(88 days)
No
The document describes a standard clinical 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 treatment.
Yes
The "Intended Use / Indications for Use" states that the device is a "clinical diagnostic audiometer" and is intended for "measurement and diagnosis of various types of hearing losses." The "Device Description" also notes its ability to provide testing capabilities for "basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss," which are all diagnostic functions.
No
The device description explicitly states it is a "one channel clinical diagnostic audiometer," which is a hardware device used for performing audiometric tests. The summary does not indicate it is solely software.
Based on the provided information, the Amplaid 171S 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.
- Amplaid 171S Function: The Amplaid 171S is a clinical diagnostic audiometer. It measures hearing ability by presenting sounds to the patient's ear and assessing their responses. This is a non-invasive, in vivo diagnostic procedure, not an in vitro test on a biological sample.
- 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 direct interaction with the patient, not laboratory testing of samples.
Therefore, the Amplaid 171S falls under the category of a medical device used for diagnosis, but specifically an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Amplaid 171S 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 171S is a one 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, and speech,
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
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)
The results of bench and user testing indicates that the new device is as safe and effective as the predicate evia e
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Amplaid 308 Clinical Audiometer (K891988)
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
5972862
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
OCT 31 1007
August 1, 1997
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: Amplaid 171S Classification Name: Audiometer 77EWO Ocentro .. L. Name: Clinical Dingnostic Aveller
ﺎ .
- Identification of the Device: Proprietary-Trade Name: Amplaid 171S Classification Name: Audiometer 77EWO Ocentro .. L. Name: Clinical Dingnostic Aveller
-
- Equivalent legally marketed devices This product is similar in design and function to the Amplaid 308 Clinical Audiometer (K891988)
-
- Indications for Use (intended use) The Amplaid 171S 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 audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
-
- Description of the Device: The Amplaid 171S is a one 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, and speech,
-
5 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 'evia e
1
| Characteristic
| Predicate device:
Amplaid 308
Clinical diagnostic audiometric
applications | New device:
Amplaid 171S
(Same) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Physical characteristics:
Size/weight | 17.3" W x 19.3" D x 7" H.
28 lbs. | 11 3/8" W x 12"D x 4 3/4" H
6.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) |
| Hardcopy Output: | Possible via computer interface | (Same) |
| Standards and Safety
characteristics:
Audiometric: | ISO 389-1975, ANSI S3.6-1969,
ANSI S3.13-1972, IEC 645 | ISO 389-1989, ANSI S3.6-1989,
IEC 645-1,-2, -4 (Same,
standards have been updated) |
| Electrical safety: | UL-544, IEC 601 | (Same) |
6. Substantial Equivalence Chart
Conclusion 7.
- After analyzing both bench and effective as the predicate device, has few
that the Amplaid 171S is as safe and effective as the predicate device, has few that the Amplaid 1715 is as sale and chective as the productions for use, thus rendering it
technological differences, and has no new indications for use, thus rendering it technological differenter, and the predicate Device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 1997
Daniel Kamm, P.E c/o Kamm & Associates PO Box 7007 Deerfield, IL 60015 USA Re: K972862.
Amplaid 171S Clinical Audiometer Dated: August 1, 1997 Received: August 4, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Kamm:
We have reviewed your Section 5100x) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions 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, 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 requirement, 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 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
hĩ liau Yu
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
3
i) Indications for Use
510(k) Number 11973862
Device Name: Amplaid 171S Clinical Audiometer
Indications for Use: The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which our perform an audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
Concurrence of CDRH, Office of Device Evaluation (JDz)
Prescription Use
ﻟﻠﺴﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ
ਾਲ
Over the Counter Use (Per 21 CFR 801.109)
Jamil A. Segran
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number J