(25 days)
Not Found
No
The summary describes standard audiology tests and measurements without mentioning any AI/ML components or capabilities.
No.
The device is used for evaluating middle ear functions and performing acoustic reflex tests, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The device evaluates middle ear functions, performs acoustic reflex tests, and determines acoustic reflex thresholds, all of which are diagnostic activities.
No
The device description clearly states it is an "Admittance Meter," which is a hardware device used to measure acoustic impedance. The functions described (tympanometry, acoustic reflex tests) are performed by this hardware.
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 A756 Screening Admittance Meter evaluates middle ear functions and performs acoustic reflex tests. It does this by interacting directly with the ear canal and middle ear, not by analyzing samples taken from the body.
- Intended Use: The intended use describes evaluating middle ear functions and performing tests related to sound and pressure within the ear. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a medical device used for physiological measurement and evaluation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Amplaid A756 Screening Admittance Meter can
- Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform . myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
- Perform Acoustic reflex test. .
- . Determine acoustic reflex threshold
- Perform reflex decav test. .
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Product codes (comma separated list FDA assigned to the subject device)
77ETY, ETY
Device Description
The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle ear, eardrum, ear canal
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)
bench and user testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
KO31978
JUL 2 1 2003
EXHIBIT 2 Amplaid -Biomedical division of Amplimedical S.p.A. (Amplifon Group) Via Donizetti. 12 - 20090 Assago - Milan (Italy) Tel. +39 02 45790303 +39 02 45790340 Fax. Contact: Giovanni Rollier, CEO June 24, 2003
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietarv-Trade Name: Amplaid A756 Classification Name: Auditory Impedance Tester 77ETY Common/Usual Name: Admittance Meter
-
- Equivalent legally marketed devices This product is similar in design and function to the AMPLAID A724 and A728 ADMITTANCE METERS (K992370)
-
- Indications for Use (intended use) The Amplaid A756 Screening Admittance Meter can
- Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform . myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
- Perform Acoustic reflex test. .
- . Determine acoustic reflex threshold
- Perform reflex decav test. .
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
-
- Description of the Device: The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
-
- 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 device.
1
6. Substantial Equivalence Chart
| Characteristic | Predicate K992370
Amplaid A724 –A728 | Amplaid A756 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Clinical auditory impedance
testing applications | Screening audiometry impedance
testing applications |
| Technical characteristics | | |
| Physical characteristics: | | |
| Computer interface | RS232 Bi-directional | SAME |
| Display | Built-in liquid crystal | SAME |
| Control interface | Built-in keyboard | SAME |
| Size/weight | 19.6"w x 16"d x 8"h
18.8 lbs. | 14' x 11" x 7"
7.7 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz
(100 va) | SAME (40 va) |
| Hardcopy Output: | Built-in Thermal printer | SAME |
| Standards and Safety characteristics: | | |
| Audiometric: | Performance Standards
IEC 61027 (1993); Instruments
for the measurement of aural
acoustic impedance/admittance
ANSI S3.39(1987): Specifications
for Instruments to Measure Aural
Acoustic Impedance and
Admittance (Aural Acoustic
Immittance);
IEC 60645-1: Audiometers - Part
1: Pure-tone audiometers
ANSI S3.6 (1996): Specification
for audiometers;
EN ISO 389 (1995): Acoustics –
Standard reference zero for the
calibration of pure-tone air
conduction audiometers | SAME |
| Electrical safety: | EN 60601-1 Class I Type BF
(1990);
EN 60601-1/A1 (1993);
EN 60601-1/A2 (1995);
EN 60601-1/A13 (1996)
EMC: EN 60601-1-2 (1993) | EN 60601-1 Class I Type B
(1990);
EN 60601-1/A1 (1993);
EN 60601-1/A2 (1995);
EN 60601-1/A13 (1996)
EMC: EN 60601-1-2 (1993) |
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Amplaid. that the Amplaid A756 is safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border. Inside the circle is a symbol that resembles an eagle with three lines representing its wings. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Amplaid c/o Daniel Kamm, P.E. Regulatory Engineer P.O. Box 7007 Deerfield. IL 60015
Re: K031978
Trade/Device Name: Amplaid A756 Screening Admittance Meter Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY Dated: June 24, 2003 Received: June 26, 2003
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Daniel Kamm, P.E.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.
Alegi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number_ KO 31978
Device Name: Amplaid A756 Screening Admittance Meter
Indications for Use: The Amplaid A756 Screening Admittance Meter can
- I . Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
-
- Perform Acoustic reflex test.
-
- Determine acoustic reflex threshold
-
- Perform reflex decay test.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K031975 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over the Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |