(44 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on electroacoustic and psychoacoustic testing, which are traditional methods for hearing aid analysis.
No.
The device is used to test the performance of hearing aids and to determine a patient's psychoacoustic comfort levels, not to directly treat an illness or condition.
Yes
The device "determine[s] the electroacoustic performance of the hearing aid" and "present[s] sound to the patient's ear in a test to determine his psychoacoustic comfort levels," which are forms of assessment or measurement, fitting the definition of a diagnostic device.
No
The device description explicitly names a hardware product, "Fonix FP35 Hearing Aid Analyzer," which is a physical device used for testing hearing aids. The description of its function also implies interaction with physical components (hearing aids, couplers/sound boxes, presenting sound to the ear).
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 Fonix FP35 Hearing Aid Analyzer clearly states its purpose is to analyze the performance of hearing aids and present sound to a patient's ear for psychoacoustic testing. It does not involve the analysis of biological samples like blood, urine, tissue, etc.
- The intended use is related to hearing aid performance and psychoacoustic testing. This falls under the realm of audiology and hearing health, not in vitro diagnostics.
Therefore, the Fonix FP35 Hearing Aid Analyzer, as described, does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.
Product codes
77 ETW, 77 EWO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 1998
Re:
George J. Frye President Frye Electronics. Inc. P.O. Box 23391 Tigard, OR 97281-3391 K980377 Fonix FP35 Hearing Aid Analyzer Dated: January 29, 1998 Received: February 2, 1998 Regulatory class: II 21 CFR 874.3310/Procode: 77 ETW 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Frye:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Comments 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 vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivaliation 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 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/cdr/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page l of ( of 1 )
510(k) NUMBER (IF KNOWN) :
DEVICE NAME: F635
INDICATIONS FOR USE:
The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient.
If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
: 上一
OR .
Over-The-Counter-Use (Optional Format 1-2-96)
Uamil G. Ayman
(Division Sign Off)
Sign-On)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980377