SABRE COMPAC

K011842 · Sle Limited · GWJ · Jan 8, 2002 · Neurology

Device Facts

• Record ID: K011842
• Device Name: SABRE COMPAC
• Applicant: Sle Limited
• Product Code: GWJ · Neurology
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2

Intended Use

The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.

Device Story

The SABRe Compac is an evoked potential device used for hearing disorder diagnosis. It functions by producing sound stimuli to elicit auditory evoked responses. Operated by trained professionals in clinical settings, the device measures these responses to assist in the determination of hearing disorders. It serves as a diagnostic tool for healthcare providers to assess patient auditory function.

Technological Characteristics

Evoked potential device; produces sound stimuli for evoked response measurements. Specific materials, dimensions, and software architecture are not detailed in the provided documentation.

Indications for Use

Indicated for use by trained professionals for the determination of hearing disorders via evoked response measurements.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• SLE SABRE ABR Screener (K993177)

Submission Summary (Full Text)

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K011842

## 8 2002 JAN

## 510(K) SUMMARY

Manufacturer:

SLE Limited Diagnostics Group Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom

Submitted By:

Ferguson Medical Consultant to SLE

Stimulator, Auditory, Evoked Response Classification Name:

- Hearing Screener, Auditory Screener, Auditory Common/Usual Name: Brainstem Response Screener, and others.
- Proprietary Name: SABRe Compac

Classification Number: 21 CFR 882.1900/Procode: 84 GWJ

SLE SABRE ABR Screener (K993177) Substantial Equivalence:

Device Description: The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.

- The SABRe Compac Auditory Brainstem Response Screener Intended Use: is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.
Technological Characteristics: The SABRe Compac ABR device is similar in its intended use to predicate devices and existent methodologies.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 JAN

SLE Limited c/o Frank Ferguson Ferguson Medical P. O. Box 12038 La Jolla, California 92039-2038

Re: K011842 Trade Name: SABRe Compac Regulation Number: 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: II Product Code: GWJ Dated: November 25, 2001 Received: December 10, 2001

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket 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) 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. Frank Ferguson

This letter will allow you to begin marketing your device as described in your Section Fills letter will anow you to began a Finding of substantial equivalence of your 510(k) premiation nourceation. The 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 II you desire specific ad 1100 for in vitro diagnostic devices), please contact the and additionally 21 OFF are 004-4659. Additionally, for questions on the promotion Office of Comphance at (evice, please contact the Office of Compliance at (301) 594and advertising of your do regulation entitled, (Misbranding by reference to premation 4059. Also, prease note all regariances information on your responsibilities nourceation((210) {{210} {{ } {{ } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its aller Collistmer I issuese ank http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rhodes

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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510(k) Number (If known): Koll & 4 L

Device Name: SABRe Compac

Indications For Use:

The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyatt Riveles

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use __ XX -(Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________