(210 days)
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.
The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.
Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the SABRe Compac Auditory Brainstem Response Screener, which primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the text is missing:
- A table of acceptance criteria and reported device performance: There are no specific performance metrics or thresholds mentioned for the device.
- Sample size used for the test set and data provenance: The document does not describe any specific test set or the characteristics of the data used for testing.
- Number of experts used to establish ground truth and their qualifications: This information is not present.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no indication of such a study being conducted or its results.
- Standalone (algorithm-only) performance: The device is described as an "evoked potential device" and "Screener" for use by "trained professionals," suggesting it's generally a diagnostic tool, but no standalone algorithmic performance is detailed.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned as there's no description of an AI/ML algorithm being "trained" in the typical sense.
- How ground truth for the training set was established: Not applicable given the lack of training set information.
The core of the provided text is about the device's intended use and its substantial equivalence to a previously cleared device (SLE SABRE ABR Screener, K993177). This type of submission relies on demonstrating that the new device has similar technological characteristics and performs comparably to an already approved device, rather than presenting a full de novo study with detailed performance metrics against specific acceptance criteria.
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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 ________________________________________________________________________________________________________________________________________________________
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).