(85 days)
The SABRE 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 evaluation of hearing function.
The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.
The provided 510(k) summary for the SABRE Auditory Brainstem Response Screener does not contain information regarding detailed acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or comparative effectiveness with human readers. The document is primarily focused on establishing substantial equivalence to predicate devices based on intended use and technological characteristics.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: Not available.
- Sample size used for the test set and data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
- Adjudication method for the test set: Not available.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available.
- Standalone (algorithm-only) performance: Not available.
- Type of ground truth used: Not available.
- Sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document states that the SABRE ABR device is "similar in its intended use to predicate devices and existent methodologies," implying that its performance is expected to be comparable to these established devices, rather than being demonstrated through a detailed independent study described within this summary.
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NOV I 6 1999
K99 3177
510(K) Summary
Manufacturer :
SLE Limited Diagnostics Group Twin Bridges Rusiness Park 232 Seledon Road South Croydon Surrey CR2 6PL United Kingdom
Forguson Medical Submitted By: Consultant to SLE
Classification Name: Stimulator, Auditory, Evoked Response .
Common/Usual Namc: Hearing Screener, Auditory Screener, Auditory Brainstem Response Analyzer, and others.
Proprietary Name: SARKE
21 CFR 882.1900/Procode: 84 GWJ Classification Number:
- Substantial Equivalence: Natus Medical, Inc. Algo-2 Newborn Hearing Screener (K936093), Sonamed Corporation Clarity System II (K952080), Intelligent Hearing Systems SmartScreener (K925648), and others.
Device Description: The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.
The SABRE 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 evaluation of hearing function.
Tachnological Characteristics: The SABRE 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
NOV 1 6 1999
SLE Limited c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 8524 Villa La Jolla Drive, Suite 161 La Jolla, California 92037
Re: K993177
Trade Name: SABRE Auditory Brainstorm Response Screener Regulatory Class: II Product Code: GWJ Dated: August 22, 1999 Received: August 23, 1999
Dear Mr. Ferguson:
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 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 (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 the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 regulations.
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Page 2 - Mr. Frank Ferguson
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stipt. Rhodes
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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K993177 510(k) Number (If known):
SABRE Device Name:
Indications For Use:
The SABRE Auditory Brainstem Response Screener is a device that produces a sound stimulus for It is use in evoked response measurements. intended to be used by trained professionals in the evaluation of hearing function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stut. Rluds
(Division Sign-Off) Division of General Restorative Devices K993177 510(k) Number _
Prescription Use ਸੰਸ (Fer 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
§ 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).