(27 days)
Not Found
No
The description details a standard optical slit lamp with mechanical adjustments and illumination controls, with no mention of AI/ML features or image processing capabilities beyond direct observation.
No.
The device is used to aid in the diagnosis of diseases or trauma, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment." This directly indicates its role in the diagnostic process.
No
The device description clearly details a physical, AC-powered slit lamp biomicroscope with hardware components like an XYZ translation base, illumination system, observation system, chinrest assembly, and rheostat. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Keeler Slit Lamp is a medical device 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 physical structures of the eye.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is used for direct observation of the patient's eye in vivo.
Therefore, the Keeler Slit Lamp falls under the category of an ophthalmic diagnostic device used for direct examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HJO
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.
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
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)
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.
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.
0
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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Image /page/1/Picture/0 description: The image shows the words "Keeler Ophthalmic Instruments". The word "Keeler" is in a larger, bold font, and the words "Ophthalmic Instruments" are in a smaller font below it. The text is black and the background is white.
3.4 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.
3.5 Indications for Use
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.
Project 210
Issue B
2
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 Device
Haag-Streit Slit Lamp
BQ 900 | Keeler Slit Lamp
H- Series | Discussion |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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 | 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 | Same |
| Microscope | Galilean converging
binoculars | Galilean converging
binoculars | Same |
| Type | AC Powered Biomicroscope
Slit Lamp | AC Powered Biomicroscope
Slit Lamp | Same |
| Angle of
Convergence | 13° | 13° | Same |
| Magnification | 6.3x / 10x / 16x / 25x / 40x | x6, x10, x16, x25 & x40 | The difference are not
significant and does not
affect the safety or
effectiveness of the
device |
| Objective lens
working distance | 105mm | 107mm | The difference are not
significant and does not
affect the safety or
effectiveness of the
device |
| 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 not
significant and does not
affect the safety or
effectiveness of the
device |
| Range of PD
adjustment | 52 - 78 mm | 49.0 to 77mm | There is a difference in
the range of adjustment
however this does not
affect safe or
effectiveness on the
devices as both
conform to the
requirement of ISO
10939 |
| Eyepiece dioptric
adjustment
range | + 8 to - 8 diopters | + 8 to - 8 diopters | same |
| Slit Projection
Unit | | | |
| Slit Length | 1-8 mm continuous | 12mm (1mm - 12mm
continuously variable) | The difference is not
significant
An Iris usually has a
diameter of 6mm max,
therefore a slit length of
12mm is more than
sufficient, meeting the
requirement specified
in ISO 10939 and does
not affect the safety or
effectiveness of the
device |
| Slit Width | 0 - 8 mm continuous | 0-12mm continuously
variable | The difference is not
significant; this does
not affect safety or
effectiveness of the
devices as both
conform to the
requirement of ISO
10939.
Slit lamps are used to
examine the inner part
of the eye and usually
a narrow slit of less
than 1mm is needed.
For this reason the
maximum slit width is
not critical as long as it
is ≥ 8mm |
| Light source | 7.5V, 38 W Halogen Lamp
24VDC 1A LED | 6V 20W Halogen lamp and
LED - As the slit lamp
conform to the relevant
standard
ISO 10939, there are no
issues of safety and
effectiveness. | There is a difference in
light sources used
however all light
sources must conform
to the requirements of
15004-2 Photo-toxicity
therefore 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 |
| Light intensity
selection | Three selections: Full, 1/4
and 1/16 via neutral density
filter. | 0-100% continuous
potentiometer | The difference is not
significant as they allow
the user to select the
necessary light
intensity to perform the
relevant task |
| Filter | Blue, red free (green), grey
(10%)
The UV filter and the heat
absorption filter are
permanently mounted | Clear; red free; neutral
density; diffuser; blue; IR
heat absorbing filter
permanently installed | The difference is not
significant and does not
affect safety or
effectiveness, both
devices have a
permanently installed
heat absorbing filter |
| Electrical
ratings | | | |
| 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 |
| Compliance
with Safety
standards | IEC60601-1-2
IEC60601-1
ISO 15004-2 | IEC 60601-1-2
IEC 60601-1
ISO15004-2 | Same |
510K Keeler H-Series Slit Lamp
Issue B
3
Keeler
Ophthalmic Instruments
510K Keeler H-Series Slit Lamp
,
・
:
Project 210
.
100 - 100
Issue B
Page 8 of 53
4
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.
5
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
6
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
7
Keeler
Ophthalmic Instruments
2. Indications for Use Form
510(k) Number (if known):
Device Name: Keeler Slit Lamp H-Series.
Indications for Use:
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.
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 |