The Focus VNG/ENG is a PC-based system, which consist of software modules for installation on a PC, an isolation transformer, a hardware platform, a mains adapter, stimulation devices and recording devices.

The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.

AI/ML Overview

The provided 510(k) summary for the Focus VNG/ENG type 1068 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way one might expect for a new AI/ML-based device.

Instead, this submission leverages the substantial equivalence pathway, common for traditional medical devices. This means the device's "effectiveness" is primarily demonstrated by its similarity to a legally marketed predicate device (ICS Medical CHARTR ENG/VNG Diagnostic System, K991497) and its compliance with relevant safety standards.

Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided in this document" because the nature of the submission does not involve a performance study against specific, quantified acceptance criteria for an AI algorithm.

Here's a breakdown based on the available information:

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Effectiveness: The device is "substantially equivalent" to a legally marketed predicate device (ICS Medical CHARTR ENG/VNG Diagnostic System, K991497). The predicate device is "of a technology type that is available and accepted in the market."	The Focus VNG/ENG performs the same intended function: measuring, recording, and displaying involuntary movements (nystagmus) of the eyeball, similar to the predicate. The submission indicates the device's effectiveness relies on its similarity and established market acceptance of this technology type.
Safety: Compliance with relevant medical device safety standards.	- EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 NO 601.1-90:1990 (Medical Electrical Equipment. Part 1: General requirements for safety) - EN 60601-1-1:2001 (Medical Electrical Equipment. Part 1: General requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems) - EN 60601-1-2:2001 (Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) - EN 60601-2-40:1998 (Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment) - ISO 9001:2000 (Quality Management Systems – Requirements) - ISO13485:2003 (Quality management systems Requirements for regulatory purposes)
Technological Characteristics: Key components and interfaces are comparable or offer improvements over the predicate in a way that doesn't raise new safety or effectiveness questions.	Differs from predicate (CHARTR ENG/VNG) in: - External hardware platform with USB interface: (Predicate has built-in hardware, integrated in computer) - Software: (No specific performance difference described, assumed to perform similarly) - Video goggles: (Not detailed, but implies recording/stimulation mechanism is comparable)

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided in this document. This submission is based on substantial equivalence to a predicate device, not on a clinical performance study with a test set of patient data to evaluate algorithmic performance. The effectiveness is inferred from the predicate's established performance and the new device's comparable design and intended use.

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):

Not applicable / Not provided in this document. No "ground truth" establishment for a test set is described, as it's not an AI/ML performance study.

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

Not applicable / Not provided in this document. No test set or adjudication method is described.

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:

Not applicable / Not done. This is not an AI-assisted diagnostic device, but a measurement and recording device for a physiological signal. No MRMC study or human reader improvement with AI assistance is mentioned.

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

Not applicable / Not done. This device is a complete system (hardware and software) intended for use by a clinician, not a standalone algorithm. Its effectiveness is based on its function as a nystagmograph, not as an AI algorithm.

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

Not applicable / Not provided in this document. As it's not a performance study of an AI algorithm, no specific ground truth for performance evaluation is described. The "ground truth" for its function as a nystagmograph is implicitly the established medical understanding of involuntary eye movements and the ability of such devices to measure them.

8. The sample size for the training set:

Not applicable / Not provided in this document. This is a hardware and software system, not an AI/ML model that requires a training set.

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

Not applicable / Not provided in this document. No training set or ground truth establishment for a training set is described.

Summary

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K061791

JUL 1 1 2006

510(k) Summary of Safety and Effectiveness

Submitter

Name and address:	GN Otometrics A/SDybendalsvaenget 2DK-2630 TaastrupDenmark
Phone:	+45 7211 1555
Fax:	+45 7211 1548
Contact person:	Per Pape Thomsen

Summary prepared: January 30, 2006

Device name

Common/Usual name: Trade/Proprietary name: Classification name:

Vestibular Testing System Focus VNG/ENG type 1068 Nystagmograph

Predicate device

Focus VNG/ENG is similar to the product ICS Medical CHARTR ENG/VNG Diagnostic System (K991497) but differs in three ways: external hardware platform with USB interface, software and video goggles.

Description

The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.

Indications for Use

The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

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Technological Characteristics

Device Specifications	Focus VNG/ENG	CHARTR ENG/VNG
Safety compliance	EN 60601-1	EN 60601-1
Construction type	PC-based system withexternal hardware platformand peripherals	PC-based system with built-in hardware and peripherals
Power source	Mains	Mains
Computer interface	USB cable connection	Integrated in computer

Safety

Focus VNG/ENG is designed to provide safety to the patient as well as the user and complies with:

EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 NO 601.1-90:1990 . Medical Electrical Equipment. Part 1: General requirements for safety
. EN 60601-1-1:2001: Medical Electrical Equipment. Part 1: Generel requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems
EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: Generel . requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
EN 60601-2-40:1998 Medical electrical equipment Part 2-40: Particular . requirements for the safety of electromyographs and evoked response equipment

Focus VNG/ENG is designed, developed and manufactured according to the following standards:

ISO 9001:2000 Quality Management Systems -- Requirements .
· ISO13485:2003 Quality management systems Requirements for regulatory purposes

Effectiveness

The Focus VNG/ENG is a nystagmograph for replacement of an existing product of a technology type that is available and accepted in the market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GN Otometrics A/S % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen Staff Engineer – Medical Devices 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

JUL 1 1 2006

Re: K061791

Trade/Device Name: Focus VNG/ENG type 1068 Regulation Number: 882.1460 Regulation Name: Nystagmograph Regulation Class: II Product Code: GWN Dated: June 23, 2006 Received: June 26, 2006

Dear Mr. Lehtonen:

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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Page 2 - Mr. Daniel W. Lehtonen

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 (240) 276-0120 . 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Aniceto

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

おすすめになってするというなんて

K061791 510(k) Number (if known):

Focus VNG/ENG type 1068 Device Name:

Indications For Use:

The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

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)

Barbara Brehm
(Division Sign Off)

(Division Sig Division of General, Restorative, and Neurological Devices

Page 1 of __

510(k) Number K061791

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).