touchTymp

K162210 · Maico Diagnostics GmbH · ETY · Nov 16, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K162210
• Device Name: touchTymp
• Applicant: Maico Diagnostics GmbH
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Nov 16, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagic disorders. It features tympanometry and acoustic reflex audiometry.

Device Story

The touchTymp is an auditory impedance analyzer used by audiologists, ENTs, and trained technicians in clinical settings. It functions by changing air pressure in the external auditory canal and delivering test tones via a probe. The device measures and graphs tympanic membrane mobility to evaluate middle ear function and detects abnormalities related to stiffness, flaccidity, or pathology. It also measures acoustic reflex thresholds via stapedial muscle contraction response to stimuli. The device is software-controlled; the software manages probe stimuli, processes measurements, and displays results on an integrated screen. Operators interpret all data to assess central vs. peripheral pathologies and identify uncomfortable loudness levels. The device aids clinical decision-making by providing objective data on middle ear health.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, design verification, and validation performed in accordance with medical device safety, EMC, and performance standards for impedance testers.

Technological Characteristics

Auditory impedance tester; software-controlled probe for pressure and tone stimuli; integrated display. Complies with ANSI S3.39. Class II device.

Indications for Use

Indicated for use by audiologists, ENTs, or trained technicians to conduct diagnostic hearing evaluations and assist in the diagnosis of otologic disorders in patients requiring tympanometry and acoustic reflex audiometry.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MI 24 (K905704)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 16, 2016

Maico Diagnostics Gmbh Mr. Uwe Ledworuski Regulatory Affairs Manager Sickingenstr. 70-71 Berlin, 10553 DE

Re: K162210

Trade/Device Name: Touchtymp Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: August 2, 2016 Received: August 5, 2016

Dear Mr. Ledworuski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K162210

Device Name touchTymp

Indications for Use (Describe)

The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagic disorders. It features tympanometry and acoustic reflex audiometry.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(K) SUMMARY

touchTymp

MAICO Diagnostics GmbH

Sickingenstr. 70-71

[phone] - 0

[phone] - 99

[e-mail]

10553 Berlin Germany

#### Submitter Information:

Company Name Address

Telephone Fax e-mail Contact Person

Date Summary Prepared

#### Device Identification:

- Trade Name Common Name Classification Name Product Code Panel Device Class 510(k) No.
# Predicate Devices:

Trade Name Manufacturer 510(k) No. Date Cleared

Uwe Ledworuski, Manager Regulatory Affairs June 11, 2016 touchTymp Audiometric equipment Tester, Auditory Impedance

ETY Ear Nose & Throat Class II (According to 21 CFR 874.1090) K162210

MI 24 MAICO Hearing Instruments, Inc. K905704 04/30/1991

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Device Description The touchTymp is an auditory impedance analyser. The device 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 middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers. Indications for Use The touchTymp tympanometer is an electroacoustic test instrument 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. It features tympanometry and acoustic reflex audiometry. Intended operator The touchTymp tympanometer is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians. Technological The instrument is software controlled. The software controls the Characteristics probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers. Nonclinical tests summary Following the design control procedure the design verification and validation were performed according to current standards for medical device safety and EMC and performance of impedance tester. The device was found in compliance with current standards

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and demonstrated substantial equivalence with the predicate device.

Clinical tests None applicable Conclusion The touchTymp as a modification to the predicate device (the previous cleared revision of MI 24 uses similar technology and has the same intended use as the predicate device. The verification and validation activities show substantial equivalence with the predicate device and that the modified touchTymp is as safe and effective as the predicate device for its claimed purpose.