(29 days)
No
The device description focuses on hardware modifications (power supply, display, button, form factor) and explicitly states the device has identical functionality to the predicate, which is a TENS-type device. There is no mention of AI or ML in the document.
Yes
The device is indicated for symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain, and post-operative pain, which are therapeutic applications.
No
The device is described as a "Neuromodulation Pain Therapy Device" intended for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," which indicates a therapeutic rather than diagnostic purpose.
No
The device description explicitly details hardware modifications including a new power supply (batteries), a larger LCD display, a physical PAUSE button, and a smaller form factor. This indicates it is a physical device with hardware components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," "Symptomatic relief of acute pain," and "Symptomatic relief of post-operative pain." These are all related to treating pain in a living patient.
- Device Description: The description identifies it as a "TENS type device with a single optimized operational mode for the treatment of pain." TENS (Transcutaneous Electrical Nerve Stimulation) devices are used externally on the body to alleviate pain.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use to treat pain.
N/A
Intended Use / Indications for Use
The BiowaveHOME 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 Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain.
Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:
- . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
- . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
- . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
- . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.
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
Not Found
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)
Homewave Neuromodulation Pain Therapy Device, K072123
Reference Device(s)
Deepwave (BiowavePRO) Neuromodulation Pain Therapy Device, K053389, Deepwave Percutaneous (BiowavePENS) Neuromodulation Pain Therapy System, K053389
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2015
Biowave Corporation Mr. Bradford Siff Founder and Chief Technology Officer 16 Knight St. Norwalk, Connecticut 06851
Re: K152437
Trade/Device Name: BiowaveHOME Neuromodulation Pain Therapy System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: August 27, 2015 Received: August 28, 2015
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. 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 mav 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
- for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K152437
Device Name
BiowaveHOME Neuromodulation Pain Therapy System
Indications for Use (Describe) The BiowaveHOME 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
| 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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Special 510(k) Summary
for Biowave Corporation's
BiowaveHOME Neuromodulation Pain Therapy Device
1. Sponsor
Biowave Corporation 16 Knight Street Norwalk, CT 06851
Contact Person: Brad Siff Telephone: 1-877-246-9283 ext 6 or 203-247-9020
Date Prepared: Auqust 12, 2015
2. Device Name
| Proprietary Name: | BiowaveHOME Neuromodulation Pain Therapy Device |
|---|---|
| Common/Usual Name: | Electrical Nerve Stimulator |
| Classification Names: | Transcutaneous Electrical Nerve Stimulator |
| K152437 - Product Code: GZJ |
3. Predicate Devices
Homewave Neuromodulation Pain Therapy Device, K072123
Deepwave (BiowavePRO) Neuromodulation Pain Therapy Device, K053389
Deepwave Percutaneous (BiowavePENS) Neuromodulation Pain Therapy System, K053389
4. Intended Use
The BiowaveHOME 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
5. Device Description
The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain.
4
Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:
- . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
- . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
- . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
- . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.
6. Basis for Substantial Equivalence
Biowave Corporation's BiowaveHOME and Homewave Neuromodulation Pain Therapy Devices are similar in design and function. Both devices deliver and target a summation of two alternating current high frequency sinusoidal waveforms into deep tissue within the body from which a low frequency electric field forms encompassing the source of pain.
Both the proposed and parent devices are software driven TENS type units that provide the user with a single optimized treatment program for pain reduction.
The conclusion of this technical comparison is that Biowave Corporation's BiowaveHOME Neuromodulation Pain Therapy Device is substantially equivalent to the parent devices for the indications specified.