(26 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the technology described (AABR) is a standard audiological technique.
No.
The device is used for screening hearing loss, not for treatment or therapy.
Yes
Explanation: The device is described as a "Newborn Hearing Screener," which is used to "screen infants for hearing loss." Screening is a form of early detection to identify potential health problems, which falls under the purview of diagnostic activities.
No
The device description explicitly states it is a "portable, noninvasive instrument," indicating it is a hardware device, not software only.
Based on the provided information, the ALGO® 3i Newborn Hearing Screener is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ALGO® 3i Newborn Hearing Screener is described as a noninvasive instrument that screens infants for hearing loss by using AABR® technology. This technology involves measuring the brain's response to sounds, which is a physiological measurement, not an analysis of a biological specimen.
Therefore, the device falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
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.
Product codes
GWJ
Device Description
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.
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
babies between the ages of 34 weeks (gestational age) and 6 months
Intended User / Care Setting
Not Found
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
Intended Use:
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.
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
1
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.
2
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
3
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