technological characteristics.
Reported Device Performance: No specific performance metrics or clinical study results with numerical values are reported to demonstrate efficacy against pre-defined acceptance criteria. The claim of performance is implicitly that it performs equivalently to the predicate device for pain relief.

2. Sample Size and Data Provenance for Test Set: Not applicable. The document does not describe a clinical study with a test set in the conventional sense of a diagnostic or predictive device.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not mentioned as such. The basis for efficacy is the established use of similar technology in the predicate device for pain relief.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable.

6. Standalone Performance Study: Not mentioned or applicable.

7. Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy studies. The "ground truth" for the device's intended use (symptomatic relief of pain) is based on the therapeutic effect of electrical stimulation, which is a well-established mechanism for pain management. The submission relies on the established safety and efficacy of the predicate device.

8. Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for the Training Set Was Established: Not applicable.

Summary of Device Comparison (Basis for Substantial Equivalence):

The document states that the Deepwave Neuromodulation Pain Therapy Device's indications for use are identical to those of the predicate device (Chattanooga Group Forte Model CPS 200 Stimulator Device, K982828).

Identical Indications:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
- Symptomatic relief of post-traumatic acute pain.
- Symptomatic relief of post-operative pain.
Similar Design and Function: Both devices offer a biphasic waveform, sine waves, and a beat frequency in the range of 100-200 Hz. Both are software-driven TENS units that provide a treatment program for pain reduction.

Conclusion: The submission concludes that the Biowave Deepwave Device is substantially equivalent to the predicate devices for the specified indications based on the identical indications for use and similar technological characteristics. This type of 510(k) submission primarily relies on comparisons to legally marketed devices, rather than new extensive clinical trials, to demonstrate safety and effectiveness.

Summary

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K052289

DEC 1 3 2005

510(k) Summary for the Biowave Deepwave Neuromodulation Pain Therapy Device

SPONSOR 1.

Biowave Corporation 16 Knight Street Norwalk, CT 06851

Brad Siff Contact Person: (203) 247-9020 Telephone:

November 16, 2005 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Deepwave Neuromodulation Pain Therapy Device
Common/Usual Name:	Electrical Muscle and Nerve Stimulator
Classification Names:	Powered Muscle Stimulator, Interferential CurrentStimulator

PREDICATE DEVICES 3.

Chattanooga Group Forte Model CPS 200 Stimulator Device K982828.

4. INTENDED USE

The Deepwave Neuromodulation Pain Therapy Device is indicated for:

Symptomatic relief of chronic, intractable pain, post surgical and post-. traumatic acute pain;
Symptomatic relief of post-traumatic acute pain .
Symptomatic relief of post-operative pain .

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DEVICE DESCRIPTION ನ.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The Biowave Corporation Neuromodulation Pain Therapy is indicated for the following:

Symptomatic relief of chronic, intractable pain, post surgical and post-. traumatic acute pain;
Symptomatic relief of acute pain t
Symptomatic relief of post-operative pain relief .

These indications are identical to those indicated for the predicate device. Therefore, the indications for use of the Deepwave Neuromodulation Pain Therapy Device are essentially identical to those for predicate electrical stimulator devices that have been previously cleared for marketing in the United States.

The Biowave device and the Chattanooga device are similar in design and function. Both devices offer a biphasic waveform, sine waves and a beat frequency in the range of 100-200 Hz. Both the proposed and predicate devices are software driven TENs units that provide the user with a treatment program for pain reduction. The conclusion of this technical comparison is that the Biowave Deepwave Device is substantially equivalent to the predicate devices for the indications specified.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines representing wings or streams.

DEC 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biowave Corporation c/o Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K052289

Trade/Device Name: Deepwave Neuromodulation Pain Therapy Device Regulatory Class: Unclassified Product Codes: LIH Dated: November 16, 2005 Received: November 17, 2005

Dear Mrs. McNamara-Cullinane:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by Page 2 - Mrs. McNamara-Cullinane

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Page 2 -- Mrs. McNamara-Cullinane

reference to premarket notification" (21CFR Part 807.97). You may obtain other general informational and reference to premarket notification (21) it it in to responsible in the mational and your responsibilities under the Act from the Division of Small Managers of Shiritorial of Shiperial Shiress http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson
Acting Director

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _K052289

Device Name: Deepwave Neuromodulation Pain Therapy Device

The Deepwave Neuromodulation Pain Therapy Device is indicated for:

Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
Symptomatic relief of post-traumatic acute pain .
Symptomatic relief of post-operative pain .

Prescription Use __ X -(Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052289

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).