(106 days)
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.
The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator and a charger unit. The charger unit serves both as a continuous charger as well as a convenient base for the instrument. The slit illumination is focused onto the corneal surface, which is observed through the operating microscope (or the surgeon may also alter the angle of the slit illumination). The length and width of the slit may be altered by the surgeon. The slit illuminator allows the control of slit width to enhance observation of structural detail. The slit illuminator allows control of slit width from 0 to 10.0 mm via means of sliding control knobs.
The provided text describes a 510(k) premarket notification for the VISX CV SI-1 CustomVue™ Slit Illuminator. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or AI-powered device.
Therefore, many of the requested categories (such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from the given text.
The text primarily outlines the device's intended use, its description, and non-clinical testing for compliance with electrical and electromagnetic compatibility standards. It concludes that based on these non-clinical tests, the device supports its proposed indication for use and presents no new safety concerns compared to the predicate device.
Here's a breakdown of the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred from Non-Clinical Testing):
- Compliance with IEC 60601-1 (general requirements for medical electrical equipment).
- Compliance with IEC 60601-1-2 (electromagnetic compatibility requirements for medical electrical equipment).
- Demonstration of no new safety characteristics compared to the predicate device.
- Full support of the proposed indication for use (inspection of the anterior segment of the eye).
- Reported Device Performance: The document states that the testing demonstrated the device "fully supports the proposed indication for use, and that no new safety has demonstrated that it fully Supports the proposed tharacteristics of this new device." It also passed the specified IEC standards.
2. Sample sized used for the test set and the data provenance
- Not applicable/Not provided. The text refers to "non-clinical testing results," which typically involve testing the physical device against engineering and safety standards, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth establishment with experts is not relevant for this type of non-clinical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- No MRMC study was done. This device is a Slit Illuminator, a diagnostic illumination tool, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a physical illumination device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the context of diagnostic performance studies is not relevant here. The "ground truth" for this device's performance would be its ability to physically illuminate the eye as intended and meet safety standards.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
CUSTOMVUE™ SLIT ILLUMINATOR
PREMARKET NOTIFICATION
510(K) Summary
C043503
The information contained in this premarket notification 510(k) summary is submitted as required by 21 CFR 807.92(c):
Submitter:
VISX, Incorporated 3400 Central Expressway Santa Clara, California 95051 USA Tel: 408-773-7336 Fax: 408-773-7324
- Alan F. Russell, Ph.D. Contact Person: Vice President, Regulatory & Clinical Affairs
December 17, 2004 Date Summary Prepared:
VISX CV SI-1 CustomVue™ Slit Illuminator Device Trade Name:
AC-Powered Slit Lamp Device Common Name:
Class II (Special Controls) / Ophthalmic Devices Device Classification/Panel:
Substantial equivalence is claimed based on the Kowa Identification of Predicate Device: identification of I redicate device (K954782), with its similar intended use, and its classification as a slit lamp, as defined in 21 CFR 886.1850.
Device Description: The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator Device Describion. The VIOX OF OF For Case harger unit serves both as a continuous charger as well as a convenient base for the instrument.
The slit illumination is focused onto the corneal surface, which is observed through the The Silt Indinination is 100000 "Show Excimer Laser System). The length and width of the operating microscope (or the surgeon may also alter the angle of the slit illumination sill may be allered by the surgeon. The slit illuminator allows the control of slit width
to enhance observation of structural detail. The slit illuminator allows of to entialies observation of ethattars. I to 10.0 mm via means of sliding control knobs.
Intended Use (Indication for Use): The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic milling of the manon for ook . The the inspection of the structures of the anterior segment of the eye.
Summary of Non-clinical Studies: Testing for compliance to standards IEC 6001-1, EC 1 Sunmaly of Nort-Giffical Clause. - Febrity (EMC) were performed on the VISX CV SI-1 60001-1-2 and electioniagnetic ochipatisms (ETA) was conducted to Ouslom ac "Oll." hicens of patient exposure and practitioner interface.
Conclusion: Based on non-clinical testing results, the VISX CV SI-1 CustomVue Silt Illuminator has demonstrated that it fully supports the proposed indication for use, and that no new safety nas demonstrated that it fully Supports the proposed tharacteristics of this new device.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public" and "Health" being the most prominent words.
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
2005 APR 5
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VISX, Inc c/o Alan F. Russell, Ph.D. Vice President, Regulatory and Clinical Affairs 3400 Central Expressway Santa Clara, CA 95051
Re: K043503
Trade/Device Name: VISX CV SI-1 CustomVue™ Slit Illuminator Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 17, 2004 Received: December 20, 2004
Dear Dr. Russell:
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.
{2}------------------------------------------------
Page 2 - Alan F. Russell, Ph.D.
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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
CustomVue™ Slit Illuminator
PREMARKET NOTIFICATION 510(K)
STATEMENT OF INDICATIONS FOR USE FORM
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K043503 |
| Device Name: | VISX CV SI-1 CustomVue™ Slit Illuminator |
Device Name:
Indications for Use:
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use_ Prescription Use (Per 21 CFR 801. 109) ivision Sian-Off vision of Ophthalmic Ear.
Nose and Throat Devises
510(k) Number
01-012
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.