EV-807P Electrical Muscle Stimulator is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:

Relaxing muscle spasms -
Increasing local blood circulation. ﻤ
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. -
Muscle re-education. -
Maintaining or increasing range of motion -
Preventing or retarding disuse atrophy -

Device Description

The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications including linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case. The modifications of the predicate device make the stimulation even more comfortable and effective.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Neuromuscular Electrical Stimulator (EV-807P). The submission claims substantial equivalence to a predicate device (Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd., 510k# K020750) rather than presenting a de novo device with acceptance criteria and a study proving performance against those criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission strategy relies on demonstrating that the modified device (EV-807P) is "safe and effective as the predicate device" through a comparison of technological characteristics.

Here's how the document addresses the concept of "performance" in the context of substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity). The concept of "acceptance" here relates to demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The document states that "Performance" of the EV-807P is "Similar" to the predicate device (K020750) in the "Summary comparing technological characteristics with other predicate device" table. No specific performance data or quantitative metrics are provided.

The following points (2-9) are not applicable as no performance study was conducted or reported in this 510(k) submission.

Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 (the device is an electrical stimulator, not an AI-assisted diagnostic tool).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of the document's argument for safety and effectiveness:

The submission focuses entirely on demonstrating "substantial equivalence" to a previously cleared device (K020750). The modifications to the device are described as "linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case." The submitter argues these modifications make the stimulation "even more comfortable and effective" but provides no new data or studies to support this claim or any specific performance metrics. Instead, it relies on the predicate device's existing safety and effectiveness determination.

The FDA's letter concurs with the substantial equivalence determination, allowing the device to be marketed based on its equivalence to the predicate, rather than on new performance criteria and studies for the modified device.

Summary

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K033140

OCT 2 9 2003

As Required by 21 section 807.92 ( c )

510(k) Summarv

Everyway Medical Instruments Co., Ltd 1-Submitter Name:

3FL. No.5. LANE 155. Sec. 3. Peishen Rd 2-Address:
- Shen Keng Hsiang. Taipei Hsien. Taiwan (ROC)
(770) 777- 4146 3-Phone:

(678) 623- 3765 4-Fax:

Mr Robert Tu (General Manager) 5-Contact Person:

6-Date summary prepared: September 25th, 2003
7 Official Correspondent: Mansour Consulting LLC
8- Address: 1308 Morningside Park Dr. Alpharetta, GA 30022 USA
9- Phone: 770-777-4146

10- Fax: 678-623-3765

11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name: Neuromuscular Electrical Stimulator

13-Device Common or usual name: EMS

14-Device Classification Name: Stimulator, muscle, powered
15-Substantial Equivalency is claimed against the following device:
- Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. . 510k# K020750

16-Description of the Device:

The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, operating principles for the changed devices are equivalent to those of the predicate device.

17-Intended use of the device: (refer to FDA form attached)

Relaxing muscle spasms -
Increasing local blood circulation. ﻤ
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. -
Muscle re-education. -
Maintaining or increasing range of motion -
Preventing or retarding disuse atrophy -

18-Safety and Effectiveness of the device:

This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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19-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that EV-807P is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.

FDA file reference number	510k # of predicate : K020750
Attachments inside notification submission file	510k summary print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Nor Applicable
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Not Applicable
Anatomical sites	Not Applicable
Human factors	Not Applicable
Energy used and/or delivered	Similar
Compatibility with environment and other	Identical
devices
Where used	Identical
Standards met	Identical
Electrical safety	Identical
Thermal safety	Identical.
Radiation safety	Not Applicable.

Detailed technical comparison is included within main submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.

Public Health Service

OCT 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everyway Medical Instruments Co., Ltd. C/o Mr. Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K033140

Trade/Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 25, 2003 Received: September 30, 2003

Dear Mr. Mansour:

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 (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.

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Page 2 - Mr. Jay Mansour, MSQA, BE, LA, RAC

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.

sincerely yours,

Mark N Millman

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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Page 1 of

510(k) Number (if known): 1633191

Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator)

Indications for Use:

Relaxing muscle spasms -
Increasing local blood circulation. -
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Muscle re-education. -
Maintaining or increasing range of motion -
Preventing or retarding disuse atrophy -

Marti A. Milkman

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

(033140 510(k) Number -

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

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

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).