MODEL PS-1 PENA MUSCLE STIMULATOR

K980448 · Radionics, Inc. · IPF · Apr 3, 1998 · Physical Medicine

Device Facts

• Record ID: K980448
• Device Name: MODEL PS-1 PENA MUSCLE STIMULATOR
• Applicant: Radionics, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to identify striated muscle in the treatment of high and low anorectal malformations

Device Story

Model PS-1 Peña Muscle Stimulator; electrical stimulator used to identify striated muscle during anal reconstruction procedures for high and low anorectal malformations. Device provides electrical stimulation to assist surgeons in locating specific muscle groups. Includes audio indicators for functional status and battery test function for pre-use verification. Operated by clinicians in surgical settings. Output assists in surgical decision-making by confirming muscle location, potentially improving surgical outcomes for patients with anorectal malformations.

Clinical Evidence

Bench testing only. System and unit testing results verify safety and reliability of the device, including audio indicators and battery test functionality.

Technological Characteristics

Electrical muscle stimulator; constant current stimulation; includes audio indicators for functional status and battery test circuitry. No specific materials or software algorithm class specified.

Indications for Use

Indicated for use as an adjunct in the treatment of high and low anorectal malformations to identify striated muscles for use in anal reconstructions. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Radionics Model 433-A General Hospital Stimulator
• P.B. Services Model A-200 Constant Current Peripheral Nerve Stimulator

Submission Summary (Full Text)

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### Model PS-1 Peña Muscle Stimulator 510(k)

APR - 3 1998 980448

#### Appendix A: Summary of Safety and Effectiveness

# General Information

| Classification: | Class II |
|---------------------------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Muscle Stimulator |
| Device Trade Name: | Model PS-1 Peña Muscle Stimulator |
| Intended Uses: | Used to identify striated muscle in the<br>treatment of high and low anorectal<br>malformations |
| Predicate Devices: | Radionics Model 433-A General Hospital<br>Stimulator<br>P.B. Services Model A-200 |
| Establishment Name and<br>Address: | Radionics, Inc.<br>22 Terry Avenue<br>Burlington, MA 01803 |
| Contact Name and Phone | Nichole Riek, [phone] ext. 274 |
| Establishment Registration<br>Number: | 1222895 |
| Performance Standards: | None established under Section 514 |

### Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

### Safety Summary

The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable. Audio indicators inform the user that the unit is properly functioning. In addition, a battery test function allows the user to check the batteries prior to use.

### General Safety and Effectiveness Concerns

The device labeling contains Instructions for Use which include indications for use, cautions and warnings as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the device.

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## Description of the Device and Basis for Substantial Equivalence

The PS-1 Peña Muscle Stimulator, addressed in this premarket notification, has the same technological characteristics as the commercially available Radionics Model 433-A General Hospital Stimulator and the P. B. Services Model A-200 Constant Current Peripheral Nerve Stimulator. Like these devices, the PS-1 is intended to be used as a stimulator.

Radionics' opinion with regards to substantial equivalence is based on the fact that the PS-1 complies with the same or equivalent requirements or standards as the above predicate devices. The design of the stimulating circuitry raises no new safety or effectiveness concerns. Radioncs believes that the information and testing provided in this premarket notification clearly describe the PS-1 Peña Muscle Stimulator and demonstrate that it is as safe and effective as the aforementioned predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Ms. Nichole Riek Regulatory Associate Radionics, Inc. P.O. Box 438 22 Terry Avenue 01803 Burlington, Massachusetts

K980448 Re: Model PS-1 Peña Muscle Stimulator Requlatory Class: II Product Code: IPF Dated: February 3, 1998 February 5, 1998 Received:

Dear Ms. Riek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with manne the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Nichole Riek

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Celia M. Whitton, Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Model PS-1 Peña Muscle Stimulator 510(k)

#### Indications for Use Section II:

# Indications for Use:

The PS-1 is indicated for use as an adjunct in the treatment of high and low anorectal The FS-I is indicated for be as an adjurier in the aboutinated muscles to be used in anal reconstructions.

Prescription Use
(Per 21 CFR 801.109)

Acosta

(Division Sign-Off) Division of General Re 510(k) Numbe