(132 days)
No
The document describes a standard auditory impedance tester and does not mention any AI or ML components or functionalities.
No
The device is described as an auditory impedance tester used to evaluate the functional condition of the middle ear and perform various measurements, not to treat or cure a condition.
Yes
Explanation: The device is described as an "auditory impedance tester" intended to "evaluate the functional condition of the middle ear" and "measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing," all of which are diagnostic functions.
No
The device description explicitly lists hardware components such as a charger unit, handheld unit, probe, and contra earphone, in addition to software.
Based on the provided information, the OTOflex 100 type 1012 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OTOflex Function: The OTOflex 100 directly interacts with the patient's body (external auditory canal, middle ear, tympanic membrane) to measure physical characteristics (air pressure changes, mobility, acoustic reflexes). It does not analyze biological specimens.
The device is a diagnostic tool, but it falls under the category of in vivo diagnostic devices, as it performs measurements directly on a living organism.
N/A
Intended Use / Indications for Use
The OTOflex 100 type 1012 is an auditory impedance tester 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. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
Product codes
ETY
Device Description
The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contra earphone, and software for installation on a PC. The probe and contra earphone is connected to the handheld unit. The handheld unit can be operated as a standalone device, as a desktop device when placed in the charger, or as a PC-based system from the software via a Bluetooth radio link.
The handheld unit is powered from batteries that are recharged when the unit is placed in the mains powered charger unit and two transducers for contra stimulus presentation are available: Probe and Insert phone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external auditory canal, middle ear, tympanic membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 OTOflex is an Auditory Impedance Tester for replacement of an existing product of a technology type that is available and accepted in the market. OTOflex complies with product performance standards for impedance/admitance instruments: EN 61027 and ANSI S3.39.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zodiac 901 Middle-Ear Analyzer (K910247)
Reference Device(s)
Handtymp (K923072), GSI 2000 Middle Ear Analyzer (K000097)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 3 1 2004
510(k) Summary of Safety and Effectiveness
Submitter
| Name and address: | GN Otometrics A/S |
|---|---|
| Dybendalsvaenget 2 | |
| DK-2630 Taastrup | |
| Denmark | |
| Phone: | +45 7211 1555 |
| Fax: | +45 7211 1548 |
| Contact person: | Per Pape Thomsen |
November 14, 2003 Summary prepared:
Device name
Common/Usual name: Trade/Proprietary name: Classification name;
AudioDiagnostic Testing System OTOflex 100 type 1012 Auditory Impedance Tester
Predicate devices
OTOflex is similar to the product Zodiac 901 Middle-Ear Analyzer (K910247) but differs in three ways: handheld operation powered by batteries, measurement with 1000 Hz probe tone and wireless computer interface.
Handheld operation powered by batteries is currently performed by Handtymp (K923072) and measurement with 1000 Hz probe tone is currently performed by GSI 2000 Middle Ear Analyzer (K000097).
Description
The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contra earphone, and software for installation on a PC. The probe and contra earphone is connected to the handheld unit. The handheld unit can be operated as a standalone device, as a desktop device when placed in the charger, or as a PC-based system from the software via a Bluetooth radio link.
The handheld unit is powered from batteries that are recharged when the unit is placed in the mains powered charger unit and two transducers for contra stimulus presentation are available: Probe and Insert phone.
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Intended Use
The OTOflex 100 type 1012 is an auditory impedance tester 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. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
Technological Characteristics
| Device Specifications | OTOflex | Zodiac 901 |
|---|---|---|
| Safety compliance | EN 60601-1 | EN 60601-1 |
| Construction type | Handheld, Desktop, PC- | |
| based system | Desktop system | |
| Power source | Batteries recharged from | |
| mains powered charger unit | Mains | |
| Computer interface | Bluetooth radio link | RS232 cable connection |
| Supporting software | NOAH database SW | NOAH and PAX database |
Safety
OTOflex is designed to provide safety to the patient as well as the user and complies with:
- EN 60601-1, UL 2601-1, CAN/CSA-C22.2 NO 601.1-90: Medical Electrica1 . Equipment. Part 1: Generel requirements for safety
- EN 60601-1-1: Medical Electrical Equipment. Part 1: Generel requirements . ● for safety. 1. Collateral standard: Safety requirements for medical electrical systems
- EN 60601-1-2: Medical Electrical Equipment. Part 1-2: Generel requirements � for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 60601-1-4: Medical Electrical Equipment. Part 1: Generel requirements . for safety. 4. Collateral standard: Programmable electrical medical systems
- Medical devices Directive 93/42/EEC
2
OTOflex is designed, developed and manufactured according to:
-
ISO 9001: Quality Management Systems Requirements .
. -
ISO13485: Quality Systems Medical devices Particular requirements for . the application of ISO 9001
Effectiveness
The OTOflex is an Auditory Impedance Tester for replacement of an existing product of a technology type that is available and accepted in the market. OTOflex complies with product performance standards for impedance/admitance instruments: EN 61027 and ANSI S3.39. :
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
GN Otometrics A/S c/o Per Pape Thomsen 2 Dybendalsvænget P.O. Box 119 DK-2630 Taastrup Denmark
Re: K033645
Trade/Device Name: OTOflex 100 Type 1012 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY Dated: February 25, 2004 Received: March 2, 2004
Dear Mr. Thomsen:
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.
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Page 2 - Per Pape Thomsen
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.
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
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Statement of Indications for Use
The OTOflex 100 type 1012 is an auditory impedance tester 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. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
(033645) 510(k) Number