The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. 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 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 Description

The ALGO® Pro is a fully automated hearing screening device used to screen infants for hearing loss. It provides consistent, objective pass/refer results. The ALGO Pro device utilizes Auditory Brainstem Response (ABR) as the hearing screening technology, which allows the screening of the entire hearing pathway from outer ear to the brainstem. The ABR signal is evoked by a series of acoustic broadband transient stimulus (clicks) presented to a subject's ears using acoustic transducers and recorded by sensors placed on the skin of the patient. The ALGO Pro generates each click stimulus and presents to the patient's ear using acoustic transducers attached to disposable acoustic earphones. The click stimulus elicits a sequence of distinguishable electrophysiological signals produced as a result of signal transmission and neural responses within the auditory nerve and brainstem of the infant. Disposable sensors applied to the infant's skin pick up this evoked response, and the signal is transmitted to the screener via the patient electrode leads. The device employs advanced signal processing technology such as amplification, digital filtering, artifact rejection, noise monitoring and noise-weighted averaging, to separate the ABR from background noise and from other brain activity. The ALGO Pro uses a statistical algorithm based on binomial statistics to determine if there is a response to the stimulus that matches to the ABR template of a normal hearing newborn. If a response is detected that is consistent with the ABR template derived from normal hearing infants (automated auditory brainstem response technology, AABR), the device provides an automated 'Pass' result. A 'Refer' result is automatically generated if the device cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ALGO Pro Newborn Hearing Screener, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission primarily focuses on demonstrating substantial equivalence to a predicate device (ALGO 5) rather than setting specific, numerical acceptance criteria for a new clinical performance study. The "acceptance criteria" here are implied through the comparison with the predicate device's established performance and the demonstration that the ALGO Pro performs comparably.

Acceptance Criterion (Implied)	Reported Device Performance (ALGO Pro / Comparative)
Safety	Complies with: IEC 60601-1 Ed. 3.2, IEC 60601-2-40 Ed. 2.0, IEC 60601-1-6, IEC 62366-1, IEC62304, IEC 62133-2, IEC 60601-1-2 Ed. 4.1, IEC 60601-4-2, FCC Part 15.
Biocompatibility	Passed Cytotoxicity, Sensitization, and Irritation tests (ISO 10993-1:2018 for limited contact).
Mechanical Integrity	Passed drop and tumble, cable bend cycle, electrode clip cycle, power button cycle, connector mating cycle, bassinet hook cycle, and docking station latch/pogo pin cycle testing.
Effectiveness (AABR Algorithm Performance)	Utilizes the exact same AABR algorithm as predicate ALGO 5.
Algorithmic Sensitivity	99.9% for each ear (using binomial statistics, inherited from ALGO AABR algorithm).
Overall Clinical Sensitivity	98.4% (combined results from independent, peer-reviewed clinical studies using the ALGO AABR algorithm, e.g., Peters (1986), Herrmann et al. (1995)).
Specificity	96% to 98% (from independent, peer-reviewed clinical studies using the ALGO AABR algorithm).
Performance Equivalence to Predicate	Bench testing confirmed equivalence of acoustic stimuli, recording of evoked potentials, and proper implementation of ABR template and algorithm, supporting device effectiveness.
Software Performance	Software Verification and Validation testing conducted, Basic Documentation Level provided.
Usability	Formative and summative human factors/usability testing conducted, no concerns regarding safety and effectiveness raised.

2. Sample Size Used for the Test Set and Data Provenance

No new clinical "test set" was used for the ALGO Pro in the context of a prospective clinical trial. The performance data for the AABR algorithm (sensitivity and specificity) are derived from previously published, peer-reviewed clinical studies that validated the underlying ALGO AABR technology.

Sample Size for AABR Algorithm Development: The ABR template, which forms the basis of the ALGO Pro's algorithm, was determined by superimposing responses from 35 neonates to 35 dB nHL click stimuli.
Data Provenance for ABR Template: The data for the ABR template was collected at Massachusetts Eye and Ear Infirmary during the design and development of the original automated infant hearing screener.
Data Provenance for Clinical Performance (Sensitivity/Specificity): The studies cited (Peters, J. G. (1986) and Herrmann, Barbara S., Aaron R. Thornton, and Janet M. Joseph (1995)) are generally long-standing research from various institutions. The document doesn't specify the exact country of origin for the studies cited beyond the development of the template in the US. These studies would be retrospective relative to the ALGO Pro submission, as they describe the development and validation of the original ALGO technology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document for the studies that established the ground truth for the ABR template or the clinical performance of the ALGO AABR algorithm. The template was derived from "normal hearing" neonates, implying a clinical assessment of their hearing status, but the specifics of how that ground truth was established (e.g., specific experts, their qualifications, or methods other than the ABR itself) are not detailed within this submission summary.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical "test set" requiring adjudication for the ALGO Pro itself was conducted or reported in this submission. The historical studies developing the AABR algorithm would have defined their own ground truth and validation methods, but these are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The ALGO Pro is an automated hearing screener that provides a "Pass" or "Refer" result without requiring human interpretation of the ABR signals themselves. It is not an AI-assisted human reading device, but rather a standalone diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment of the AABR algorithm (which is essentially the "algorithm only" component) was done indirectly through historical studies and directly through bench testing.

The core AABR algorithm has a 99.9% algorithmic sensitivity (based on binomial statistics).
Historically, independent clinical studies (cited) showed an overall clinical sensitivity of 98.4% and specificity of 96% to 98% for the ALGO AABR technology when used in clinical settings.
For the ALGO Pro specifically, bench testing was performed to confirm the equivalence of the acoustical stimuli, recording of evoked potentials, and proper implementation of the ABR template and algorithm between the ALGO Pro and its predicate device (ALGO 5). This bench testing effectively confirmed the standalone performance of the ALGO Pro's algorithm against the established performance of the predicate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For ABR Template Development: The ABR template was based on the morphology of ABR waveforms from normal hearing neonates. This implies a ground truth established by clinical assessment of "normal hearing" status.
For Clinical Performance (Sensitivity/Specificity): The clinical studies cited (Peters, Herrmann et al.) would have established ground truth for hearing status through follow-up diagnostic audiologic evaluations, which could include behavioral audiometry, auditory steady-state response (ASSR) testing, or other objective measures (likely expert consensus based on these diagnostic tests). The document does not specify the exact ground truth methodology of these historical studies.

8. The Sample Size for the Training Set

The document states that the ABR template, which underpins the algorithm, was derived by superimposing responses from 35 neonates. This set of 35 neonates effectively served as the "training set" or foundational data for the ABR template.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the "training set" (the 35 neonates used to derive the ABR template) was established based on their status as "normal hearing" infants. This implies a determination of their hearing status through established clinical methods for neonates at the time (e.g., standard audiologic evaluation to confirm normal hearing), though the specific details of these diagnostic methods are not provided in this summary.

Summary

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March 8, 2024

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Bronwyn Kelly Senior Regulatory Affairs Specialist 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada

Re: K233649

Trade/Device Name: ALGO Pro Newborn Hearing Screener (ALGO Pro) Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 8, 2024 Received: February 8, 2024

Dear Bronwyn Kelly:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233649

Device Name

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510K Summary

Date: 12 February 2024

Natus Medical Incorporated Submitted By:

DBA Excel-Tech Ltd. (XLTEK)

2568 Bristol Circle

Oakville, Ontario

Canada L6H 5S1

Contact Person: Bronwyn Kelly

Senior Regulatory Affairs Specialist Natus Medical Incorporated Tel: +353 (0)91 647400 Fax: +353 (0)91 630050 E-mail: Bronwyn.Kelly@natus.com

Proprietary Name: ALGO Pro Newborn Hearing Screener Common Name: Stimulator, Auditory, Evoked Response Regulation Number: 21 CFR 882.1900 Classification Name: Stimulator, Auditory, Evoked Response Product code: GWJ Device Class: II Predicate Device: ALGO 5 510(k) number: K073665

natus.

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ALGO Pro 510k

DEVICE DESCRIPTION:

The ALGO Pro generates each click stimulus and presents to the patient's ear using acoustic transducers attached to disposable acoustic earphones. The click stimulus elicits a sequence of distinguishable electrophysiological signals produced as a result of signal transmission and neural responses within the auditory nerve and brainstem of the infant. Disposable sensors applied to the infant's skin pick up this evoked response, and the signal is transmitted to the screener via the patient electrode leads.

The device employs advanced signal processing technology such as amplification, digital filtering, artifact rejection, noise monitoring and noise-weighted averaging, to separate the ABR from background noise and from other brain activity.

The ALGO Pro uses a statistical algorithm based on binomial statistics to determine if there is a response to the stimulus that matches to the ABR template of a normal hearing newborn. If a response is detected that is consistent with the ABR template derived from normal hearing infants (automated auditory brainstem response technology, AABR), the device provides an automated 'Pass' result. A 'Refer' result is automatically generated if the device cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template.

The ALGO Pro system utilizes the following main components and accessories at minimum to achieve its intended use:

Handheld screener
Cable assemblies ●
- o Patient Cable Attachment (PCA)
- Acoustic Transducer Assembly Cable (ATA)
Single-use supplies o
- o Disposable earphones (Flexi-coupler Earphones)
- o Disposable electrodes/sensors (Jelly Tab Sensors)

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Other accessories available for use with the ALGO Pro include:

AC/DC power supply and power cords ●
DC/DC converter module
Bassinet hook ●
Docking station ●
Mobile Cart, with room for accessories, supplies, storage and transport ●
Wireless keyboard
Wireless label printer
Equipment Check Kit ●

INTENDED USE & INDICATIONS FOR USE:

The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) technology for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. 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 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISITICS WITH THE PREDICATE DEVICE

The subject and predicate device both operate on the technological principle of measuring the electrical activity in the auditory nerve and brainstem in response to sound stimuli. At a high level, the subject and predicate devices are based on the following same technological elements:

Acoustic stimulus energy delivered (35 or 40 dB nHL) -
AABR screening algorithm -
Electrode cable ("PCA cable") l
Transducer cable ("ATA cable") -
Consumable supplies (Flexicoupler earphones and Jelly tab sensor electrodes)
Screening workflow -

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ALGO Pro 510k

Equipment check kit

The following technological differences exist between the subject and predicate devices:

Consolidated hardware architecture embodied in a portable handheld -
-EEG preamplifier integrated into the handheld device
Use of a docking station for the handheld device -
Use of a bassinet hook to secure the handheld device during screening -
Use of a smaller user interface display for portability -
Use of a rechargeable battery as a source of power for the handheld device -
-Use of a different mobile cart. The predicate device can only be used as cart-based system whereas the subject device can be used as a cart based or handheld.
Use of a different label printer and keyboard with wireless capabilities. -
Connectivity options limited to Bluetooth, USB, and Wi-Fi -

Specification/Feature	ALGO Pro (subject)	ALGO 5 (predicate, clearedunder K073665)	Comparisons(Similarities orDifferences)
General
Intended Use& Indicationsfor Use	The ALGO Pro Newborn HearingScreener is a mobile, noninvasiveinstrument used to screen infantsfor hearing loss. The screener usesAutomated Auditory BrainstemResponse (AABR®) technologyfor automated analysis of AuditoryBrainstemResponse (ABR) signals recordedfrom the patient. The screener isintended for babies between theages of 34 weeks (gestation age)and 6 months. Babies should bewell enough to be ready fordischarge from the hospital, andshould be asleep or in a quiet stateat the time of screening. Thescreener is simple to operate. Itdoes not require special technical	The ALGO 5 Newborn HearingScreener is a mobile,noninvasive instrument used toscreen infants for hearing loss.The screener uses AABRⓇ(AutomatedAuditory Brainstem Response)technology. The screener isintended for babies between theages of 34 weeks (gestationalage) and 6 months. Babiesshould be well enough to beready for discharge from thehospital, and should be asleep orin a quiet state at the time ofscreening. The screener is simpleto operate. It does not requirespecial technical skills orinterpretation of results. Basic	Same
Specification/Feature	ALGO Pro (subject)	ALGO 5 (predicate, clearedunder K073665)	Comparisons(Similarities orDifferences)
	skills or interpretation of results.Basic training with the equipmentis sufficient to learn how to screeninfants who are in good healthand about to be discharged fromthe hospital. A typical screeningprocess can be completed in 15minutes or less. Sites appropriatefor screening include the well-baby nursery, NICU, mother'sbedside, audiology suite,outpatient clinic, or doctor's office.	training with the equipment issufficient to learn how to screeninfants who are in good health. Atypical screening process can becompleted in 15 minutes or less.Sites appropriate for screeninginclude thewell-baby nursery, NICU,mother's bedside, audiologysuite, outpatient clinic, ordoctor's office.
Patientpopulation	Newborns between the ages of 34weeks (gestation age) and 6months, well enough to be readyfor discharge from the hospital.	Newborns between the ages of34 weeks (gestation age) and 6months, well enough to be readyfor discharge from the hospital.	Same
Anatomicalsites	External ear for acousticstimulation; forehead, nape, andshoulder for electrode placement	External ear for acousticstimulation; forehead, nape andshoulder for electrode placement	Same
IntendedUsers	ALGO Pro is intended to be usedby audiologists, ear-nose-throatdoctors, nurses and other healthcare professionals that are trainedto provide hearing screeningservices. It is notintended to be operated by layusers.	ALGO 5 is intended to be usedby audiologists, ear-nose-throatdoctors, nurses and other healthcare professionals that aretrained to provide hearingscreening services. It is notintended to be operated by layusers.	Same
Where used	Well-baby nursery, neonatalintensive care unit (NICU),mother's bedside, audiology suite,outpatient clinic, or doctor'soffice.	Well-baby nursery, neonatalintensive care unit (NICU),mother's bedside, audiologysuite, outpatient clinic, ordoctor's office.	Same
Energydelivered	Acoustic	Acoustic	Same
Technological Characteristics

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Image /page/7/Picture/0 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a registered trademark symbol after the "s".

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Image /page/8/Picture/0 description: The image shows the logo for Natus Medical Incorporated. The logo is in a teal color and features the word "natus" in a sans-serif font. A registered trademark symbol is located to the right of the word.

ALGO Pro 510k
Specification/Feature	ALGO Pro (subject)	ALGO 5 (predicate, clearedunder K073665)	Comparisons(Similarities orDifferences)
Hardwarearchitecture	Handheld, battery operated device	Panel PC based with proprietaryDSP based hardware used toexecute AABR screening algorithm.	Similar - seesubstantialequivalencediscussion
User interface	7-in Color LCD, with touchscreen;	17-in Color LCD withtouchscreen;	Similar - seesubstantialequivalencediscussion
Connectivity,Data Transfer	Bluetooth, USB, Wi-Fi	Ethernet, Wi-Fi, USB, CD-ROM	Similar - Seesubstantialequivalencediscussion
Power	Rechargeable Battery	AC Mains only	Similar - Seesubstantialequivalencediscussion
AABR Screening Technological Characteristics
ABRScreeningTechnology	Proprietary ALGO AABRScreening Technology	Proprietary ALGO AABRScreening Technology	Same
ABRDetectionAlgorithm	Proprietary binomial statisticalalgorithm with template derivedfrom normal hearing infants	Proprietary binomial statisticalalgorithm with template derivedfrom normal hearing infants	Same
Consumables– EarphonesandElectrodes	Proprietary Flexicouplerearphones and Jelly tab sensorelectrodes	Proprietary Flexicouplerearphones and Jelly tab sensorelectrodes	Same
Transducer	ATA cable (with integratedmicrophone and speaker)	ATA cable (with integratedmicrophone and speaker)	Same
ElectrodeCable	PCA cable (with 3 electrode leads)	PCA cable (with 3 electrodeleads)	Same
AABRScreeningWorkflow	Operation via touchscreenleveraging guided workflows forease of use	Operation via touchscreenleveraging guided workflows forease of use	Same

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Image /page/9/Picture/0 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a registered trademark symbol to the right of the "s".

ALGO Pro 510k
Specification/Feature	ALGO Pro (subject)	ALGO 5 (predicate, clearedunder K073665)	Comparisons(Similarities orDifferences)
ScreeningModes	Sequential, Simultaneous, Left,Right Ear	Sequential, Simultaneous, Left,Right Ear	Same
StimulusSignal	Click	Click	Same
StimulusIntensity	35 dB nHL, 40 dB nHL	35 dB nHL, 40 dB nHL	Same
Stimulus Rate	Alternating 34/sec and 37/sec	Alternating 34/sec and 37/sec	Same
ResultInterpretation	Device reports Pass or Refer testresult requiring no interpretation	Device reports Pass or Refer testresult requiring no interpretation	Same
Resultrepresentation	PASS/REFER	PASS/REFER	Same
Standards met
AppliedStandards	All relevant Electrical Safety andBiocompatibility standards	All relevant Electrical Safety andBiocompatibility standards	Same (seebelow for adetailed list ofappliedstandards)

SUBSTANTIAL EQUIVALANCE DISCUSSION

The ALGO Pro device consolidates much of the hardware functionality in the predicate device into a battery-operated handheld form factor with a smaller 7-in LCD and capacitive touchscreen. Additionally, the ALGO Pro handheld integrates the functionality of the external EEG preamplifier cable found in the predicate device (see discussion below regarding the AABR measuring algorithm). The ALGO Pro hardware architecture employs multiple processor cores to provide the necessary computing power to execute the software user interface and the AABR screening algorithm. The ALGO Pro design enables it to be used with or without the cart accessory to provide additional portability, allowing users to conduct AABR screening tests in limited-space environments.

The ALGO Pro AABR algorithm and acoustic stimulus are identical to the predicate ALGO 5. Bench testing was performed for relevant audiological characteristics of the stimulus delivered to the patient as well as interpretation of the recorded potential (i.e., creating a PASS/ REFER/ INCOMPLETE result). The bench tests included frequency, timing, polarity and sound level of the stimulus, myogenic noise detection, ambient noise detection, electrode impedance and signal to noise measurements detectable by the device. Bench testing demonstrated substantially equivalent performance between the subject (ALGO Pro) and predicate device (ALGO 5).

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ALGO Pro 510k

Like the predicate device, the ALGO Pro device is powered and operated by AC Mains power when placed in the accompanying docking station. In addition, the ALGO Pro handheld device can operate on the internal Li-Ion rechargeable battery. The ALGO Pro battery was independently tested to and complies with the applicable Li-Ion battery safety standard IEC 62133-2.

The ALGO Pro device uses similar connectivity options as the predicate device which include Bluetooth, USB, and Wi-Fi. The subject device does not support archiving patient data to a CD or connecting the device to a network with an ethernet cable as the predicate device. Instead, patient data is transferred to a PC through the USB port or wirelessly when connected securely to a remote drive location. All connectivity options were tested through formal verification testing.

The ALGO Pro mobile cart is a commercially available healthcare mobile cart with some minor customization to accommodate the ALGO Pro docking station and accessories. The mobile cart includes several ergonomic improvements not available in the predicate such as an adjustable work surface height (i.e., lift mechanism) which facilitates use of the cart while sitting or standing. The ALGO Pro cart is also much lighter, making it easier to maneuver and transport.

Screening tests are performed with the ALGO Pro handheld device placed on the cart, securely attached to the mobile cart's accompanying docking station. In addition, the ALGO Pro handheld gives the user the option to perform screening tests in space constrained locations that are difficult to access with the mobile cart. The bassinet hook on the ALGO Pro handheld allows the user to safely attach the device to a bassinet during the screening test. A wireless off-the-shelf keyboard and wireless label printer have been included to provide flexibility in placement on the cart. The ALGO Pro user interface and workflow is identical to the predicate device.

The ALGO Pro handheld, mobile cart, user interface and accessories were evaluated through formative and summative human factors\usability testing, which included simulated use of the ALGO Pro device with and without the use of the cart (i.e., handheld device only). Human factors\usability testing did not raise any concerns regarding safety and effectiveness.

The ALGO Pro system, which includes the cart and all other system accessories was also independently tested to applicable biocompatibility, Safety, EMC, Usability, and Software lifecycle standards and demonstrate the subject device is as safe and effective as the predicate device. Reliability testing was also conducted on the ALGO Pro device and accessories by a third party.

In conclusion, ALGO Pro is substantially equivalent to the predicate device ALGO 5 with respect to Intended Use, technological characteristics, and non-clinical Performance data.

PERFORMANCE DATA

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The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation was conducted according to ISO 10993-1:2018. The following tests

were considered applicable:

Cytotoxicity
Sensitization
Irritation

The device and its accessories are classified as limited contact (≤24 hours) contact and contact with Intact skin. No issues were found during biocompatibility testing.

Electrical safety, EMC, and other applied standards

The ALGO Pro system was tested to and complies with the following applicable safety, electromagnetic compatibility standards and all other applicable standards:

IEC 60601-1 Ed. 3.2 en:2020 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-2-40 Ed. 2.0 b:2016 Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
IEC 60601-1-6: Ed. 3.2 b:2020 Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability,
IEC 62366-1:2015+ AMD1:2020 (Ed.1.1) Medical devices - Application of usability engineering to medical devices.
IEC62304 Medical Device Software - Software Lifecycle processes
IEC 62133-2:2017 Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
IEC 60601-1-2 Ed. 4.1 en:2020 General requirements for basic safety and essential ● performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-4-2 Ed. 1.0 b:2016 Medical Electrical Equipment – Part 4-2: Guidance and Interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
. FCC Part 15 Regulation for Radio Transmitters

Software Verification and Validation Testing

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Software Verification and Validation testing were conducted, and Basic Documentation Level was provided as recommended by FDA's Guidance for Industry and Staff 'Content of Premarket Submissions for Device Software Functions'.

Mechanical testing

Drop and tumble testing (device, bassinet hook and patient cables)
Patient cable bend cycle testing (PCA, ATA) ●
PCA electrode cable clip cycle testing ●
Power button cycle testing
Connector mating cycle testing ●
Bassinet hook cycle testing
Docking station latch cycle testing ●
Docking station pogo pin contact cycle testing

Clinical Performance of AABR Algorithm:

The algorithmic sensitivity of the ALGO AABR algorithm is 99.9% for each ear using binomial statistics. Independent clinical studies published peer-reviewed clinical performance data showed a combined overall sensitivity of 98.4%. Specificity of the ALGO device ranged from 96% to 98% in these studies. Relevant studies are listed in the section Clinical Performance Studies (see below) Equivalence of the ALGO Pro to the predicate device in sensitivity and specificity PASS/REFER results has been proven in bench testing.

The AABR algorithm used in the predicate ALGO 5 device was originally developed internally by Natus Medical, Incorporated. Therefore, proper implementation of the AABR algorithm in the subject device is well understood. The ALGO Pro device utilizes the exact same methods and parameters to evoke, record, process and detect ABR responses as implemented in the predicate ALGO 5 device.

The ABR template used in the ALGO Pro is based on the morphology of normal hearing, near threshold, infant ABR waveforms, determined by superimposing the responses of 35 neonates to 35 dB nHL click stimuli. The data was collected at Massachusetts Eye and Ear Infirmary during the design and development of the original automated infant hearing screener using ABR. This technology was originally commercialized as ALGO I device, and details of the ALGO technology, including the template and its collection info was provided under 510(k) submission K852687. The same template and detection algorithm has been used in all the subsequent FDA cleared ALGO devices, including ALGO 2 (K936039), ALGO 3 (K013137), ALGO 3i (K030823), and the predicate ALGO 5 (K073665).

The ABR template and AABR algorithm used in all ALGO devices were originally developed and validated in the following studies:

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ALGO Pro 510k

Clinical Performance Studies

Peters, J. G. "An automated infant screener using advanced evoked response technology." The Hearing Journal 39 (1986): 25-30.
. Herrmann, Barbara S., Aaron R. Thornton, and Janet M. Joseph. "Automated infant hearing screening using the ABR: development and validation." American Journal of Audiology 4.2 (1995): 6-14.

Nonclinical performance data, including bench testing and code reviews during the verification phase, confirmed the equivalence of the acoustic stimuli, recording of evoked potentials, and proper implementation of the ABR template and algorithm. Furthermore, thorough testing of the AABR screening algorithm with both the subject and predicate devices support that device effectiveness supports substantial equivalence, eliminating the need for additional clinical performance data.

CONCLUSION

Device safety is demonstrated via non-clinical performance testing to support substantial equivalence. The hardware and software verification activities demonstrate that the ALGO Pro performs as intended in the specified use conditions. During the verification phase, bench testing and code reviews demonstrated substantial equivalence of the ALGO Pro AABR screening algorithm to the predicate. The results of these activities demonstrate that the ALGO Pro is as safe, effective, and substantially equivalent to the predicate device.

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).