(107 days)
The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and is 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 affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorized healthcare professionals
The Keeler Slit Lamp Z-series (modified device) exists in two variants: non-digital and digital. The Z-series variant of the product is introduced as a lower cost alternative of the H-series to meet expectations of the optometry market. The Keeler Slit Lamp Zseries includes bottom-illuminating tower assembly instead of top-illuminating Haagtype illuminating tower. The high percentage of components/assemblies used on cleared Keeler Slit Lamp H-series (unmodified device) will be utilized on the Z-series slit lamp.
The modified device will come in a few different configurations assembled from the same components (022 Configurations of the Modified Device). High percentage of components shared between H-series and Z-series slit lamps are used on the cleared H-series device.
Similar to the H-series slit lamp, the Z-series will offer a digital option for recording and storing images and a range of magnifications from x6 to x40. The Z-series slit lamp will only come with LED as a light source, the same as in cleared H-series device, but unlike the H-series slit lamp the bulb version will not be available for the Z-series. The modified device will offer converging and parallel viewing optics, the same options as available on the unmodified device.
The provided document is a 510(k) premarket notification for the Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital. It focuses on demonstrating substantial equivalence to a previously cleared device (Keeler Slit Lamp H-series). The document does not describe a study that establishes acceptance criteria for diagnostic performance or compares the device's diagnostic abilities against a ground truth.
Instead, the document details engineering, safety, and performance testing related to the physical device itself, primarily to ensure it meets recognized medical device standards and is safe for use.
Here's an analysis based on the information provided, highlighting why it doesn't fit the requested criteria for diagnostic performance evaluation:
1. A table of acceptance criteria and the reported device performance
This document does not provide acceptance criteria or reported performance for diagnostic accuracy (e.g., sensitivity, specificity) as it is not a study evaluating the diagnostic capability of the device.
The "performance" described pertains to engineering and safety standards:
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ISO 15004-2 / ISO 10939: Optical Radiation Hazard | Compliant (new exposure safety limits added to IFU) |
| IEC 60601-1: Electrical Safety | Compliant |
| IEC 60601-1-2: Electromagnetic Compatibility (EMC) | Compliant |
| Functionality (e.g., magnification, illumination) | Performs as intended (e.g., offers x6 to x40 magnification, LED light source, converging/parallel optics) |
2. Sample size used for the test set and the data provenance
This is not applicable as the document describes engineering and safety testing on device prototypes/configurations, not a diagnostic study using patient data. The "test set" in this context refers to the device configurations themselves. The provenance of raw patient data is not mentioned because no such data was used for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The evaluations conducted relate to device safety and functionality based on engineering standards and design specifications, not expert interpretation of diagnostic output.
4. Adjudication method for the test set
This is not applicable. No expert adjudication of diagnostic outcomes was performed.
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
This is not applicable. This document describes a physical medical device (slit lamp) and not an AI or software-as-a-medical-device (SaMD) product. Therefore, no MRMC study, AI assistance, or effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical diagnostic tool for human operators, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" or reference was the established requirements and limits of the relevant international standards (e.g., ISO 15004-2, IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set
This is not applicable as no AI or machine learning model was developed or trained.
9. How the ground truth for the training set was established
This is not applicable as no AI or machine learning model was developed or trained.
In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates the device's adherence to safety and operational standards and its substantial equivalence to a predicate device. It does not contain information about studies evaluating diagnostic performance, human-in-the-loop performance, or AI-driven diagnostic accuracy, as these are outside the scope of this type of submission for this particular device.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Keeler Limited Ms. Irina Proutski Head of Regulatory And Quality Affairs Clewer Hill Road Windsor, Berkshire GB SL4 4AA United Kingdom
Re: K151394
Trade/Device Name: Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: August 7, 2015 Received: August 10, 2015
Dear Ms. Proutski:
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.
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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 of medical devicerelated adverse events) (21 CFR 803); 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.
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 yours.
Kesia Y. Alexander -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) K151394
Device Name
Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital
Indications for Use (Describe)
The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and is 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 affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorized healthcare professionals
| 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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Image /page/3/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray font. The logo is simple and clean, and it is likely used on the company's website and marketing materials.
510(k) Summary of Safety and Effectiveness
1.1 Submitter's Information
The submitter of this special pre-market notification is:
| Name: | Dr. Irina Proutski (Head of Regulatory and Quality Affairs). |
|---|---|
| Address: | Keeler Limited, Clewer Hill Road, Windsor, |
| Berkshire, SL4 4AA, UK | |
| Company Phone No: | +44 (0) 1753 827125 |
| Company Fax No: | +44 (0) 1753 827145 |
| Contact Person: | Dr Irina Proutski |
| Date summary prepared: | 17th April 2015 |
1.2 Device Identification (Unmodified)
Device Trade Name: Keeler Slit Lamp - H Series and Keeler Slit Lamp H-series Digital (FDA approval letters K131589 and K140451) Common Name: AC Powered Slit lamp Bio-microscope Class: Classification Panel: 86 Product Code: HJO Regulation Number: 886.1850
1.3 Device Description
Unmodified Device 1.3.1
There are two cleared unmodified devices used as predicate for the purpose of this registration: The Keeler Slit Lamp H-Series device and its digital variant. Both are ACpowered slit lamp bio-microscopes intended for use in eye examination that projects a thin intense beam of light into the patient's eve through a control diaphragm. It is mounted on an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third party's table top (refraction unit) by suitably trained technicians.
Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The patient is seated in front of the slit lamp with his/her chin in the adjustable chin rest and forehead against the forehead rest. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the biomicroscope.
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Image /page/4/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" in a smaller, gray font. The logo is simple and clean, and the colors are professional and modern.
The digital option for the H-Series Slit Lamp enables digital photographs to be taken to capture the image being observed, for further viewing and record purposes. It comprises an additional USB camera module that can be fitted by the user between the binocular eyepiece assembly and the main body of the bio-microscope, which is connected to a powered USB3 hub enclosed within the bio-microscope base, for onward connection to a medically approved PC. To accommodate addition of this option the illumination tower has been modified to provide background lighting via a fibre optic light tube when capturing digital images.
There are two variants of the H-Series Digital Slit lamp. The first variant uses an incandescent light source, which is used to illuminate the eye during examination and provide background illumination to aid digital photography. The second product variant is an LED illumination option, which again provides light to illuminate the eye during examination and provides background illumination for digital photography.
1.3.2 Modified Device
The Keeler Slit Lamp Z-series (modified device) exists in two variants: non-digital and digital. The Z-series variant of the product is introduced as a lower cost alternative of the H-series to meet expectations of the optometry market. The Keeler Slit Lamp Zseries includes bottom-illuminating tower assembly instead of top-illuminating Haagtype illuminating tower. The high percentage of components/assemblies used on cleared Keeler Slit Lamp H-series (unmodified device) will be utilized on the Z-series slit lamp.
The modified device will come in a few different configurations assembled from the same components (022 Configurations of the Modified Device). High percentage of components shared between H-series and Z-series slit lamps are used on the cleared H-series device.
Similar to the H-series slit lamp, the Z-series will offer a digital option for recording and storing images and a range of magnifications from x6 to x40. The Z-series slit lamp will only come with LED as a light source, the same as in cleared H-series device, but unlike the H-series slit lamp the bulb version will not be available for the Z-series. The modified device will offer converging and parallel viewing optics, the same options as available on the unmodified device. While the unmodified device has been cleared with converging viewing optics only and the parallel option has been added at a later stage, this design change has been thoroughly verified and validated internally during the course of this project, reports are available on request.
Z-type illumination tower with LED light source is brighter than H-series with 240k Lux, the change in light intensity has been appropriately assessed for optical radiation hazard and new exposure safety limits added to the IFU. The modified device complies with ISO 15004-2:2007 and other standards listed in the Standards Data Report.
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Image /page/5/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a large, bold, blue font. Below that, the words "Ophthalmic Instruments" are in a smaller, gray font. The logo is simple and professional.
1.4 Indications for Use
The following indications for use for the Keeler Slit Lamp Z-Series remain unchanged by introduction of the Z-type illumination tower, additional options of parallel optics and a choice of magnifications:
"The Keeler Slit Lamp is an AC-powered Slit lamp bio-microscope and is 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 affects the structural properties of the anterior eye segment
This device is intended to be used only by suitably trained and authorized healthcare professionals "
1.5 Comparison with Cleared Device
The Keeler Slit Lamp has been modified to include a bottom illuminating system that comes with the same light source (LED) and the higher light output. The bulb version of the device is not available for the Keeler Slit Lamp Z-series. The modified device will have a choice of parallel and converging optics and 3x and 5x magnification block.
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1.6 Summary of Design Control Activities
In accordance with FDA guidance on submission of a Special 510(k), risk management, verification/validation and other related activities were carried out to assure continuing safety and effectiveness of the device. In particular, the Keeler Slit Lamp Z-Series has been re-evaluated against ISO 15004-2/ISO 10939 for optical radiation hazard, IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
For the purpose of safety testing the "worst case scenario" configuration was selected for Optical radiation hazard, electrical safety and EMC testing (Keeler Slit Lamp Zseries digital with parallel optics and 5x magnification), while verification/validation tasks were performed for all components used in all configurations.
In all tests, the Keeler Slit Lamp Z-series (including digital variant) was found to be in compliance with these FDA recognized standards.
1.7 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, Keeler Limited conclude that the modified version of the H-Series Slit Lamp, including the digital version, with the bottom-illuminating projection system is safe and effective, and substantially equivalent to the unmodified versions of this device used as a predicate.
§ 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.