(86 days)
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.
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).
This document describes the Amplaid A315 and A319 Series clinical diagnostic audiometers and their substantial equivalence to a predicate device, the Amplaid 460 (K971747). The submission focuses on direct comparison to the predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device as a standalone entity.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the new device. Instead, the acceptance criterion is implied to be "substantial equivalence" to the predicate device in terms of safety and effectiveness.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Amplaid A315 and A319TM) |
|---|---|---|
| Intended Use | Must be the same as the predicate device (Clinical audiometric applications) | Same as the predicate device. Intended for use by qualified/trained audiologist on adult and pediatric subjects for measurement and diagnosis of various types of hearing losses. |
| Safety | Must be as safe as the predicate device. Compliance with relevant electrical safety standards (UL, IEC) is expected. | "As safe and effective as the predicate device." Complies with UL-2601, IEC 60601 (updated standards from predicate). |
| Effectiveness | Must be as effective as the predicate device in performing all audiometric tests normally performed in a clinical situation. Compliance with audiometric standards (ISO, ANSI, IEC) is expected. | "As safe and effective as the predicate device." Performs all audiometric tests (pure tone, Speech, High Frequency, Multifrequency, Bekesy, SISI, ABLB, DLI, MLB, Tone Decay, MLD). Complies with ISO 389-1989, ANSI S3.6-1989, IEC 645-1,-2,-4. |
| Technological Differences | Minor technological differences are acceptable as long as they do not raise new questions of safety or effectiveness. | Differences in size/weight, hardcopy output (external printer option, PC integration via ASA software), and updated electrical safety standards. Minor technological differences. |
2. Sample size used for the test set and the data provenance:
The document mentions "bench and user testing data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for a test set. The evaluation was a comparison to a predicate device.
4. Adjudication method for the test set:
The document does not describe an adjudication method for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is an audiometer, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This describes a medical device, an audiometer, which is operated by a human audiologist. The device itself is not an algorithm that performs diagnosis independently.
7. The type of ground truth used:
The "ground truth" in this context is the performance and safety established by the predicate device, Amplaid 460 (K971747). The new devices are compared against this established benchmark. There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel diagnostic scenario.
8. The sample size for the training set:
Not applicable. This submission describes a hardware medical device (audiometer) and its substantial equivalence to a predicate, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device submission.
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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
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- Identification of the Device: Proprietary-Trade Name: "Amplaid A315 and A319TM" Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Audiometer
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- Equivalent legally marketed devices This product is similar in design and function to the Amplaid 460 (K971747)
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- 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.
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- 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).
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- 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.
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| Characteristic | Predicate device: TheAmplaid 460 (K971747) | New device: "AmplaidA315 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 thermalprinter | External printer via parallelCentronics interface. Built in via640 point thermal printer (ModelA319), or via PC using ASAsoftware. |
| Standards and Safetycharacteristics: | ||
| 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.
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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
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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)
§ 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.