(85 days)
No
The document describes a standard clinical audiometer and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is described as a "clinical diagnostic audiometer" used for "measurement and diagnosis of various types of hearing losses," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "measurement and diagnosis of various types of hearing losses." Additionally, the "Device Description" section repeatedly uses the term "diagnostic audiometer" and lists various "diagnostic audiometric tests."
No
The device description explicitly states it is a "two channel clinical diagnostic audiometer," which is a hardware device used for performing audiometric tests. The summary does not indicate that the device is solely software controlling external hardware.
Based on the provided information, the Amplaid 460 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Amplaid 460 Function: The Amplaid 460 is an audiometer. It measures hearing ability by presenting sounds to the patient and assessing their responses. This is a direct interaction with the patient's sensory system, not an analysis of a biological specimen.
- Intended Use: The intended use clearly states it's for "measurement and diagnosis of various types of hearing losses" by a qualified audiologist on patients. This involves behavioral and physiological responses, not laboratory analysis of samples.
Therefore, the Amplaid 460 falls under the category of a clinical diagnostic device that interacts directly with the patient, rather than an IVD device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Amplaid 460 is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
Product codes
77EWO
Device Description
The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
qualified/trained audiologist / clinical situation
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
The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG - 5 1997
EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472.482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President
April 30, 1997
510(k) Summary of Safety and Effectiveness
-
Identification of the Device: -Proprietary-Trade Name: Amplaid 460 Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Diagnostic Audiometer
-
Equivalent legally marketed devices This product is similar in design and function 2 to the Amplaid 309 Clinical Audiometer (K880059)
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- Indications for Use (intended use) The Amplaid 460 is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
-
- Description of the Device: The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1997
Amplifon S.P.A. Daniel Kamm Regulatory Engineer c/o Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K971747
Amplaid 460 Research and Clinical Audiometer Dated: April 30, 1997 Received: May 12, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Kamm:
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 Cosmetic Act (Act). You may, therefore, 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 (c 1 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 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 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
hTliau Yi
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
2
j) Indications for Use
K471747 510(k) Number
Device Name: Amplaid 460 Research and Clinical Audiometer
Indications for Use: The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which can personn an ualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over the Counter Use __
(Per 21 CFR 801.109)
Ra-Pally
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971747