(153 days)
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
- 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
BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover. The BE-550 is intended to be used as an electronic muscle stimulator.
BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.
The provided text is a 510(k) summary for the Besmed 550 and Besmed 660 electrical muscle stimulation devices. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.
Typically, 510(k) submissions for devices like muscle stimulators rely heavily on established standards and direct comparisons to predicate devices for assessing performance and safety. They do not usually involve extensive AI-specific validation studies with ground truth establishment or MRMC studies.
Therefore, for the specific questions requested, much of the information is not available in the provided document, as it outlines a different regulatory pathway (substantial equivalence) compared to what would be required for a novel AI/ML device with performance claims.
Here's a breakdown based on the available information and an explanation of why other information is not present:
Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" in the way one would expect for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC). Instead, the performance assessment is based on technological characteristic equivalence to a predicate device and adherence to general device safety and effectiveness principles.
| Acceptance Criterion | Reported Device Performance (from document) |
|---|---|
| Technological Equivalence | "As can be seen in both the Comparison and Standards sections, the Besmed devices and the BioStim device have similar technological characteristics and are equivalent." (Implies meeting the functional and safety profile of the predicate device). |
| Intended Use Equivalence | The indicated uses for the Besmed devices (Relaxation of muscle spasms, prevention 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) are explicitly stated and aligned with the general class of electrical muscle stimulation devices. |
| Safety and Effectiveness | Implied through substantial equivalence to a legally marketed predicate device (BioStim Digital NMS, K010749) and adherence to general controls (e.g., GMP, labeling). |
Study Details and Missing Information
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document describes a 510(k) submission for an electrical muscle stimulator based on substantial equivalence to a predicate device. It does not mention a "test set" of data for performance evaluation in the context of AI/ML. Performance is inferred through comparison of technological characteristics and intended use.
-
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)
- Not applicable/Not provided. No "ground truth" establishment process is described, as the device is not an AI/ML diagnostic or screening tool requiring such validation.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there is no "test set" in the context of an AI/ML study.
-
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
- No. This is not an AI-assisted device. Therefore, no MRMC study was conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (electrical muscle stimulator), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No specific "ground truth" is discussed for the device's performance, as it is a physical stimulator. Its effectiveness is based on the known physiological effects of electrical muscle stimulation and the equivalence to a legally marketed predicate.
-
The sample size for the training set
- Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.
-
How the ground truth for the training set was established
- Not applicable/Not provided. There is no "training set" or corresponding ground truth establishment described for this device.
Summary Explanation:
The document describes a traditional 510(k) submission for an electrical muscle stimulator. The core of this submission type is to demonstrate that the new device (Besmed 550 and 660) is "substantially equivalent" to a legally marketed predicate device (BioStim Digital NMS). This means showing that the device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the performance evaluation is generally focused on:
- Comparing technical specifications (e.g., output parameters, waveforms) to the predicate.
- Ensuring compliance with relevant electrical safety and biocompatibility standards (though not explicitly detailed in the provided snippet, these are standard requirements for such devices).
- Reviewing the labeling and indications for use to ensure they align with the predicate and are appropriate for the device type.
The questions regarding "acceptance criteria," "test set," "ground truth," "AI assistance," "MRMC studies," and "training sets" are highly relevant for AI/ML-driven medical devices, but they do not apply to the type of device and regulatory submission described in the provided text.
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031820 1/2
Multinational
1223 Wilshire Boulevard, Suite 112 Santa Monica, California 90403 Tel/Fax (310) 393-1749
510(k) SUMMARY
| Submitter's name: | Multinational |
|---|---|
| Address: | 1223 Wilshire Blvd, Ste. 112 |
| Phone: | 310-393-1749 |
| Fax number: | 310-393-1749 |
Name of contact person:
Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-
2821
grace@requlatoryspecialists.com
Date the summary was prepared:
November 4, 2003
| Name of the device: | Besmed 550 and Besmed 660 |
|---|---|
| Trade or proprietary name: | Besmed 550 and Besmed 660 |
| Common or usual name: | Electrical muscle stimulation device |
| Classification name: | Power muscle stimulator (per 21 CFR section 890.5850) |
The leqally marketed device to which we are claiming equivalence [807.92(a)(3)]:
BioStim Digital NMS, manufactured by BioMedical Life Systems. The clearance number is K010749.
Description of the device:
BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.
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K03 820
The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover.
The BE-550 is intended to be used as an electronic muscle stimulator.
BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.
Intended use of the device:
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
-
- 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 5. venous thrombosis
-
- Maintaining or increasing range of motion
Summary of the technological characteristics of our device compared to the predicate device:
As can be seen in both the Comparison and Standards sections, the Besmed devices and the BioStim device have similar technological characteristics and are equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2003
Multinational C/o Ms. Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K031820 Trade Name: BE-550 and BE-660
Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: September 8, 2003 Received: September 10, 2003
Dear Ms. Holland:
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.
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Page 2 - Ms. Grace Holland
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,
Miriam C. Provost
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):
BE-550 and BE-660 Device Name:
Indications For Use:
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation 3.
- ধ: Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent ട്. venous thrombosis
-
- Maintaining or increasing range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative and Neurological Device
510(k) Number K031820
§ 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).