(210 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is consistent with a standard evoked potential device.
Yes
The device is used to determine hearing disorders and aid in diagnosis, which are therapeutic purposes.
Yes
The device description explicitly states, "The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders." Additionally, the intended use section mentions its role "in the determination of hearing disorders," which is a diagnostic function.
No
The description explicitly states the device "produces a sound stimulus," which implies a hardware component is involved in generating the sound. Software alone cannot produce a physical sound stimulus.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- Device Function: The SABRe Compac Auditory Brainstem Response Screener produces a sound stimulus and measures evoked responses. This is a non-invasive procedure that does not involve testing samples taken from the body.
- Intended Use: The intended use is for the determination of hearing disorders by trained professionals, which is a diagnostic process, but not one that relies on in vitro testing.
Therefore, the device falls under the category of a diagnostic device, but specifically an in vivo diagnostic device, as it interacts directly with the patient's body (through sound stimulation and measurement of physiological responses) rather than testing samples outside the body.
N/A
Intended Use / 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.
Product codes
84 GWJ
Device Description
The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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.
2
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
3
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 ________________________________________________________________________________________________________________________________________________________