(88 days)
The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.
The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.
The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images.
The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ConfoScan 2 Confocal Microscope:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the way one might see for a diagnostic accuracy study. Instead, the performance evaluation focuses on compliance with established standards and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Meets all requirements of EN 60601-1. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1. |
| Electromagnetic Compatibility: Meets all requirements of EN 60601-1-2. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1-2. |
| Programmable Electrical Medical Systems: Meets all requirements of EN 60601-1-4. | ConfoScan 2 Confocal Microscope found to meet all requirements of EN 60601-1-4. |
| Ophthalmic Instruments Fundamental Test Requirements & Methods: Meets all requirements of ISO 15004. | ConfoScan 2 Confocal Microscope found to meet all requirements of ISO 15004. |
| Light Energy Levels: Negligible amount of light energy transferred to the patient during normal examination (1-2 minutes). | Amount of light energy transferred to the patient during 1-2 minute examination found to be negligible. |
| Endothelial Cell Analysis Software Validation: Automatic cell density values comparable to results from at least two other commercially available specular microscopes. | 134 samples analyzed, and resulting automatic cell density values validated by comparison to two other commercially available specular microscopes. (The exact level of agreement/equivalence is not quantified in the summary, only that it was "validated"). |
| Substantial Equivalence: Same intended use and fundamental scientific technology as the predicate device (Tomey ConfoScan Confocal Microscope K972953). | "The results of this comparison demonstrate that the ConfoScan 2 Confocal Microscope device has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the "Endothelial Cell Analysis Software Validation," 134 samples (extracted from corneal images) were used.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth for the "Endothelial Cell Analysis Software Validation," nor their qualifications. The validation involved "comparison to the results of two other commercially available specular microscopes," implying these microscopes (and their inherent cell analysis methods) served as a reference or "ground truth surrogate," rather than a distinct panel of human experts.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The validation was a comparison against other commercially available devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The performance evaluation focuses on device-to-standard compliance and device-to-device comparison for the endothelial cell analysis software. There is no mention of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone evaluation of the algorithm's performance was done for the "Endothelial Cell Analysis Software Validation." The ConfoScan 2 Confocal Microscope's software analyzed 134 samples and produced automatic cell density values, which were then compared to other commercial devices. This is a standalone assessment of the algorithm's output.
7. The Type of Ground Truth Used
For the "Endothelial Cell Analysis Software Validation," the ground truth was based on the results obtained from two other commercially available specular microscopes. This suggests a comparative reference standard, rather than a definitive "true" value derived from pathology or long-term outcomes. For the other tests (electrical safety, etc.), the "ground truth" was compliance with harmonized standards.
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size used for training the ConfoScan 2 Confocal Microscope's software or any algorithms.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information regarding how the ground truth for any potential training set was established.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CONFOSCAN 2 CONFOCAL MICROSCOPE
SUBMITTER INFORMATION
| A. | Company Name: | Nidek Technologies Srl |
|---|---|---|
| B. | Company Address: | Via Regina, 88Vigonza (Padova), Italy 35010 |
| C. | Company Phone:Company Fax: | 39 49 89 35 19139 49 62 55 84 |
| D. | Contact Person: | Mr. Aldo CocchigliaManaging DirectorNidek Technologies Srl |
| E. | Date Summary Prepared: | October 24, 2001 |
DEVICE IDENTI
| A. | Classification Name: | AC-Powered Slit-Lamp Biomicroscope |
|---|---|---|
| B. | Trade/Proprietary Name: | ConfoScan 2 Confocal Microscope |
| C. | Device Classification: | Class II (886.1850) |
| D. | Product Code: | HJO |
DEVICE DESCRIPTION
The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images.
10-24-01
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The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.
INTENDED USE
The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.
SUBSTANTIAL EQUIVALENCE
The ConfoScan 2 Confocal Microscope device has the same intended use and the same fundamental scientific technology as the following predicate device:
| Predicate Device | 510(k) Holder | 510(k) No. | Date Cleared |
|---|---|---|---|
| ConfoScan ConfocalMicroscope | Tomey Corporation | K972953 | August 14,1997 |
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ConfoScan 2 Confocal Microscope and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the ConfoScan 2 Confocal
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Microscope device has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device.
| CONFOCAL MICROSCOPE TECHNOLOGICAL COMPARISON | ||
|---|---|---|
| Nidek Technologies SrlConfoScan 2 Confocal Microscope | Tomey ConfoScan ConfocalMicroscopePredicate Device - K971953 | |
| Indications For Use | The Nidek Technologies SrlConfoscan 2 Confocal Microscope isindicated for use as a diagnostic toolfor observation of the cell layers ofthe anterior parts of the eye. | The Tomey Confoscan ConfocalMicroscope is indicated for use as adiagnostic tool for looking at the celllayers of the anterior parts of the eye. |
| Corneal Contact | In normal use the front surface of theeye does not contact the objectivelens; however, corneal contact canoccur. The ConfoScan 2 has anautomatic sensing feature whichdetects if the cornea has beentouched (a warning is sounded andthe objective reverses direction). | In normal use the front surface of the eyedoes not contact the objective lens;however, corneal contact can occur. |
| Floating Objective Lens | Yes | Yes |
| Working Distance BetweenCornea and Objective | 1.98 mm | 0 to 10 mm (depending on lens) |
| Focus | Fixed | Fixed |
| Adjustment Direction | The examination device ishorizontally adjusted while thepatient is sitting straight in front ofthe device (automatic or manualadjustment option). | The examination device is horizontallyadjusted while the patient is sittingstraight in front of the device (manualadjustment only). |
| Front Lens Area | 16.61mm2 | 16.61mm2 |
| Nidek Technologies SrlConfoScan 2 Confocal Microscope | Tomey ConfoScan ConfocalMicroscopePredicate Device - K971953 | |
| Type Scanning Aperture | Slit | Slit |
| Light Source | 100W Halogen, Internal | 100W Halogen, External |
| Objective Lens | Water Immersion Lens Achroplan40x | Water Immersion Lens Achroplan 40x |
| Depth Resolution | 10 microns | 10 microns |
| Horizontal Resolution | 1 micron | 1 micron |
| Pre Sterilized Lens | No. Lens disinfected according toinstructions for use. | No. Lens disinfected according toinstructions for use. |
| Working Position | Horizontal | Horizontal |
| Standard Magnification | 40x | 40x |
| Mean Magnification | 500x on 15" display (1024 x 768pixels). | 500x on 15" display (1024 x 768 pixels). |
| Numerical Aperture (na) | 0.75 | 0.75 |
| CCD Camera | Yes, (monochrome, 5 milliLuxsensitivity) | Yes, (monochrome, 5 milliLuxsensitivity) |
| Image Storage | Image directly stored in PC RAM,then saved to a PC hard drive | Image stored on VCR tape, thentransferred to a PC |
| Automated Endothelial CellAnalysis Software | Yes, the program provides the userwith a cell density (cells/mm²) | Yes, the program provides the user with acell density (cells/mm²). |
| Optical Pathway | Typical confocal microscope opticalpath with IR and UV filters. Slitoscillation is controlled by a steppermotor. | Typical confocal microscope optical pathwith IR and UV filters. ConjugateScanning slits with Galvin meter controlsslit movement. |
| Physical Layout | The lift table, PC, and Optical headare integrated into one piece | The lift table, PC, and Optical head arethree separate modules |
| Operating Software | NAVIS | Confo-Commander |
| Z-Scan Principle (CorneaProfile Measurement) | A CCD camera is used instead of thephoto multiplier to record thescattered light from each cornealimage. This value is calculateddirectly from the recorded image andplaced within a profile curve. Thereis now an image correlated to eachpoint on the curve. | An intensity profile is taken via the photomultiplier as a standing slit is scannedthrough the cornea. The Photo multiplierrecords scattered light profiles of thecornea. The values are then placed on agraph that provides the user with a profilecurve of the cornea without a correlatedimage. |
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PERFORMANCE EVALUATION
The following testing was performed on the ConfoScan 2 Confocal Microscope to demonstrate that it meets all specified requirements and is equivalent to the predicate device:
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Electrical Safety Testing & Electromagnetic Compatibility A.
The ConfoScan 2 Confocal Microscope was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards. -
Programmable Electrical Medical Systems B.
The ConfoScan 2 Confocal Microscope was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard. -
Fundamental Test Requirements and Test Methods for Ophthalmic Instruments C.
The ConfoScan 2 Confocal Microscope was tested in accordance with ISO 15004 and was found to meet all requirements of the standard.
Light Energy Levels D.
The amount of light energy transferred to the patient during the normal examination time of one to two minutes was found to be negligible.
- Endothelial Cell Analysis Software Validation E.
A total of 134 samples (extracted from corneal images) were analyzed by the ConfoScan 2 Confocal Microscope to validate the resulting automatic cell density
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values via comparison to the results of two other commercially available specular microscopes.
CONCLUSIONS
Nidek Technologies Srl has demonstrated through its evaluation of the ConfoScan 2 Confocal Microscope that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people or families, in a flowing, interconnected design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2001
NIDEK TECHNOLOGIES SRL c/o Ms. Carol L. Patterson Patterson Consulting Group, Inc. 21911 Erie Lane, Lake Forest, CA 92630
Re: K012416
Trade/Device Name: ConfoScan 2 Confocal Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slip-Lamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: July 27, 2001 Received: July 30, 2001
Dear Ms. Patterson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
| 510(k) Number: | K012416 (To Be Assigned By FDA) |
|---|---|
| Device Trade Name: | ConfoScan 2 Confocal Microscope |
| Indications For Use: | The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Tharsha L. Burke Nichols
(Division Sign-Off) Division of Ophthalmic Devices 24110 K, 01 510(k) Number .
OR
Confidential
07/23/01
§ 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.