(273 days)
Not Found
Not Found
No
The document describes a standard TENS device for pain relief and lumbar support, with no mention of AI or ML capabilities in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "transcutaneous electrical nerve stimulation" device intended for "symptomatic relief and management of chronic and intractable pain," which is a therapeutic purpose.
No
The device is described as a transcutaneous electrical nerve stimulator intended for pain relief and lumbar support, not for diagnosing conditions.
No
The device description explicitly states it is a "self-contained battery operated transcutaneous electrical muscle stimulator" and includes "adhesive electrodes are mounted on a belt," indicating it is a hardware device with electrical components and physical accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The BAXOLVE™ TENS device is a transcutaneous electrical nerve stimulator. It delivers electrical impulses through the skin to the nerves for pain relief. It also provides lumbar support.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. Its function is based on delivering electrical stimulation externally.
Therefore, the device's intended use and mechanism of action clearly fall outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for prescriptive use.
Indications for Use:
- Transcutaneous electrical nerve stimulation for the symptomatic relief and . management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision.
- . Lumbar support.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IQE
Device Description
The BAXOLVE™ TENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.
The device is intended to provide a non-invasive prescriptive therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back
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)
Non- clinical Tests
Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;
- . IEC 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety.
- . IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- . IEC 61000-4-2:1995: Electromagnetic compatibility
- IEC 61000-4-3:1997: Electromagnetic compatibility
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .
Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.
A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.
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.
NeuroTech© Smart-TENS , Type 456
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
AUG 2 5 2003
510(k) Summary Page 1 of 2
| Image: BMR logo and Bio-Medical Research Ltd address | |||
|---|---|---|---|
| 510 (k) Summary of Safety and Effectiveness. | |||
| This summary is submitted in accordance with 21 CFR 807.92 | |||
| a) | 1 | Submitted by | Bio-Medical Research Ltd |
| BMR House | |||
| Parkmore Business Park, West | |||
| Galway | |||
| Republic of Ireland | |||
| Establishment Registration | |||
| Number | |||
| Contact Person | |||
| Phone | |||
| Fax | |||
| 8020867 | |||
| Michelle Sawyer | |||
| +353 91 774361 | |||
| +353 91 773302 | |||
| msawyer@des.bmr.ie | |||
| Title | |||
| Date of Preparation | Regulatory Affairs Manager | ||
| November 2002. | |||
| 2 | Trade Name of Device | NeuroTech© BAXOLVETM. Type 294. | |
| Common Name | NeuroTech© BAXOLVETM | ||
| Classification name | Transcutaneous Electrical Nerve | ||
| Stimulator.(882.5810) | |||
| 3 | Identification of predicate | ||
| device | NeuroTech© Smart-TENS , Type 456, |
1
Page 2 of 2 510(k) Summary
Description of Device 4
The BAXOLVE™ TENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.
The device is intended to provide a non-invasive prescriptive therapy.
ട Intended Use
The device is indicated for:
- · Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and manaqement of chronic lower back pain.
- · Lumbar support.
Technological Comparison ട
The BAXQLVE™ is similar to the Smart-TENS in it's delivery of the stimulation signal and has similar parameter settings. Both products utilise a LCD screen with user compliance logging.
Non- clinical Tests 7
Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;
- . IEC 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety.
- . IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- . IEC 61000-4-2:1995: Electromagnetic compatibility
- IEC 61000-4-3:1997: Electromagnetic compatibility
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .
Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.
A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
AUG 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michelle Sawyer Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park, West Galway Republic of Ireland
Re: K023913
Trade/Device Name: NeuroTech® BAXOLVE™, Type 294 Regulation Number: 21 CFR 882.5890; 890.3490 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Truncal orthosis Regulatory Class: II Product Code: GZJ, IQE Dated: May 22, 2003 Received: May 27, 2003
Dear Ms. Sawyer:
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.
3
Page 2 - Ms. Michelle Sawyer
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark n Mellem
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Not yet available
Device Name:
NeuroTech© BAXOLVE™ , type 294
Sponsor Name:
Bio-Medical Research Ltd.
KDZ3913
The device is intended for prescriptive use.
Indications for Use:
- Transcutaneous electrical nerve stimulation for the symptomatic relief and . management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision.
- . Lumbar support.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use
Mark N. Milliken
eral, Restorative
510(k) Number.
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