(30 days)
Not Found
No
The device description mentions "advanced signal processing technology" and a "statistical algorithm" to compare responses to a "template of ABRs derived from normal hearing infants." While this involves data processing and comparison, it does not explicitly describe the use of AI or ML techniques like neural networks or deep learning for pattern recognition or prediction. The comparison to a fixed template suggests a more traditional algorithmic approach rather than a learning-based system.
No
The device screens for hearing loss, it does not treat it.
Yes
The device is described as a "Newborn Hearing Screener" used to "screen infants for hearing loss," which falls under the definition of a diagnostic device. It "detects the auditory brainstem response (ABR)" and "uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants," indicating it provides information to assess a medical condition.
No
The device description explicitly mentions hardware components such as the Acoustic Transducer Assembly cable, disposable earphones, sensors, Patient Cable Attachment, and Preamplifier assemblies, which are integral to the device's function.
Based on the provided text, the ALGO 5 Newborn Hearing Screener is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ALGO 5 Function: The ALGO 5 works by detecting the auditory brainstem response (ABR) to sound stimuli delivered to the infant's ears. This involves applying sensors to the infant's skin to pick up electrical signals from the brain. It does not involve analyzing any biological specimens taken from the body.
Therefore, the ALGO 5 is a non-invasive medical device used for screening, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ALGO 5 Newborn Hearing Screener is a mobile, 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 (gestation 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.
The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good heath and about to be discharged from the hospital. A typical screening process. can be completed in 15 minutes or less. Sites appropriate for screening include the wellbaby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.
Product codes
GWJ
Device Description
The ALGO 5 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 5 generates soft clicks at 35 dB nHL or at 40 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones).
Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity.
The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer ear to the brainstem
Indicated Patient Age Range
babies between the ages of 34 weeks (gestation age) and 6 months
Intended User / Care Setting
well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.
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)
Non-clinical Performance Data:
Summaries of design verification and validation are included to demonstrate that the ALGO 5 performs equivalently to the ALGO 3.
Clinical Performance Data:
No clinical performance data are included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ALGO® 3 Newborn Hearing Screener (K013137)
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
Special 510(k): Device Modification Natus Medical ALGO 5 Newborn Hearing Screener
510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
K073665
A. Submitter
Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070
Contact
Tom Boles (650) 801-7262
Date Summary Prepared
January 15, 2008
B. Device Names
Classification Name Common/Usual Name Proprietary Name
Stimulator, Auditory Evoked Response Hearing Screener ALGO® 5 Newborn Hearing Screener
C. Predicate Device:
ALGO® 3 Newborn Hearing Screener (K013137)
D. Device Description
The ALGO 5 detects the auditory brainstem response (ABR) to a series of stimulus clicks ('clicks'), which screens the entire hearing pathway from the outer ear to the brainstem. The ABR is not affected by the status of the middle ear, and evaluation of middle ear status is not required prior to ABR detection. The ALGO 5 generates soft clicks at 35 dB nHL or at 40 dB nHL ('normal hearing level' scale) which are delivered to the infant's ears through an Acoustic Transducer Assembly cable (ATA) to disposable earphones (Flexicouplers™ Disposable Earphones).
Each click evokes a series of identifiable brain waves from the auditory brainstem area of the infant's brain. Sensors (Jelly Tab™ Sensors) applied to the infant's skin pick up the brain wave response and transmit the signals to the screener via the Patient Cable Attachment (PCA) and Preamplifier (Preamp) assemblies. The ALGO 5 uses advanced signal processing technology to separate the ABR from background noise and from other brain activity.
The ALGO 5 uses a statistical algorithm to determine if there is a response to the stimulus, and if a response is detected, whether the response is consistent with a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology, AABR).
E. Intended Use
The ALGO 5 Newborn Hearing Screener is a mobile, 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 (gestation 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.
The screener is simple to operate. It does not require special technical skills or interprefation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good heath and about to be discharged from the hospital. A typical screening process can be
Page A-002
1
Special 510(k): Device Modification Natus Medical ALGO 5 Newbom Hearing Screener
completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.
Contraindications for Use:
Screening infants with known neurologic conditions should be done only under well-informed medical and/or audiological supervision.
F. Comparison with Predicate Device
The ALGO 5 is a hardware and software modification of the ALGO 3 Newborn Hearing Screener. The ALGO 5 and the ALGO 3 have the same intended use and use the same operating principle.
Based on the data and information presented here, the ALGO 5 Newborn Hearing Screener is substantially equivalent to the ALGO 3 Newborn Hearing Screener currently manufactured and distributed by Natus Medical, Inc.
G. Non-clinical Performance Data
Summaries of design verification and validation are included to demonstrate that the ALGO 5 performs equivalently to the ALGO 3.
H. Clinical Performance Data
No clinical performance data are included.
Page A-003
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natus Medical, Incorporated % Mr. Tom Boles QA Manager 1501 Industrial Road San Carlos, California 94070
Re: K073665
Trade/Device Name: ALGO 5 Newborn Hearing Screener Regulation Number: 21 CFR 882. 1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: December 20, 2007 Received: December 26, 2007
Dear Mr. Boles:
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.
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.
3
Page 2 - Mr. Tom Boles
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkinson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Natus Medical ALGO 5 Newborn Hearing Screener
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K073665
Device Name: ALGO 5 Newborn Hearing Screener
Indications for Use:
The ALGO 5 Newborn Hearing Screener is a mobile, 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 (gestation 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.
The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good heath and about to be discharged from the hospital. A typical screening process. can be completed in 15 minutes or less. Sites appropriate for screening include the wellbaby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Michelle A. Millhiser
(Division Sign-Oil) (Division Sign-On)
Division of General, Restorative, Division of Gercal Devices
510(k) Number_
Page A-001