(60 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on Real Ear Measurement for hearing aid adjustment.
No
The device is used to assist in the adjustment of hearing aids, which implies it is a measurement and adjustment tool rather than a device directly providing therapy. It helps professionals fine-tune another therapeutic device (hearing aids).
No
The device performs Real Ear Measurement and assists in adjusting hearing aids, which is a functional measurement and adjustment process, not a diagnostic one. It helps in the fitting and optimization of treatment (hearing aids) rather than identifying a medical condition or disease.
No
The description mentions the "REM440 system" and "Thor Platform modules in the same housing," implying hardware components are involved, even if the specific REM440 itself might have a software element. The description does not explicitly state it is software-only.
Based on the provided information, the REM440 system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. This involves measuring sound levels in the ear canal, which is a physiological measurement related to hearing aid performance, not an analysis of biological samples in vitro (outside the body).
- Device Description: The description focuses on a system for Real Ear Measurement, which is a clinical procedure performed on a living patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (substances in biological samples)
- Diagnosis, monitoring, or screening of diseases based on biological sample analysis.
The REM440 system is clearly intended for use in a clinical setting to assist with hearing aid fitting, which is a process involving the patient directly.
N/A
Intended Use / Indications for Use
The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.
Product codes
ETW
Device Description
REM440, (for use with Thor Platform System Products)
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
Not Found
Intended User / Care Setting
ENT-professionals and in clinics for hearing aid fitting.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Not Found
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Interacoustics A/S, Assens c/o Mr. Daniel Eggan Manager of Regulatory Affairs/QA Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344
APR 2 9 2005
ﭘﻮ
Re: K050496 Trade/Device Name: REM440 Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing Aid Analyzer Regulatory Class: Class II Product Code: ETW Dated: April 29,2005 Received: April 29,2005
Dear Mr. Eggan:
This letter corrects our substantially equivalent letter of April 29,2005 regarding the regulation number.
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 deyices 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 (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 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
1
Page - Mr. Daniel Eggan
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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.aovlcdrWdsma/dsmamain.html
Sincerely yours,
Orenette RBeeus PhD
lavid M. Whipple Acting 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: REM440, (for use with Thor Platform System Products)
Indications For Use:
..............................................................................................................................................................................
The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Con
Evaluation (ODE)
(Per 21 CFR 801.109)
·
YKL 4/29/05
Prescription Use
(Per 21 CFR 801.109) K050496
MC 4/29/05
(Division Sign-Off)
510(k) Number K050496