(89 days)
The Odyssey Optical Systems S2LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
The S-LO is a medical imaging device utilizing three Class I lasers of different wavelengths (532 nm, 670 nm and 810 nm). Illumination from these lasers can be used independently or collectively to diagnose and monitor diseases and disorders of the posterior pole of the eye. The device operates on a 12 volt power supply and produces 0.8 mW/cm2 of retinal illumination. The non-invasive, non-contact S2LO allows imaging of the posterior segment of the human eye. High resolution images of the posterior segment of the eye can be captured, printed, stored electronically or transmitted for referral purposes.
The provided text (K981640) for the Odyssey Optical Systems S2LO does not contain information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document is a 510(k) summary and subsequent FDA clearance letter for a medical imaging device (Scanning Laser Ophthalmoscope). The core of this submission is a claim of substantial equivalence to legally marketed predicate devices, rather than a demonstration of meeting specific performance acceptance criteria through a new study.
Here's why the requested information cannot be provided from this document:
- No Acceptance Criteria or Performance Study: The document explicitly states: "Performance Data: None. The specifications and indications for use of the Odyssey Optical Systems S-LO are the same or very similar to those of the claimed predicate devices. The Odyssey Optical Systems ScLO has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."
- Substantial Equivalence Pathway: The 510(k) pathway is primarily for demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often relies on comparing technical specifications and intended use, rather than conducting new performance studies that necessitate detailed acceptance criteria and study designs.
Therefore, since no performance study demonstrating the device meets acceptance criteria was conducted or reported in this 510(k) submission, the requested table and study details cannot be filled.
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AUG - 5 1998
Appendix D
510(K) SUMMARY ODYSSEY OPTICAL SYSTEMS S2LO
This 510(K) summary of safety and effectiveness for the scanning laser ophthalmoscope is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(K) summary.
Odyssey Optical Systems, LLC Applicant:
30-31 Union Wharf Address: Boston, MA 02109
Greg Heacock, Ph.D. Contact Person: Vice President
617-720-5254 Telephone: 617-720-5260 (fax)
Preparation Date: May, 1998 (of the Summary)
Odyssey Optical Systems ScLO Device Name:
Common Name: Ophthalmoscope
Classification: Class II (see: 21 CFR 886.1570). Product Code: HLI. Panel: 86. Name:
Legally marketed
predicate
device: Rodenstock Scanning Laser Ophthalmoscope and Humphrey Optical Coherence Tomography Scanner
Description
of the Device: The S-LO is a medical imaging device utilizing three Class I lasers of different wavelengths (532 nm, 670 nm and 810 nm). Illumination from these lasers can be used independently or collectively to diagnose and monitor diseases and disorders of the posterior pole of the eye. The device operates on a 12 volt power supply and produces 0.8 mW/cm2 of retinal illumination.
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The non-invasive, non-contact S2LO allows imaging of the posterior segment of the human eye. High resolution images of the posterior segment of the eye can be captured, printed, stored electronically or transmitted for referral purposes.
Indications for
Use:
The S2LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
Comparison to: The specifications of the Odyssey Optical Systems S2LO are the same or very similar to those of the claimed predicates.
None. The specifications and indications for use of the Odyssey Performance Optical Systems S-LO are the same or very similar to those of the claimed Data: predicate devices. The Odyssey Optical Systems ScLO has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use.
Because of this, performance data were not required.
Conclusion: Based on the foregoing, Odyssey Optical believes that the S2O is substantially equivalent to legally marketed predicate devices.
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Image /page/2/Picture/1 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 to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Odyssey Optical Systems, LLC c/o Ms. Maureen A. O'Connell 2710 Oakbrook Lane
Re: K981640
Weston, FL 33332
Trade/Device Name: S2O Scanning Laser Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: July 27, 1998 Received: July 27, 1998
MAY 2 9 2007
Dear Ms. O'Connell:
This letter updates our substantially equivalent letter of August 5, 1998.
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 - Ms. Maureen A. O'Connell
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,
Evenitta R. Rees PhD
Image /page/3/Picture/7 description: The image shows a handwritten signature. The signature is in black ink and appears to be a stylized version of the letters 'for'. The 'f' is written with a long, curved stroke, and the 'or' is connected to the 'f' in a flowing manner. The signature is simple and legible.
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
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Appendix B
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Odyssey Optical Systems S2LO
Indications For Use:
The Odyssey Optical Systems S2LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
Evenittel
Beer
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981640
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 810.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.