(106 days)
Not Found
No
The device description and performance studies focus on basic illumination and mechanical controls, with no mention of AI/ML or image processing.
No
The device is described as a "diagnostic illumination device" intended "to inspect the structures of the anterior segment of the eye," which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly states it consists of a "slit illuminator and a charger unit," which are hardware components.
Based on the provided information, the VISX CV SI-1 CustomVue Slit Illuminator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device used to inspect the structures of the anterior segment of the eye directly. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "inspect[ing] the structures of the anterior segment of the eye," which is an in-vivo (within the living body) examination.
Therefore, this device falls under the category of an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HJO
Device Description
The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator unit and a recharger unit. The recharger 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 will be altered by the surgeon. The slit illuminator allows the control of slit width to enhance observation of structural detail. The slit illuminator allows slit widths from 0 to 10.0 mm via means of sliding control knobs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior segment of the eye
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)
Summary of Non-clinical Studies: Testing for compliance to standards IEC 6001-1, IEC 60001-1-2 and electromagnetic compatability (EMC) were performed on the VISX CV SI-1 CustomVue™ Slit Illuminator. Risk analysis was conducted to establish that issues 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 has demonstrated that it fully supports the proposed characteristics of this new device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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