The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.

Device Description

The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 3 models LS880, LS1100, and LS1400. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.

AI/ML Overview

The Luxvision Slit Lamp is a Class II medical device (regulated under 21 CFR 886.1850) that was cleared through the 510(k) pathway, asserting substantial equivalence to a predicate device rather than providing de novo performance criteria or a detailed clinical study demonstrating its effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Compliance with ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes	The USOphthalmic Luxvision Slit Lamp "complies with the requirements of listed FDA Recognized Consensus Standards", specifically mentioning ISO 10939:1998.
Compliance with IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety	The USOphthalmic Luxvision Slit Lamp "complies with the requirements of listed FDA Recognized Consensus Standards", specifically mentioning IEC 60601-1.
Substantial Equivalence to Predicate Device (66 Vision-Tech YZ Slit Lamp K033190)	"This has been demonstrated through an 8-point technological comparison of features." The document states: "The devices were found to be substantially equivalent."
Intended Use (eye examination of the anterior eye segment to aid in diagnosis of diseases/trauma)	The device's technological characteristics are "`essentially identical`" to the predicate, leading to the belief that it "performs as well as or better than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

No specific "test set" or clinical data is mentioned for the Luxvision Slit Lamp. The clearance is based on technological comparison and compliance with standards, not performance against a specific dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth establishment by experts for a test set is not described as part of this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not done. The submission focuses on technological equivalence to a predicate device, not on measuring human reader improvement with AI assistance (as this is not an AI device).

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

Not applicable. This is a traditional medical device (slit lamp), not an algorithm or AI. Standalone performance for an algorithm is not a relevant criterion.

7. The Type of Ground Truth Used:

The "ground truth" for the Luxvision Slit Lamp's acceptance is based on adherence to recognized consensus standards (ISO 10939:1998 and IEC 60601-1) and technological characteristics being substantially equivalent to a legally marketed predicate device. There is no mention of expert consensus, pathology, or outcomes data being used to establish device performance.

8. The Sample Size for the Training Set:

Not applicable. This is a traditional medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned for this device.

Summary

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063410

Summary of Safety and Effectiveness for the Luxvision Slit Lamp

DEC - 7 2006

submitted by USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33186 Phone: (305) 969-4545

Ezequiel D. Lukin Contact Person: Device Trade Name: Luxvision Slit Lamp Common Name: Slit Lamp Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850 Classification Name:

Identification of a Legally Marketed Predicate Device

The USOphthalmic Luxvision Slit Lamp is substantially equivalent to 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD pursuant to premarket notification K033190.

Device Description

Intended Use

Summary of Technological Characteristics

An 8-point comparison of technological characteristics of the USOphthalmic Luxvision Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent.

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Summary of Performance Data

The USOphthalmic Luxvision Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.

ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes .
. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety

The USOphthalmic Luxvision Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.

Because the USOphthalmic Luxvision Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2006

U. S. Ophthalmic LLC c/o Mr. Al Weisenborn 7255 NW 68th St. Unit #9 Miami, FL 33166

Re: K063416

Trade/Device Name: Luxvision Slit Lamp (Models LSL880, LSL 1100, and LSL 1400) Regulation Number: 21 CFR 886.1850 Regulation Name: Slit Lamp Regulatory Class: II Product Code: HJO Dated: November 3, 2006 Received: November 13, 2006

Dear Mr. Weisenborn:

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. Al Weisenborn

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) 276-0115. 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,

M.B. Eychlesheimer MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of 1

0634 510(k) Number (if known):

Device Name: Luxvision Slit Lamp

Indications for Use:

Prescription Use X (Per 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)

Daryl L. Kaufman

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K063416

Page 1 of 1

USOphthalmic

November 3, 2006

Regulation Number and Section

§ 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.