(144 days)
Not Found
No
The summary describes a standard optical slit lamp for visual examination and photography, with no mention of AI, ML, or advanced image processing beyond basic capture.
No
The device is used to aid in the diagnosis of diseases or trauma affecting the anterior eye segment through examination, not to treat them.
Yes
The "Intended Use / Indications for Use" 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 clearly states it is a physical instrument (slit lamp) with an illumination unit, binocular stereo microscope, and the ability to connect to a digital camera unit. It also mentions bench testing for electrical and optical safety standards, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Slit Lamp SL-D301 is a biomicroscope used for direct visual examination of the anterior segment of the eye. It uses light and magnification to allow a healthcare professional to observe the structures of the eye.
- Method of Use: The device is used in vivo (on a living patient), not in vitro (on a specimen outside the body).
- Intended Use: The intended use is to aid in the diagnosis of diseases or trauma by allowing for visual examination, not by analyzing a biological sample.
The device is a diagnostic tool, but it falls under the category of ophthalmic diagnostic equipment used for direct observation, not IVD.
N/A
Intended Use / Indications for Use
The Slit Lamp SL-D301 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 trauma which affect the structural properties of the anterior eye segment.
Product codes
HJO
Device Description
This instrument is a slit lamp to observe, examine and photograph the eyeball and appendage of the eye. The slit lamp has the illumination unit for illumination and the binocular stereo microscope, and allows for stereoscopic observation. This instrument allows users to photograph and save the observed images by combining with an accessory, the digital camera unit DC-4. This instrument consists of the main body and accessories.
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 following bench testing was conducted in order to demonstrate compliance with recognized consensus standards:
- AAMI ANSI/ES60601-1:2005/(R)2012 and C1:2009(R)2012 and A2:2010(R)2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability - Requirements and Tests;
- 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;
- ISO 10939:2007 Ophthalmic Instruments - Slit-lamp microscopes:
The performance testing demonstrated that the Slit Lamp SL-D301 is as safe and effective as the predicate device, and performs as well or better than the predicate. The test results showed that the Slit Lamp SL-D301 met the same electrical safety, optical safety and slit lamp standards as the predicate 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Topcon Corporation % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K161972
Trade/Device Name: Slit Lamp SL-D301 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: November 7, 2016 Received: November 8, 2016
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -S
for 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
510(k) Number (if known)
Device Name Slit Lamp SL-D301
Indications for Use (Describe)
The Slit Lamp SL-D301 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 trauma which affect the structural properties of the anterior eye segment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Topcon Corporation Slit Lamp SL-D301
510(k) Owner
Topcon Corporation 75-1 Hasunuma-Cho Itabashi-Ku Tokyo, Japan 174-8580 Phone: (201) 599-5187 Facsimile: (201) 599-5258 Contact Person: James Lorkowski
Submission Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245
Date Prepared: December 9, 2016
Trade Name of Device Slit Lamp SL-D301
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
Predicate Devices TOPCON CORPORATION Slit Lamp SL-D701 (K133667)
Device Description
This instrument is a slit lamp to observe, examine and photograph the eyeball and appendage of the eye. The slit lamp has the illumination unit for illumination and the binocular stereo microscope, and allows for stereoscopic observation. This instrument allows users to photograph and save the observed
4
images by combining with an accessory, the digital camera unit DC-4. This instrument consists of the main body and accessories.
Intended Use / Indications for Use
The Slit Lamp SL-D301 is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eve 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.
Substantial Equivalence
The Slit Lamp SL-D301 is substantially equivalent to Topcon's Slit Lamp SL-D701 cleared in K133667. The Slit Lamp SL-D301 has the same intended use and indications for use, and similar principles of operation and technological characteristics as the previously cleared predicate device.
The Topcon Slit Lamp SL-D301 has similar technological characteristics to the predicate device. The Slit Lamp SL-D301 and the predicate device are both ACpowered 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 device. The slit image width is 0-9 mm in the Slit Lamp SL-D301 and 0-14 mm in the SL-D701. The slit image length is 1-8 mm in the Slit Lamp SL-D301 and 1-14 mm in the SL-D701. These ranges are in compliance with ISO 10939:2007 and differences are not significant.
The light source for the Slit Lamp SL-D301 is a Halogen Bulb. In the Topcon Slit Lamp SL-D301 the maximum brightness of the Halogen Bulb is 230,000 Lux while in the SL-D701 the maximum brightness is up to 450,000 Lux. Both the Topcon Slit Lamp SL-D301 and SL-D701 have the same magnification steps and eyepiece lens magnification.
Both the Topcon Slit Lamp SL-D301 and the SL-D701 cleared in K133667 comply with the following consensus standards: IEC 60601-1, IEC60601-1-2, ISO 15004-2:2007 and ISO 10939:2007.
The Slit Lamp SL-D301 has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate. Thus, the Slit Lamp SL-D301 is substantially equivalent to its predicate.
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Performance Data
The following bench testing was conducted in order to demonstrate compliance with recognized consensus standards:
- . AAMI ANSI/ES60601-1:2005/(R)2012 and C1:2009(R)2012 and A2:2010(R)2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability - Requirements and Tests;
- 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;
- . ISO 10939:2007 Ophthalmic Instruments - Slit-lamp microscopes:
The performance testing demonstrated that the Slit Lamp SL-D301 is as safe and effective as the predicate device, and performs as well or better than the predicate. The test results showed that the Slit Lamp SL-D301 met the same electrical safety, optical safety and slit lamp standards as the predicate device.