(121 days)
Not Found
No
The summary describes standard audiometry and tympanometry devices and does not mention any AI or ML capabilities.
No
The device is described as diagnostic, used for hearing evaluations and assisting in the diagnosis of disorders, not for treating them.
Yes
The "Intended Use / Indications for Use" section states that the devices are for "conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders." Additionally, the "Device Description" calls Flute a "diagnostic device" and Viola integrates a "diagnostic audiometer."
No
The device description explicitly states that Flute and Viola are "stand-alone" devices and mentions the option of an "integrated thermal printer," indicating they are hardware devices with integrated software, not software-only.
Based on the provided information, the Inventis Middle Ear Analyzers, Flute and Viola, are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states that the devices are for "conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While the device interacts with the patient's ear directly, the analysis of the acoustic impedance and admittance measurements is used to diagnose conditions related to the middle ear.
- Device Description: The devices are described as "diagnostic devices" and "diagnostic audiometer."
- Anatomical Site: The focus is on the "Middle Ear," which is a part of the human body.
- Performance Studies: The performance studies mention testing against standards related to "Aural Acoustic Impedance and Admittance," which are physiological measurements used in diagnosis.
While the device doesn't process images or use AI/ML, and the input is not a traditional "specimen" like blood or tissue, the core function of measuring and analyzing physiological responses from the human body for diagnostic purposes firmly places it within the scope of an In Vitro Diagnostic device. The term "In Vitro" in IVD refers to tests performed outside of the living organism, but the regulatory definition is broader and includes devices that analyze samples or measurements taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer.
Product codes
ETY
Device Description
Flute is stand-alone tympanometry / reflex diagnostic device. Viola is a stand-alone combined unit, integrating a screening middle ear analyzer and a diagnostic audiometer capable of performing air and bone conduction threshold and speech exams. Flute and Viola are available with or without the integrated thermal printer.
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
six months of age or older
Intended User / Care Setting
trained operators in hospitals, nurseries, ENT clinics and audiology offices
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)
All necessary bench testing was conducted on the Inventis Middle Ear Analyzers (Flute and Viola) to support a determination of substantial equivalence to the predicate device. The safety and performance testing included the following tests:
- Electrical and mechanical safety testing
- Electromagnetic compatibility safety testing
- Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (ANSI S3.39)
- Instruments for the measurement of aural acoustic impedance (IEC 60645-5)
The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with both the standards IEC 60601-1-2:2007 and IEC 60601-1:2005 and is safe as the predicate device. The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
INVENTIS MIDDLE EAR ANALYZER TRADITIONAL 510(K) PREMARKET NOTIFICATION
510(k) Summary
1 - Information
510(k) Notification: K133013
GENERAL INFORMATION
| Applicant: | Inventis srl |
|---|---|
| Corso Stati Uniti 1/3, 35127 Padova Italy | |
| Tel: +39 049 8962844 | |
| Fax: +39 049 8966 343 | |
| Registration Number: 3008699634 |
Massimo Martinelli Contact Person: General Manager E-mail: massimo.martinelli@inventis.it
t
Date: December 18, 2013
DEVICE INFORMATION
The Inventis Middle Ear Analyzers (Flute and Viola) are conventional Auditory Impedance Testers. Below you can find the information related to the subject device.
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:
And Controller Comments
| Classification: | 21 CFR§874.1090
Class II |
|-------------------------|---------------------------------------|
| Product Code: | ETY |
| Trade Name: | Middle Ear Analyzers, Flute and Viola |
| Common name: | Middle Ear Analyzer |
| Classification
Name: | Auditory Impedance Tester |
JAN 2 4 2014
・
1
PREDICATE DEVICES
Inventis Middle Ear Analyzers are substantially equivalent to the Interacoustics Audio Traveller, Model AA222 for the constructive technological features and the performance.
INDICATIONS FOR USE
The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer.
PRODUCT DESCRIPTION
Flute is stand-alone tympanometry / reflex diagnostic device. Viola is a stand-alone combined unit, integrating a screening middle ear analyzer and a diagnostic audiometer capable of performing air and bone conduction threshold and speech exams. Flute and Viola are available with or without the integrated thermal printer.
2 - Substantial Equivalence
Inventis Middle Ear Analyzers (Flute and Viola) represent a modification of the cleared device, Interacoustics Audiotraveller, Model AA222 (510(k) number: K022728). The changes are of minor nature and do not concern the main functions of the predicate device. In particular, the differences regard:
- the pressure range, which is -600 to +400 daPa instead of -600 to +300 daPa and .
- the introduction of an Internal Flash Memory where the speech material is stored. .
In further support of a substantial equivalence determination, Section 12-Substancial Equivalent Discussion provides a comparison table between the submitted device and the predicate device. The main comparison features are reported in the following table:
2
· ·
.
.
| Predicate Device | New Device | ||
|---|---|---|---|
| Features | Interacoustics Audiotraveller, | ||
| Model AA222 | |||
| (510(k) n.: K022728) | Flute | Viola | |
| Type | 2 - Impedance | ||
| (ANSI S3.39) | |||
| 2- Tone Audiometer | |||
| (ANSI S3.6) | |||
| B-E Speech Audiometer | |||
| (ANSI S3.6) | 2-Impedance | ||
| (ANSI S3.39) | 2-Impedance | ||
| (ANSI S3.39) | |||
| 3-Tone Audiometer | |||
| (ANSI S3.6) | |||
| Probe Tone Frequency | 226 Hz, 678 Hz, 800 Hz, 1 kHz | 226 Hz, | |
| 1kHz (model HF) | 226 Hz | ||
| Compliance Range | up to 8.0 ml | Same | |
| Pressure Range | -600 to +300 daPa | -600 to +400 daPa | |
| Safety Limitations for | |||
| pressuring system | -800 daPa and +600 daPa | Same | |
| Acoustic Reflex | |||
| outputs | Ipsi (I), Contra (C) | Same | |
| Acoustic Reflex Stimuli | 250Hz (C), 500Hz, 1kHz, 2kHz, | ||
| 3kHz, 4kHz, 6kHz (C), 8kHz (C), | |||
| BBN, LPN, HPN | 250Hz (C), 500Hz, 1kHz, 2kHz, 4kHz | ||
| Audiometry: | |||
| Available Frequencies | 125Hz, 250Hz, 500Hz, 750Hz, | ||
| 1kHz, 1.5kHz, 2kHz, 3kHz, 4kHz, | |||
| 6kHz, 8kHz | Same | ||
| Audiometry Outputs | AC, BC, FF, insert mask | AC, BC, insert mask | |
| Audiometry Inputs | PTA: pure tone, warble | PTA: pure tone, | |
| warble | |||
| Speech: EXT1, EXT2, MIC | |||
| Masking: NBN, WN, SN | Speech: EXT1, EXT2, | ||
| INT, MIC | |||
| Masking: NBN, WN, | |||
| SN | |||
| Max Power | |||
| Consumption | 45VA | 19.2 W | |
| Display Description | Graphic monochrome display | Graphical color display | |
| Size | 16.5 x 12.5 x 4 in | ||
| (42 x 32 x 10.2 cm) | 12.6 x 12.6 x 3.5 in (32 x 32 x 9 cm); | ||
| w/printer: 12.6 x 15.4 x 3.5 in (32 x 39 x 9 cm) | |||
| Weight | 9 lbs (4,1 kg) | 4.19 lbs (1,9 kg); | |
| w/printer: 5.29 lbs (2,4kg) | |||
| Safety and | |||
| Effectiveness | Impedance | ||
| ANSI S3.39/IEC 60645-5: Type 2 | Impedance | ||
| ANSI S3.39/IEC 60645-5: Type 2 | |||
| Audiometer | |||
| ANSI S3.6/IEC 60645-1: | |||
| Type 2 Tone Audiometer | |||
| ANSI S3.6/IEC 60645-2: | |||
| Speech Type B-E | Audiometer (only Viola models) | ||
| ANSI S3.6/IEC 60645-1: | |||
| Type 3 Pure-tone Audiometer | |||
| Safety | |||
| IEC 60601-1, Class I, Type B | |||
| IEC 60601-1-2 | Safety | ||
| IEC 60601-1, Class II, Type BF | |||
| IEC 60601-1-2 |
3
Inventis Middle Ear Analyzers (Flute and Viola) are substantially equivalent to the predicate device with regard to design, function, safety and technological and performance characteristic, intended use.
Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the proposed Inventis Middle Ear Analyzers are substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the Inventis Middle Ear Analyzers (Flute and Viola) to support a determination of substantial equivalence to the predicate device. The safety and performance testing included the following tests:
- . Electrical and mechanical safety testing
- . Electromagnetic compatibility safety testing
- . Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (ANSI S3.39)
- . Instruments for the measurement of aural acoustic impedance (IEC 60645-5)
CONCLUSION STATEMENT
All the necessary electromagnetic compatibility and electrical safety tests were performed and documented in the Section 17-Electromagnetic compatibility and electrical safety. The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with both the standards IEC 60601-1-2:2007 and IEC 60601-1:2005 and is safe as the predicate device.
All the necessary performance tests in support of substantial equivalence determination were conducted and documented in the Section 18-Performance testing - Bench. The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device.
The minor differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy.
Based on these results, we conclude that the Inventis Middle Ear Analyzer is substantially equivalent to the existing legally marketed device Interacoustics Audiotraveller Model AA222 under Federal Food, Drug and Cosmetic Act.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 24, 2014
Inventis Srl c/o Mr. Massimo Martinelli General Manager Corso Stati Uniti 1/3 35127, Padova Italy
Re: K133013
Trade/Device Name: Inventis Middle Ear Analyzers, Flute and Viola Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: December 18, 2013 Received: December 23, 2013
Dear Mr. Martinelli:
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.
5
Page 2 - Mr. Massimo Martinelli
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/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
Enclosure
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SECTION 04
INDICATIONS FOR USE STATEMENTS
INDICATIONS FOR USE
510(k) Number (if known): K133013
Device Name: Inventis Middle Ear Analyzers, Flute and Viola
Indications for Use: The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer, which reduces the amount of necessary equipment.
Prescription Use _ Y (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuchen Peng -S
Shuchen Peng -S 2014.01.28 13:37:04 -05:00,
SECTION 04
Page 04 - 1 of 1 Pages