(217 days)
The MediStim PLUS is indicated for:
- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education .
- Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis
- Maintaining or increasing range of motion.
The MediStim PLUS is a portable two-channel battery operated neuromuscular electrical stimulator. The device is intended for prescriptive use per 21 CFR 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 (type 6/22) battery located in a compartment to the rear of the device with a detachable batterv cover. The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.
The provided text describes a powered muscle stimulator, the MediStim PLUS, and its regulatory submission (510(k)). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document details the device's technical specifications and safety standards it was tested against (IEC 601-1, IEC 601-2-10, IEC 601-1-2), but it does not specify clinical "acceptance criteria" (e.g., a certain percentage of muscle re-education success) or comparative performance data against these criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing. The document mentions "non-clinical tests" and adherence to "recognised and established industry practices" for final performance testing, but it does not describe any clinical test sets, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Missing. No information on expert involvement for establishing ground truth is provided, as no clinical test set details are available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information on any adjudication method is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to "human readers" or "AI assistance" is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device with no mention of an algorithm or AI component for standalone performance evaluation in the context of what is typically considered "AI device" standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing. As no clinical test data or methodology is described, the type of ground truth used is not mentioned. The document primarily focuses on electrical safety and performance standards.
8. The sample size for the training set
- Not applicable / Missing. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Missing. Correspondingly, no information on establishing ground truth for a training set is provided.
Summary of available information regarding compliance:
The document states that the MediStim PLUS:
- Was designed to and independently tested to:
- IEC 601-1: 1998 +A1: 1991+ A2: 1995 (General requirements for safety)
- IEC 601-2-10:1987 (Particular requirements for the safety of nerve and muscle stimulators)
- IEC 601-1-2:1993 (Electromagnetic compatibility issues)
- Adheres to recognized and established industry practices.
- Is subject to final performance testing.
- Underwent Hazard analysis, risk analysis, and failure mode effects analysis.
These are non-clinical performance and safety criteria that the device aims to meet. The study proving these were met is the independent testing to the listed IEC standards, along with internal final performance testing and risk analyses. However, the exact data from these tests (e.g., specific measured voltage outputs, current limits, EMI resilience levels) are not provided in this summary. The FDA's 510(k) clearance (K014019) confirms their review of this evidence and a determination of substantial equivalence to a predicate device (Staodyn EMS +2), implying these non-clinical criteria were satisfactorily addressed for market clearance.
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JUL 11 2002
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 | NT MediStim PLUS |
| Common name | Powered muscle stimulator |
| Classification name | External functional neuromuscularstimulator |
| Identification of predicateDevice. | Staodyn EMS +2 |
Description of the device.
The MediStim PLUS is a portable two-channel battery operated neuromuscular electrical stimulator. The device is intended for prescriptive use per 21 CFR 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 (type 6/22) battery located in a compartment to the rear of the device with a detachable batterv 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
SKI
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Intended use.
The MediStim PLUS is intended for use with a wide range of patients, some of who may have limited dexterity. It is intended to use the principles of neuromuscular electrical nerve stimulation through skin contact surface electrodes for the purpose of activation of weak and atrophied muscles or the inhibition of overactive muscle.
「echnological comparison.
The MediStim PLUS is similar to the EMS+2 in that it delivers a stimulation signal. which is almost identical with similar parameter settings. The MediStim PLUS has an LCD screen with user compliance monitoring, where as the EMS+2 does not have this feature.
Non-clinical tests.
The MediStim 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.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11 2002
Mrs. Michelle Sawyer Bio-Medical Research Ltd. BMR House Parkmore Business Park West Galway, Ireland
Re: K014019
Trade/Device Name: Neurotech Medstim PLUS, Type 291 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF 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, 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)
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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,
Styph Rhodes
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
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Indications for use statement
510(k) number (if known):
Not available
014019
Device Name:
NeuroTech MediStim PLUS, Type 291.
Sponsor Name:
Bio-Medical Research Ltd. (NeuroTech is a division of Bio-Medical Research Ltd.)
Indications for use.
The MediStim PLUS is indicated for:
- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy �
- Increasing local blood circulation �
- Muscle re-education .
- Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis
- Maintaining or increasing range of motion.
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
Styph Clurle
Division of General, Restorative and Neurological Devices
510(k) Number_ 5014019
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).