(137 days)
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.
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.
The provided 510(k) summary for the Keeler Slit Lamp H-Series Digital does not contain information about specific acceptance criteria or a study proving the device meets performance criteria in the way typically expected for AI/ML-driven devices (e.g., sensitivity, specificity, accuracy against a recognized standard).
This document describes a traditional medical device (a digital slit lamp biomicroscope), which primarily focuses on substantial equivalence to predicate devices rather than novel performance metrics. The "device performance" in this context refers to its
functional capabilities and safety compliance, not diagnostic accuracy in the way AI algorithms are evaluated.
Therefore, many of the requested details about acceptance criteria for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not present in this type of submission.
However, I can extract the relevant information regarding what constitutes "acceptance" for this device, which relies on demonstrating substantial equivalence and compliance with established standards.
Here's an attempt to answer your request based on the provided document, adapting where necessary due to the nature of the device:
Acceptance Criteria and Device Performance for Keeler Slit Lamp H-Series Digital (K140451)
Given that the Keeler Slit Lamp H-Series Digital is an AC-powered slit lamp biomicroscope with an added digital camera module, the "acceptance criteria" discussed in this 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate non-digital slit lamp and a predicate digital camera option, and compliance with relevant safety and performance standards. There are no specific diagnostic or AI performance metrics (like sensitivity, specificity, or AUC) as the device is an imaging tool, not a diagnostic algorithm.
The "study" proving the device meets the acceptance criteria is the 510(k) submission itself, which presents a comparison of features and compliance with standards.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional medical device submission, the "acceptance criteria" are derived from the substantial equivalence comparison and compliance with recognized standards. "Device performance" refers to its technical specifications and demonstrated compliance.
| Acceptance Criterion (Based on Substantial Equivalence & Standards) | Reported Device Performance (Keeler Slit Lamp H-Series Digital) |
|---|---|
| Intended Use (Substantially equivalent to predicate) | "AC-powered slit lamp bio-microscope... for use in eye examination of the anterior eye segment... to aid in the diagnosis of diseases or trauma... used only by suitably trained and authorized healthcare professionals." (No change from predicate). |
| Bio-microscope Components (Similar to predicate) | Galilean converging binoculars with detachable eyepiece head. |
| Digital Camera Module Functionality (Similar to predicate) | Optional fitment, Image Capture Button fitted to joystick, Camera Exposure Buttons adjacent to joystick, Internal USB3 Hub. Captures digital photographs and video for documentation. |
| Slit Lamp Illumination Options (Safe and effective) | 12VDC 30W halogen bulb or LED option. Provides slit lamp illumination and background lighting. (Increased power for halogen bulb compared to non-digital predicate, but quantity of light for illuminating the eye is comparable and poses no additional risk). Both variants comply with ISO 15004-2:2007. |
| Background Illumination Control and Source | Fitted to top of illumination tower for optimum lighting for digital photography. 12VDC 30W halogen bulb or LED. |
| Phototoxicity (Halogen Bulb Option) | Limited to 6 minutes for 50% duty cycle at maximum brightness. Maximum exposure increased from 13 to 17 minutes based on testing to ISO 15004-2 (LED maximum exposure unchanged at 12.5 minutes). (Ensures body of light source does not exceed 62.3ºC limit demanded by IEC 60601-1 compliance). |
| Electrical Ratings | AC 100-240 V, 50/60Hz input voltage. 52VA (2.2A) power output. 24V DC output voltage for bulb option, 12V DC for LED option. |
| Compliance with Safety Standards | IEC60601-1, IEC60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939. |
| Digital Camera Specifications (Similar to predicate Haaf Streit) | Sony ICX274 CCD sensor, 1600x1200 pixels resolution, 1/1.8" (7.04x5.28mm) sensor dimensions, 12 fps frame rate. |
| Computer Specifications | Intel Core i5, 2 GHz or higher, with at least 4GB RAM and Windows OS required for image display. Complies with IEC 60601-1 or operated with transformer to isolate PC from mains. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable in the traditional sense of an AI/ML test set. This submission does not describe a "test set" of images to evaluate an algorithm's diagnostic performance. Instead, it relies on engineering testing and comparisons to predicate devices.
- Data Provenance: The document refers to compliance with international standards (e.g., ISO, IEC) and comparisons to existing devices on the market (UK for Keeler's non-digital, and Haag Streit for a digital camera module, which operates in the US market). The engineering tests conducted would typically occur in the manufacturer's facilities (UK).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. As there is no "test set" for an AI algorithm's diagnostic performance, there were no experts establishing ground truth for such a purpose. The device's safety and effectiveness are evaluated through engineering tests and comparison to predicates, which would involve qualified engineers and regulatory affairs personnel but not clinical "ground truth" experts in this context.
4. Adjudication Method for the Test Set
- Not Applicable. Without a test set for an AI algorithm, there is no adjudication method described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically performed for diagnostic devices, especially those incorporating AI, to assess the impact of the AI on human reader performance. This device is an imaging system, not a diagnostic algorithm, and therefore such a study was not performed or necessary for this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a hardware imaging system. There is no standalone algorithm being evaluated for diagnostic performance. The digital camera module captures images, which are then viewed by a human operator, making it inherently "human-in-the-loop."
7. The Type of Ground Truth Used
- Not Applicable in the context of diagnostic performance. The "ground truth" for this device relates to:
- Functional specifications: Whether the camera captures images at the stated resolution and frame rate.
- Safety compliance: Ensuring the device meets phototoxicity limits (ISO 15004-2), electrical safety standards (IEC 60601-1, IEC 60601-1-2), and other relevant standards.
- Substantial equivalence: Demonstrating that its features and performance are acceptably similar to legally marketed predicate devices without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. This device does not employ machine learning or AI algorithms that would require a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
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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,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
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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[K131589] | H-Series Slit LampDigital | Discussion |
|---|---|---|---|
| Intended use | As stated | As stated | No change |
| Bio-microscopecomponents | |||
| Bio-microscope | Galilean convergingbinoculars withdetachableeyepiece head | Galilean convergingbinoculars withdetachableeyepiece head | As head can be separated fromthe body, intervention of moduledoes not change these elements |
| Digital Camera Module | Not fitted | Optional fitment | Fitted by user when required, orsupplied fitted for customers |
| Image Capture Button | Not fitted | Fitted to joystick | Required for digital facility |
| Camera ExposureButtons | Not fitted | Adjacent to joystickfor camera apertureadjustment | Required for digital facility |
| USB3 Hub (Internal) | Not fitted | Fitted in XYZ base | Required for digital facility |
| Slit Lamp IlluminationOptions | 6VDC 20W halogenbulb | 12VDC 30Whalogen bulb | Required for slit lampillumination with some light usedfor background lighting |
| LED | LED (first) | Required for slit lampillumination | |
| Background IlluminationAdjuster | Not fitted | Fitted to top ofillumination tower | Allows adjustment for optimumlighting for digital photography |
| Background Light SourceOptions | Not fitted | 12VDC 30Whalogen bulb asabove | Required for higher backgroundlight output but still conforms torequirements of 15004-2 Photo-toxicity with slightly longerexposure time |
| Not fitted | LED (second) | Required for background lighting | |
| Background lighting dutycycle - halogen bulboption only | Not applicable | Limited to 6minutes for 50%duty cycle atmaximumbrightness | Ensures body of light sourcedoes not exceed 62.3ºC limitdemanded by IEC 60601-1compliance |
| Duration of illumination | Maximumexamination timesaccording to ISO15004-2 and ISO10939 | Maximumexamination timesaccording to ISO15004-2 and ISO10939 | As a result of phototoxicitytesting to ISO 15004-2 maximumexposure increased from 13 to17 minutes for bulb option (LEDmaximum exposure isunchanged 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
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| Feature | H-Series Slit Lamp[K131589] | H-Series Slit LampDigital | Discussion |
|---|---|---|---|
| Output Voltage (bulboption) | 12 V DC | 24 V DC | Required for change to 12V bulb |
| Output Voltage (LEDoption) | 12 V DC | 12 V DC | No change to PSU required |
| Compliance with SafetyStandards | IEC60601-1IEC60601-1-2ISO 15004-1ISO 15004-2ISO 10939 | IEC60601-1IEC60601-1-2ISO 15004-1ISO 15004-2ISO 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 900Camera Option | Keeler DSL DigitalCamera Option | Comment |
|---|---|---|---|
| Digital CameraModule | |||
| Stated Intended Use | Digital photography and videofor documentation of eye | Digital photography and videofor documentation of eye | Same |
| Mounting Methods | CM01 module mountedbetween eyepiece assemblyand magnification block,utilizing same locking ringsecuring method | Keeler module mountedbetween eyepiece assembly andmagnification block utilizingsame screw knob/pin securingmethod | Essentially samemounting mechanismwith insignificantdifferences betweensecuring methods |
| Beam Splitter Control | Two position control on side ofmodule to allow 100% of lightto reach observer or 30% toobserver and 70% to camera | 30% to observer and 70% tocamera all the time | Camera function ispermanently enabled atthe same level. |
| Aperture Control | 6-position control on side ofmodule | Aperture fixed at maximum | Image qualitymaximised |
| Power Supply | Supplied from separate supplyunit via control module | Supplied from isolated medicalPC USB port | Essentially same |
| Digital CameraSpecifications | |||
| Beam Path | Right Side | Left Side (see note below) | A camera can bemounted on eithereyepiece.Manufacturingpreference. No impacton 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 900Camera Option | Keeler DSL DigitalCamera Option | Comment |
| LED Red/GreenIndicators | USB status | USB status | Same |
| Camera ControlModule | |||
| Construction | Retrofittable RM01 modulemountable on bio-microscopeXYZ table, with exposurecontrols and trigger bar,secured to base by magnets | Additional USB hub andassociated capture button onjoystick and exposure controlbuttons on base cover, pre-installed on digital version of slitlamp | Keeler features arebuilt in predicate deviceuses retro-fit modules.Essentially same. |
| Cable Connections | Between camera module andcontrol module, and controlmodule and PC | Between camera module andcontrol module, and controlmodule and PC | Same |
| ExposureAdjustments | 2 sets of 2 buttons providing arange of settings on triggermodule cover | 1 set of 2 buttons providing arange of settings on triggermodule cover | Essentially samefunction |
| Exposure Trigger | Trigger bar at front of triggermodule | Capture button incorporated intotop of joystick | Essentially samefunction |
| StandardsCompliance | 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 |
| BackgroundIllumination | |||
| Construction | Alternative (backgroundillumination ready) lamp headfor illumination tower provideslight output for fibre opticconnection to illumination area | Custom designed lamp cover.provides light output for fibreoptic connection to illuminationarea | Essentially samefunction |
| Illumination Control | Variable rheostat on XYZtranslation base | Variable rheostat on XYZtranslation base | Essentially same |
| Auxiliary Diffuser andBlue Filter | Provided | Provided | Same |
| ComputerSpecifications | |||
| Electrical Safety | Requires conformity with IEC60601-1 or operated withtransformer to isolate PC frommains | Requires conformity with IEC60601-1 or operated withtransformer to isolate PC frommains | Same |
| PerformanceSpecification | Intel Pentium 5 or better, 2GHzor higher, with at least 3GBRAM and Windows OS | Intel Core i5, 2 GHz or higher,with at least 4GB RAM andWindows 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 (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
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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'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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§ 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.