(449 days)
The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber laver and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The device is indicated for assessing the area, location, and measurement of retinal thickness, including in patients with retinal pathologies. In addition, the device is indicated to detect separation between identified retinal layers and surfaces, i.e., retinal tissue layers.
The Topcon 3D OCT-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
The Topcon 3D OCT-1000 for Measurement of Retinal Thickness uses optical coherence tomography, which relies upon interferometry of superluminescent diode light reflected from the fundus of the eye to obtain cross-sectional images of the retina. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is identical to the FDA-cleared Topcon 3D OCT-1000 (K063388), with the exception of the addition of a new software module allowing for the measurement of retinal thickness.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "The device provides accurate measurements that correlate with manually identified retinal boundaries in both healthy and diseased retinas.",
"Reported Device Performance": "Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements. Additional performance testing demonstrated that the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries in a population with healthy retinas and a population with diseased retinas."
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the test set is not specified. The study included 'a population with healthy retinas and a population with diseased retinas'. Data provenance (country of origin, retrospective/prospective) is not specified.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The document states that measurements were correlated with 'manually identified retinal boundaries'. The number and qualifications of experts involved in this manual identification are not specified.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Adjudication method is not specified.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the correlation between device measurements and manually identified boundaries, not on human reader performance with or without AI assistance.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone performance study was conducted. The document states, 'Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements.' and 'the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries'. This indicates an evaluation of the algorithm's direct measurement capabilities.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth used was based on 'manually identified retinal boundaries'. This implicitly suggests expert human assessment as the basis for comparison.",
"8. The sample size for the training set": "The sample size for the training set is not specified.",
"9. How the ground truth for the training set was established": "How the ground truth for the training set was established is not specified in the provided document."
}
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JAN 1 3 2009
K072971 510(k) SUMMARY
Topcon Corporation's 3D OCT-1000 Optical Coherence Tomography System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174
Additional Correspondents:
Topcon Medical System, Inc. 37 West Century Road Paramus, NJ 07652 Phone: (201) 599-5153 Facsimile: (201) 599-5240 Contact Person: Maureen O'Connell, Regulatory Consultant
OR
Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004 Phone: (202) 637-5794 Facsimile: (202) 637-5910
Date Prepared: October 19, 2007
Name of Device and Name/Address of Sponsor
Topcon 3D OCT-1000 Optical Coherence Tomography System Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174
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Common or Usual Name
AC- Powered Ophthalmoscope
Classification Name
Ophthalmoscope; 21 C.F.R. 886.1570
Predicate Devices
Topcon Corporation's 3D OCT-1000 Optical Coherence Tomography System Carl Zeiss Meditec, Inc., STRATUSOCT™ with Retinal Nerve Fiber Layer and Macula Normative Database
Talia Technology, Ltd., RTA 5 & RTA Model E Retinal Thickness Analyzer Talia Technology, Ltd., RTA Retinal Thickness Analyzer
Intended Use / Indications for Use
The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber laver and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The device is indicated for assessing the area, location, and measurement of retinal thickness, including in patients with retinal pathologies. In addition, the device is indicated to detect separation between identified retinal layers and surfaces, i.e., retinal tissue layers.
Technological Characteristics
The Topcon 3D OCT-1000 for Measurement of Retinal Thickness uses optical coherence tomography, which relies upon interferometry of superluminescent diode light reflected from the fundus of the eye to obtain cross-sectional images of the retina. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is identical to the FDA-cleared Topcon 3D OCT-1000 (K063388), with the exception of the addition of a new software module allowing for the measurement of retinal thickness.
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Performance Data
Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements. Additional performance testing demonstrated that the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries in a population with healthy retinas and a population with diseased retinas. The performance data demonstrate that the Topcon 3D OCT-1000 for Measurement of Retinal Thickness is as safe and effective as the predicate devices, and thus, substantially equivalent.
Substantial Equivalence
The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is as safe and effective as the cleared Topcon 3D OCT-1000 Optical Coherence Tomography System, the Carl Zeiss Meditec, Inc., STRATUSOCT™ with Retinal Nerve Fiber Laver and Macula Normative Database, the Talia Technology, Ltd., RTA 5 & RTA Model E Retinal Thickness Analyzer, and the Talia Technology, Ltd., RTA Retinal Thickness Analyzer. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences between the 3D OCT-1000 for Measurement of Retinal Thickness and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Topcon 3D OCT-1000 for Measurement of Retinal Thickness is as safe and effective as the predicate devices. Thus, the 3D OCT-1000 for Measurement of Retinal Thickness is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle with three stylized lines representing its wings.
Public Health Service
JAN 1 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TopCon Medical Systems, Inc., c/o Jonathan Kahan Partner Hogan & Hartson, LLP Columbia Square 5555 Thirteen St. NW Washington, DC 20004
Re: K072971
Trade Name: TopCon 3D OCT-1000 for Measurement of Retinal Thickness Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: December 19, 2008 Received: December 19, 2008
Dear Mr. Kahan:
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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Page 2 – Jonathan Kahan
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marlina B. Esguerra, M.D.
Malvina B. Evdelman. 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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Indications for Use
510(k) Number: K072971
Device Name: TOPCON 3D OCT-1000 for Measurement of Retinal Thickness
Indications For Use:
The Topcon 3D OCT-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Osin.
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices
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510(k) Number K072971
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.