The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

Device Description

The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses Natus AABR® technology. The ALGO 3i Newborn Hearing Screener is a modification of the ALGO 3 Newborn Hearing Screener. The ALGO 3i and the ALGO 3 Newborn Hearing Screeners have the same intended use and use the same operating principle. The new device performs and is specified within all performance parameters of the predicate device.

AI/ML Overview

The provided 510(k) summary for the ALGO® 3i Newborn Hearing Screener (K030823) explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

Therefore, based on the provided document, the device did not undergo a study to demonstrate its performance against specific acceptance criteria. The submission indicates that the device is a modification of the ALGO 3 Newborn Hearing Screener (K013137) and that it "performs and is specified within all performance parameters of the predicate device." This implies that its acceptance was based on its substantial equivalence to the predicate, rather than new performance data.

Therefore, the following information cannot be extracted from the provided document:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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Ko3a823

510(k) Summary

APR 0 9 2003

Submitter:

Natus Medical, Inc. 1501 Industrial Road San Carlos, CA 94070

Contact:

Ronald Kohlhardt

Date Summary Prepared: March 9, 2003

Device Trade Name:

Classification name	Stimulator, Auditory Evoked Response
Common/usual name	Hearing Screener
Proprietary name	ALGO® 3i Newborn Hearing Screener
Predicate Device:	ALGO 3 Newborn Hearing Screener,

Predicate Device:

K013137

Intended Use:

Comparison with the Predicate Device:

The ALGO 3i Newborn Hearing Screener is a modification of the ALGO 3 Newborn Hearing Screener. The ALGO 3i and the ALGO 3 Newborn Hearing Screeners have the same intended use and use the same operating principle. The new device performs and is specified within all performance parameters of the predicate device.

Nonclinical Performance Data: None

Clinical Performance Data: None

Additional Information: None

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black lines. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald Kohlhardt Director, Regulatory Affairs/Quality Assurance Natus Medical, Inc. 1501 Industrial Road San Carlos, California 94070

Re: K030823

Trade/Device Name: ALGO® 3i Newborn Hearing Screener Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated: March 13, 2003 Received: March 14, 2003

Dear Mr. Kohlhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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.

APR 0 9 2003

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. Ronald Kohlhardt

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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Kosof2 510(k) Number (if known): pending

Device Name: ALGO® 3i Newborn Hearing Screener

Indications for Use:

The ALGO® 31 Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

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

K030823 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR Use __________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter

(Per 21 CFR 801.109)

(Optional Format 1-2-96

Regulation Number and Section

§ 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).