(178 days)
No
The summary describes the device's evaluation of test results based on "signal statistics" and a pre-defined "ABR template" derived from a fixed dataset, not adaptive learning or AI/ML techniques.
No
Explanation: The device is a diagnostic tool used to screen for hearing status in newborns. It does not provide treatment or therapy.
Yes
Explanation: The device is described as a "Newborn Hearing Screener" which is "intended to objectively determine the hearing status of a newborn/infant." This indicates its purpose is to identify a medical condition (hearing status), which falls under the definition of a diagnostic device. The results are presented as "PASS/REFER/INCOMPLETE", further supporting its diagnostic nature by categorizing the hearing status.
No
The device description explicitly states it consists of the ALGO 7i device with a touch screen display together with different accessories such as cables, docking station, and transducers. It also mentions hardware components like memory chips in the plugs. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the ALGO® 71 Newborn Hearing Screener is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ALGO 7i Function: The ALGO 7i directly interacts with the patient's body by applying stimuli and measuring physiological responses (auditory brainstem responses) through electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "objectively determine the hearing status of a newborn/infant" by measuring their physiological response to sound, not by analyzing a biological sample.
Therefore, the ALGO 7i falls under the category of a medical device that performs a diagnostic function in vivo (within the living body), rather than in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.
Exclusion Criteria
The following criteria should be used to exclude an infant from screening with the Natus ALGO hearing screeners:
- Infants not between 34 weeks gestational and 6 months of age
- Infants on ventilators or in incubators
- Infants on CNS (central nervous system) stimulants
- Infants receiving ototoxic medications
- Infants with compromised skin or jaundice
ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses and audiologically trained personnel. Basic training with the device is sufficient for performing screening of patients in good health. It is not intended to be operated by lay users.
Product codes
GWJ
Device Description
ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded plug-in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible.
Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station.
The ALGO 7i offers hearing screening using AABR technology.
The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics. Besides that, result information is displayed as PASS/REFER/INCOMPLETE.
The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.
The following accessories are available to conduct a measurement:
- ATA (Acoustic Transducer Assembly) Cable: PATH ATA-S, ATA-L
- Equivalent to Natus ATA Cables, equivalent to the cables used with the predicate o ALGO 3i, similar to the PATH Ear Coupler Cables used with the reference Sentiero
- Electrode cable: PATH ABR-S. ABR-L
- shielded, passive cable to connect the instrument to electrodes o
These accessories can be connected to ALGO 7i using special color and mechanical coded plugs, which holds the information about the connected transducer / cable. By that, the firmware can make use of this information and adapt the measurement procedure according to calibration values or provide information to the user via its display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Auditory pathway/ear
Indicated Patient Age Range
from 34 weeks gestational age to 6 months old.
Intended User / Care Setting
ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses and audiologically trained personnel. Basic training with the device is sufficient for performing screening of patients in good health. It is not intended to be operated by lay users.
ALGO 7i devices are designed for use in clinical environments, such as the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, audiology suite, outpatient clinic, or doctor's office as well as in community settings.
Description of the training set, sample size, data source, and annotation protocol
The ABR template used in the ALGO 7i is based on the morphology of normal hearing, near-threshold, infant ABR waveforms, determined by superimposing the responses of 35 neonates to 35 dBnHL 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Nonclinical performance studies (bench testing, software verification and validation, biocompatibility, electrical safety and EMC, mechanical and acoustic testing).
Sample Size: Not Applicable.
AUC: Not Applicable.
MRMC: Not Applicable.
Standalone Performance: The algorithmic sensitivity of the ALGO is set to 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.
Key Results: Bench testing demonstrated substantially equivalent performance between subject (ALGO 7i) and predicate device (ALGO 3i) for relevant audiological characteristics (frequency, timing, polarity, sound level, noise resistance, lowest potential measurable). Biocompatibility, electrical safety, and EMC testing also showed compliance with standards. The ALGO 7i uses the exact same methods, parameters, template, and algorithm as the predicate ALGO 3i, supporting substantial equivalence in clinical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The algorithmic sensitivity of the ALGO is set to 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.
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 14, 2021
Path Medical GmbH Ing. Oswald Managing Director Landsberger Strasse 65 Germering, Bavaria 82110 Germany
Re: K211147
Trade/Device Name: ALGO 7i Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: September 9, 2021 Received: September 13, 2021
Dear Ing. Oswald:
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. 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 Data base located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 inf ormation about labeling regulations, please see Device (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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K211147
Device Name ALGO 7i
Indications for Use (Describe)
The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.
Exclusion Criteria
The following criteria should be used to exclude an infant from screening with the Natus ALGO hearing screeners:
- = Infants not between 34 weeks gestational and 6 months of age
- Infants on ventilators or in incubators
- · Infants on CNS (central nervous system) stimulants
- Infants receiving ototoxic medications
- Infants with compromised skin or jaundice
ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses and audiologically trained personnel. Basic training with the device is sufficient for performing screening of patients in good health. It is not intended to be operated by lay users.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in bold black letters, with the word "MEDICAL" in smaller black letters below it.
510(k) Summary
SUBMISSION INFORMATION
| Date of preparation: | October 14, 2021 |
|---|---|
| 510(k) Submitter: | PATH MEDICAL GmbH |
| Landsberger Str. 65 | |
| 82110 Germering | |
| Germany | |
| Phone: ++49-89-80076502 | |
| Fax: ++49-89-80076503 | |
| Contact Person: | Dr. Johann Oswald, Director |
| Landsberger Str. 65 | |
| 82110 Germering | |
| Germany | |
| Phone: ++49-89-80076502 | |
| Fax: ++49-89-80076503 | |
| Email: oswald@pathme.de |
DEVICE INFORMATION
| Device Name: | ALGO 7i |
|---|---|
| Device Trade Names: | ALGO 7i, A7i |
| Device Identification Codes: | 101049 |
| Common Name: | Evoked Response Auditory Stimulator |
| Classification Name: | Evoked Response Auditory Stimulator |
| FDA 21 CFR section 882.1900 |
PREDICATE DEVICE
| ALGO 3i | 510(k) Number: K030823 |
|---|---|
| --------- | ------------------------ |
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Image /page/4/Picture/0 description: The image contains the logo for Path Medical. The logo consists of a red square with a white design inside, and the words "PATH MEDICAL" in black text to the right of the square. The word "PATH" is in a larger font than the word "MEDICAL".
REFERENCE DEVICE
SENTIERO
510(k) Number: K133012
DEVICE DESCRIPTION
ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded plug-in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible.
Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station.
The ALGO 7i offers hearing screening using AABR technology.
The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics. Besides that, result information is displayed as PASS/REFER/INCOMPLETE.
The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.
The following accessories are available to conduct a measurement:
- ATA (Acoustic Transducer Assembly) Cable: PATH ATA-S, ATA-L
- Equivalent to Natus ATA Cables, equivalent to the cables used with the predicate o ALGO 3i, similar to the PATH Ear Coupler Cables used with the reference Sentiero
- Electrode cable: PATH ABR-S. ABR-L
- shielded, passive cable to connect the instrument to electrodes o
These accessories can be connected to ALGO 7i using special color and mechanical coded plugs, which holds the information about the connected transducer / cable. By that, the firmware can
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Image /page/5/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white design on the left and the words "PATH MEDICAL" in black on the right. The word "PATH" is in a larger font than the word "MEDICAL".
make use of this information and adapt the measurement procedure according to calibration values or provide information to the user via its display.
INDICATIONS FOR USE
The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.
Exclusion Criteria
The following criteria should be used to exclude an infant from screening with the Natus ALGO hearing screeners:
- = Infants not between 34 weeks gestational and 6 months of age
- Infants on ventilators or in incubators
- Infants on CNS (central nervous system) stimulants
- Infants receiving ototoxic medications
- Infants with compromised skin or jaundice
ALGO 71 devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses, and audiologically trained personnel. Basic training with the device is sufficient for performing screening of patients in good health. It is not intended to be operated by lay users.
INTENDED USE
ALGO 7i devices are designed for use in clinical environments, such as the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, audiology suite, outpatient clinic, or doctor's office as well as in community settings. The ALGO 7i is not intended for use in oxygenrich environments.
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Image /page/6/Picture/0 description: The image is a logo for Path Medical. The logo has a red square on the left side with a white curved line going through it. To the right of the square, the word "PATH" is written in large, bold, black letters, and below that, the word "MEDICAL" is written in smaller, bold, black letters.
COMPARISON TO SIMILAR DEVICES
The ALGO 7i will be compared to the predicate device ALGO 3i in terms of intended purpose, physiological features, accessories and applied screening algorithm. For workflow, technology, applied standards and user interface a comparison will be drawn to the reference device Sentiero. COMPARISON TO THE PREDICATE DEVICE ALGO 3i:
| | ALGO 7i (subject) | ALGO 3i
(predicate) | Equivalency |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended purpose | | | |
| Intended Use | ALGO 7i devices are
designed for use in
clinical environments,
such as the well-baby
nursery, neonatal
intensive care unit
(NICU), mother's
bedside, audiology
suite, outpatient clinic,
or doctor's office as
well as in community
settings. The ALGO 7i
is not intended for use
in oxygen-rich
environments. | The ALGO 3i
screener is simple to
operate and does not
require special
technical skills or
interpretation of
results. Basic
training with the
equipment is
sufficient to learn
how to screen
infants correctly. A
typical screening can
be completed in 15
minutes or less in
any clinical
environment (i.e.
well-baby nursery,
NICU, mother's
bedside, audiology
suite, outpatient
clinic,
or doctor's office). | Same (different
wording,
description of
ALGO 7i is more
specific) |
| Indications for Use | The ALGO® 7i
Newborn Hearing
Screener is a hand-held,
portable hearing
screener intended to
objectively determine
the hearing status of a
newborn/infant from 34
weeks gestational age
to 6 months old. Babies
should be well enough
for hospital discharge
and should be asleep or | The ALGO 3i
Newborn Hearing
Screener is a
portable,
noninvasive device
for screening the
hearing of infants
between the ages of
34 weeks corrected
gestational age and
six months.
Screening can be
performed by trained
personnel in any | Same |
| | | | |
| | in a quiet state at the
time of screening. | clinical environment
(i.e. well-baby
nursery, NICU,
mother's bedside,
audiology suite,
outpatient clinic, or
doctor's office) | |
| | Exclusion Criteria
The following criteria
should be used to
exclude an infant from
screening with the
Natus ALGO hearing
screeners:
• Infants not between
34 weeks gestational
and 6 months of age
• Infants on ventilators
or in incubators
• Infants on CNS
(central nervous
system) stimulants
• Infants receiving
ototoxic medications
• Infants with
compromised skin or
jaundice | | |
| | ALGO 7i devices are
intended for use by
audiologists, ear-nose-
throat (ENT) doctors,
and other hearing
health care
professionals, nurses
and audiologically
trained personnel. Basic
training with the device
is sufficient for
performing screening
of patients in good
health. It is not
intended to be operated
by lay users. | | |
| Physiological features | | | |
| Biosignal | Evoked potential | Evoked potential | Same |
| Electrode position | Head and neck | Head and neck | Same |
| Stimulation target | Cochlea | Cochlea | Same |
| EEG recording
channels, number of
electrode contacts | 1,3 | 1,3 | Same |
| Accessories | | | |
| Transducer | ATA-Cable (different
plug) | ATA-Cable | Same |
| Electrode Cable | Patient Cable
(shielded, 3 clamps)
(different plug) | Patient Cable,
(shielded, 3
clamps) | Same |
| Electrodes | Natus Jelly Tabs | Natus Jelly Tabs | Same |
| Ear Coupler | Natus FlexiCoupler | Natus FlexiCoupler | Same |
| Implementation details | | | |
| Screening options | Each ear individually,
simultaneously or
sequentially | Each ear
individually,
simultaneously or
sequentially | Same |
| Stimulus | Click | Click | Same |
| Stimulus repetition
rate | 34/37 Hz | 34/37 Hz | Same |
| Stimulus level | 35, 40 dB nHL | 35, 40 dB nHL | Same |
| Noise cancellation
(acoustic & myogenic) | Ambient noise
microphone
(acoustic);
Dual channel
sampling (myogenic) | Ambient noise
microphone
(acoustic);
Dual channel
sampling
(myogenic) | Same |
| Applied algorithm | Natus AABR | Natus AABR | Same |
| Result interpretation | By the device | By the device | Same |
| Result representation | PASS/REFER/
INCOMPLETE | PASS/REFER/
INCOMPLETE | Same |
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Image /page/8/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
Table 5. 1 Comparison to predicate device
The ALGO 7i will issue a PASS result when it collects sufficient data to establish with > 99% statistical confidence that an ABR signal is present and consistent with the template. This confidence level can be reached at a minimum of 1000 sweeps for 35dBnHL screening, and 2000 sweeps for 40dBnHL screening. The ALGO screener will continue to collect data up to 15,000 noise-weighted sweeps. If it has not established with > 99% statistical confidence that the ABR signal is present after 15,000 noise-weighted sweeps, it will issue a REFER result. Aborting a test will result in an INCOMPLETE result. The same procedure is implemented in the predicate ALGO 3i.
The ALGO 7i uses the same patented signal processing technology to separate the ABR from background noise and other brain activity as the predicate ALGO 3i. These responses are matched against a stored pattern called a "template", derived from the ABRs of normal-hearing infants. The ALGO 7i must detect the ABR with very high statistical confidence in order to issue a PASS result. This technology includes a patented dual-artifact rejection system to prevent non-ABR activity
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Image /page/9/Picture/0 description: The image is a logo for PATH Medical. The logo consists of a red square with a white, stylized "P" inside of it. To the right of the square, the word "PATH" is written in large, black letters, and below that, the word "MEDICAL" is written in smaller, black letters. The logo is simple and modern, and the use of red and black gives it a professional look.
from contributing toward a PASS result. This ensures a very high degree of accuracy of the PASS result issued by an ALGO 7i device. The template cannot be replaced or modified.
In conclusion, the ALGO 7 system is substantially equivalent to the predicate device ALGO 3i in terms of intended use, accessories used, operating principle and algorithm.
COMPARISON TO REFERENCE DEVICE:
Design and working principles of ALGO 7i are very similar to Sentiero. The similarity can be attributed to the fact that the same engineers at PATH MEDICAL, who designed the Sentiero products, also designed the ALGO 7i. In order to expedite development, hardware properties (e.g. PCB design, housing, connectors) as well as firmware features (workflow, User Interface, development environment, compiler) were mirrored from the Sentiero Backbone as starting point of development). The ALGO 7i test method ABR is a subset of the test methods available on the Sentiero, which in addition to ABR also offers various different test methods such as OAE or TYMP as well as diagnostic modules. Due to the variety of available modules and their differences in operation principle, the comparison of the ALGO 7i to the reference device will be drawn to the Sentiero and its ABR module:
| | ALGO 7i (subject) | SENTIERO
(reference) | Equivalency |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Intended Purpose | | | |
| Patient population | Newborn/infant from 34
weeks gestational age to 6
months old | All ages | Same (Subset) |
| Indications for Use | Determination of the
hearing status of a
newborn/infant | Determination of the
hearing status | Same (Subset) |
| Intended User | Audiologists, ear-nose-
throat (ENT) doctors, and
other hearing health care
professionals, nurses and
audiologically trained
personnel. It is not
intended to be operated
by lay users. | Audiologists, ear-
nose-throat (ENT)
doctors, and other
hearing health care
professionals and
audiologically
trained technicians in
a medical
environment. It is
not intended to be
operated by lay
users. | Same |
| Medical principle | Determination of hearing
status by evoking and
recording potentials in the
auditory pathway. | Determination of
hearing status by
evoking and
recording potentials
in the auditory
pathway. | Same |
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Image /page/10/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square on the left side with a white curved line running through it. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
| Technical implementation | |||
|---|---|---|---|
| Mode of operation | Handheld, standalone | Handheld, standalone | Same |
| User interface | Branded and reduced version of the Sentiero user interface | Sentiero user interface | Same (Subset) |
| Workflow | Operation via touch screen, device control via header/footer, online information | Operation via touch screen, device control via header/footer, online information | Same |
| Battery | Rechargeable | Rechargeable | Same |
| Connectors for accessories | Push-pull ODU-Plug | Push-pull ODU-Plug | Same |
| Display | 3.5" TFT-LC backlight touch-sensitive display | 3.5" TFT-LC backlight touch-sensitive display | Same |
| Power plug | Medical grade | Medical grade | Same |
| Data transfer | USB (via Multidata cable or docking station) | USB | Same |
| PC software | PC Software for data analysis and archiving. User management configurable. Can be used to load data from/ to the device. | PC Software for data analysis and archiving. User management configurable. Can be used to load data from/ to the device. | Same |
| Applied standards | All relevant Audiology, Electrical Safety and Biocompatibility standards | All relevant Audiology, Electrical Safety and Biocompatibility standards | Same (For a detailed list of applied standards see below) |
Table 5. 2 Comparison to reference device
The primary mechanical difference between ALGO 7i and Sentiero is the charging of the built-in rechargeable batteries. ALGO 7i can be connected to a docking station or a dedicated multidata cable for charging and data transfer. In contrast thereto, Sentiero must be connected to a custommade plug for connecting to the charger.
Due to the similarity in hardware and workflow, the ALGO 7i and Sentiero require compliance to the same standards. Both Devices show similar performance data and compliance to the following standards:
- EN 10993-1:2018 Biological evaluation of medical devices (relevant tests: Cytotoxicity, -Sensitization, Irritation)
- -ISO 15223-1:2012 Symbols, labeling, and information to be provided
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- IEC 60601-1:2005/AMD1:2012 Medical Electrical Equipment: General requirements for safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance
- IEC 60601-1-4:1996 Programmable electrical system -
- IEC 60601-1-6:2010 Usability -
- -IEC 60601-2-40:1998 and 2016 Safety of electromyographs and devices for evoked potentials
- -IEC 62304:2010 Software lifecycle
- EN 1041:2013 Information provided by the manufacturer -
- -IEC 60645-7:2009 Acoustically evoked potentials
- EN 60645-3:2007 Electroacoustics: Audiometric Equipment Part 3: Test signals of short duration
- -EN 62366:2008 + A1:2015 Application of usability engineering to medical devices
In conclusion, ALGO 71 is substantially equivalent to the reference device Sentiero with respect to technological characteristics and non-clinical performance data.
Biocompatibility testing
The biocompatibility evaluation was conducted according to ISO 10993-1:2018. Following tests are considered applicable:
- Cytotoxicity ।
- -Sensitization
- Irritation -
The device and its accessories are classified as short-term contact and contact with skin. No issues were found during biocompatibility testing.
Electrical safety and electromagnetic compatibility (EMC)
The ALGO 7i was tested according to and complies to following electrical safety and electromagnetic compatibility standards: IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-40:1998 and 2016.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Mechanical and Acoustic Testing:
- 트 Tensile strength of accessory cable
- I Flex life of accessory cable
- I Frequency content, polarity, timing, sound level, and repetition rate of the Click stimulus equivalent to the predicate ALGO 3i stimulus
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- 트 Similar myogenic and acoustic noise detection and rejection, impedance detection of the ALGO 7i to the predicate ALGO 3i
- Maximum possible sound level will remain below a possibly threatening level even under I failure
- I Push, Drop, and Mould Stress Relief test
Sensitivity and Specificity for PASS/REFER:
The algorithmic sensitivity of the ALGO is set to 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 Studies. Equivalence of the ALGO 7i to the predicate device in result detection has been proven in bench testing.
Clinical Performance Data:
No clinical performance data was collected for the subject device, ALGO 7i. The core automated ABR (AABR) technology is licensed from the predicate device ALGO 3i's manufacturer, Natus Medical Incorporated. ALGO 71's substantial equivalence to predicate ALGO 3i was the main design goal. This was accomplished with the direct incorporation of this licensed technology, including the weighted-binary template-matching algorithm and associated ABR template used in ALGO 3i. Therefore, ALGO 7i device utilizes the exact same methods and parameters to evoke, record, process and detect ABR responses as implemented in the predicate ALGO 3i device. The equivalency of the presented stimulus and the use of the identical algorithm for interpretation of the recorded signal demonstrates substantial equivalence of the subject device to the predicate device in terms of clinical performance. As such, additional clinical performance data was not needed.
The equivalency of the acoustic stimuli and recording of the evoked potentials as well as the correct implementation of the template and algorithm was established with nonclinical performance data and code reviews during the verification phase. Additionally, the literature review in the clinical evaluation shows that the implementation of ABR screening on the ALGO 7i, which is identical to the implementation on the ALGO 3i, matches the current state of the art.
The ABR template used in the ALGO 7i is based on the morphology of normal hearing, nearthreshold, infant ABR waveforms, determined by superimposing the responses of 35 neonates to 35 dBnHL 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 FDAcleared ALGO devices, including ALGO 2 (K936039), ALGO 3 (K013137), the predicate ALGO 3i (K030823), and ALGO 5 (K073665).
The template and AABR algorithm used in all ALGO devices were developed and validated in the following studies:
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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.
SUBSTANTIAL EQUIVALENCE
The ALGO 7i's stimulus input and measuring algorithm are identical to the predicate ALGO 3i. Bench testing was performed for relevant audiological characteristics of the stimulus delivered to as well as interpretation of of the recorded potential (creating the patient a PASS/REFER/INCOMPLETE result). The bench tests included frequency, timing, polarity and sound level of the stimulus as well as noise resistance and the lowest potential measurable or detectable by the device. Additionally, biocompatibility, electrical safety, and EMC testing was conducted to demonstrate that the subject device is as safe and as effective as the predicate device. Although the hardware was updated with the state-of-the-art hardware (touch sensitive, colored display, PCB layout, robust Patient Cable, Smaller, color and mechanically coded plugs instead of D-SUB 9 plugs, more powerful, but smaller battery, lightweight material), bench testing demonstrated substantially equivalent performance between subject (ALGO 7i) and predicate device (ALGO 3i).
The ALGO 7 i hardware is based on the reference device (Sentiero). The ALGO 7i uses the same material and manufacturer for the housing, sockets, plugs, charger, display and PCB as the Sentiero device. The well-known Lilon battery technology as incorporated in the Sentiero was used in the ALGO 7i. Additionally, the user interface and PCB design of the ALGO 7i is based on the Sentiero.
The biocompatibility and electrical safety as well as EMC of the hardware was independently verified by external laboratories.
Main differences between the subject ALGO 7i and the predicate ALGO 3i are the hardware changes as described above and their implication on the handling of the device. The screen displays information in color, facilitating e.g. differentiation of ears by color coding to audiological conventions (right ear = red, left ear = blue). Also. the operating principle changed to maneuvering through the device by swiping and scrolling as current standard for e.g. smartphone use. This was enabled by implementing a touch- sensitive color display. The weight reduction makes the device easier to handle and carry, while color and mechanical coding minimizes the risk of using the wrong connector. Those features have been used in the reference device Sentiero for years without any adverse events reported.
Summarized, the main differences of the ALGO 7i compared to the predicate ALGO 3i represents a design which has been independently tested by third parties, bench tested and a long history of use for the same intended use. The differences between the subject ALGO 7i and predicate ALGO 3i do not raise any new questions concerning safety or effectiveness.
Nonclinical performance testing has shown that the ALGO 7i is substantially equivalent to the ALGO 3i.
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It can be concluded, that the ALGO 7i is substantially equivalent to the ALGO 3i in terms of measuring performance based on stimulus and algorithm and substantially equivalent to the reference Sentiero in terms of hardware and user interface.
OVERALL CONCLUSION
The ALGO 7i shows similar safety, effectiveness and performance data as the predicate ALGO 3i. Through modernization of the hardware platform as well as the update of the applicable standards to their most recent versions and implementation of new relevant standards such as IEC 62366, the ALGO 7i is a state-of-the-art newborn hearing screener.