(275 days)
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
(EMS) Electrical Neuromuscular Stimulator For Muscle Reeducation - Class II Model BMLS02-5
The provided text is a 510(k) premarket notification approval letter for an Electrical Neuromuscular Stimulator (EMS) device (Model BMLS02-5). This document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or diagnostic accuracy study.
Instead, the letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The "Indications for Use" section (Attachment VIII) describes the therapeutic purposes of the device, which are typical for an EMS (e.g., muscle reeducation, relaxation of muscle spasm, prevention of disuse atrophy).
Therefore, I cannot provide the requested information as it is not present in the given document. The document describes a regulatory approval process based on substantial equivalence, not a clinical study assessing predefined acceptance criteria against device performance metrics like sensitivity, specificity, or AUC using a test set with expert ground truth.
To reiterate, the provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for a test set, data provenance, or training set size.
- Details about experts establishing ground truth or adjudication methods.
- Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used in the context of a diagnostic study.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a bowl. The emblem is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
FEB 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Saxon President BioMedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360
Re: K021588
Trade/Device Name: ELECTRO NEUROMUSCULAR STIMULATOR Model BMLS02-5 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 20, 2002 Received: November 26, 2002
Dear Mr. Saxon:
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.
{1}------------------------------------------------
Page 2 - Mr. Richard Saxon
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) 594-4639. 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,
R. Mark N. Milliman
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
{2}------------------------------------------------
ATTACHMENT VIII
Page 1 of 1
| 510(k) Number (if known): | K021588 |
|---|---|
| Device Name: | (EMS) Electrical Neuromuscular StimulatorFor Muscle Reeducation - Class IIModel BMLS02-5 |
| Indications for Use: | External electrical neuromuscular stimulation using biphasic output is indicated astherapeutic adjunct for: prevention or retardation of muscle disuse atrophy;relaxation of muscle spasm; muscle reeducation; maintaining and increasing therange of motion; increasing local blood circulation and as immediate postsurgicalstimulation of calf muscles to prevent venous thrombosis. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
ﺮ ﺍﻟﻤﺪﻳﻨﺔ
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Miller(Optional Format 3-10-98)
Division Sign-Off
. 286 httive
510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------
and Neurological Devices
§ 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).