(112 days)
Not Found
No
The provided text does not mention AI, ML, or any related technologies. The device description focuses on basic electrical stimulation and user controls.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain." relieving pain is a therapeutic application.
No
The device description and indications for use clearly state its purpose is for "pain therapy" and "symptomatic relief of pain" via neuromodulation, not for identifying or diagnosing a condition.
No
The device description clearly outlines a physical, battery-powered hardware device with dimensions, weight, buttons, an LCD display, and wires connected to electrode pads. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a battery-powered unit that delivers electrical stimulation through electrodes placed on the skin. This is consistent with a physical therapy or pain management device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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 .
Product codes (comma separated list FDA assigned to the subject device)
LIH
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Current |
| Stimulator |
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.
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).
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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3
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)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052289