CAPELLA COCHLEAR EMISSIONS ANALYZER

K983851 · Madsen Electronics, Inc. · EWO · Jan 28, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K983851
• Device Name: CAPELLA COCHLEAR EMISSIONS ANALYZER
• Applicant: Madsen Electronics, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Capella is designed to test cochlear function of both infants and adults in a hospital, nursery, ENT clinic or audiology office. It allows the operator to get information about a person's hearing without requiring a response from the individual being tested.

Device Story

Capella Cochlear Emissions Analyzer; evaluates cochlear function; inputs otoacoustic emissions signals; processes signals to assess hearing status; output provides objective hearing information; used in hospitals, nurseries, ENT clinics, audiology offices; operated by clinicians/audiologists; enables hearing assessment without requiring active patient response; benefits patients unable to provide subjective feedback.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Cochlear emissions analyzer; intended for clinical use; electronic diagnostic device; class II; 21 CFR 874.1050.

Indications for Use

Indicated for testing cochlear function in infants and adults in clinical settings (hospitals, nurseries, ENT clinics, audiology offices) to assess hearing without requiring patient response.

Regulatory Classification

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Tracy Millier Madsen Electronics, Inc. 5600 Rowland Road Minnetonka, MN 55343 Re:

K983851

Capella Cochlear Emissions Analyzer Dated: October 27, 1998 Received: October 30, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Ms. Millier:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

| 510/k) Number (if known): | ﻟ<br>ર દ્વ<br>્વ જ<br>く<br>ﻟﻤﺴﻠﺴﺔ ﺍ<br>ﻟﻤﺴﺘﺸﻤﺴﻪ ﺍﻟﻤﺴﺘﺸﻤﻞ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ<br>The first and the contract and the contract of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the con |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

Capella Cochlear Emissions Analyzer Device Name:_

Indications For Use:

. .

Capella is designed to test cochlear function of both infants and adults
of the first and any EVT alinic or audiology office. Capella is designed to test cochiear randiology office.
in a hospital, mursesy, ENT clinic or audiology office.
In a hospital, manates to get information about a perso in a hospital, nursery, ENT Clinic or addrough or resorts hearing without
It allows the open to from the individual being tested. It allows the operator to get information and the many tested.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

---

(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dey

510(k) Number

**Prescription Use** √
(Per 21 CFR 801.109)

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)