NYDIAG 200

K102364 · Interacoustics A/S · LXV · Dec 23, 2010 · EN

Device Facts

• Record ID: K102364
• Device Name: NYDIAG 200
• Applicant: Interacoustics A/S
• Product Code: LXV · EN
• Decision Date: Dec 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Pediatric

Intended Use

The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

Device Story

Nydiag 200 is a motorized rotary chair used to stimulate balance organs to elicit Vestibulo-Ocular Reflexes (VOR). Device consists of a chair unit with restraints, patient discomfort signal, and goggle connections (Firewire/USB), plus a motor pedestal. Operated by a clinician in a diagnostic setting; controlled via computer software over USB connection. Output is physical rotation of the patient; used in conjunction with eye movement recording systems to assess vestibular function. Benefits include standardized stimulation for diagnosing vestibular lesions.

Clinical Evidence

Bench testing only. Device tested against appropriate standards to confirm safety and efficiency.

Technological Characteristics

Rotary chair with frame assembly, seat belts, patient discomfort signal, and goggle connectivity (Firewire/USB). Pedestal includes power unit, motor, and gearing. Software-controlled via USB. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for patients aged 2 years or older, weighing <135 kg (300 lbs), undergoing testing for bilateral or unilateral peripheral vestibular organ lesions.

Predicate Devices

• System 2000 ROTATIONAL VESTIBULAR CHAIR (K922037)

Submission Summary (Full Text)

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# Nydiag 200 Rotary Chair

Premarket Notification Submission 510(I

DEC 2 3 2010

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Nydiag 200 Rotary Chair

| SUBMITTER INFORMATION | |
|-------------------------|---------------------------------------------|
| Company Name | Interacoustics A/S |
| Company Address | Drejervaenget 8<br>Assens, DK-5610, Denmark |
| Company Phone | [phone] |
| Company Fax | [phone] |
| Company e-mail | [e-mail] |
| Contact Person | Erik Nielsen, Quality Manager |
| Date Summary Prepared | 05. July 2010 |
| DEVICE IDENTIFICATION | |
| Trade Name | Nydiag 200 |
| Common Name | Rotary Chair |
| Classification Name | Apparatus, vestibular analysis |
| Product Code | LXV |
| Panel | Ear Nose & Throat |
| Device Class | Unclassified |
| SUBSTANTIAL EQUIVALENCE | |
| Predictive Device | System 2000<br>ROTATIONAL VESTIBULAR CHAIR |
| Manufacturer | Micromedical Technologies, Inc |
| 510(k) No. | K922037 |
| Date Cleared | 10/26/1992 |

#### Device Description

The Nydiag 200 is a rotation chair, including a chair unit and a motor pedestal unit. The Nydiag 200 is controlled by software.

The rotating chair is an optional accessory and is used for stimulation of the patients balance organs. The chair is supplied from the mains and controlled from a computer through an USB connection.

#### Indications For Use

The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

Image /page/0/Picture/10 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left and the word "Interacoustics" in bold, white letters on a black background. Below the logo, the words "leading diagnostic solutions" are written in a smaller font.

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# Nydiag 200 Rotary Chair

#### Technological Characteristics

The chair unit includes the chair itself attached to a frame assembly, seat belts and other restraints, patient discomfort signal device and goggle connections (Firewire and USB). The pedestal includes a power unit and motor and gearing units.

#### Summary (Bech testing)

During bench test the device was tested according to appropriate standards and found safe and efficient according to the purpose of the device.

#### Conclusion

The Nydiag 200 was found to be equivalent to the predicate device in technological characteristics and indications for use.

Image /page/1/Picture/9 description: The image shows the logo for Interacoustics, a company that provides leading diagnostic solutions. The logo consists of a globe-like icon on the left, followed by the company name in bold, white letters on a black background. Below the logo, the tagline "leading diagnostic solutions" is written in a smaller font size.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Interacoustics A/S c/o Mr. Erik Nielsen Quality Manager Drejervaenget 8 Assens, DK-5610 Denmark

DEC 2 3 2010

Re: K102364

Trade/Device Name: Nydiag 200 Rotary Chair Regulation Number: None Regulation Name: None

Regulatory Class: Unclassified Product Code: LXV Dated: November 9, 2010 Received: November 12, 2010

Dear Mr. Nielsen:

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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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/CDRH/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Debrah Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Nydiag 200 Rotary Chair

Premarket Notification Submission 510(k)

# Indications for Use

Applicant: Interacoustics A/S

DEC 2 3 2010

510(k) Number (if known): K102364

Device Name: Nydiag 200

# Indications For Use:

The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vasat Baitha

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102364

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Image /page/4/Picture/18 description: The image shows the Interacoustics logo. The logo consists of a stylized globe on the left and the word "Interacoustics" in a bold, sans-serif font on the right. Below the logo, there is the text "leading diagnostic solutions" in a smaller font.

er 21 CFR 801,1091