The Slit Lamp SL-2G is an AC-powered slitlamp 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 segment.

Device Description

The Slit Lamp SL-2G 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. The Slit Lamp SL-2G is composed of the following components: microscope unit, illumination unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

AI/ML Overview

This submission describes a slit lamp biomicroscope, a medical device used for eye examinations. The acceptance criteria and supporting studies for this type of device are primarily focused on compliance with recognized performance standards related to safety, electromagnetic compatibility, and specific ophthalmic instrument requirements, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in the context of this traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
IEC 60601-1 (Safety)	Conforms
IEC 60601-1-2 (EMC)	Conforms
ISO 15004-1 (Ophthalmic General)	Conforms
ISO 15004-2 (Light Hazard)	Conforms
ISO 10939 (Slit Lamp Specific)	Conforms
Exposure Parameters	Within predicate specifications:
Slit image width	Within specifications
Slit image length	Within specifications
Illumination field diameter	Within specifications
Slit direction	Within specifications
Brightness	Maximum 160,000 Lux (within range of predicate's available light sources)
Magnification steps	Same as predicate (BP 900)
Eyepiece lens magnification	Same as predicate (BP 900)

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

Not applicable for this type of device. The "test set" here refers to the device itself undergoing engineering and performance testing against established standards, not a clinical data set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth for a physical medical device's compliance with safety and performance standards is established through engineering tests, measurements, and adherence to manufacturing specifications, not typically through expert consensus on a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" is not relevant for testing against engineering and performance standards.

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. This is a traditional medical device (slit lamp), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC comparative effectiveness study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a manual medical device operated by a human, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards (IEC, ISO) and its demonstration of similar technological characteristics and performance parameters to previously cleared predicate devices. This involves direct measurement, engineering verification, and comparison of specifications.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" demonstrating the device meets the acceptance criteria is a substantial equivalence comparison to predicate devices, supported by compliance with recognized international consensus standards.

Substantial Equivalence: The Topcon Slit Lamp SL-2G was compared to the HAAG-STREIT Slit Lamps BM 900/BQ 900/BP 900 (K100202) and BC 900 (K982057).
- Identical Intended Use/Indications for Use: Both the proposed device and predicates are intended for eye examination of the anterior eye segment to aid in diagnosing diseases or trauma.
- Similar Technological Characteristics: Both are AC-powered slit lamp biomicroscopes that project a light beam into the patient's eye.
- Equivalent Performance Parameters: "Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are all within the specifications of the previously cleared predicate devices."
- Light Source: While the SL-2G uses an LED (max 160,000 Lux), this is noted as one of the available light sources for the predicate BM 900/BQ 900/BP 900 series (which has a maximum brightness up to 450,000 Lux). The SL-2G's brightness is within an acceptable range for a slit lamp.
- Magnification: The SL-2G has the same magnification steps and eyepiece lens magnification as the predicate BP 900.
Compliance with Standards: The device conforms to the following standards, which define electrical safety, electromagnetic compatibility, and specific requirements for ophthalmic instruments and slit lamp microscopes:
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- ISO 15004-1 (Ophthalmic Instruments - General Requirements)
- ISO 15004-2 (Light Hazard Protection)
- ISO 10939 (Slit Lamp Microscopes Specific)

The conclusion is that the Topcon Slit Lamp SL-2G is "substantially equivalent" to its predicate devices because it shares the same intended use, similar technological characteristics, and conforms to the same recognized performance standards. This demonstrates that the device meets safety and effectiveness requirements without raising new questions of safety or effectiveness.

Summary

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K110489

510(k) SUMMARY

MAY 2 3 2011

Topcon Medical Systems, Inc. Slit Lamp SL-2G

510(k) Owner's Name, Address, Telephone Number, Contact Person and Date Prepared

Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436 Phone: (201) 599-5153 Facsimile: (201) 599-5240 Contact Person: Randy Samuels

1 : 16

Additional Correspondent:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541

Date Prepared: February 18, 2011

Trade Name of Device Topcon Slit Lamp SL-2G

Common or Usual Name

AC- Powered Slit-Lamp Biomicroscope

Classification Name

AC-powered slitlamp biomicroscope; 21 C.F.R. 886.1850 Class II Product Code: HJO

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Predicate Devices

1. 1. 1. 4

Haag-Streit AG BM 900/BQ 900/ BP 900 (K100202) Haag-Streit AG BC 900 (K982057)

Device Description

Intended Use / Indications for Use

Performance Data

The Slit Lamp SL-2G conforms to following standards: IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment 1, 1991; Amendment 2, 1995; IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007; ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments;, ISO 15004-2:2007 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection and ISO 10939:2007 Ophthalmic Instruments-Slit Lamp Microscopes.

Substantial Equivalence

The Topcon Slit Lamp SL-2G is substantially equivalent to the predicate devices, the HAAG-STREIT Slit Lamps BM 900/BQ 900/BP 900 (K100202) and BC 900 (K982057).

The Slit Lamp SL-2G and the predicated devices have the same intended use and indications for use as the predicate devices. The intended use for the Slit Lamp SL-

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2G and the identified predicate devices is to examine the anterior eye segment for diagnostic purposes. The Topcon Slit Lamp SL-2G has similar technological characteristics to the predicate devices. The Slit Lamp SL-2G and the predicate devices are all AC-powered slit lamp biomicroscopes that project a beam of light into the patient's eye through a control diaphragm. Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are all within the specifications of the previously cleared predicate devices. The light source for the SL-2G is an LED which is one of the available light sources for the BM 900/BQ 900/BP 900 series of slit lamps. In the Topcon Slit Lamp SL-2G the maximum brightness of the LED is 160,000 Lux while in the Haag Streit slit lamps the maximum brightness is up to 450,000 Lux. Both the Topcon Slit Lamp SL-2G and the BP 900 have the same magnification steps and eyepiece lens magnification. The Slit Lamp SL-2G conforms to the same recognized performance standards as the predicate devices which further demonstrates substantial equivalence. Therefore, the Slit Lamp SL-2G is substantially equivalent to the identified predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Topcon Medical Systems, Inc. c/o Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

MAY 2 3 2011

Re: K110489

Trade Name: Topcon Slit Lamp SL-2G Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: February 18, 2011 Received: February 22, 2011

Dear Ms. O'Connell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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(21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Debora Falls

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):

K110489

Device Name: Topcon Slit Lamp SL-2G

Indications for Use:

Prescription Use _X (Part 21 C.F.R. 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use_ (21 C.F.R. 807

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K110489

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.