(86 days)
Not Found
No
The description focuses on the hardware and image acquisition method (SLO) and does not mention any AI/ML components or algorithms for image analysis or diagnosis. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is used for diagnosing and monitoring diseases, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye."
No
The device description explicitly details hardware components like lasers, deflection systems, light detectors, and a personal computer with a display, indicating it is a hardware device with associated software.
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 description clearly states that this device is a "wide field ophthalmoscope" and a "Scanning Laser Ophthalmoscope (SLO)". It works by scanning a laser across the retina of the eye to generate an image.
- Intended Use: The intended use is for "diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye." This is done by directly imaging the eye, not by analyzing samples taken from the body.
Therefore, this device falls under the category of medical imaging devices used for direct examination of the body, not IVDs.
N/A
Intended Use / Indications for Use
Optos plc's ("Optos") Panoramic200 and Odyssey Optical System's S2LO ("the Odyssey . . . SLO") and G. Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the Rodenstock SLOs") is intended to examine the retina of the eye. The Panoramic200 and the Odyssey S2O, and the Rodenstock SLOs are indicated for diagnosing and monitoring disease and disorders that manifest themselves in the posterior pole of the eye. Thus, the Panoramic200 Ophthalmoscope has the same intended use and the same indications as these predicate devices.
This device is indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye.
Product codes
HLI
Device Description
The Optos' Panoramic200 and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. They use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina of the eye to generate a color image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture either in a personal computer and displayed either on a cathode ray tube or an liquid crystal display. The technological differences between the Panoramic200 Ophthalmoscope and its predicate devices are the Panoramic200's lack of an infrared laser, the size and shape of the Panoramic200's deflection system, and the Panoramic200's different display format, wider imaging angle, higher resolution, and use of an eye piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanning Laser Ophthalmoscopy
Anatomical Site
retina of the eye, posterior pole of the eye
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
FEB 3 1999
510(k) Summary 2
Optos Panoramic200
| Name of Device | Panoramic200 Ophthalmoscope |
|---|---|
| Common or Usual Name | Scanning Laser Ophthalmoscope (SLO) |
| Classification Name | Ophthalmoscope, AC powered |
| (per 21 C.F.R. 866.1570) | |
| Product Code | HLI |
| Submitter | Optos plc |
| 16 Comely Park, | |
| Dunfermline, | |
| Fife, | |
| Scotland | |
| United Kingdom | |
| Phone: | 011 44 1383 628714 |
| Facsimile: | 011 44 1383 628706 |
| Contact Person: | Mr. Philip Rickett |
1 November 1998
Predicate Devices
Date Prepared:
| Trade name | Manufacturer | 510(k) |
|---|---|---|
| S2LO | Odyssey Optical Systems | K981640 |
| Scanning Laser Ophthalmoscope (SLO) | Rodenstock | K882517 |
| Scanning Laser Ophthalmoscope (SLO) | Rodenstock | K871268 |
Intended Uses
Optos plc's ("Optos") Panoramic200 and Odyssey Optical System's S2LO ("the Odyssey
. . . SLO") and G. Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the ୍ଲ
Rodenstock SLOs") is intended to examine the retina of the eye. The Panoramic200 and the
Odyssey S2O, and the Rodenstock SLOs are indicated for diagnosing and monitoring disease
1
and disorders that manifest themselves in the posterior pole of the eye. Thus, the Panoramic200 Ophthalmoscope has the same intended use and the same indications as these predicate devices.
Principles of Operation and Technological Characteristics
The Optos' Panoramic200 and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. They use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina of the eye to generate a color image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitized and used to build up an electronic picture either in a personal computer and displayed either on a cathode ray tube or an liquid crystal display.
The technological differences between the Panoramic200 Ophthalmoscope and its predicate devices are the Panoramic200's lack of an infrared laser, the size and shape of the Panoramic200's deflection system, and the Panoramic200's different display format, wider imaging angle, higher resolution, and use of an eye piece. However, these differences do not raise any new questions of safety or effectiveness
Performance Standards
The Optos Panoramic200 Ophthalmoscope is a Class I laser device. This device complies with 21 C.F.R., Parts 1010 and 1040.
The Optos Panoramic200 Ophthalmoscope complies with the following standards:
| BS EN 60601-1:1993 | Medical electrical equipment. General
requirements for safety; |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN 60601-1-1:1993 | Medical electrical equipment. General
requirements for safety. Collateral standard. Safety
requirements for medical electrical systems; |
| BS EN 60601-1-2:1993 | Medical electrical equipment. General
requirements for safety. Collateral standard.
Electromagnetic compatibility |
2
| BS EN 60601-1-4:1997 | Medical electrical equipment. General
requirements for safety. Collateral standard.
General requirements for programmable electrica
medical systems. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN 60825-1:1994
AMD2 | Safety of laser products. Part 1. Equipment
classification, requirements and user's guide. |
| UL2601:1994 | Medical electrical equipment. General
requirements for safety. |
| CAN/CSA-C22.2
No.601.1-M90 | Medical electrical equipment. General
requirements for safety. |
| AS 3200.1:1990/
NZ 6150:1990 | Medical electrical equipment. General
requirements for safety. |
| JIST 1001/1002:1992 | Medical electrical equipment. General
requirements for safety |
Conclusion
The Panoramic200 has the same intended use, the same indications and very similar principles of operation and technological characteristics as the Odyssey S2O and the Rodenstock SLOs. The minor differences between the Panoramic200 and the predicate devices do not raise any new questions of safety or effectiveness. Thus, the Optos Panoramic200 Ophthalmoscope is substantially equivalent to legally marketed Scanning Laser Ophthalmoscopes (SLO).
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 1999
Optos PLC c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K983999 Trade Name: Panoramic200 Ophthalmoscope Regulatory Class: II Product Code: 86 HLI Dated: November 9, 1998 Received: November 9, 1998
Dear Mr. Holstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Howard Holstein
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Aleph Rosenthal
A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K983999 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Optos Panoramic200 Scanning Laser Ophthalmoscope
Indications for Use:
This device is indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye.
(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 Devices | |
| 510(k) Number | K983999 |
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)