Relax muscle spasms
Prevent or retard disuse atrophy
Maintain or increase range of motion
Increase local blood circulation
Re-educate muscle
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Pain Relief, Interferential Current Modality
Relieve acute pain
Relieve and manage chronic pain

Device Description

The RS-4i device family consists of a hardware/software system that is identical to its predicate device (the RS-4M+ device family K100114). The RS-4i device family manufacturing process has been changed to a Surface Mount process and components. The RS-4i device family includes a 'Pattern Stimulation' modality that allows sequential 'pattern' output of the standard muscle stimulation pulses.
The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

AI/ML Overview

The provided document is a 510(k) summary for the RS-4i Muscle Stimulator family. It describes the device, its indications for use, and declares substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This type of premarket notification for a Class II device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with detailed performance metrics against pre-defined acceptance criteria.

The key points from the provided text are:

Predicate Device: The RS-4i family is substantially equivalent to its legally marketed predecessor, the RS-4M+ (K000114) muscle stimulator.
Device Changes: The primary changes are a manufacturing process change to Surface Mount technology and components, and the addition of a 'Pattern Stimulation' modality.
Performance Specifications: The document lists technical specifications (e.g., peak voltage, mA, pulse width, frequency for muscle stimulation; mA peak for interferential modality) but these are device specifications, not acceptance criteria for a clinical outcome study.

Therefore, based on the provided text, I cannot complete the requested tables and information. A 510(k) submission for a device like this typically relies on bench testing and comparisons to the predicate's technical specifications and safety profile, rather than extensive clinical efficacy trials with predefined acceptance criteria and human expert evaluation in the way you've described.

A 510(k) submission is generally intended to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not typically require a new clinical study to establish "acceptance criteria" for clinical performance in the way a PMA (Pre-Market Approval) or a de novo classification might.

If this were a PMA or a de novo application, or if the FDA had required specific clinical data beyond substantial equivalence, then the document would contain the type of information you're asking for.

In summary, the provided document does not contain the information required to populate your requested table and study details.

Summary

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Ko 32652 1/2

Premarket Notification RS Medical RS-4i

SEP 1 2 2003

510(k) SUMMARY RS-4i family July 15, 2003

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87.

1. Applicant, Official Correspondent and Owner of 510(k)

RS Medical 14401 SE First St. Vancouver, WA 98684

Attn: Mike McGraw, Vice President, Product Development Telephone: (360) 896-2503 Fax: (306) 896-2566

Submitter of 510(k) and Consultants

Underwriters Laboratories Inc. 2600 NW Lake Road Camas, WA 98607-8542 Telephone: (360) 817-5515 Fax: (360) 817-6133

2. Name of Device

Trade/Proprietary Name: RS-4i Muscle Stimulator family

Common/Usual Name: Muscle and Interferential Current Stimulator

Classification Name: 21 CFR 890.5850 "Powered Muscle Stimulator", Class II.

3. Legally Market Predicate Devices

The RS-4i family is substantially equivalent to its legally marketed predecessor the RS-4M+ (K000114) muscle stimulator.

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KO32652

2/2

Premarket Notification RS Medical RS-4!

4. Indications for Use

Muscle Stimulation, Interferential and Non-Interferential Modality

Relax muscle spasms ●
Prevent or retard disuse atrophy .
Maintain or increase range of motion ●
Increase local blood circulation ●
Re-educate muscle ●
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Pain Relief, Interferential Current Modality

Relieve acute pain ●
Relieve and manage chronic pain .

5. Device Description and Substantial Equivalence

The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.

The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.

The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.

Public Health Service

SEP 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RS Medical c/o Mr. Marc M. Mouser Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607

Re: K032652

Trade/Device Name: RS-4i Muscle Stimulator family Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH Dated: August 21, 2003 Received: August 28, 2003

Dear Mr. Mouser:

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 – Mr. Marc M. Mouser

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

ar 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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Premarket Notification RS Medical RS-4i

Premarket Notification

Indications For Use

Device Name: RS-4i Muscle Stimulator family

Indications For Use:

Muscle Stimulation, Interferential and Non-Interferential Modality

Relax muscle spasms ●
Prevent or retard disuse atrophy ●
Maintain or increase range of motion ●
Increase local blood circulation
Re-educate muscle ●
Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis

Pain Relief, Interferential Current Modality

Relieve acute pain ●
. Relieve and manage chronic pain

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter:

(Optional Format 1-2-96)

Miriam L. Provost

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

510(k) Number K632652
-17-

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).