The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope 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 authorised healthcare professionals.

Device Description

An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light.

This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties 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 illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction.

The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam.

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 microscope. The base unit has a rheostat to control the illumination level.

Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally.

AI/ML Overview

The Keeler Slit Lamp - H Series is an AC-powered 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 affecting the structural properties of the anterior eye segment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/diagnostic devices. Instead, the focus is on demonstrating substantial equivalence to a predicate device (Haag-Streit Slit Lamp BQ 900, K100202) through comparison of technical specifications and compliance with recognized safety and performance standards.

The "acceptance criteria" can be inferred to be compliance with relevant safety and performance standards and demonstrating that any differences from the predicate device do not affect safety or effectiveness.

Feature	Predicate Device (Haag-Streit BQ 900)	Keeler Slit Lamp H-Series	Acceptance Criteria (Implicit)	Reported Performance (Keeler H-Series)
Intended Use	"An AC-powered slit lamp biomicroscope is an AC-powered device..."	"An AC-powered slit lamp biomicroscope is an AC-powered device..."	Same intended use as predicate.	Same.
Operating Principle	Not explicitly detailed, but implied by device type.	Not explicitly detailed, but implied by device type.	Same operating principle as predicate.	Same.
Basic Optical Design	Not explicitly detailed, but implied by device type.	Not explicitly detailed, but implied by device type.	Same basic optical design as predicate.	Same.
Magnification	6.3x / 10x / 16x / 25x / 40x	x6, x10, x16, x25 & x40	Differences are not significant and do not affect safety or effectiveness.	Differences noted (6x vs 6.3x, etc.), but deemed not significant and not affecting safety or effectiveness.
Objective lens working distance	105mm	107mm	Differences are not significant and do not affect safety or effectiveness.	Differences noted, but deemed not significant and not affecting safety or effectiveness.
Field of view	32.0 @ 6.3x / 20.0 @ 10x / 12.7@ 16x / 8.0@ 25x / 5.1@ 40x	34.0 @ 6x / 22.0 @ 10x / 14 @ 16x / 8.5 @ 25x / 5.5 @ 40x	Differences are not significant and do not affect safety or effectiveness.	Differences noted, but deemed not significant and not affecting safety or effectiveness.
Range of PD adjustment	52 - 78 mm	49.0 to 77mm	Range conforms to requirement of ISO 10939 and does not affect safety or effectiveness.	Differences noted, but conformance to ISO 10939 and no affect on safety/effectiveness is reported.
Eyepiece dioptric adjustment range	+8 to -8 diopters	+8 to -8 diopters	Same as predicate.	Same.
Slit Length	1-8 mm continuous	12mm (1mm - 12mm continuously variable)	Difference not significant; sufficient for clinical use (e.g., iris diameter), meets ISO 10939, does not affect safety/effectiveness.	Differences noted, but deemed not significant. 12mm is more than sufficient for clinical use (iris diameter max 6mm), meets ISO 10939, and does not affect safety or effectiveness.
Slit Width	0 - 8 mm continuous	0-12mm continuously variable	Difference not significant; not critical as long as ≥ 8mm, meets ISO 10939, does not affect safety/effectiveness.	Differences noted, but deemed not significant. Maximum slit width not critical as long as ≥ 8mm, with narrow slits often needed for examination. Meets ISO 10939, and does not affect safety or effectiveness.
Light source	7.5V, 38 W Halogen Lamp, 24VDC 1A LED	6V 20W Halogen lamp and LED	All light sources conform to ISO 15004-2 (Photo-toxicity) and do not affect safety or effectiveness.	Differences noted, but all light sources conform to ISO 15004-2 and there is no affect on safety or effectiveness.
Duration of illumination	Maximum examination times according to ISO 15004-2 and ISO 10939	Maximum examination times according to ISO 15004-2 and ISO 10939	Same as predicate, conforming to ISO 15004-2 and ISO 10939.	Same.
Light intensity selection	Three selections: Full, 1/4 and 1/16 via neutral density filter.	0-100% continuous potentiometer	Allows the user to select the necessary light intensity to perform the relevant task, difference not significant.	Differences noted, but deemed not significant as both allow user to select necessary light intensity for the task.
Filters	Blue, red-free (green), grey (10%); UV and heat absorption filters permanently mounted.	Clear; red-free; neutral density; diffuser; blue; IR heat absorbing filter permanently installed.	Difference not significant and does not affect safety or effectiveness; both have permanently installed heat absorbing filter.	Differences noted, but deemed not significant and not affecting safety or effectiveness. Both devices have a permanently installed heat absorbing filter.
Electrical Ratings			Same as predicate.	Same for input voltage, power output, and output voltage.
Compliance with Safety Standards	IEC60601-1-2, IEC60601-1, ISO 15004-2	IEC 60601-1-2, IEC 60601-1, ISO15004-2	Device must be in compliance with these FDA recognized standards.	In compliance with all listed standards (BS EN ISO 15004-2, BS EN ISO 10939 for radiation hazards, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).

The study that proves the device meets the acceptance criteria is described as the "Summary of Performance, EMC and Safety Testing."

2. Sample size used for the test set and the data provenance

The document does not describe a test set involving patient data or clinical samples for performance evaluation in the context of diagnostic accuracy (e.g., retrospective or prospective studies with a specific sample size). Since this is a hardware device (slit lamp biomicroscope), testing primarily focuses on engineering performance, electrical safety, EMC, and radiation safety.

Therefore, there is no mention of:

Sample size for a test set.
Data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a viewing instrument, and its "performance" is evaluated against technical specifications and safety standards, not against clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or ground truth adjudication process is described for this type of device.

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

Not applicable. This device is an ophthalmic instrument, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device.

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 for medical electrical equipment and ophthalmic instruments (IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ISO 10939). The testing involved objective measurements against these standards, rather than clinical ground truth like pathology or expert consensus on disease diagnosis.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no training set in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, no ground truth needed to be established for it.

Summary

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K131589

Ophthalmic Instruments

3. 510(k) Summary

3.1 Submitter's information

The submitter of this pre-market notification is:

Mr. Nickie Power (Quality Manager). Keeler limited Clewer hill Road, Windsor, Berkshire, SL4 4AA, UK Company Phone No: +44 (0) 1753 827153 Company Fax No: +44 (0) 1753 827145 Contact Person: Mr. Nickie Power

Date summary prepared: January 14, 2013

3.2 Device Identification

Device Trade Name:	Keeler Slit Lamp - H Series
Common Name:	AC Powered Slit lamp Biomicroscope
Class:	==============================================================================================================================================================================
Classification Panel:	86
Product Code:	HJO
Regulation Number:	886.1850

3.3 Predicate Device

Predicate Device:	Slit Lamp BQ 900
510(k) No:	K100202
Manufacturer:	Haag-Streit AG
Common Name:	AC Powered Slit lamp Biomicroscope
Class:	II
Classification Panel:	86
Product Code:	HJO
Regulation Number:	886.1850

510K Keeler H-Series Slit Lamp

Project 210

Issue B

JUN 2 7 2013

Page 5 of 53

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3.4 Device description

Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target.

3.5 Indications for Use

This device is intended to be used only by suitably trained and authorised healthcare professionals.

Project 210

Issue B

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Keeler

Ophthalmic Instruments

3.6 Comparison of the device with the Predicate

The Haag-Streit BQ900 has been chosen as the substantially equivalent device, it has the same intended use and classification.

The Keeler Slit Lamp has the following similarities to those of the predicate device:

-has the same indication for use,

-uses the same operating principle,

-incorporates the same basic optical design.

Refer to the table below for comparison between Keeler and Haag Streit BQ 900 Slit Lamps (K100202).

Device	Predicate DeviceHaag-Streit Slit LampBQ 900	Keeler Slit LampH- Series	Discussion
Intended use	An ac-Powered slit lampbiomicroscope is an AC-powered device that is amicroscope intended for usein eye examination thatprojects into the patient's eyethrough a control diaphragma thin, intense beam of light	An ac-Powered slit lampbiomicroscope is an AC-powered device that is amicroscope intended for usein eye examination thatprojects into the patient's eyethrough a control diaphragma thin, intense beam of light	Same
Microscope	Galilean convergingbinoculars	Galilean convergingbinoculars	Same
Type	AC Powered BiomicroscopeSlit Lamp	AC Powered BiomicroscopeSlit Lamp	Same
Angle ofConvergence	13°	13°	Same
Magnification	6.3x / 10x / 16x / 25x / 40x	x6, x10, x16, x25 & x40	The difference are notsignificant and does notaffect the safety oreffectiveness of thedevice
Objective lensworking distance	105mm	107mm	The difference are notsignificant and does notaffect the safety oreffectiveness of thedevice
Field of view	32.0 @ 6.3x / 20.0 @ 10x /12.7@ 16x / 8.0@ 25x /5.1@ 40x	34.0 @ 6x / 22.0 @ 10x / 14@ 16x / 8.5 @ 25x / 5.5 @40x	The difference are notsignificant and does notaffect the safety oreffectiveness of thedevice
Range of PDadjustment	52 - 78 mm	49.0 to 77mm	There is a difference inthe range of adjustmenthowever this does notaffect safe oreffectiveness on thedevices as bothconform to therequirement of ISO10939
Eyepiece dioptricadjustmentrange	+ 8 to - 8 diopters	+ 8 to - 8 diopters	same
Slit ProjectionUnit
Slit Length	1-8 mm continuous	12mm (1mm - 12mmcontinuously variable)	The difference is notsignificantAn Iris usually has adiameter of 6mm max,therefore a slit length of12mm is more thansufficient, meeting therequirement specifiedin ISO 10939 and doesnot affect the safety oreffectiveness of thedevice
Slit Width	0 - 8 mm continuous	0-12mm continuouslyvariable	The difference is notsignificant; this doesnot affect safety oreffectiveness of thedevices as bothconform to therequirement of ISO10939.Slit lamps are used toexamine the inner partof the eye and usuallya narrow slit of lessthan 1mm is needed.For this reason themaximum slit width isnot critical as long as itis ≥ 8mm
Light source	7.5V, 38 W Halogen Lamp24VDC 1A LED	6V 20W Halogen lamp andLED - As the slit lampconform to the relevantstandardISO 10939, there are noissues of safety andeffectiveness.	There is a difference inlight sources usedhowever all lightsources must conformto the requirements of15004-2 Photo-toxicitytherefore there is noaffect on safety oreffectiveness
Duration ofillumination	Maximum examination timesaccording to ISO 15004-2and ISO 10939	Maximum examination timesaccording to ISO 15004-2and ISO 10939	Same
Light intensityselection	Three selections: Full, 1/4and 1/16 via neutral densityfilter.	0-100% continuouspotentiometer	The difference is notsignificant as they allowthe user to select thenecessary lightintensity to perform therelevant task
Filter	Blue, red free (green), grey(10%)The UV filter and the heatabsorption filter arepermanently mounted	Clear; red free; neutraldensity; diffuser; blue; IRheat absorbing filterpermanently installed	The difference is notsignificant and does notaffect safety oreffectiveness, bothdevices have apermanently installedheat absorbing filter
Electricalratings
Input voltage	AC 100-240 V, 50/60Hz	AC 100-240 V, 50/60Hz	Same
Power output	30VA	30VA	Same
Output Voltage	12 V DC	12 V DC	Same
Compliancewith Safetystandards	IEC60601-1-2IEC60601-1ISO 15004-2	IEC 60601-1-2IEC 60601-1ISO15004-2	Same

510K Keeler H-Series Slit Lamp

Issue B

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Keeler

Ophthalmic Instruments

510K Keeler H-Series Slit Lamp

・

Project 210

100 - 100

Issue B

Page 8 of 53

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Ophthalmic Instruments

3.7 Summary of Performance, EMC and Safety Testing

The Keeler Slit Lamp (H - Series) was evaluated against the requirements of BS EN ISO 15004-2 and BS EN ISO 10939 for radiation hazards, to IEC 60601-1 for electrical safety and to IEC 60601-1-2 for electromagnetic compatibility.

In all tests the slit lamp was in compliance with these FDA recognized standards.

3.8 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 concludes that the H- Series Slit Lamp is safe and effective, and substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

June 27, 2013

Public Health Service

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

Keeler Limited % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories Inc. I 2 Laboratory Drive Research Triangle Park, NC 27709

Re: K131589

Trade/Device Name: Keeler Slit Lamp - H Series Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit Lamp Regulatory Class: Class II Product Code: HJO Dated: June 4, 2013 Received: June 13, 2013

Dear Mr. Rongero:

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 includions for use stated in the enclosure) to legally marketed predicated vices marked 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, Drig. 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nsand adulteration. Please note: CDRH does not evaluate information related to contractling allie warranties. We remind you, however, that device labeling must be truthful and not miolesaling.

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, TDA coul 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You most 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

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Page 2 - Mr. Jeff D. Rongero

device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Yow/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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Keeler

Ophthalmic Instruments

2. Indications for Use Form

510(k) Number (if known):

Device Name: Keeler Slit Lamp H-Series.

Indications for Use:

This device is intended to be used only by suitably trained and authorised healthcare professionals.

Prescription Use _v (Part 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 OF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Andrew Yang -5 2013.06.27 16:08:34 -04'00'
510K Keeler H-Series Slit Lamp	Project 210
	Division of Ophthalmic and Ear, Nose and Throat Devices
	510(k) Number K131589
	Issue B

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.