(90 days)
The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.
The provided document is a 510(k) summary for the ICS Medical Model VG-30 Video Goggle, which seeks to establish substantial equivalence to a predicate device (ICS Video Goggle, K991497). This type of submission focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than presenting a detailed new performance study with acceptance criteria in the typical sense of a clinical trial.
Therefore, the requested information elements related to specific acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not explicitly detailed in this 510(k) summary because the submission relies on demonstrating substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for performance in the typical sense (e.g., a specific sensitivity or specificity target). Instead, the "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means showing that the new device is as safe and effective as the predicate.
- Reported Device Performance: The "performance" assessment is primarily a comparison of design and material specifications to the predicate device. The key performance claim is its ability to "provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function," which is identical to the predicate's intended use.
| Characteristic | Predicate Device (ICS Video Goggle - K991497) | New Device (ICS Medical Model VG-30 Goggle) | Comparison / "Acceptance Criteria Met" |
|---|---|---|---|
| Housing Material | ABS Plastic | ABS Plastic | Identical / Met |
| Face Cushion Material | Neoprene Rubber | Polyvinyl Chloride | Different, but not deemed critical |
| Number of Light Emitting Diodes (LED's) | 7 per eye (Total: 14) | Identical | Identical / Met |
| Mirror Adjustment Capability to Center the Image | Yes | Yes | Identical / Met |
| Horizontal Image Adjustment by Mirror Adjustment | Yes | Yes | Identical / Met |
| Vertical Image Adjustment by Adjusting Cameras | Yes | Yes | Identical / Met |
| Mirror Material | Polycarbonate plastic | Identical | Identical / Met |
| Strap Material | Neoprene Rubber | Identical | Identical / Met |
| Video Camera Adjustment Capability | Yes | Yes | Identical / Met |
| Friction Fit Light Occluding Cover | Yes | Identical | Identical / Met |
| Weight | Approximately 21 oz. | Approximately 18.5 oz. | Different (lighter), not deemed critical |
| Safety Standards Compliance | Met for predicate | Designed to meet same safety standards | Equivalent safety claim |
| Intended Use | Observe, record, measure eye movements during vestibular testing | Observe, record, measure eye movements during vestibular testing | Identical / Met |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: As this is a 510(k) submission for substantial equivalence based on design comparison, a "test set" in the context of clinical performance evaluation with a specific sample size is not described. The assessment is primarily based on engineering and material comparisons to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided: No "ground truth" establishment by experts for a specific test set is described, as the submission focuses on device characteristics relative to a predicate, not a de novo clinical performance study.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific test set requiring such a process.
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: The device (Video Goggle) is an accessory for observing and recording eye movements; it is not an AI-powered diagnostic tool that assists human readers in interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant to this device and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a video goggle, an accessory that provides video signals for human observation or subsequent analysis by other systems (e.g., a nystagmograph). It does not perform an "algorithm only" standalone diagnostic function, so no such performance study would be applicable or provided.
7. The Type of Ground Truth Used
- Not Applicable / Implicit via Predicate: The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate device. The new device demonstrates substantial equivalence by showing it shares the same technological characteristics, intended use, and performs similarly to the predicate. There is no independent "ground truth" (like pathology or outcomes data) established for a new clinical performance study.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is not an AI/ML-based algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided: As there is no training set mentioned, the method for establishing its ground truth is also not applicable.
In summary, this 510(k) submission successfully demonstrated substantial equivalence by comparing the design, materials, and intended use of the new VG-30 Video Goggle to a previously cleared predicate device, rather than through a new clinical performance study with acceptance criteria and ground truth as might be seen for novel diagnostic devices.
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DEC 1 0 2001
510(k) SUMMARY
(847)-534-2150
(847)-534-2151
September 7, 2001
125 Commerce Drive Schaumburg, IL 60173-5329
ICS MEDICAL CORPORATION
Submitted by:
Telephone:
FAX:
Contact Person:
Date Summary Prepared:
Classification Name:
Description of Device:
Trade Name of Device:
Video goggle Common Name:
Accessory to: Nystagmograph, Class II, 21 CFR 882.146
Robert M. Simenson, Executive Vice President
ICS Medical Model VG-30 Video Goggie
KO13060
The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.
This device is intended to provide video signals of Intended Use: patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
The Model VG-30 Video Goggles are substantially Substantial Equivalence: equivalent to the Model VG-10 Goggles cleared in 510(k): K991497.
Comparison of Similarities and Differences of Our New Medical Device to the Predicate Device:
| ICS Video Goggle(510K : K991497) | ICS Medical Model VG-30Goggle | |
|---|---|---|
| Housing Material | ABS Plastic | ABS Plastic |
| Face Cushion Material | Neoprene Rubber | Polyvinyl Chloride |
| Number of Light EmittingDiodes (LED's) | 7 per eye ( Total: 14) | Identical |
| Mirror Adjustment Capability toCenter the Image | Yes | Yes |
| Horizontal Image AdjustmentAccomplished by Means ofMirror Adjustment | Yes | Yes |
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| Vertical Image AdjustmentAccomplished by AdjustingCameras | Yes | Yes |
|---|---|---|
| Mirror Material | Polycarbonate plastic | Identical |
| Strap Material | Neoprene Rubber | Identical |
| Video Camera AdjustmentCapability | Yes | Yes |
| Friction Fit Light OccludingCover | Yes | Identical |
| Weight | Approximately 21 oz. | Approximately 18.5 oz. |
Please note that with the exception of the face cushion material both these goggles are virtually identical in design and materials.
The Model VG-30 Video Goggle is designed to meet the same safety standards as the predicate device, i.e. ICS Medical Model VG-10 Video Goggles.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2001
Robert M. Simenson Executive Vice President ICS Medical Corporation 125 Commerce Drive Schaumburg, Illinois 60173-5329
Re: K013060
Trade Name: ICS Medical Model VG-30 Video Goggle Regulation Number: 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: September 7, 2001 Received: September 11, 2001
Dear Mr. Simenson:
We have reviewed your Section 510(k) premarket 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 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. Robert Simenson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compinates at (201) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O wision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker
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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K013060
ICS Medical Model VG - 30 Video Goggles Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Walker
(Division Sign-Off) Division of General Pestorative and Neurological Devices
510(k) Number_KO13O60
§ 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).