KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)

K140451 · Keeler Limited · HJO · Jul 11, 2014 · Ophthalmic

Device Facts

• Record ID: K140451
• Device Name: KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
• Applicant: Keeler Limited
• Product Code: HJO · Ophthalmic
• Decision Date: Jul 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

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.

Device Story

Keeler Slit Lamp H-Series Digital is an AC-powered bio-microscope for anterior eye segment examination. Device projects intense light beam into patient eye; patient positioned via chin/forehead rest. Digital variant includes USB camera module (Sony ICX274 CCD) mounted between binocular eyepiece and microscope body; connects to medically approved PC via internal USB3 hub. Modifications include background illumination via fibre optic light tube and capture/exposure controls on joystick/base. Operated by healthcare professionals in clinical settings. Digital images captured for documentation/viewing. Device aids diagnosis of eye disease/trauma. Variants include incandescent or LED illumination. Safety ensured via compliance with ISO 15004-2:2007 phototoxicity standards.

Clinical Evidence

Bench testing only. No clinical data presented. Compliance with ISO 15004-2:2007 (phototoxicity) and IEC 60601-1/60601-1-2 (electrical safety/EMC) verified. Phototoxicity testing confirmed maximum exposure times (17 minutes for bulb, 12.5 minutes for LED) are safe.

Technological Characteristics

AC-powered slit lamp bio-microscope. Galilean converging binoculars. Illumination: 12VDC 30W halogen or LED. Camera: Sony ICX274 CCD, 1600x1200 resolution, 12 fps. Connectivity: USB3 hub to PC. Standards: ISO 15004-2:2007, IEC 60601-1, IEC 60601-1-2, ISO 10939. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties. For use by trained healthcare professionals.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Keeler Slit Lamp H-Series (K131589)
• Slit Lamp BQ900 (with IM900 Imaging Module Option) (K100202)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness (K140451)

#### 1. Submitter's Information

The submitter of this special pre-market notification is:

| Name: | Mr. Neil Atkins (Engineering Manager). |
|------------------------|----------------------------------------------------------------------|
| Address: | Keeler Limited, Clewer Hill Road, Windsor,<br>Berkshire, SL4 4AA, UK |
| Company Phone No: | [phone] |
| Company Fax No: | [phone] |
| Contact Person: | Mr. Neil Atkins |
| Date summary prepared: | 19th February, 2014 (Revised 10th April 2014) |

#### 2. Device Identification

| Device Trade Name: | Keeler Slit Lamp H-Series Digital |
|--------------------|-------------------------------------|
| Regulation Number: | 21 CFR 886.1850 |
| Regulation Name: | AC Powered Slit lamp Bio-microscope |
| Regualtion Cla | II |
| Product Code: | HJO, HKI |

#### 3. Predicate Device

-

For the digital version of slit lamp biomicroscope instrument, the predicate cited is the Keeler non-digital version of the same instrument:

| Device Trade Name: | Keeler Slit Lamp H- Series |
|-----------------------|-------------------------------------|
| 510(k) Number: | K131589 |
| Common Name: | AC Powered Slit lamp Bio-microscope |
| Class: | II |
| Classification Panel: | 86 |
| Product Code: | HJO |
| Regulation Number: | 886.1850 |

For the additional USB digital camera module fitted to the Keeler Slit Lamp H-Series Digital instrument by the user for image capture, the predicate cited, which offers the same digital camera option in the US market, is:

| Device Trade Name: | Slit Lamp BQ900 (with IM900 Imaging Module Option) |
|-----------------------|----------------------------------------------------|
| Manufacturer: | Haag Streit AG |
| 510(k) Number: | K100202 |
| Common Name: | AC Powered Slit lamp Bio-microscope |
| Class: | II |
| Classification Panel: | 86 |
| Product Code: | HJO |
| Regulation Number: | 886.1850 |

510(k) Keeler H-Series Digital

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Keeler

#### 4. Device Description

The Keeler Slit Lamp H-Series device is AC-powered slit lamp bio-microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. 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 microscope.

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 microscope, which is connected to a powered USB3 hub enclosed within the microscope base, for onward connection to a medically approved PC.

Addition of this option necessitates modifications to the illumination tower 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 bulb is more powerful than the bulb sited in the predicate 510(k) [K131589] due to the requirement for additional background illumination for digital photography. The quantity of light for illuminating the eye is comparable to the product sited in K131589, and therefore posses no additional risk to the safety and effectiveness of the product.

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. Both variants are factory fitted and comply with ISO 15004-2:2007.

#### 5. Indications for Use

The following indications for use for the Keeler Slit Lamp H-Series remain unchanged by addition of the digital photography option:

"The Keeler Slit Lamp is an AC-powered Slit lamp bio-microscope and is 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 affects the structural properties of the anterior eye segment

This device is intended to be used only by suitably trained and authorized healthcare professionals "

#### 6. Comparison with Cleared Device

The Keeler Slit Lamp has been modified to accommodate an additional USB digital camera module, which is connected to a USB hub in the microscope base, for onward connection to a

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standard PC for displaying the captured images.

These hardware additions have necessitated additions or changes to the product labeling on the previously cleared device [K131589], some of which are associated with the higher-powered halogen bulb option. Details of the significant differences are shown in the following substantial equivalence table comparing the cleared Keeler non-digital and modified digital devices:

| Feature | H-Series Slit Lamp<br>[K131589] | H-Series Slit Lamp<br>Digital | Discussion |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | As stated | As stated | No change |
| Bio-microscope<br>components | | | |
| Bio-microscope | Galilean converging<br>binoculars with<br>detachable<br>eyepiece head | Galilean converging<br>binoculars with<br>detachable<br>eyepiece head | As head can be separated from<br>the body, intervention of module<br>does not change these elements |
| Digital Camera Module | Not fitted | Optional fitment | Fitted by user when required, or<br>supplied fitted for customers |
| Image Capture Button | Not fitted | Fitted to joystick | Required for digital facility |
| Camera Exposure<br>Buttons | Not fitted | Adjacent to joystick<br>for camera aperture<br>adjustment | Required for digital facility |
| USB3 Hub (Internal) | Not fitted | Fitted in XYZ base | Required for digital facility |
| Slit Lamp Illumination<br>Options | 6VDC 20W halogen<br>bulb | 12VDC 30W<br>halogen bulb | Required for slit lamp<br>illumination with some light used<br>for background lighting |
| | LED | LED (first) | Required for slit lamp<br>illumination |
| Background Illumination<br>Adjuster | Not fitted | Fitted to top of<br>illumination tower | Allows adjustment for optimum<br>lighting for digital photography |
| Background Light Source<br>Options | Not fitted | 12VDC 30W<br>halogen bulb as<br>above | Required for higher background<br>light output but still conforms to<br>requirements of 15004-2 Photo-<br>toxicity with slightly longer<br>exposure time |
| | Not fitted | LED (second) | Required for background lighting |
| Background lighting duty<br>cycle - halogen bulb<br>option only | Not applicable | Limited to 6<br>minutes for 50%<br>duty cycle at<br>maximum<br>brightness | Ensures body of light source<br>does not exceed 62.3ºC limit<br>demanded by IEC 60601-1<br>compliance |
| Duration of illumination | Maximum<br>examination times<br>according to ISO<br>15004-2 and ISO<br>10939 | Maximum<br>examination times<br>according to ISO<br>15004-2 and ISO<br>10939 | As a result of phototoxicity<br>testing to ISO 15004-2 maximum<br>exposure increased from 13 to<br>17 minutes for bulb option (LED<br>maximum exposure is<br>unchanged at 12.5 minutes) |
| Electrical ratings | | | |
| Input voltage | AC 100-240 V,<br>50/60Hz | AC 100-240 V,<br>50/60Hz | Same |
| Power output | 30VA | 52VA (2.2A) | Required for change to 12V bulb |

510(k) Keeler H-Series Digital

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| Feature | H-Series Slit Lamp<br>[K131589] | H-Series Slit Lamp<br>Digital | Discussion |
|-------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------|
| Output Voltage (bulb<br>option) | 12 V DC | 24 V DC | Required for change to 12V bulb |
| Output Voltage (LED<br>option) | 12 V DC | 12 V DC | No change to PSU required |
| Compliance with Safety<br>Standards | IEC60601-1<br>IEC60601-1-2<br>ISO 15004-1<br>ISO 15004-2<br>ISO 10939 | IEC60601-1<br>IEC60601-1-2<br>ISO 15004-1<br>ISO 15004-2<br>ISO 10939 | Same |

A further substantial equivalence comparison has been made between the USB digital camera modules offered as options by Keeler and Haag Streit for their digital slit lamps:

| Feature | Haag Streit IM 900<br>Camera Option | Keeler DSL Digital<br>Camera Option | Comment |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Digital Camera<br>Module | | | |
| Stated Intended Use | Digital photography and video<br>for documentation of eye | Digital photography and video<br>for documentation of eye | Same |
| Mounting Methods | CM01 module mounted<br>between eyepiece assembly<br>and magnification block,<br>utilizing same locking ring<br>securing method | Keeler module mounted<br>between eyepiece assembly and<br>magnification block utilizing<br>same screw knob/pin securing<br>method | Essentially same<br>mounting mechanism<br>with insignificant<br>differences between<br>securing methods |
| Beam Splitter Control | Two position control on side of<br>module to allow 100% of light<br>to reach observer or 30% to<br>observer and 70% to camera | 30% to observer and 70% to<br>camera all the time | Camera function is<br>permanently enabled at<br>the same level. |
| Aperture Control | 6-position control on side of<br>module | Aperture fixed at maximum | Image quality<br>maximised |
| Power Supply | Supplied from separate supply<br>unit via control module | Supplied from isolated medical<br>PC USB port | Essentially same |
| Digital Camera<br>Specifications | | | |
| Beam Path | Right Side | Left Side (see note below) | A camera can be<br>mounted on either<br>eyepiece.<br>Manufacturing<br>preference. No impact<br>on effectiveness. |
| Camera Model | Sony ICX274 | Sony ICX274 | Same |
| Sensor Technology | CCD | CCD | Same |
| Resolution | 1600x1200 pixels | 1600x1200 pixels | Same |
| Sensor Dimensions | 1/1.8" (7.04x5.28mm) | 1/1.8" (7.04x5.28mm) | Same |
| Frame Rate | 12 fps (frames per second) | 12 fps (frames per second) | Same |
| Feature | Haag Streit IM 900<br>Camera Option | Keeler DSL Digital<br>Camera Option | Comment |
| LED Red/Green<br>Indicators | USB status | USB status | Same |
| Camera Control<br>Module | | | |
| Construction | Retrofittable RM01 module<br>mountable on bio-microscope<br>XYZ table, with exposure<br>controls and trigger bar,<br>secured to base by magnets | Additional USB hub and<br>associated capture button on<br>joystick and exposure control<br>buttons on base cover, pre-<br>installed on digital version of slit<br>lamp | Keeler features are<br>built in predicate device<br>uses retro-fit modules.<br>Essentially same. |
| Cable Connections | Between camera module and<br>control module, and control<br>module and PC | Between camera module and<br>control module, and control<br>module and PC | Same |
| Exposure<br>Adjustments | 2 sets of 2 buttons providing a<br>range of settings on trigger<br>module cover | 1 set of 2 buttons providing a<br>range of settings on trigger<br>module cover | Essentially same<br>function |
| Exposure Trigger | Trigger bar at front of trigger<br>module | Capture button incorporated into<br>top of joystick | Essentially same<br>function |
| Standards<br>Compliance | IEC 60601-1 (Class 1 Type B)<br>and IEC 60601-1-2 | IEC 60601-1 (Class II Type BF)<br>and IEC 60601-1-2 | Essentially same |
| Background<br>Illumination | | | |
| Construction | Alternative (background<br>illumination ready) lamp head<br>for illumination tower provides<br>light output for fibre optic<br>connection to illumination area | Custom designed lamp cover.<br>provides light output for fibre<br>optic connection to illumination<br>area | Essentially same<br>function |
| Illumination Control | Variable rheostat on XYZ<br>translation base | Variable rheostat on XYZ<br>translation base | Essentially same |
| Auxiliary Diffuser and<br>Blue Filter | Provided | Provided | Same |
| Computer<br>Specifications | | | |
| Electrical Safety | Requires conformity with IEC<br>60601-1 or operated with<br>transformer to isolate PC from<br>mains | Requires conformity with IEC<br>60601-1 or operated with<br>transformer to isolate PC from<br>mains | Same |
| Performance<br>Specification | Intel Pentium 5 or better, 2GHz<br>or higher, with at least 3GB<br>RAM and Windows OS | Intel Core i5, 2 GHz or higher,<br>with at least 4GB RAM and<br>Windows OS | Essentially same |
| | | | |

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# Keeler

## Ophthalmic Instruments

Display of images captured by the camera module requires use of FDA cleared image display
software on the medically approved PC, which is stand-alone and included in this submission.

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#### 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 with the digital capture option is safe and effective, and substantially equivalent to the unmodified version of this device used as a predicate.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 11, 2014

Mr. Eugene R. VanArsdale Marketing Manager c/o Keeler Instruments Inc. 456 Parkway Broomall, PA 19008-4295

Re: K140451

Trade/Device Name: Kecler Slit Lamp H-Series Digital Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO, HKI Dated: April 11, 2014 Received: April 14, 2014

Dear Mr. VanArsdale:

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 docs 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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Page 2 - Mr. Eugene R. VanArsdale

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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140451

Device Name Keeler Slit Lamp H-Series Digital

Indications for Use (Describe)

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 authorised 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Dexiu Shi -S 2014.06.30 11:26:50 -04'00'

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