(217 days)
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.
The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109.
It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.
The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover.
The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.
Acceptance Criteria and Device Performance Study
The provided document describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called the Neurotech MediTENS PLUS, Type 290. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on showing the new device is as safe and effective as a device already on the market, rather than conducting new clinical trials to prove efficacy from scratch.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating substantial equivalence, largely through non-clinical tests and technological comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Safety and Electrical Performance | Compliance with IEC 601-1: 1998 +A1: 1991+ A2: 1995 (Medical Electrical Equipment - General requirements for safety) | Device was designed to and independently tested to these standards. |
| Specific Performance for TENS Devices | Compliance with IEC 601-2-10:1987 (Medical Electrical Equipment - Particular requirements for the safety of nerve and muscle stimulators) | Device was designed to and independently tested to this standard. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 601-1-2:1993 (Medical Electrical Equipment - Safety requirements - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Device was designed to and independently tested to this standard. |
| Quality System Adherence | Adherence to recognized and established industry practices. | Bio-Medical Research LTD adheres to these practices; all devices subject to final performance testing. |
| Risk Management | Hazard analysis, risk analysis, and failure mode effects analysis (FMEA) performed. | These analyses have been carried out for the device. |
| Functional Equivalence | Deliver stimulation signal "almost identical" to predicate device with similar parameter settings. | The MediTENS PLUS delivers a stimulation signal that is "almost identical with similar parameter settings" to the Promax device. |
| Intended Use | Consistent with the predicate device for symptomatic relief of chronic pain and muscle spasm. | The MediTENS PLUS is intended for symptomatic relief of chronic pain and relaxation of muscle spasm, aligning with the general intended uses of TENS devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" with human subjects in the way
a de novo clinical trial would. The evaluation is primarily based on non-clinical (bench) testing and technological comparison. Therefore, details like "sample size used for the test set," "data provenance," "country of origin," or "retrospective/prospective" are not applicable in their traditional sense for this type of submission.
The "test set" referred to in the context of the IEC standards would be the physical device (MediTENS PLUS) itself, subjected to the various electrical, safety, and EMC tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided document does not report on a study involving human experts establishing ground truth for a set of patient data or images. The "ground truth" here is compliance with established engineering and safety standards, verified by independent testing laboratories.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. No human expert adjudication was involved in validating the device's performance against the technical standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through technical comparison and compliance with standards, not on demonstrating improved human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an electrical stimulator, not an AI or algorithmic device that would have "standalone performance" in the context of image analysis or diagnostic support. Therefore, this question is not applicable. The "standalone" performance here refers to the device operating according to its technical specifications, which was assessed through the non-clinical tests.
7. The Type of Ground Truth Used
The "ground truth" for this submission is compliance with recognized international electrical safety and performance standards (IEC standards) and technical equivalence to a legally marketed predicate device.
- IEC 601-1: general safety requirements.
- IEC 601-2-10: specific safety and performance requirements for nerve and muscle stimulators.
- IEC 601-1-2: electromagnetic compatibility.
- Technological comparison: The stimulation signal's parameters and output characteristics were compared to the predicate device to establish functional equivalence.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI or machine learning product that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
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JUL 11 2002
10140200
510(k) Summary of safety and effectiveness.
This summary is submitted in accordance with 21 CFR 807.92
| a) Submitted by | Bio-Medical Research LtdBMR HouseParkmore Business Park. WestGalwayRepublic of Ireland. |
|---|---|
| Contact person | Michelle Sawyer |
| Phone | +353 91 774361 |
| Fax | +353 91 774302 |
| msawyer@des.bmr.ie | |
| Title | Regulatory Affairs Specialist- |
| Date of preparation | 04 December 2001 |
| Trade name of Device | NI MediTENS PLUS |
| Common name | |
| Classification name | Transcutaneous electrical nervestimulator |
| Identification of predicateDevice. | Rehabilicare Promax |
Description of the device.
The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109.
It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.
The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover.
The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.
Built in safety features are clearly outlined in this submission. which greatly reduce the possibility of mis-use.
Page 1 of 2
PM
Q II
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Intended use.
The MediTENS PLUS is intended for use with a wide range of patients. It is intended to effect non-invasive stimulation therapy for the symptomatic relief of chronic pain and relaxation of musele spasm
Fechnological comparison
The MediTENS PLUS is similar to the Promax device in that it delivers a stimulation signal. which is almost identical with similar parameter settings.
Non-clinical tests.
The MediTENS PLUS was designed to. and has been independently tested to IEC 601-1: 1998 +A1: 1991+ A2: 1995. IEC 601-2-10:1987. IEC 601-1-2:1993. Bio-Medical Research LTD adheres to recognised and established industry practices and all devices are subject to final performance testing.
A Hazard analysis. risk analysis and failure mode effects analysis have been carried out for the device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
... 11 2002
Mrs. Michelle Sawyer Bio-Medical Research Ltd. BMR House Parkmore Business Park West Galway, Ireland
Re: K014020
Trade/Device Name: Neurotech MediTENS PLUS, Type 290 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 10, 2002 Received: April 15, 2002
Dear Mrs. 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. Ilsting 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)
{3}------------------------------------------------
Page 2 - Mrs. Sawyer
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stipt Clwodu
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):
Device Name:
Sponsor Name:
Not available
NeuroTech MediTENS PLUS. Type 290.
Bio-Medical Research Ltd. (NeuroTech is a division of Bio-Medical Research Ltd.)
Indications for use.
The MediTENS PLUS is indicated for:
-
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.
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
er- Use
Styph Plurdy
Division S:
(Division Sign-Off) Division of General, Restorative The ablon of General, Resto
510(k) Number_KO14 oz o
§ 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).