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 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. 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.

AI/ML Overview

The Nydiag 200 Rotary Chair is a medical device, and the provided document is a 510(k) premarket notification summary. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, many of the typical performance study details (like sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in this type of submission for this particular device. The "acceptance criteria" here are primarily about meeting safety standards and demonstrating equivalence to the predicate device in terms of technological characteristics and intended use.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration for 510(k))	Reported Device Performance
Safety and Efficiency	Tested according to appropriate standards; found safe and efficient for its purpose.
Technological Characteristics Equivalence	Functionally similar to the predicate device (System 2000 ROTATIONAL VESTIBULAR CHAIR). Both are rotary chairs controlled by software, used for vestibular stimulation.
Indications for Use Equivalence	Same indications for use as the predicate device: eliciting Vestibulo-Ocular Reflexes in patients (2+ years old, <135 kg) for bilateral or unilateral peripheral vestibular lesions.

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

Sample Size: Not applicable/not provided. The submission focuses on bench testing and comparison of characteristics, not on a clinical test set with patient data.
Data Provenance: Not applicable, as no human data is mentioned for testing.

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

Number of Experts: Not applicable/not provided. Ground truth in a clinical sense is not established for this type of technical equivalence submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This type of study is not mentioned as it's not typically required for a Class I/Unclassified device demonstrating substantial equivalence through bench testing and comparison of technical specifications. The comparison is between devices, not human readers.
Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Performance Study: A "bench test" was performed on the device. However, this refers to engineering and functional testing of the hardware and software components (e.g., motor rotation accuracy, safety features, software control) against relevant standards, not a clinical performance study measuring diagnostic accuracy.
- "During bench test the device was tested according to appropriate standards and found safe and efficient according to the purpose of the device." This confirms some form of performance assessment but not a diagnostic accuracy study.

7. The Type of Ground Truth Used

Ground Truth Type: For the bench testing, the "ground truth" would be established by engineering specifications, relevant industry standards, and the intended functional performance of the device (e.g., if it's supposed to rotate at X speed, does it?). For the equivalence claim, the ground truth is the predicate device's established characteristics and indications for use.

8. The Sample Size for the Training Set

Sample Size: Not applicable/not provided. As this is not an AI/ML device that learns from data, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. No training set is involved.

Summary

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Nydiag 200 Rotary Chair

Premarket Notification Submission 510(I

DEC 2 3 2010

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER INFORMATION
Company Name	Interacoustics A/S
Company Address	Drejervaenget 8Assens, DK-5610, Denmark
Company Phone	+45 6371 3555
Company Fax	+45 6371 3522
Company e-mail	info@interacoustics.com
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 2000ROTATIONAL 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

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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

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

Regulation Number and Section

N/A