(103 days)
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.
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.
The provided text details a 510(k) premarket notification for the "touchTymp" device, an auditory impedance tester. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria or a detailed "reported device performance" table in the way one might expect for a study comparing a new algorithm's performance against a gold standard. Instead, it relies on demonstrating compliance with existing standards and substantial equivalence to a predicate device.
The closest we can get to implied "acceptance criteria" and "performance" from this document are:
| Acceptance Criteria (Implied from the document) | Reported Device Performance (Implied from the document) |
|---|---|
| Technological Characteristics Equivalence: The device's technological characteristics must be substantially equivalent to the predicate device. This includes its ability to change air pressure, measure and graph tympanic membrane mobility, evaluate middle ear function, and measure acoustic reflex thresholds. It also implies compliance with the consensus standard ANSI S3.39 for auditory impedance testers. Safety and EMC Compliance: The device must comply with current standards for medical device safety and electromagnetic compatibility (EMC). Performance Equivalence: The device must perform as safely and effectively as the predicate device for its claimed purposes (conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, featuring tympanometry and acoustic reflex audiometry). Software Control and Interpretation: The software must effectively control probe stimuli, measure results, and present them on a display, with all functions interpretable by the operator. | Technological Characteristics Equivalence: The document explicitly states: "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." Safety and EMC Compliance: "The device was found in compliance with current standards [for medical device safety and EMC]." Performance Equivalence: "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." Software Control and Interpretation: "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical tests None applicable" (page 5), indicating that no clinical test set was used for this 510(k) submission. The determination of substantial equivalence was based on nonclinical tests verifying compliance with standards and technological similarity to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was used to establish a ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states "Clinical tests None applicable." This type of study would fall under clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a way. The "Nonclinical tests summary" discusses "design verification and validation" performed "according to current standards for medical device safety and EMC and performance of impedance tester." This implies standalone testing of the device's functional performance against engineering specifications and industry standards, without human interpretation as part of a clinical study. However, this is not performance in the sense of an AI algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
For the nonclinical tests mentioned:
- Compliance with standards: The "ground truth" was the specifications and requirements outlined in standards like ANSI S3.39 for auditory impedance testers, and general medical device safety and EMC standards.
- Equivalence to predicate device: The "ground truth" was the established performance and characteristics of the predicate device (MI 24, K905704).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that undergoes a "training set." Its functionality is based on established electroacoustic principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
touchTymp
MAICO Diagnostics GmbH
Sickingenstr. 70-71
+49 30 70 71 71 46 - 0
+49 30 70 71 46 - 99
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.
§ 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.