(21 days)
The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 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 measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. 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 3D OCT-2000 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. During OCT imaging, the scan beam for the 3D OCT-2000 is delivered as pulsed lighting. The PC software of the 3D OCT-2000 has same functions of the PC software of the 3D OCT-1000 and 3D OCT-10000 MARK II and also the PC software of the 3D OCT-2000 has same functions for the measurement of retinal thickness of the 3D OCT-1000 for Measurement of Retinal Thickness.
The provided text describes the Topcon 3D OCT-2000 and its substantial equivalence to previous models. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for test or training sets, ground truth establishment methods, expert involvement, or MRMC studies for this device.
The document focuses on the device's intended use, technological characteristics, and conformity to general medical device standards. The "Performance Data" section states that "Software validation testing (with PC software) and image capture testing were performed on the 3D OCT-2000. And also, the test results for the 3D OCT-2000 demonstrated sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness." However, it does not elaborate on these test results or specify any quantitative acceptance criteria.
Therefore, many of the requested details cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document mentions conformity to several IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 15004-1:2006, ISO 15004-2:2007). These standards define general safety, electromagnetic compatibility, laser safety, and fundamental requirements for ophthalmic instruments. While successfully meeting these standards implies acceptance, the document does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity for disease detection) with corresponding acceptance thresholds.
- Reported Device Performance: The document only generally states, "The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device." It also mentions "sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness," but no numerical data is provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: 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)
- Not specified. The document does not detail any studies involving expert ground truth establishment for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- Not specified. This device (3D OCT-2000) is a diagnostic imaging device, not explicitly an AI-assisted diagnostic tool as described in the context of MRMC for AI improvement. The document presents it as substantially equivalent to prior predicate devices based on technological characteristics and intended use, not necessarily improved human reader performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is an imaging system. Its 'performance' would be related to image quality, measurement accuracy, and safety, not an algorithm's standalone diagnostic performance in the AI sense. The document states "software validation testing" was done, but gives no specifics on algorithm-only performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. The document describes a "substantially equivalent" declaration, not a de novo clearance for a machine learning algorithm that typically requires a distinct training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
Summary of available information:
| Category | Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly stated as specific performance metrics. Implicitly, conformity to general medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 15004-1:2006, ISO 15004-2:2007) and "sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness" were the basis for acceptance. |
| Reported Device Performance | "The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device." "demonstrated sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness." No specific quantitative performance values are provided. |
| Sample Size (Test Set) | Not specified. |
| Data Provenance (Test Set) | Not specified. |
| Number of Experts (Ground Truth) | Not specified. |
| Qualifications of Experts | Not specified. |
| Adjudication Method | Not specified. |
| MRMC Comparative Effectiveness Study | Not performed/Not applicable in the context of typical AI-driven improvement studies. The device is an imaging instrument, declared substantially equivalent to previous models based on its core imaging capabilities. |
| Standalone Performance Study (Algorithm) | Not explicitly detailed or applicable in the sense of AI algorithm performance. "Software validation testing" and "image capture testing" were performed. |
| Type of Ground Truth Used | Not specified for any performance evaluation in terms of disease detection. For retinal thickness measurement equivalence, the ground truth would presumably be the measurements from the predicate device (3D OCT-1000 for Measurement of Retinal Thickness). |
| Sample Size (Training Set) | Not applicable for a traditional medical device substantial equivalence submission where an AI algorithm's training set is not the primary focus. |
| Ground Truth for Training Set | Not applicable. |
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5. 510(k) SUMMARY
510(k) Owner:
Topcon Corporation. 75-1 Hasunuma-cho, Itabashi-ku-Tokyo, Japan 174-8580 Phone Number: +81-3-3558-2566 FAX Number: +81-3-3965-6532
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 Phone Number: (201) 599-5153 FAX Number: (201) 599-5240
Contact person:
Takao Sugawara Manager TOPCON CORPORATION 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174-8580 Phone Number: +81-3-3558-2566 FAX Number: +81-3-3965-6532
Date:
August 6, 2009
Trade Name:
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Common names:
OPTICAL COHERENCE TOMOGRAPHY
Classification Name:
Tomography, Optical coherence 21CFR886.1570 Ophthalmoscope
Product Code: OBO
510(k) Number: K092470 SEP - 2 2009
Page 1
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Identification of a Legally Marketed Predicate Device
The 3D OCT-2000 is substantially equivalent to the 3D OCT-1000 (K06388), 3D OCT-1000 for Measurement of Retinal Thickness (K072971) and 3D OCT-1000 MARK II (K083316). All of those predicate devices are marketed by TOPCON CORPORATION and FDA Product Code is OBO.
General 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 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.
The 3D OCT-1000 for Measurement of Retinal Thickness is identical to the 3D OCT-1000 with the exception of the addition of a new software module allowing for the measurement of retinal thickness.
The technological characteristics of the 3D OCT-1000 MARK II are the identical for the 3D OCT-1000, with the exception that during OCT imaging, the scan beam for the 3D OCT-1000 is delivered as continuous wave (CW) light; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 MARK II.
The 3D OCT-2000 has same intended use and indication for use as the 3D OCT-1000, 3D OCT-1000 for Measurement of Retinal Thickness and 3D OCT-1000 MARK II. The technological characteristics are the identical.
During OCT imaging, the scan beam for the 3D OCT-2000 is delivered as pulsed lighting same as 3D OCT-1000 MARK II. The PC software of the 3D OCT-2000 has same functions of the PC software of the 3D OCT-1000 and 3D OCT-10000 MARK II and also the PC software of the 3D OCT-2000 has same functions for the measurement of retinal thickness of the 3D OCT-1000 for Measurement of Retinal Thickness.
Intended Use / Indication for Use
The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 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 measurement of posterior ocular structures including retinal nerve fiber layer, macula, and optic disk: It is intended for use as a diagnostic device to aid in the detection and management of
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ocular diseases affecting the posterior segment of the eye.
Patient profiles
This instrument has not been designed to apply to infants. Use this instrument meticulously for infants.
This instrument is contraindicated in the following patients.
- . The patient who has a history of photosensitivity.
- The patient who has just received the treatment of photodynamic therapy (PDT) ● (For the prohibition period, refer to the package insert of the taken light-sensitive substance.) -
- The patient who takes the medicine that can cause the photosensitiyity as its side ● effect.
Use this instrument meticulously for the following patients.
- The patient who has epidemic kerato conjunctivitis, or any other infectious disease.
- . The patient who has taken the medicine that can cause the photosensitivity as its side effect.
- · The patient who is at high risk for the optical radiation hazard, such as aphakic eye, infant, and the patient who diminishes the sensibility to light by fundus disease.
Performance Data
Software validation testing (with PC software) and image capture testing were performed on the 3D OCT-2000. And also, the test results for the 3D OCT-2000 demonstrated sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness.
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-2000 is substantially equivalent to the 3D OCT-1000 (K06388), 3D OCT-1000 for Measurement of Retinal Thickness (K072971) and 3D OCT-1000 MARK II (K083316) marketed by Topcon. The 3D OCT-2000 and predicate devices mentioned above have same FDA Product Code OBO, and regulation 21CFR§886.1570 (Ophthalmoscope) in technological characteristics, engineering design and specifications, software design and specifications, optical coherence tomography light source classification (IEC 60825-1) and intended use.
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Standards for testing
TOPCON conducted several tests for the 3D OCT-2000 to ascertain conformity to following standards.
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements forSafety, 1988; Amendment 1, 1991; Amendment 2, 1995 |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests Edition3:2007 |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification andrequirements, 1993; Amendment 1, 1997; Amendment 2, 2001 |
| ISO 15004-1:2006 | Ophthalmic instruments - Fundamental requirements and testmethods - Part 1: General requirements applicable to allophthalmic instruments |
| ISO 15004-2:2007 | Ophthalmic Instruments - Fundamental requirements and testmethods Part 2: Light hazard protection |
No deviation or adaptation is made in the use of above mentioned standards.
See Attachment 1 for IEC 60601-1 Test Reports and IEC 60601-1-2 Test Reports.
See Attachment 2 for IEC 60825-1 Verification Reports
See Attachment 3 for ISO 15004-1:2006 evaluation results
See Attachment 4 for ISO 15004-2:2007 evaluation results
See Attachment 5 for Form FDA 3654 of each standard.
r
The 3D OCT-2000 has no component which contacts with blood, bodily fluid or mucous membrane. Therefore, Biocompatibility tests were not performed.
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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & H" is partially visible, wrapping around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
- 2 2009
Topcon Corporation c/o Takao Sugawara Manager 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174-8580
Re: K092470
Trade/Device Name: 3D Optical Coherence Tomography 3D OCT-2000 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: August 6, 2009 Received: August 12, 2009
Dear Mr. Sugawara:
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 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); medical device reporting (reporting of medical device-related adverse events) { 21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 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,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
K092470 510(k) Number (if known):
Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Indications for Use:
The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 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 measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. 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.
X Prescription Use (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)
Bruce Drum
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092470
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TOPCON CORPORATION Proprietary and Confidential Information
§ 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.