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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Inventis Middle Ear Analyzers, based on the provided 510(k) summary:

The document indicates that the Inventis Middle Ear Analyzers (Flute and Viola) underwent bench testing to demonstrate substantial equivalence to a predicate device, the Interacoustics Audiotraveller, Model AA222 (K022728). The acceptance criteria are largely implicitly defined by compliance with established electrical, mechanical, electromagnetic compatibility, and performance standards for auditory impedance testers and audiometers.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance (Inventis Middle Ear Analyzers)
Electrical and Mechanical Safety	IEC 60601-1 (Class I, Type B for predicate; Class II, Type BF for new device)	Compliance with IEC 60601-1:2005. "The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with...IEC 60601-1:2005 and is safe as the predicate device."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Compliance with IEC 60601-1-2:2007. "The results demonstrate that the Inventis Middle Ear Analyzer is in compliance with...IEC 60601-1-2:2007."
Impedance Measurement Performance	ANSI S3.39 / IEC 60645-5 (Type 2 for both predicate and new device)	"All the necessary performance tests in support of substantial equivalence determination were conducted... The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device." Specific impedance features match, with minor differences: Probe Tone Frequency: 226 Hz, 1kHz (Flute HF); 226 Hz (Viola) vs. 226 Hz, 678 Hz, 800 Hz, 1 kHz (predicate). Compliance Range: up to 8.0 ml (Same as predicate). Pressure Range: -600 to +400 daPa vs. -600 to +300 daPa (predicate).
Audiometer Performance (Viola only)	ANSI S3.6 / IEC 60645-1 (Type 3 Pure-tone Audiometer for new device; Type 2 Tone Audiometer for predicate)	"All the necessary performance tests in support of substantial equivalence determination were conducted... The tests demonstrate that the Inventis Middle Ear Analyzer is effective and performs as well as the predicate device." Specific audiometry features match, e.g., Available Frequencies, Outputs, Inputs. Note: Viola is a Type 3, predicate was a Type 2.
Substantial Equivalence to Predicate Device	Overall design, function, safety, technological and performance characteristics, intended use.	"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."

2. Sample Size Used for the Test Set and Data Provenance:

The document describes bench testing, which typically does not involve human subjects or a "test set" in the sense of clinical data. It refers to testing on the device itself against engineering and performance standards. Therefore, specific sample sizes for a "test set" or data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission, as it focuses on demonstrating technical equivalence rather than clinical performance from patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth for bench testing is established by the specifications defined in the relevant engineering and performance standards (e.g., ANSI S3.39, IEC 60601-1). There is no "test set" requiring expert adjudication for diagnosis, as would be the case in a clinical study for an AI-powered diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical "test set" in this context that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not done. This 510(k) submission is for a traditional medical device (auditory impedance tester and audiometer), not an AI-assisted diagnostic tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. The device described is a medical instrument for conducting diagnostic evaluations, not an algorithm, and its performance is inherently mechanical/electronic, not based on an independent algorithm's output.

7. The type of ground truth used:

The ground truth for the "tests" performed (bench testing) is defined by the specifications and criteria outlined in the referenced international and national standards (e.g., ANSI S3.39, IEC 60645-5, IEC 60601-1, IEC 60601-1-2, ANSI S3.6, IEC 60645-1). These standards set the benchmarks for electrical safety, EMC, and the accuracy/performance parameters of impedance and audiometry measurements.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As no training set is used, no ground truth needed to be established for it.

Summary

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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

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.

Katalogia (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1)

And Controller Comments

Classification:	21 CFR§874.1090Class II
Product Code:	ETY
Trade Name:	Middle Ear Analyzers, Flute and Viola
Common name:	Middle Ear Analyzer
ClassificationName:	Auditory Impedance Tester

JAN 2 4 2014

・

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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

PRODUCT DESCRIPTION

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:

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· ·

	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 forpressuring system	-800 daPa and +600 daPa	Same
Acoustic Reflexoutputs	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, MICMasking: NBN, WN, SN		Speech: EXT1, EXT2,INT, MICMasking: NBN, WN,SN
Max PowerConsumption	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 andEffectiveness	ImpedanceANSI S3.39/IEC 60645-5: Type 2	ImpedanceANSI S3.39/IEC 60645-5: Type 2
	AudiometerANSI S3.6/IEC 60645-1:Type 2 Tone AudiometerANSI S3.6/IEC 60645-2:Speech Type B-E	Audiometer (only Viola models)ANSI S3.6/IEC 60645-1:Type 3 Pure-tone Audiometer
	SafetyIEC 60601-1, Class I, Type BIEC 60601-1-2	SafetyIEC 60601-1, Class II, Type BFIEC 60601-1-2

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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.

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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

Regulation Number and Section

§ 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.