(115 days)
No
The device uses a statistical algorithm based on binomial statistics and an ABR template derived from normal hearing infants to determine pass/refer results. While it uses "advanced signal processing technology," there is no mention of AI or ML techniques like neural networks or deep learning. The algorithm is described as a "statistical algorithm" and relies on a pre-defined "ABR template," which is not characteristic of typical AI/ML approaches that learn from data.
No
The device is a hearing screener, which is a diagnostic or screening device, not a therapeutic one. It is used to detect and identify potential hearing loss, not to treat it.
Yes
The device screens infants for hearing loss by performing automated analysis of Auditory Brainstem Response (ABR) signals, generating a 'Pass' or 'Refer' result based on whether a response consistent with a normal hearing infant's ABR template is detected. This process directly identifies a potential health condition (hearing loss), fitting the definition of a diagnostic device.
No
The device description explicitly mentions hardware components such as acoustic transducers, disposable acoustic earphones, disposable sensors, and patient electrode leads, which are integral to the device's function of stimulating and recording physiological signals.
Based on the provided text, the ALGO Pro Newborn Hearing Screener is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- ALGO Pro's Mechanism: The ALGO Pro works by presenting acoustic stimuli to the infant's ear and recording electrophysiological signals (ABR) from sensors placed on the skin. It analyzes these signals to determine a "Pass" or "Refer" result based on the presence and characteristics of the ABR.
- No Specimen Examination: The device does not examine any biological specimens derived from the infant's body. It interacts with the infant's physiological responses directly.
Therefore, the ALGO Pro falls under the category of a non-invasive medical device used for screening, not an In Vitro Diagnostic.
N/A
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®) 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.
Product codes
GWJ
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.
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)
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External ear for acoustic stimulation; forehead, nape, and shoulder for electrode placement
Indicated Patient Age Range
babies between the ages of 34 weeks (gestation age) and 6 months
Intended User / Care Setting
Intended_Users: ALGO Pro is intended to be used by audiologists, ear-nose-throat doctors, nurses and other health care professionals that are trained to provide hearing screening services. It is not intended to be operated by lay users.
Where_used: Well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, audiology suite, outpatient clinic, or doctor's office.
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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).
Summary of Performance Studies
study_type: Biocompatibility testing, Electrical safety, EMC, and other applied standards, Software Verification and Validation Testing, Mechanical testing, Clinical Performance of AABR Algorithm (bench testing and code reviews).
sample_size: Clinical performance data showed a combined overall sensitivity of 98.4% and specificity ranging from 96% to 98% based on independent clinical studies.
AUC: Not Found
MRMC: Not Found
standalone_performance: The algorithmic sensitivity of the ALGO AABR algorithm is 99.9% for each ear using binomial statistics.
key_results: Biocompatibility testing: No issues were found. Electrical safety, EMC, and other applied standards: The ALGO Pro system was tested to and complies with the listed applicable safety, electromagnetic compatibility standards and all other applicable standards. Software Verification and Validation Testing: 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: Tests performed on device, bassinet hook, patient cables, electrode cable clip, power button, connector mating, bassinet hook cycle, and docking station. Clinical Performance of AABR Algorithm: Equivalence of the ALGO Pro to the predicate device in sensitivity and specificity PASS/REFER results has been proven in bench testing. 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. Thorough testing of the AABR screening algorithm with both the subject and predicate devices supports that device effectiveness supports substantial equivalence, eliminating the need for additional clinical performance data.
Key Metrics
Algorithmic sensitivity: 99.9% for each ear using binomial statistics.
Overall sensitivity: 98.4% (combined from independent clinical studies).
Specificity: 96% to 98% (in independent clinical studies).
Predicate Device(s)
Reference Device(s)
K852687, K936039, K013137, K030823
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
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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).
1
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
2
Indications for Use
510(k) Number (if known) K233649
Device Name
ALGO Pro Newborn Hearing Screener (ALGO Pro)
Indications for Use (Describe)
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.
| 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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3
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.
4
ALGO Pro 510k
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.
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)
5
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 -
6
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, cleared
under K073665) | Comparisons
(Similarities or
Differences) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| General | | | |
| 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 | The ALGO 5 Newborn Hearing
Screener is a mobile,
noninvasive instrument used to
screen infants for hearing loss.
The screener uses AABRⓇ
(Automated
Auditory Brainstem Response)
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 | Same |
| Specification/
Feature | ALGO Pro (subject) | ALGO 5 (predicate, cleared
under K073665) | Comparisons
(Similarities or
Differences) |
| | 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. | training with the equipment is
sufficient to learn how to screen
infants who are in good health. 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. | |
| Patient
population | Newborns between the ages of 34
weeks (gestation age) and 6
months, well enough to be ready
for discharge from the hospital. | Newborns between the ages of
34 weeks (gestation age) and 6
months, well enough to be ready
for discharge from the hospital. | Same |
| Anatomical
sites | External ear for acoustic
stimulation; forehead, nape, and
shoulder for electrode placement | External ear for acoustic
stimulation; forehead, nape and
shoulder for electrode placement | Same |
| Intended
Users | ALGO Pro is intended to be used
by audiologists, ear-nose-throat
doctors, nurses and other health
care professionals that are trained
to provide hearing screening
services. It is not
intended to be operated by lay
users. | ALGO 5 is intended to be used
by audiologists, ear-nose-throat
doctors, nurses and other health
care professionals that are
trained to provide hearing
screening services. It is not
intended to be operated by lay
users. | Same |
| Where used | Well-baby nursery, neonatal
intensive care unit (NICU),
mother's bedside, audiology suite,
outpatient clinic, or doctor's
office. | Well-baby nursery, neonatal
intensive care unit (NICU),
mother's bedside, audiology
suite, outpatient clinic, or
doctor's office. | Same |
| Energy
delivered | Acoustic | Acoustic | Same |
| Technological Characteristics | | | |
7
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8
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, cleared | |||
| under K073665) | Comparisons | ||||
| (Similarities or | |||||
| Differences) | |||||
| Hardware | |||||
| architecture | Handheld, battery operated device | Panel PC based with proprietary | |||
| DSP based hardware used to | |||||
| execute AABR screening algorithm. | Similar - see | ||||
| substantial | |||||
| equivalence | |||||
| discussion | |||||
| User interface | 7-in Color LCD, with touchscreen; | 17-in Color LCD with | |||
| touchscreen; | Similar - see | ||||
| substantial | |||||
| equivalence | |||||
| discussion | |||||
| Connectivity, | |||||
| Data Transfer | Bluetooth, USB, Wi-Fi | Ethernet, Wi-Fi, USB, CD-ROM | Similar - See | ||
| substantial | |||||
| equivalence | |||||
| discussion | |||||
| Power | Rechargeable Battery | AC Mains only | Similar - See | ||
| substantial | |||||
| equivalence | |||||
| discussion | |||||
| AABR Screening Technological Characteristics | |||||
| ABR | |||||
| Screening | |||||
| Technology | Proprietary ALGO AABR | ||||
| Screening Technology | Proprietary ALGO AABR | ||||
| Screening Technology | Same | ||||
| ABR | |||||
| Detection | |||||
| Algorithm | Proprietary binomial statistical | ||||
| algorithm with template derived | |||||
| from normal hearing infants | Proprietary binomial statistical | ||||
| algorithm with template derived | |||||
| from normal hearing infants | Same | ||||
| Consumables | |||||
| – Earphones | |||||
| and | |||||
| Electrodes | Proprietary Flexicoupler | ||||
| earphones and Jelly tab sensor | |||||
| electrodes | Proprietary Flexicoupler | ||||
| earphones and Jelly tab sensor | |||||
| electrodes | Same | ||||
| Transducer | ATA cable (with integrated | ||||
| microphone and speaker) | ATA cable (with integrated | ||||
| microphone and speaker) | Same | ||||
| Electrode | |||||
| Cable | PCA cable (with 3 electrode leads) | PCA cable (with 3 electrode | |||
| leads) | Same | ||||
| AABR | |||||
| Screening | |||||
| Workflow | Operation via touchscreen | ||||
| leveraging guided workflows for | |||||
| ease of use | Operation via touchscreen | ||||
| leveraging guided workflows for | |||||
| ease of use | Same |
9
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, cleared | |
| under K073665) | Comparisons | ||
| (Similarities or | |||
| Differences) | |||
| Screening | |||
| Modes | Sequential, Simultaneous, Left, | ||
| Right Ear | Sequential, Simultaneous, Left, | ||
| Right Ear | Same | ||
| Stimulus | |||
| Signal | Click | Click | Same |
| Stimulus | |||
| Intensity | 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 |
| Result | |||
| Interpretation | Device reports Pass or Refer test | ||
| result requiring no interpretation | Device reports Pass or Refer test | ||
| result requiring no interpretation | Same | ||
| Result | |||
| representation | PASS/REFER | PASS/REFER | Same |
| Standards met | |||
| Applied | |||
| Standards | All relevant Electrical Safety and | ||
| Biocompatibility standards | All relevant Electrical Safety and | ||
| Biocompatibility standards | Same (see | ||
| below for a | |||
| detailed list of | |||
| applied | |||
| standards) |
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).
10
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.