(74 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology. The device description and intended use focus on standard hearing testing and hearing aid fitting functionalities.
No
The device is intended for detection, diagnosis, and adjustment of hearing aids, not for treating a condition.
Yes
The AC440 system explicitly states its intended use is for "detection and diagnosis of suspected hearing loss," which indicates it is a diagnostic device.
No
The description mentions "system" and "housing," implying hardware components are involved, and there is no explicit statement that the device is software-only.
Based on the provided information, neither the AC440 system nor the HIT440 system are IVDs (In Vitro Diagnostics).
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.
- Intended Use: The intended uses described for both devices involve the detection of hearing loss and the testing/fitting of hearing aids. These activities are performed directly on or in relation to the patient's ear, not on samples taken from the body.
- Device Description: While the device description is "Not Found," the intended use clearly indicates a function related to hearing and hearing aids, which are not in vitro activities.
- Anatomical Site: The anatomical site is the "Ear," which is an in vivo (within the living body) site, not an in vitro (outside the living body) site.
Therefore, these devices fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss.
The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers.
Product codes
EWO; ETW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Used by manufacturers of hearing aids and in clinics for hearing aid fitting.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2005
Interacoustics AS c/o Daniel Eggan 7625 Golden Triangle Drive Eden Prarie, MN 55344
Re: K043219
K043219
Trade/Device Name: Affinity (cabinet name), AC440, HIT44, or the combination of systems
Trade/Device Name: Affinity (cabinet name), AC CER 2019 Trade/Device Namer 21 CFR 874.1050; 21 CFR 874.3310 Regulation Name: Audiometer; Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: EWO; ETW Dated: January 19, 2005 Received: January 21, 2005
Dear Mr. Eggan:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained is substantially equivalent (for the indications
referenced above and have determined the device and success marketed in inters referenced above and have decembed the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced promised Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require upproval or werels controls provisions of the Act. The You may, merelore, market the device, because in a general controls provisions of the frective request required in the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) in the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation E may be subject to such adultional controlis. Existing increase of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts Forester be found in the Code of Poderal Registering your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a but other requirements of the Act
that FDA has made a determination that your device and of a fealers and one must that FDA nas made a delerinmanon that your as res be other Federal agencies. You must as and listing and listing or any Federal statutes and regulations administered of end limited to: registration and listing (21 l comply with all the Act STEquiltenes, more and manufacturing practice requirements as setting CFR Part 807); labering (21 CFR Part 800); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Daniel Eggan
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
A. Ralph 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
2
Section A
Indications for Use Statement
Applicant: Interacoustics A/S
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AFFINITY (Cabinet name), AC440, HIT440, Or the combination of systems
Indications For Use:
The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss.
The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Oohthalmic Ear.
510(k) Number
Prescription Use (Per 21 CFR 801.109)
se and Throat Devises
K043219
0(k) Number