(130 days)
K934658S1
Not Found
No
The summary describes a device that presents acoustic stimuli and measures otoacoustic emissions. There is no mention of AI, ML, or any related concepts in the provided text. The device's function appears to be based on direct measurement and signal processing, not learning algorithms.
No
This device is an audiometer used to assess cochlear function, not to treat a condition.
Yes
The device's purpose is to "assess the status of cochlear function" by measuring otoacoustic emissions, which directly indicates its role in diagnosing or evaluating a physiological state.
No
The device description explicitly states that the device utilizes a probe containing a microphone and two speakers, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the GSI SA60 clearly states that it presents an acoustic stimulus to the ear and measures an evoked otoacoustic emission. This is a direct measurement of a physiological response within the body, not an analysis of a biological sample taken from the body.
- The intended use is to assess cochlear function. This is a diagnostic assessment of a physical part of the body, not a diagnostic test performed on a sample.
The device is an audiometric device used for assessing hearing function, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.
Product codes
77 ETW
Device Description
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GS1 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cochlear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
The GSI SA60 is an extension of the current GSI 60 system and operates in the same manner. The GSI SA60 allows the use of the system with a notebook computer without the need for a docking station which is required for the GSI 60. The GSI SA60 is therefor more portable than the GSI 60 making it equivalent or better in effectiveness for the testing of cochlear function.
Key Metrics
Not Found
Predicate Device(s)
K934658S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
JUN - 6 1997
"510(k) SUMMARY" Summary of Safety and Effectiveness
| Submitter's Name & Address: | Grason-Stadler Inc.
1 Westchester Drive
Milford, N.H. 03055-3056 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person & Telephone: | Norman L. Schultz
(603) 672-7303 | |
| Date Summary Prepared: | January 22, 1997 | |
| Device Name: | Classification Name - Audiometer
Common/Usual Name - Otoacoustic Emissions/Screening
Audiometer
Proprietary Name - GSI SA60 DPOAE System | |
| Predicate Device: | Grason-Stadler Inc. model GSI 60 DPOAE system (ref.
510(k) #K934658S1). | |
Device Description, intended Use & Effectiveness:
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GS1 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.
Technological Characteristics:
See attachment "A" for a comparison of the GSI SA60 to the predicate device.
Safety:
The GSI SA60 system is designed to provide electrical safety to the patient as well as the user. The system is designed to be used with a notebook computer powered either by its internal battery or by the supplied low voltage ungrounded DC power supply. The notebook computer used with
1
the system will be specified to meet standards pertaining to the safety of Information Technology Equipment namely: IEC 950, UL1950, CSA 950 and CE mark. The instrument portion of the system may be powered by its internal battery or by the supplied low voltage DC power supply. The instrument enclosure is also connected to protective earth (ground) when powered by the low voltage DC power supply. No other mains powered equipment will be connected to the system during patient testing. The front panel of the instrument will have status indicators that inform the user of the following conditions: 1) Battery charging, 2) low battery voltage, and 3) power applied. The battery charger status will be constantly monitored and the instrument will not collect data when the battery charge is too low to reliably operate the instrument. The system is designed to meet the following standards related to electrical safety: IEC 601-1, UL2601, and CSA 601-1-M90. A preliminary design review was conducted with a competent test laboratory and the design will meet requirements for electrical safety of an IEC 601-1 class 1, type B medical instrument.
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 89/336/EEC Electromagnetic Compatibility Directive. |
Summary of Effectiveness:
The GSI SA60 is an extension of the current GSI 60 system and operates in the same manner. The GSI SA60 allows the use of the system with a notebook computer without the need for a docking station which is required for the GSI 60 (See attachment "A" Chart of Predicate Device Comparison). The GSI SA60 is therefor more portable than the GSI 60 making it equivalent or better in effectiveness for the testing of cochlear function.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Norman L. Schultz Senior Quality Engineer Grason-Stadler, Inc. 1 Westchester Drive Milford, NH 03055-3056 Re: K970324 Grason-Stadler GSI SA60 DPOAE Otoacoustic Emission (OAE) Test Instrument Dated: March 18, 1997 ... Received: March 19, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 ETW
Dear Mr. Schultz: 44
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 (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 misbranion.
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 an be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: · General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(x) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radology devices, Nose and Throat devices. Additionally, for questions on the promotion 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 premarket 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,
William Y
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
Enclosure
3
510(k) Number (if known): K970324
Device Name: GSI SA60 DPOAE System
Indications For Use:
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of | Reproductive, Abdominal, ENT, |
| and Radiologic | Reproductive, Abdominal, ENT, |
| Medical Devices | |
| 510(k) Number | K970324 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | __ |
|---|---|---|---|---|
| ------------------ | ---------------------------------------------------- | ---- | ---------------------- | ----------------------------------------------------- |
(Optional Format 1-2-96)