BIOMOVE 5000 SYSTEM by CURATRONIC, LTD.

The Biomove 5000 is a powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The following accessories are supplied with the system: Patient Cable, re-usable electrodes (Biotrodes).

AI/ML Overview

The provided 510(k) summary for the Biomove 5000 System does not contain a study that proves the device meets specific acceptance criteria based on performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Biomove 3000 (K042650), in terms of intended use, indications for use, technological characteristics, performance, and user interface.

Therefore, many of the requested sections below cannot be populated as the provided document does not describe a clinical performance study with acceptance criteria.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
No specific performance metrics or thresholds are presented in the document.	The device is stated to be "substantially equivalent" to its predicate in terms of performance characteristics, implying similar safety and effectiveness without quantifiable metrics.

The 510(k) summary states that the Biomove 5000:

"complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables."
"complies with the following recognized standards: IEC 60601-1(1988), including amendments #1(1991), #2(1995); IEC 60601-2-10 (1987)."
"complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999)."

These are regulatory and design compliance statements, not direct performance acceptance criteria from a clinical study.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No clinical test set data is provided.
Data Provenance: Not applicable. No clinical study data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical study data is provided, and therefore no ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set:

Not applicable. No clinical study data 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 muscle stimulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (muscle stimulator), not an algorithm or AI system. Its performance is inherent to its physical and electrical characteristics.

7. The type of ground truth used:

Not applicable. As no clinical performance study demonstrating the device's efficacy against specific clinical outcomes is presented, there is no mention of a "ground truth" (e.g., pathology, extended outcomes) being used for validation. The submission relies on substantial equivalence to a legally marketed predicate.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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K0860787

APR 1 7 2008

510(K) SUMMARY

Biomove 5000 System

510(k) Number K_

A. Applicant's Name: Curatronic Ltd.

4 Atsmon Street. Hashmonaim 73127, Israel Tel.: +972-8-9761441 Fax .: +972-8-9762020 e-mail: philipson@curatronic.com

Ofer Hornick M.D. B. Contact Person: A. Stein - Regulatory Affairs Consulting 20 Ha'Ta'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 February 2008 C. Date Prepared:

Biomove 5000 System D. Trade Name:

Name: stimulator, muscle, powered E. Classification: Product Code: IPF Regulation No: 890.5850 Class': II Panel: Physical Medicine

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F. Predicate Devices: The Biomove 5000 is substantially equivalent to the Biomove 3000 device manufactured by the same company and cleared under number K042650 in terms of intended use, indications for use, technological characteristics, performance and user interface.
Both predicate devices are Class II medical devices.

A discussion of substantial equivalence is provided in this submission.

G. Device Description: The Biomove 5000 is a powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke.
The following accessories are supplied with the system: Patient Cable, re-usable electrodes (Biotrodes).

H. Intended Use / Indication for Use: The Biomove 5000 is indicated for:

1. Stroke Rehabilitation by Muscle Re-education
1. Prevention of retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion
I. Performance Standards: The Biomove 5000 complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables.

The device complies with the following recognized standards:

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IEC 60601-1(1988), including amendments #1(1991), . #2(1995)
IEC 60601-2-10 (1987) �

The device complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999).

J. Technological Characteristics: The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Biomove 5000 device are substantially equivalent to the predicate device cited above.
K. Substantial Equivalence: The Biomove 5000 System is substantially equivalent to its predicate device as cited above and raises no new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2008

Curatronic, Limited % Ms. Ahava Stein Regulatory Affairs Consulting 20 Hata'as Street Kfar Saba 44425 Israel

Re: K080787

Trade/Device Name: Biomove 5000 system Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator. Regulatory Class: Class II Product Code: IPF Dated: March 16, 2008 Received: March 20, 2008

Dear Ms. Stein:

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

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Page 2 - Ms. Ahava Stein

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. 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark N Millman

Mark N. Melkerson 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): _ K 080787

Device Name: Biomove 5000 System.

Indications for Use:

The Biomove 5000 is indicated for:

1. Stroke Rehabilitation by Muscle Re-education
1. Prevention of retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) AP 111

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K090787

136

Regulation Number and Section

§ 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).