Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that combines existing audiometry technologies and does not mention any AI or ML capabilities.

Therapeutic

No
The device's purpose is to detect and track hearing loss and abnormal middle ear conditions, not to treat them.

Diagnostic

Yes
The "Intended Use / Indications for Use" states, "The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients." The ability to detect conditions indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand held instrument" and combines multiple testing capabilities (Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry) within this instrument, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The description of the GSI 70 AudioPath™ Hearing Screener clearly states its purpose is to "detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients" by performing tests directly on the patient (Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry). These tests involve interacting with the patient's ear and auditory system, not analyzing biological samples taken from the patient.
The intended use and device description focus on functional testing of the auditory system. The tests performed by the device (OAE, Tympanometry, Pure Tone Audiometry) are all methods of assessing the function of the ear and auditory pathways. This is distinct from the analysis of biological markers or substances found in bodily fluids or tissues, which is the domain of IVDs.

Therefore, the GSI 70 AudioPath™ Hearing Screener is a diagnostic device, but it falls under the category of in vivo diagnostic devices (devices used to examine the body directly) rather than in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

Product codes (comma separated list FDA assigned to the subject device)

77 EWO, 77 ETY

Device Description

The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (From premature infants through adults age). The instrument has a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry. The device is intended to be used by trained personnel in a medical or school environment. This device is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids, cochlea implants or wireless microphones.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

From premature infants through adults

Intended User / Care Setting

Trained personnel in a medical or school environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The GSI 70 AudioPath™ Screener is a consolidation of three current audiological products into one portable instrument making it equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1), GSI 37 Auto Tymp (ref. 510(k) #K911095 ), GSI 17 Screening Audiometer (ref. 510(k) #K902540)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.

Summary

0

"510(k) SUMMARY" Summary of Safety and Effectiveness

| Submitter's Name & Address: | Grason-Stadler Inc.
1 Westchester Drive
Milford, N.H. 03055-3056 | | | FEB 10 1998 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Contact Person & Telephone: | Norman L. Schultz
(603) 672-7303 | | | |
| Date Summary Prepared: | September 12, 1997 | | | |
| Device Name: | Classification Name - Audiometer
Common/Usual Name - Screening Audiometer
Proprietary Name - GSI 70 AudioPath™ Screener | | | |
| Predicate Device: | Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and the
GSI 17 Screening Audiometer (ref. 510(k) #K902540). | | | |

Device Description, intended Use & Effectiveness:

The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (From premature infants through adults age). The instrument has a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry. The device is intended to be used by trained personnel in a medical or school environment. This device is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids, cochlea implants or wireless microphones.

Technological Characteristics:

See attachment "A" for a comparison of the GSI 70 AudioPath™ Screener to the predicate device.

Safety:

The GSI 70 AudioPath™ Screener is designed to provide electrical safety to the patient as well as the user. The system is designed to meet the following standards related to electrical safety: IEC 601-1, UL2601, and CSA 601-1-M90. To prevent excessive tone levels within the ear the system is designed with watchdog timers that monitor the system and disable the tone generation when disparity is detected. Also, the speakers that are used within the probes are

1

incapable of producing enough decibels to permanently damage the ear. The pump for the tympanometry function has been designed such that the volume of the pump is incapable of producing a pressure that would exceed the safe level as specified within ANSI S3.39.

The system will also be certified to the following standards:

| EMI EN55011 | Group 1 Class B requirements (medical equipment, conducted and radiated
emissions). |
|-------------|-------------------------------------------------------------------------------------------------|
| IEC801-2 | ESD Susceptibility. |
| IEC801-3 | Radiated Electromagnetic Field Susceptibility. |
| IEC801-4 | Conducted Susceptibility to Line Transients. |
| CE Mark | Conforms with provisions of European Council Directive 93/42/EEC concerning
medical devices. |

Summary of Effectiveness:

The GSI 70 AudioPath™ Screener is a consolidation of three current audiological products into one portable instrument making it equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults).

2

Attachment A Chart of Predicate Device Comparison

| Technological

Specification	GSI 17	GSI 37	GSI 60	GSI 70
Power Source	Powered by a low
voltage DC wall
mounted power supply.	Powered by a low
voltage DC wall
mounted power supply.	Powered by battery or
a low voltage DC wall
mounted power
supply.	Powered by re-
chargeable battery.
Battery Low
Indication.	None	None	LED lights on front of
instrument.	Battery low indicator on
display.
Safety
Compliance.	IEC 601-1 and UL544	IEC 601-1 and UL544	IEC 601-1 and
UL2601-1	IEC 601-1 and UL2601-
1
Computer Interface	RS232	None	DSP Board plugged
into printer interface.	IRDA communications
Audiometry	Technology used is
speaker headset that
present tones to patient
which if perceived is
indicated by a patient
response switch. Tone
quality and frequency
specified per ANSI S3.6.	N/A	N/A	Tones are presented by
a minature speaker
within the probe which if
perceived is indicated
by the patient using a
response switch. Tone
quality and frequency
specified per ANSI S3.6.
Tympanometry	N/A	Tones are presented
during a pressurization
of the ear by a
minature pump and
response is recorded
by a microphone. Tone
quality and frequency
controlled by ANSI
S3.39.	N/A	Same as GSI 37
OAE Probe Design	N/A	N/A	Two speakers and a
microphone present
and record response
from cochlea of ear.	Same as GSI 60
DSP Software for
OAE Function			GSI 60 DSP Software	Same
Supporting software
for OAE Function			Windows based
software that graphs
DP result, allows
changes to protocall,
export of data, and
changes to patient ID.	Windows based
software that shows
result, allows export of
data, and updating of
patient ID.

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN..." is arranged in a circular fashion around the left side of the emblem, partially obscured.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Norman L. Schultz Senior Quality Engineer Grason-Stadler, Inc. 1 Westchester Drive Milford, New Hampshire 03055-3056 Re:

K974237 GSI 70 AudioPath TM Hearing Screener Dated: November 7, 1997 Received: November 12, 1997 Regulatory class: II Procode: 77 EWO, 21 CFR 874.1050 77 ETY, 21 CFR 874.1090

Dear Mr. Schultz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the ensement 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Portugions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Onality System Regulation (OS) for Medical Devices: General regulation (21/CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vity diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and " advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premailed notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

4

510(k) Number (if known): イタフ 4 237

Device Name: GSI 70 AudioPath™ Hearing Screener

Indications For Use:

The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Simpson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)