(86 days)
No
The document describes a standard audiometer and does not mention any AI or ML capabilities.
No
The device is described as a "clinical diagnostic audiometer" intended for "measurement and diagnosis of various types of hearing losses," not for treating them. It performs tests to identify hearing issues, but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "measurement and diagnosis of various types of hearing losses," and the "Device Description" section notes its capability for "diagnosis of various types of hearing losses."
No
The device description explicitly states it is a "two channel clinical diagnostic audiometer," which implies a hardware device with channels for audio output and input, not solely software. The description of various audiometric tests further supports this, as these tests require hardware components to generate and measure sound.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Amplaid Models A315 and A319 are audiometers. They measure hearing ability by presenting sounds to the patient's ear and recording their responses. This is a direct measurement of a physiological function, not an analysis of a biological sample taken from the body.
- Intended Use: The intended use clearly states it's for "measurement and diagnosis of various types of hearing losses" by a qualified audiologist. This involves interacting directly with the patient's auditory system.
Therefore, while it's a diagnostic device, it falls under the category of a clinical diagnostic device that interacts directly with the patient, rather than an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Amplaid A315 and A319 Series are clinical diagnostic audiometers 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 A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. They provide 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 subjects
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
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
K98 3915
JAN 29 1999
EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-02-57472.482 Fax ++39-02-57409427 Contact: Giovanni Rollier, President
November 1, 1998
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "Amplaid A315 and A319TM" Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Audiometer
-
- Equivalent legally marketed devices This product is similar in design and function to the Amplaid 460 (K971747)
-
- Indications for Use (intended use) The Amplaid A315 and A319 Series are clinical diagnostic audiometers 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 A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. They provide 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
| Characteristic | Predicate device: The
Amplaid 460 (K971747) | New device: "Amplaid
A315 and A319TM" |
|------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Clinical audiometric applications | (Same) |
| Physical characteristics: | | |
| Size/weight | 17.3" W x 19.3" D x 7" H,
28 lbs. | 18.9" W x 15.7" D x 7.8" H, 8 kg
=17.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) |
| Hardcopy Output: | Built in via 640 point thermal
printer | External printer via parallel
Centronics interface. Built in via
640 point thermal printer (Model
A319), or via PC using ASA
software. |
| Standards and Safety
characteristics: | | |
| Audiometric: | ISO 389-1989, ANSI S3.6-1989,
IEC 645-1,-2, -4 | (Same) |
| Electrical safety: | UL-544, IEC 601 | UL-2601, IEC 60601 |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid A315, A319 Series™" audiometers are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate Device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 29 1999
Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, IL 60015
Re:
Amplaid A315 and A319 Audiometers Dated: November 1, 1998 Received: November 4, 1998 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 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). 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 notfication"(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
j. Indications for Use
510(k) Number K98 Kg83915
Device Name: Amplaid A315, A319 Series Clinical Audiometers
Indications for Use: The Amplaid Models A315 and A319 are two channel clinical diagnostic audiometers 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number
Prescription Use V
OR Over the Counter Use (Per 21 CFR 801.109)