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.

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.

AI/ML Overview

This 510(k) summary for the Optos Panoramic200 Ophthalmoscope does not provide a study to prove the device meets acceptance criteria.

Instead, it argues for substantial equivalence to predicate devices (Odyssey S2LO and Rodenstock SLOs) based on similar intended use, indications, and principles of operation. The document focuses on regulatory compliance and comparison to existing, legally marketed devices rather than presenting a performance study with specific acceptance criteria and results.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this document.

Here's an overview of what can be extracted based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable - No Performance Study Provided)

Since no performance study is detailed, there are no explicit acceptance criteria or reported device performance metrics in the context of a clinical or technical performance study. The document focuses on compliance with general safety and electrical standards.

Study Details (Not Applicable - No Performance Study Provided)

Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 applicable. The device is an imaging tool, not one with AI assistance for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that is available from the document:

Intended Use: To examine the retina of the eye for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
Predicate Devices: Odyssey Optical Systems' S2LO (K981640), Rodenstock Scanning Laser Ophthalmoscope (K882517), and Rodenstock Scanning Laser Ophthalmoscope (K871268).
Technological Characteristics: Scanning Laser Ophthalmoscope (SLO) method, using a laser light source scanned across the retina to generate a color image. Returned light is detected, digitized, and displayed electronically.
Differences from Predicates (and why they don't raise new safety/effectiveness questions):
- Lack of an infrared laser.
- Different size and shape of the deflection system.
- Different display format.
- Wider imaging angle.
- Higher resolution.
- Use of an eyepiece.
- The document asserts these differences "do not raise any new questions of safety or effectiveness."
Compliance Standards: The device is a Class I laser device and complies with 21 C.F.R., Parts 1010 and 1040. It also complies with various international and national electrical and safety standards (BS EN 60601 series, BS EN 60825-1, UL2601, CAN/CSA-C22.2 No.601.1-M90, AS 3200.1:1990/NZ 6150:1990, JIST 1001/1002:1992).

Conclusion: The submission for the Optos Panoramic200 relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a novel performance study to meet specific acceptance criteria for a new clinical claim.

Summary

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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 plc16 Comely Park,Dunfermline,Fife,ScotlandUnited 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

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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 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. Generalrequirements for safety;
BS EN 60601-1-1:1993	Medical electrical equipment. Generalrequirements for safety. Collateral standard. Safetyrequirements for medical electrical systems;
BS EN 60601-1-2:1993	Medical electrical equipment. Generalrequirements for safety. Collateral standard.Electromagnetic compatibility

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BS EN 60601-1-4:1997	Medical electrical equipment. Generalrequirements for safety. Collateral standard.General requirements for programmable electricamedical systems.
BS EN 60825-1:1994AMD2	Safety of laser products. Part 1. Equipmentclassification, requirements and user's guide.
UL2601:1994	Medical electrical equipment. Generalrequirements for safety.
CAN/CSA-C22.2No.601.1-M90	Medical electrical equipment. Generalrequirements for safety.
AS 3200.1:1990/NZ 6150:1990	Medical electrical equipment. Generalrequirements for safety.
JIST 1001/1002:1992	Medical electrical equipment. Generalrequirements 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).

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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

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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)

Regulation Number and Section

§ 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.