(15 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard hardware and software components for measuring and recording nystagmus.
No
The device is a diagnostic tool used to measure and record involuntary eye movements, which aids in diagnosis rather than providing therapy.
Yes
Explanation: The device is described as a "nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball," which indicates its use in diagnosing conditions related to nystagmus. Additionally, it lists a predicate device (K991497 ICS Medical CHARTR ENG/VNG Diagnostic System) that explicitly includes "Diagnostic System" in its name.
No
The device description explicitly states it includes hardware components such as an isolation transformer, a hardware platform, a mains adapter, stimulation devices, and recording devices, in addition to software.
Based on the provided information, the Focus VNG/ENG is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure, record, and display involuntary movements (nystagmus) of the eyeball." This describes a diagnostic process performed on the patient's body (in vivo), not on a sample taken from the patient's body (in vitro).
- Device Description: The description details hardware connected to a PC and stimulation/recording devices applied to the patient. There is no mention of analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing blood, urine, tissue, or any other biological specimen, which are hallmarks of IVD devices.
Therefore, the Focus VNG/ENG is a diagnostic device, but it operates in vivo rather than in vitro.
N/A
Intended Use / Indications for Use
The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyeball
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUL 1 1 2006
510(k) Summary of Safety and Effectiveness
Submitter
| Name and address: | GN Otometrics A/S
Dybendalsvaenget 2
DK-2630 Taastrup
Denmark |
|-------------------|------------------------------------------------------------------------|
| 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 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.
Indications for Use
The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.
1
Technological Characteristics
| Device Specifications | Focus VNG/ENG | CHARTR ENG/VNG |
|---|---|---|
| Safety compliance | EN 60601-1 | EN 60601-1 |
| Construction type | PC-based system with | |
| external hardware platform | ||
| and 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.
2
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.
3
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
4
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