The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and Chartr EP Auditory Evoked Response systems. The GN Otometrics Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

Device Description

The GN Otometrics Insert Earphones are transducers that convert electrical stimulus, provided by GN Otometrics Audiometers and GN Otometrics Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

AI/ML Overview

The provided text describes a 510(k) submission for the GN Otometrics Insert Earphones, focusing on its substantial equivalence to a predicate device, the Etymotic Research ER-3 Insert Earphones. As such, the study described is a non-clinical performance and comparison study, rather than a clinical trial with human subjects using the AI device.

Here's an analysis of the provided information relative to your requested categories:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Established from Predicate Device & Standard)	Reported Device Performance (GN Otometrics Insert Earphones)
Acoustic and Electrical Parameters as specified in ANSI/ASA S 3.6-2004, Specification for Audiometers	(Implicitly meets these specifications through substantial equivalence to predicate)
Function as transducers to convert electrical stimulus into acoustic stimulus	Converts electrical stimulus into acoustic stimulus
Interface to patient's ear via disposable foam eartips, fitting infants, children, and adults	Delivers auditory stimulus to patient's ears using disposable foam eartips, fitting infants, children, and adults

Note: The document states that "Substantial equivalence to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003) was based on non-clinical performance testing of the acoustic and electrical parameters as specified in the ANSI/ASA S 3.6-2004, Specification for Audiometers." While the specific numerical performance results for the GN Otometrics device are not explicitly listed in this summary, the FDA's clearance implies that these criteria were met and demonstrated to be substantially equivalent to the predicate device, which itself met these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This was a non-clinical performance study. Therefore, the concept of "test set" and "data provenance" in the context of human data does not directly apply. The testing would have involved physical units of the GN Otometrics Insert Earphones being subjected to various acoustic and electrical measurements in a laboratory setting. No information on the specific number of units tested is provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This being a non-clinical performance study, "ground truth" was established based on engineering specifications and adherence to the ANSI/ASA S 3.6-2004 standard. No human experts were involved in establishing "ground truth" in the way they would be for medical image interpretation or clinical outcomes. The "experts" would be the engineers and technicians conducting the performance tests and comparing the results against the standard and predicate device's characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was a non-clinical performance study and did not involve human interpretation or adjudication. The comparison was based on objective physical measurements and engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an accessory for auditory stimulus delivery, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, a "standalone" non-clinical performance study was conducted. The performance of the GN Otometrics Insert Earphones was evaluated on its own merits against the specified acoustic and electrical parameters and in comparison to the predicate device's characteristics. There is no "algorithm" in the sense of AI; it's a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this non-clinical study was the adherence to established engineering specifications and the performance characteristics of the legally marketed predicate device (Etymotic Research ER-3 Insert Earphones, K930003) as defined by the ANSI/ASA S 3.6-2004 standard for audiological equipment.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

Not applicable. As above, this is a physical medical device, not an AI algorithm.

Summary

{0}------------------------------------------------

510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones

Section 5:

JUL 1 4 2008

510(k) Summary

Date:	April 30, 2008
Submitted By:	GN Otometrics125 E. Commerce DriveSchaumburg, IL 60173USA
Telephone:Fax:	847-534-2150 #6932847-534-2153
Contact Person:	Daniel SansonettiManager of Research & Developmentdsansonetti@gnotometrics.com
Name of Device:	OtoInsert
Common Name:	Insert Earphones for auditory stimulus delivery
Classification Name:	Accessories to devices with classification:Audiometer (per 21 CFR section 874.1050)andAccessories to devices with classification:Stimulator, Auditory, Evoked Response.(per 21 CFR section 882.1900)
Predicate Device:	Etymotic Research ER-3 Insert Earphones, 510(k)#K930003

: 上一篇:

{1}------------------------------------------------

Description of the Device:

The Electrical Transmission Path consists of a shielded cable. The cable is connected to the Audiometer or Auditory Evoked Response Stimulator, by means of a connector. The other end of the cable is attached to the left and right Electrical Filter Sections.

Each Electrical Filter section (left and right) consists of a passive analog filter to provide electrical pre-emphasis response shaping to the stimulus prior to reaching the Speakers.

Each Speaker (left and right) converts the electrical stimulus into an acoustic stimulus. The acoustic stimulus is delivered to the patient's ear by means of the Acoustic Transmission Path.

Each Acoustic Transmission Path (left and right) consists of a front acoustic transmission path and a back acoustic transmission path. The back acoustic transmission path consists of a series of tubes and cavities which are configured to create two resonant acoustic circuits. These resonant circuits are used to smooth the acoustic output at the eartip, by reducing the primary and secondary resonant peaks caused by the impedance mismatch at both ends of the front transmission path. The front acoustic transmission path consists of silicon tubing, tube nipple, and an eartip. The tube nipple provides acoustic and mechanical connection to the disposable eartip. The disposable eartips interface to the patient's ear and deliver the acoustic stimulus.

Each Transducer Case (left and right) houses an Electrical Filter, Speaker, and back acoustic transmission path. Each Transducer case provides means of handling and labeling and means to secure the Electrical Transmission Path (cable).

Intended Use of the Device:

The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and GN Otometrics Auditory Evoked Response systems. The GN Otometrics Insert Earphone devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

{2}------------------------------------------------

510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones

Comparison to Predicate Device:

The GN Otometrics Insert Earphones were designed to be a direct replacement to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003). The GN Ottometrics Insert Earphones share the same technological characteristics as the Etymotic Research ER-3 Insert Earphones (510(k) #K930003). Both insert earphones are comprised of the same sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Spcaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

The Electrical Transmission Path in both the GN Otometrics and Etymotic Insert Earphones are comprised of a cable with a connector on each end. The only differences are cable manufacturer, cable color, durometer, nominal dimensions, and connector type.

The Electrical Filter sections of both the GN Otometrics and Etymotic Insert Earphones are identical with respect to component values and configuration. The only difference is component manufacturers.

The Speaker in both the GN Otometrics and Etymotic Insert Earphones are from the same manufacturer and are the same model number.

The Acoustic Transmission Path in both the GN Otometrics and Etymotic Insert Earphones are identical with respect to nominal dimensions and configuration. Both the GN Otometrics and Etymotic Insert Earphones have a front and back acoustic transmission path. The only difference in the back transmission path is the material and construction method. The Etymotic Insert Earphones use PVC tubing to create the acoustic resonant circuits, while the GN Otometrics uses stainless steel tubes inseted into a rubber molded part. The end result of both construction methods is the same. The front transmission path is identical with respect to materials, dimensions, and counting means to the patient. Both the GN Otometrics and Etymotic Insert Earphones use the same disposable eartips from the same manufacturer.

The Transducer Case in both the GN Otometrics and Etymotic Insert Earphones are similar with exception to shape and color.

The intended use of both the GN Otometrics and Etymotic Insert Earphones is the same. Both the GN Otometrics and Etymotic Insert Earphones are intended to been a transducers to convert electrical stimulus, delivered by an Audiometer or Evoked Potential stimulator, into acoustic stimulus, which is then delivered to the patient's ear by means of a disposable Eartip.

Substantial Equivalence Performance Metrics:

Substantial equivalence to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003) was based on non-clinical performance testing of the acoustic and electrical parameters as specified in the ANSI/ASA S 3.6-2004, Specification for Audiometers.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UUL 1 4 2008

GN Otometrics c/o Daniel Sansonetti Manager of Research & Development 125 E. Commerce Drive Schaumburg, IL 60173

Re: K081234

Trade/Device Name: GN Otometrics Insert Earphones Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: June 27, 2008 Received: June 27, 2008

Dear Mr. Sansonetti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.

{4}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egerkins, mD

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

{5}------------------------------------------------

K081234

510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones

Section 4:

Indications for Use

510(k) Number (if known): 1/208 /234

Device Name: GN Otometrics Insert Earphones

Indications for Use:

Prescription Use X (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)

Laura Sohn

n of Ophthalmic Far and Throat Devises

510(k) Number K081234

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device 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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.