(226 days)
Carl Zeiss. Inc., Humphrey OCT Scanner, Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3
Carl Zeiss. Inc., Humphrey OCT Scanner, Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3
No
The summary describes a standard OCT imaging system and its performance compared to predicate devices. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The performance study focuses on image quality comparison, not algorithmic performance.
No
The device is described as a "diagnostic device to aid in the detection and management of ocular diseases," and its intended use is for "viewing and axial cross sectional imaging of posterior ocular structures," which means it is used for imaging and diagnosis, not 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 lists hardware components such as a Main Unit, Power Supply Unit, chin rest, and Spectroscope, indicating it is not solely software.
Based on the provided information, the Topcon 3D OCT-1000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Topcon 3D OCT-1000 Function: The description clearly states that the Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system used for in vivo imaging of posterior ocular structures. It directly images the living tissue within the eye.
- No Specimen Examination: The device does not examine specimens derived from the human body (like blood, tissue, or urine) in a laboratory setting.
Therefore, the Topcon 3D OCT-1000 falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
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 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
OBO
Device Description
The Topcon 3D OCT-1000 and the predicate devices use 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 components of the Topcon 3D OCT-1000 include a Main Unit, which houses three optical systems for observing and photographing the retina, a Power Supply Unit, a chin rest, a Spectroscope, and the ability to connect a personal computer for image viewing and analysis.
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)
Topcon collected 55 images from 31 eyes, including at least seven pairs each from subjects with normal eyes, macular holes, cystoid macular edema (CME) and epiretinal membrane (ERM), as well as both dry and wet form age-related macular degeneration. All images were obtained using both the 3D OCT-1000 device and a predicate device. Paired images were independently graded by two graders using predefined diagnostic image criteria. In all of the 55 pairs of images, the graders (with the consensus score) demonstrated that the Topcon image met as many or more image criteria to support a diagnostic use of the image than the predicate device image. Specifically, the Topcon image was scored as meeting the same number of image quality criteria to support its diagnostic use in 81 of the 110 scorings, and as meeting more of the predefined criteria in 29 of the 110 scorings. Thus, the Topcon image met the same or more criteria than the predicate device image for an overall agreement of 100% (110 of 110 images).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement of 100% (110 of 110 images).
Predicate Device(s)
Carl Zeiss. Inc., Humphrey OCT Scanner, Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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) SUMMARY
JUN 2 2 2 2007
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 Beth Zelnick Kaufman Contact Person:
OR
Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004 (202) 637-5794 Phone: Facsimile: (202) 637-5910
Date Prepared: November 8, 2006
Name of Device and Name/Address of Sponsor
Topcon 3D OCT-1000 Optical System Tomography System
Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174
1
Common or Usual Name
AC- Powered Ophthalmoscope
Classification Name
Ophthalmoscope; 21 C.F.R. 886.1570
Predicate Devices
Carl Zeiss. Inc., Humphrey OCT Scanner Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3
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 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.
Technological Characteristics
Both the Topcon 3D OCT-1000 and the predicate devices have similar technological characteristics. The Topcon 3D OCT-1000 and the predicate devices use 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.
In addition, both the Topcon 3D OCT-1000 and the predicate devices have similar components. The components of the Topcon 3D OCT-1000 include a Main Unit, which houses three optical systems for observing and photographing the retina, a Power Supply Unit, a chin rest, a Spectroscope, and the ability to connect a personal computer for image viewing and analysis. Similarly, the Carl Zeiss, Inc. Humphrey OCT Scanner the Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3 utilize optical systems for observing and photographing the retina, a digital signal processing (DSP) unit for obtaining interferometric signal and converting to retinal tomograms, a chin rest, and connection to a computer for viewing and analyzing captured images.
2
The Topcon 3D OCT-1000 also uses similar light sources as the Carl Zeiss, Inc. Humphrey OCT Scanner and the Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3, and thus has optical equivalency.
Performance Data
The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in IEC 60825-1:2001. In all instances, the Topcon 3D OCT-1000 functioned as intended.
In total, Topcon collected 55 images from 31 eyes, including at least seven pairs each from subjects with normal eyes, macular holes, cystoid macular edema (CME) and epiretinal membrane (ERM), as well as both dry and wet form age-related macular degeneration. All images were obtained using both the 3D OCT-1000 device and a predicate device. Paired images were independently graded by two graders using predefined diagnostic image criteria. In all of the 55 pairs of images, the graders (with the consensus score) demonstrated that the Topcon image met as many or more image criteria to support a diagnostic use of the image than the predicate device image. Specifically, the Topcon image was scored as meeting the same number of image quality criteria to support its diagnostic use in 81 of the 110 scorings, and as meeting more of the predefined criteria in 29 of the 110 scorings. Thus, the Topcon image met the same or more criteria than the predicate device image for an overall agreement of 100% (110 of 110 images).
Substantial Equivalence
The Topcon 3D OCT-1000 is as safe and effective as the Carl Zeiss. Inc., Humphrey OCT Scanner and the Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3. The Topcon 3D OCT-1000 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the 3D OCT-1000 and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Topcon 3D OCT is as safe and effective as the Carl Zeiss Humphrey OCT device. Thus, the 3D OCT-1000 is substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is written in a simple, sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Topcon Corporation c/o Hogan & Hartson LLP 555 Thirteenth St NW Columbia Square Washington, DC 20004 Attn: Jonathan Kahan
JUN 2 2 2007
Re: K063388
Trade/Device Name: 3D OCT-1000 Optical Coherence Tomography System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: OBO Dated: May 23, 2007 Received: May 23, 2007
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 iddications 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 1 ct . 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, WA 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematication. The PDF interest 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 if you don't operio an Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Eglemer SimWD
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
5
Indications for Use Statement
| 510(k) Number (if known): | K06388 |
|---|---|
| --------------------------- | -------- |
Device Name: Topcon 3D OCT-1000
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 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.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clay R. Bitty
of Ophthalmic Ear,
and Throat Devises
) Number K063388
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