EARCHECK ACOUSTIC REFLECTOMETER

K070312 · Innovia Medical, LLC · ETY · Mar 2, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070312
• Device Name: EARCHECK ACOUSTIC REFLECTOMETER
• Applicant: Innovia Medical, LLC
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1090
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

EarCheck Acoustic Reflectometer is an advanced medical instrument which accurately deflects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.

Device Story

EarCheck Acoustic Reflectometer detects middle ear fluid (otitis media with effusion) via acoustic reflectometry. Device emits sound waves into ear canal; measures reflected sound energy to determine presence of fluid behind eardrum. Designed for home use by parents/caregivers on children (6 months+) to young adults. Output provides indication of fluid presence, assisting users in deciding when to seek professional medical evaluation. Device serves as screening tool to facilitate timely clinical consultation.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Acoustic reflectometer; utilizes sound wave reflection to measure middle ear impedance. Class II device (21 CFR 874.1090, Product Code ETY).

Indications for Use

Indicated for children aged 6 months to young adults to detect middle ear fluid (otitis media with effusion) associated with acute ear infection. Intended for home use by parents and caregivers.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovia Medical, LLC c/o Kevin Walls Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

MAR 0 2 2007

Re: K070312

> Trade/Device Name: EarCheck Acoustic Reflectometer Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: January 16, 2007 Received: February 1, 2007

Dear Mr. Walls:

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.

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.

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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychlen Simud

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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Indications for Use

次070312 510(k) Number (if known):

Device Name:

EarCheck Acoustic Reflectometer

# Indications for Use

Indications for Use: EarCheck Acoustic Reflectometer is an advanced medical instrument which accurately deflects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.

Prescription Use (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)

**Division Sign-Off**

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devise

312

**510(k) Number**

rintion Use 21 CFR 801.109)

**Over-the-Counter Use.**

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