(94 days)
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected. The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.
The provided text is a 510(k) summary for the OTI OCT-Ophthalmoscope. It describes the device, its intended use, and states that no clinical tests were required for its clearance. Therefore, a study demonstrating the device meets acceptance criteria, as well as several other requested details, cannot be found in this document.
The document states:
- (b) Clinical tests: Not required.
- (c) Conclusions: The OCT-Ophthalmoscope is equivalent in safety and efficacy to the legally-marketed predicate device.
This indicates that the device's clearance was based on demonstrating substantial equivalence to pre-existing legally marketed devices (K012727, K943956) through non-clinical tests (accuracy, optical emissions analyses, electrical safety tests, and software validation tests), rather than a clinical study with acceptance criteria for device performance.
Therefore, the following information cannot be provided from the given text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical study.
- Sample size for the training set.
- How the ground truth for the training set was established.
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JAN 2 1 2005
Ophthalmic Technologies Inc. Special 510(k) Submission OCT- Ophthalmoscope
510(k) Summary September 30, 2004
(1) Submitter Information
Name: Ophthalmic Technologies Inc.
Address:
Ophthalmic Technologies Inc. 37 Kodiak Crescent, Unit 16 Downsview, Ontario, Canada M3J 3E5
Telephone number:
416-631-9123 · 1-800-517-4444
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: December 10, 2002
(2) Name of Device
Trade Name: OCT- Ophthalmoscope Common Name: Ophthalmoscope using optical coherence * mography Classification name: Ophthalmoscope, a-c powered, 890H1 .I
(3) Equivalent legally-marketed devices.
K012727, Optical Coherence Tomography Model 3000, Zeiss Ophthalmic Systems K943956, Retina Tomograph and Flowmeter, Heidelberg Engineering
(4) Description
The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of
A-1
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the eye fundus. In addition conventional longitudinal OCT images may also be collected.
The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.
(5) Intended Use
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected.
(6) Performance Data
(a) Non-clinical tests
The OCT-Ophthalmoscope has had accuracy tests, optical emissions analyses, electrical safety tests, and software validation tests.
(b) Clinical tests
Not required.
(c) Conclusions
The OCT-Ophthalmoscope is equivalent in safety and efficacy to the legallymarketed predicate device.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
MAY 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ophthalmic Technologies, Inc. c/o George Myers, Sc.D. Medsys, Inc. 377 Route 17 South Hasbrouck Heights. NJ 07604
K042885 Re:
Trade/Device Name: OCT-Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: October 17, 2004 Received: November 18, 2004
Dear Dr. Myers:
This letter updates our substantially equivalent letter of January 21, 2005.
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 (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
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Page 2 - George Myers, Sc.D.
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.
This letter will allow you to continue 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 Office of 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 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/dsma/dsmamain.html
Sincerely yours,
Eivenetti R. Beem PhD
Image /page/3/Picture/7 description: The image contains a handwritten word that appears to be "for". The word is written in a cursive style with the "f" having a prominent loop extending above the rest of the word. The "o" and "r" are connected, forming a continuous stroke.
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
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OTI OCT-Ophthalmoscope
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510(k) Number (if known):_
Device Name: OCT- Ophthalmoscope
Indications for Use:
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 810.109) OR
Over-the-Counter
(Optional Format 1-2-96)
Denis L. McCarthy
(Division Sign Off)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K042885
§ 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.