ALGO 3 NEWBORN HEARING SCREENER

K013137 · Natus Medical, Inc. · GWJ · Oct 16, 2001 · Neurology

Device Facts

• Record ID: K013137
• Device Name: ALGO 3 NEWBORN HEARING SCREENER
• Applicant: Natus Medical, Inc.
• Product Code: GWJ · Neurology
• Decision Date: Oct 16, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ALGO® 3 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 (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. 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 health 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 well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Device Story

ALGO 3 screens for hearing loss by detecting auditory brainstem response (ABR). Device generates 35 or 40 dB nHL stimulus clicks delivered via transducer to infant ears; sensors on skin capture brain wave responses. System uses automated signal processing to isolate ABR from background noise; compares response to template derived from normal-hearing infants. Operates in nurseries, NICUs, or clinics; used by trained non-medical personnel. Output is binary 'PASS' or 'REFER' result printed for medical chart. No user-adjustable parameters; click rate, intensity, and thresholds are pre-programmed. Integrated software tracks data and generates reports. Benefits include objective, non-invasive, rapid screening without requiring specialized interpretation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate device.

Technological Characteristics

Mobile system comprising laptop, printer, and cable assemblies (ATA, PCA, Preamp). Uses disposable FlexiCouplers earphones and Jelly Tab sensors. Employs automated auditory brainstem response (AABR) technology. Pre-programmed screening parameters (click rate, intensity, impedance/noise thresholds). Software-based signal processing for ABR detection. Standalone operation with integrated data tracking software.

Indications for Use

Indicated for hearing loss screening in infants aged 34 weeks gestational age to 6 months. Patients must be medically stable for hospital discharge and in a quiet or asleep state during screening.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• ALGO-2 Newborn Hearing Screener (KA36039)

Submission Summary (Full Text)

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OCT 1 6 2001

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ K013137

#### Submitter: A.

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

phone: [phone] [phone] fax:

Contact: Sheila Ramerman

Date Prepared: October 12, 2001

## B. Device Names:

| Classification name | Stimulator, Auditory Evoked Response |
|---------------------|--------------------------------------|
| Common/usual name | Hearing Screener |
| Proprietary name | ALGO® 3 Newborn Hearing Screener |

- C. Predicate Device:
ALGO-2 Newborn Hearing Screener, KA36039

#### D. Device Description:

Like the predicate device, the ALGO 3 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 3 generates soft clicks at 35 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); a 35 dB nHL stimulus will detect a 30 dB nHL hearing loss. 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 screener uses advanced signal processing technology to separate the ABR from background noise and from other

Natus Medical Inc. 1501 Industrial Road, San Carlos, CA94070-4111 650-802-0400 FAX [phone]

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brain activity. The ALGO 3 automatically compares the baby's ABR to a template of ABRs derived from normal hearing infants (automated auditory brainstem response technology), denved from normal learing analis (actornation a different is printed if the ALGO 3
AABR), and prints a "PASS" or "REFER" result. A "PASS" result is printed in the AADN), and prints a - 1785 - or - 100. mfidence, that an ABR is present and consistent with its template. A "REFER" result is printed if the ALGO 3 cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template. A builten with sufficient statistical volinesive or self-adhesive label, which can be affixed directly to the infant's medical chart.

The ALGO 3 is also capable of screening using clicks at 40 dB nHL. Some newborn hearing The 2000 5 is also capable of the (international programs, for example), and some programs profer to belocit ar to we the screening threshold at 40 dB nHL rather than at 35. The incorporation of a 40 dB screening application in the ALGO 3 device makes the device more useful to more users.

The ALGO 3 device is easy enough for trained volunteers and other trained non-medical personnel to use. Interpretation of screening results is not required, as the screener automatically determines if the response is consist with a template and automatically generates a "PASS" or "REFER" result, as previously discussed. In addition, training is minimal because of the easy-to-navigate graphical user interface, HELP topics in software, and a user tutorial in the ALGO 3 software.

Screening results can be tracked using the integrated ALGO DataBook® NHS Data Tracking System software. The DataBook utility retrieves and displays patient and screening data stored in ALGO 3 software. Data can be viewed on the ALGO 3's display; can be saved as an ASCII file on diskette for data management and reporting purposes; and can be exported to other databases for data management and reporting purposes.

There are no user-adjustable parameters, so that each screen is performed under exactly the same conditions. Click rate, click intensity, impedance threshold, and noise rejection thresholds are all pre-programmed into the device software, and users cannot change these screening parameters.

The ALGO 3 is composed of the following components, as is the Predicate Device:

- Screening module, with laptop computer �
- . Printer module, with label printer
- Cable assemblies (ATA, PCA, Preamp) .
- Cart for transport and component storage .
- Screening and accessory supplies 방

Accessories available for use with the ALGO 3 include single-use, disposable FlexiCouplers Disposable Earphones, and single-use, disposable Jelly Tab Sensors.

#### E. Intended Use:

The ALGO® 3 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 (gestational age) and 6 months. Babies

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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 The solconer is smiple to openate. Annoment is sufficient to learn how to screen infants who of results. Dasie anning out to be discharged from the hospital. A typical screening process are in good neard and about to oc also. Sites appropriate for screening include the wellbaby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

### Comparison with the Predicate Device: F.

The ALGO 3 Newborn Hearing Screener is a hardware, software, supplies, and materials The ALGO 3 NOW Dom Hearing Screener (K936039). The ALGO 3 and the modition of and Hearing Screeners have the same intended use and use the same operating principle.

Based on the data and information presented here, the modified ALGO 3 Newborn Hearing Screener and Accessories are substantially equivalent to the ALGO-2 Newborn Hearing Screener and Accessories manufactured and distributed by Natus Medical, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a person with outstretched arms, which is the department's official symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2001

Ms. Sheila Ramerman Director, Regulatory Affairs Natus Medical, Inc. 1501 Industrial Road San Carlos, California 94070-4111

Re: K013137

Trade Name: ALGO® 3 Newborn Hearing Screener Regulation Number: 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: September 18, 2001 Received: September 19, 2001

Dear Ms. Ramerman:

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.

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Page 2 - Ms. Sheila Ramerman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MP

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _ ALGO® 3 Newborn Hearing Screener and Accessories

Indications for Use:

The ALGO® 3 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 (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.

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 health 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 well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter |
|----------------------|-----------------------------------------------------------|--------------------------|
| (Per 21 CFR 801.109) | Use | (Optional Format 1-2-96) |
| | (Division Sign-Off) | |
| | Division of General, Restorative and Neurological Devices | |

| 510(k) Number | K013137 |
|---------------|---------|
|---------------|---------|