(137 days)
No
The document describes a standard slit lamp with a digital imaging option. There is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The image display software is described as "stand-alone" and "FDA cleared," implying it is likely standard image viewing software, not AI/ML-powered analysis software.
No
The device aids in the diagnosis of diseases or trauma but does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment".
No
The device description clearly details physical hardware components including a bio-microscope, AC power, XYZ translation base, illumination and observation system, chinrest assembly, USB camera module, and modifications to the illumination tower. While it includes software for image display, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Keeler Slit Lamp is used for direct examination of the patient's eye (an in vivo examination), not for testing samples taken from the body.
- The intended use is for eye examination and aiding in the diagnosis of diseases or trauma affecting the anterior eye segment. This is a clinical diagnostic tool used directly on the patient.
- The device description details a bio-microscope for observing the eye. This aligns with in vivo examination, not in vitro testing.
While the device does capture digital images for further viewing and record purposes, and uses image display software, this is still part of the in vivo examination process and does not involve the analysis of biological specimens.
N/A
Intended Use / Indications for 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 authorised healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
HJO, HKI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Anterior eye segment, from the cornea epithelium to the posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitably trained and authorised healthcare professionals
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)
Not Found
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/0 description: The image contains the word "Keeler" in a bold, sans-serif font. The word is presented in all lowercase letters except for the capital "K" at the beginning. The text is black against a white background, creating a high contrast and making it easily readable.
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, |
| Berkshire, SL4 4AA, UK | |
| Company Phone No: | +44 (0) 1753 827125 |
| Company Fax No: | +44 (0) 1753 827145 |
| 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
1
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
[K131589] | H-Series Slit Lamp
Digital | Discussion |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | As stated | As stated | No change |
| Bio-microscope
components | | | |
| Bio-microscope | Galilean converging
binoculars with
detachable
eyepiece head | Galilean converging
binoculars with
detachable
eyepiece head | As head can be separated from
the body, intervention of module
does not change these elements |
| Digital Camera Module | Not fitted | Optional fitment | Fitted by user when required, or
supplied fitted for customers |
| Image Capture Button | Not fitted | Fitted to joystick | Required for digital facility |
| Camera Exposure
Buttons | Not fitted | Adjacent to joystick
for camera aperture
adjustment | Required for digital facility |
| USB3 Hub (Internal) | Not fitted | Fitted in XYZ base | Required for digital facility |
| Slit Lamp Illumination
Options | 6VDC 20W halogen
bulb | 12VDC 30W
halogen bulb | Required for slit lamp
illumination with some light used
for background lighting |
| | LED | LED (first) | Required for slit lamp
illumination |
| Background Illumination
Adjuster | Not fitted | Fitted to top of
illumination tower | Allows adjustment for optimum
lighting for digital photography |
| Background Light Source
Options | Not fitted | 12VDC 30W
halogen bulb as
above | Required for higher background
light output but still conforms to
requirements of 15004-2 Photo-
toxicity with slightly longer
exposure time |
| | Not fitted | LED (second) | Required for background lighting |
| Background lighting duty
cycle - halogen bulb
option only | Not applicable | Limited to 6
minutes for 50%
duty cycle at
maximum
brightness | Ensures body of light source
does not exceed 62.3ºC limit
demanded by IEC 60601-1
compliance |
| 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 | As a result of phototoxicity
testing to ISO 15004-2 maximum
exposure increased from 13 to
17 minutes for bulb option (LED
maximum exposure is
unchanged at 12.5 minutes) |
| Electrical ratings | | | |
| Input voltage | AC 100-240 V,
50/60Hz | AC 100-240 V,
50/60Hz | Same |
| Power output | 30VA | 52VA (2.2A) | Required for change to 12V bulb |
510(k) Keeler H-Series Digital
3
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| Feature | H-Series Slit Lamp
[K131589] | H-Series Slit Lamp
Digital | Discussion |
|-------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------|
| Output Voltage (bulb
option) | 12 V DC | 24 V DC | Required for change to 12V bulb |
| Output Voltage (LED
option) | 12 V DC | 12 V DC | No change to PSU required |
| Compliance with Safety
Standards | IEC60601-1
IEC60601-1-2
ISO 15004-1
ISO 15004-2
ISO 10939 | IEC60601-1
IEC60601-1-2
ISO 15004-1
ISO 15004-2
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
Camera Option | Keeler DSL Digital
Camera Option | Comment |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Digital Camera
Module | | | |
| Stated Intended Use | Digital photography and video
for documentation of eye | Digital photography and video
for documentation of eye | Same |
| Mounting Methods | CM01 module mounted
between eyepiece assembly
and magnification block,
utilizing same locking ring
securing method | Keeler module mounted
between eyepiece assembly and
magnification block utilizing
same screw knob/pin securing
method | Essentially same
mounting mechanism
with insignificant
differences between
securing methods |
| Beam Splitter Control | Two position control on side of
module to allow 100% of light
to reach observer or 30% to
observer and 70% to camera | 30% to observer and 70% to
camera all the time | Camera function is
permanently enabled at
the same level. |
| Aperture Control | 6-position control on side of
module | Aperture fixed at maximum | Image quality
maximised |
| Power Supply | Supplied from separate supply
unit via control module | Supplied from isolated medical
PC USB port | Essentially same |
| Digital Camera
Specifications | | | |
| Beam Path | Right Side | Left Side (see note below) | A camera can be
mounted on either
eyepiece.
Manufacturing
preference. No impact
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
Camera Option | Keeler DSL Digital
Camera Option | Comment |
| LED Red/Green
Indicators | USB status | USB status | Same |
| Camera Control
Module | | | |
| Construction | Retrofittable RM01 module
mountable on bio-microscope
XYZ table, with exposure
controls and trigger bar,
secured to base by magnets | Additional USB hub and
associated capture button on
joystick and exposure control
buttons on base cover, pre-
installed on digital version of slit
lamp | Keeler features are
built in predicate device
uses retro-fit modules.
Essentially same. |
| Cable Connections | Between camera module and
control module, and control
module and PC | Between camera module and
control module, and control
module and PC | Same |
| Exposure
Adjustments | 2 sets of 2 buttons providing a
range of settings on trigger
module cover | 1 set of 2 buttons providing a
range of settings on trigger
module cover | Essentially same
function |
| Exposure Trigger | Trigger bar at front of trigger
module | Capture button incorporated into
top of joystick | Essentially same
function |
| Standards
Compliance | IEC 60601-1 (Class 1 Type B)
and IEC 60601-1-2 | IEC 60601-1 (Class II Type BF)
and IEC 60601-1-2 | Essentially same |
| Background
Illumination | | | |
| Construction | Alternative (background
illumination ready) lamp head
for illumination tower provides
light output for fibre optic
connection to illumination area | Custom designed lamp cover.
provides light output for fibre
optic connection to illumination
area | Essentially same
function |
| Illumination Control | Variable rheostat on XYZ
translation base | Variable rheostat on XYZ
translation base | Essentially same |
| Auxiliary Diffuser and
Blue Filter | Provided | Provided | Same |
| Computer
Specifications | | | |
| Electrical Safety | Requires conformity with IEC
60601-1 or operated with
transformer to isolate PC from
mains | Requires conformity with IEC
60601-1 or operated with
transformer to isolate PC from
mains | Same |
| Performance
Specification | Intel Pentium 5 or better, 2GHz
or higher, with at least 3GB
RAM and Windows OS | Intel Core i5, 2 GHz or higher,
with at least 4GB RAM and
Windows OS | Essentially same |
| | | | |
4
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.
5
Image /page/5/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a bold, sans-serif font and is placed above the words "Ophthalmic Instruments." The words "Ophthalmic Instruments" are in a smaller, sans-serif font.
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.
7
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 (800) 638-2041 or (301) 796-7100 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 (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
8
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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