(87 days)
Grason Stadler GSI- 37 Auto Tymp
Not Found
No
The summary describes standard audiometry functions and features like automatic intensity search, which are not indicative of AI/ML. There are no mentions of AI, ML, or related concepts, nor descriptions of training or test sets typically associated with AI/ML development.
No.
The device is a diagnostic tool used to identify middle ear disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is a "diagnostic middle ear analyzer" and "assists in the diagnosis of possible otologic disorders."
No
The device description explicitly states it is a "handheld diagnostic middle ear analyzer," indicating a physical hardware component is involved in the measurement and analysis process.
Based on the provided information, the Interacoustics MT10 Handheld Impedance Audiometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "handheld diagnostic middle ear analyzer." It performs tests like tympanometry and reflex testing by interacting directly with the patient's ear, not by analyzing a sample taken from the body.
- Anatomical Site: The anatomical site is the "Middle ear," which is a part of the patient's body being directly assessed.
The device is a diagnostic tool used in a clinical setting to assess the function of the middle ear, which falls under the category of in vivo diagnostic devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.
Product codes (comma separated list FDA assigned to the subject device)
77 ETY
Device Description
Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 GSI- 37 Auto Tymp
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
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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Page 1 of 2
JAN 25 1999
510(k) SUMMARY
| PREPARED BY: | INTERNATIONAL DISTRIBUTORS OF
ELECTRONICS FOR MEDICINE, INC.
(IDEM)
4814 East Second Street
Benicia, CA 94510 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Donna Ward, President |
| TELEPHONE: | 707-746-6334 |
| DATE ON WHICH THE SUMMARY
WAS PREPARED: | October 1, 1998 |
| NAME IF DEVICE: | Interacoustics Model MT10 Handheld
Impedance Audiometer |
| COMMON NAME: | Impedance Audiometer |
| PREDICATE DEVICE: | Grason Stadler GSI- 37 Auto Tymp |
DESCRIPTION OF DEVICE: Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.
Comparison of the Interacoustics Model MT10 Handheld Impedance Audiometer and the Grason Stadler GSI-37 Auto Tymp.
Indication for use - Identical for both units.
Similarities and differences:
| Model MT10 Handheld Impedance
Audiometer | Equivalent - Grason Stadler GSI-37
Auto Tymp |
|---------------------------------------------|-------------------------------------------------|
| Display Description: Digital | Digital |
| Lightweight, handheld | Lightweight, handheld |
1
| Hardcopy printout provides objective
documentation of otitis media and
other middle ear disorders. | Hardcopy printout provides objective
documentation of otitis media and
other middle ear disorders. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intensity: 10dBHL to 50dBHL | Not applicable |
| Pressure range: +300 -600daPa/sec. | +200 -400 daPa/sec. |
| Compliance range: .0 to 2.5 cc
displayed; .0 to 5.0 cc numeric | .0 to 1.5cm³ displayed |
| Tests: tympanometry, acoustic reflex
and screening audiometry | Tympanometry |
| Compatible Windows Software:
laBase 95 database program;
Printview for on-line PC monitoring and
printing; NOAH hearing aid fitting
software | None |
| Standards: meets or exceeds
standards specified in IEC 1027-1995,
ANSI 3.60 -1989, ANSI 3.60-1985,
Safety IEC 601-1-1988 | Meets ANSI S3.39 - 1987 for Type 4
Instrument and IEC 601-1-1988 |
| Available frequencies: .5kHz, 1kHz,
2kHz, 3kHz & 4kHz | Not applicable |
| Probe tone: frequency: 226 Hz, +/-3% | 226 Hz, +/-3% |
| Amplitude: 85dB SPL +/-3dB | 85.5 dB SPL, +/-2.0 dB |
| Power: NiMH batteries or Standard AA
NiCa batteries | NiCad batteries |
| Direction of Pressure Sweep: positive
to negative | Positive to negative |
| Size and Weight: Probe: 4" x 10" x 5";
1 lb.; printer/charger: 12" x 9" x 4"; 4
lbs. 11.6 oz. | Probe: 2.4" x 8.3" x 4.3"; 10.5 oz;
printer/charger 9" x 7.6" x 4"; 3 lbs. |
| External Power Supply: (optional) 1.8
Ibs (recharger power supply EPS11
power transformer-11 volts) | External Power Supply: (optional) 1.5
Ibs. (recharger power supply -9 volts) |
SAFETY AND EFFECTIVENESS:
The Interacoustics Model MT10 Handheld Impedance Audiometer is in compliance with the following performance and safety standards:
Standards in IEC 1027-1995, ANSI 3.60-1989, ANSI 3.60-1985, Safety IEC 601-1-1988. Approved for Medical CE-marking by Danish Notified Body D.G.M. Identification No. 0543, Quality System Certificate DGM 016 (CE 0543)
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 25 1999
Donna Ward President International Distributors of Electronics for Medicine, Inc. 4814 East Second Street Benicia, CA 94510
Re: K983832
Interacoustics Model MT10 Handheld Impedance Audiometer Dated: October 28, 1998 Received: October 30, 1998 Regulatory class: II: 21 CFR 874.1090/Procode: 77 ETY
Dear Ms. Ward:
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 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). 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 II (Special Controls) or 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply 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 submission 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(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting 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): 49838383
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Usc:
The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.
(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 Radiological Devices | ||
| 510(k) Number | K983832 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format) |
(Optional Formal 1-2-96)