(90 days)
Not Found
No
The summary describes a standard slit lamp biomicroscope with no mention of AI/ML, image processing, or related performance metrics.
No
The device is used for examination and diagnosis, not for treating diseases or trauma.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment."
No
The device description explicitly states it is an AC-powered device composed of physical components like a microscope unit, illumination unit, chinrest, table, and power unit, indicating it is a hardware device, not software-only.
Based on the provided information, the Slit Lamp SL-2G is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Slit Lamp Function: The description clearly states the Slit Lamp SL-2G is a biomicroscope used for the direct visual examination of the anterior segment of the eye. It projects light into the eye and uses a microscope for observation. It does not involve the analysis of biological specimens taken from the body.
- Intended Use: The intended use is for "eye examination of the anterior eye segment" and to "aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment." This is a direct examination of the living tissue, not an analysis of a sample.
Therefore, the Slit Lamp SL-2G falls under the category of ophthalmic instruments used for direct patient examination, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
HJO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the cornea epithelium to the posterior capsule
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)
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.
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-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.
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.
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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
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Haag-Streit AG BM 900/BQ 900/ BP 900 (K100202) Haag-Streit AG BC 900 (K982057)
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.
Intended Use / Indications for Use
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.
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):
Device Name: Topcon Slit Lamp SL-2G
Indications for Use:
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.
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