(183 days)
No
The description focuses on hardware modifications and a usage limitation mechanism, with no mention of adaptive algorithms, learning, or data processing that would indicate AI/ML.
Yes
The device is clearly indicated for the "symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain," which falls under the definition of a therapeutic purpose.
No
The device is described as a pain therapy device, providing symptomatic relief for various types of pain through neuromodulation. Its function is therapeutic, not diagnostic.
No
The device description explicitly mentions hardware components such as a power supply (lithium ion polymer rechargeable battery), leadwires, and an electronic integrated circuit ("chip") housed in a custom connector at the end of the electrode.
Based on the provided text, the Homewave Neuromodulation Pain Therapy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief of pain (chronic, intractable, post-surgical, post-traumatic, and acute pain). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a neuromodulation pain therapy device, similar to TENS and interferential stimulation devices. These types of devices deliver electrical stimulation to the body for therapeutic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or other materials to perform tests on samples.
The device's function is to directly interact with the patient's body to alleviate pain, which is a therapeutic action, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The Homewave Neuromodulation Pain Therapy Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain ●
Product codes
GZJ
Device Description
The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices.
Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows:
- Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave)
- . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use.
- . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave.
The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Special 510(k) Summary for the Biowave Homewave Neuromodulation Pain Therapy Device
SPONSOR 1.
Biowave Corporation 16 Knight Street Norwalk, CT 06851
FEB - 1 2005
Contact Person: Brad Siff Telephone: (203) 855-8610
Date Prepared: January 18, 2008
2. DEVICE NAME
| Proprietary Name: | Homewave Neuromodulation Pain Therapy Device |
|---|---|
| Common/Usual Name: | Electrical Nerve Stimulator |
| Classification Names: | TENS, Interferential Current Stimulator |
3. PREDICATE DEVICES
- . Deepwave Neuromodulation Pain Therapy Device, K052289
- Deepwave PENs Neuromodulation Pain Therapy Device, K061166 .
- . Johari Digital Healthcare Ltd. K060246
INTENDED USE 4.
The Homewave Neuromodulation Pain Therapy Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain ●
1
5. DEVICE DESCRIPTION
The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices.
Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows:
- Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave)
- . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use.
- . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave.
The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
Biowave Corporation's Homewave and Deepwave devices are similar in design and function. Both devices offer a dual sinusoidal signal with a frequency difference of 122 Hz. Both the proposed and predicate devices are software controlled TENS units that provide the user with pain reduction. The conclusion of this technical comparison is that Biowave's Homewave Device is substantially equivalent to the predicate devices for the indications specified.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
FEB - 1 2008
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Biowave Corporation % Mr. Brad Siff 16 Knight Street Norwalk, CT 06851
Re: K072123 Trade/Device Name: Homewave Neuromodulation Pain Therapy Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: January 18, 2008 Received: January 22, 2008
Dear Mr. Siff:
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 (OS) 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. Brad Siff
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 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Homewave Neuromodulation Pain Therapy Device
The Homewave Neuromodulation Pain Therapy Device is indicated for:
- . Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain
- Symptomatic relief of 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 Ceneral, Restorative, and Neurological Devices
510(k) Number L072123