(123 days)
Not Found
No
The summary describes a standard OCT imaging system and does not mention any AI/ML capabilities, image processing beyond basic capture, or performance studies related to AI/ML algorithms.
No
The device is described as a "diagnostic device" used to "aid in the detection and management of ocular diseases," rather than for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases."
No
The device description explicitly states it is a "non-contact ophthalmic imaging system" and mentions "image capture testing," indicating it includes hardware components for image acquisition, not just software for processing or analysis.
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 Topcon 3D OCT-1000 MARK II is an in vivo imaging system. It directly images structures within the living eye (posterior ocular structures) without taking any samples from the body.
Therefore, it falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Topcon 3D OCT-1000 MARK II 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 layer 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.
Product codes (comma separated list FDA assigned to the subject device)
OBO
Device Description
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 retinal nerve fiber layer 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 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
posterior ocular structures, retina, retinal nerve fiber layer, optic disc
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results for the 3D OCT-1000 MARK II demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k): K093316
MAR 1 3 2009
5. 510(k) Summary as required by 21 CFR 807.92(c)
- 510(k) Owner: Topcon Corporation. 75-1 I-lasunuma-cho, Itabashi-ku Tokyo, Japan 174
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 (201) 599-5153 Telephone: Facsimile: (201) 599-5240
Barbara S. Fant, Pharm.D. Contact person: Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 Phone: (513) 961-8200 Facsimile: (513) 961-2858
October 12, 2008 Date:
3D OCT-1000 MARK II Trade Name:
Optical Coherence Tomography System Common names: OCT Mark II
- Classification Name: Tomography, Optical Coherence 21 CFR§886.1570 Ophthalmoscope
Product Code: OBO (Tomography, Optical Coherence)
Identification of a Legally Marketed Predicate Device
The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K063388, FDA Product Code OBO.
General Description
1
510 (k): k-083316
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 retinal nerve fiber layer 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 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.
Intended Use
The Topcon 3D OCT-1000 MARK II 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 layer 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.
Performance Data
Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results for the 3D OCT-1000 MARK II demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.
Basis of Substantial Equivalence
The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K-63388, FDA Product Code OBO, and regulation 21CFR8886.1570 (Ophthalmoscope) in technological characteristics, engineering design and specifications, software design and specifications, laser classification and intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
MAR 1 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Topcon Medical Systems, Inc c/o Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc.
310 Terrace Avenue, Suite 201 Cincinnati, OH 45220
Re: K083316
Trade Name: 3D OCT-1000 Optical Coherence Tomography System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: October 12, 2008 Received: November 12, 2008
Dear Dr. Fant:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
3
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,
M. B. Egbertms, mD
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
4
Indications for Use Statement র .
510(k) Number (if known): __ k 083316
Device Name: 3D OCT-1000 MARK II --
Indications for Use:
The Topcon 3D OCT-1000 MARK II 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 retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular discases, including but not limited to macular edema and central serous retinopathy.
Prescription Use_
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K093316