PANORAMIC 200A by OPTOS PLC | FDA 510(k) Summary

This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.

Device Description

The Optos Panoramic 200A 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 an 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 digitised and used to build up an electronic picture in a personal computer and displayed either on a cathode ray tube or a liquid crystal display.

AI/ML Overview

The provided text describes the marketing authorization for the Optos Panoramic 200A Angiograph Ophthalmoscope based on its substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria.

The submission focuses on the lack of new questions of safety or effectiveness due to minor technological differences compared to predicate devices, and adherence to relevant safety and electrical standards. It does not present a performance study with defined acceptance criteria for the device's diagnostic capabilities.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not provided in the given document, as it's a 510(k) summary for substantial equivalence.

Here's an attempt to fill in the table and address the questions based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (from K042001 summary)
Intended Use Equivalence: The device should have the same intended use and indications as the predicate devices.	The Panoramic 200A Ophthalmoscope has the same intended use and same indications as the predicate devices (Panoramic 200, Heidelberg Retina Angiography 2, and Rodenstock SLOs) for examining the retina, diagnosing and monitoring retinal diseases/disorders, and imaging fluoresced ocular vasculature. (Explicitly stated in "Intended Uses" section)
Similar Principle of Operation: The device should work by the same method as predicate devices.	The Optos Panoramic 200A and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method: using a laser to scan across the retina, and a detector to convert returned light to an electrical signal for image display. (Explicitly stated in the first paragraph of the "Technological Characteristics" section)
No New Safety/Effectiveness Questions: Any technological differences should not raise new questions of safety or effectiveness.	The technological differences (lack of infrared laser, different display format, wider imaging angle, and associated resolution) between the Panoramic 200A and its predicate devices in angiographic mode "do not raise any new questions of safety or effectiveness." (Explicitly stated in the second paragraph of the "Technological Characteristics" section)
Compliance with Performance Standards: Adherence to relevant safety and electrical standards.	The device complies with 21 C.F.R., Parts 1010 and 1040, and the following standards: IEC 60601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, UL60601-1, and CAN/CSA-C22.2 No.601.1-M90. (Explicitly stated in the "Performance Standards" section)
Substantial Equivalence Conclusion: The device should be deemed substantially equivalent to legally marketed predicate devices.	The FDA reviewed the premarket notification and "determined the device is substantially equivalent...to legally marketed predicate devices." (Stated in the FDA's letter, K042001)

2. Sample size used for the test set and the data provenance:

Not provided. The 510(k) summary for the Panoramic 200A does not describe a clinical performance study with a specific test set. The submission is based on engineering similarity and compliance with safety standards rather than a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

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:

No. An MRMC study was not described. The device is an imaging tool, and the submission focuses on its equivalence to existing imaging tools, not on its role in aiding human readers or AI integration.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is an imaging device, not an AI algorithm. Its performance is inherent in its ability to acquire images, which is assessed for technical specifications and safety rather than standalone diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. No clinical performance study requiring ground truth is described. The "ground truth" for this 510(k) revolved around ensuring the technical specifications and safety profile were equivalent to predicate devices and met relevant standards.

8. The sample size for the training set:

Not applicable/Not provided. This device is hardware and software for image acquisition, not an AI model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary

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KO42001 Attachment 2: 510k Summary-Optos Panoramic 200A

Name of Device	Panoramic 200A Angiograph Ophthalmoscope
Common or Usual Name	Scanning laser ophthalmoscope
Classification Name	Ophthalmoscope, AC powered(per 21 C.F.R. 866.1570)
Product Code	HLI
Submitter	Optos plc,Queensferry House,Carnegie Business CampusDunfermline,Fife,KY11 8GRUnited KingdomPhone: 011 44 1383 843300Facsimile: 011 44 1383 843333
Contact Person:	Robert Tweedlie Ph.D.
Date Prepared	15th July,2004

Predicate Devices

Trade Name	Manufacturer	510(k)
Panoramic 200	Optos	K98399
Heidelberg Retina Angiography 2	Heidelberg Engineering	K97167
Scanning Laser Ophthalmoscope(SLO)	Rodenstock	K88251
Scanning Laser Ophthalmoscope(SLO)	Rodenstock	K87126

Intended Uses

Optos plc's ("Optos") Panoramic 200A, Panoramic 200, Heidelberg Retina Angiography 2 and G.Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the Rodenstock SLOs") is intended to examine the retina. The Panoramic 200A, Panoramic 200 and the Rodenstock SLOs are indicated for diagnosing and monitoring disease and disorders that manifest themselves in the retina of the eye. Additionally, the Panoramic 200A, Heidelberg Retina 2 and Rodenstock SLOs are indicated for imaging the fluoresced ocular vasculature. Thus, the Panoramic 200A Ophthalmoscope has the same intended use and same indications as these predicate devices.

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The technological differences between the Panoramic 200A Ophthalmoscope and its predicate devices in an angiographic mode are the lack of an infrared laser, different display format, wider imaging angle and associated resolution. However, these differences do not raise any new questions of safety or effectiveness.

Performance Standards

The Optos Panoramic 200A Ophthalmoscope is a Class 1 laser device. This device complies with 21 C.F.R., Parts 1010 and 1040.

The Optos Panoramic 200A Ophthalmoscope complies with the following standards:

IEC 60601-1 Second Edition 1988/A1: 1991& A2:1995	Medical electrical equipment. GeneralRequirements for safety.
EN 60601-1:1990/A1:1993, A11:1993, A12:1993& A2:1995, A13:1996	Medical electrical equipment. Generalrequirements for safety.
EN 60601-1-1:2001	Medical electrical equipment. GeneralRequirements for safety. CollateralStandard. Safety requirements forMedical electrical systems.
EN 60601-1-2:2001	Medical electrical equipment. GeneralRequirements for safety. CollateralStandard. Electromagnetic compatibilityRequirements and tests;

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EN 60601-1-4:1996	Medical electrical equipment. GeneralRequirements for safety. CollateralStandard. General requirements forProgrammable electrical medicalSystems;
UL60601-1 First Edition:2003	Medical electrical equipment.General requirements for safety;
CAN/CSA-C22.2 No.601.1-M90 including S1-94	Medical electrical equipment. Generalrequirements for safety;

Conclusion

The Panoramic 200A has the same intended use, the same indications and very similar principles of operation and technological characteristics as the predicate devices. The minor differences between the Panoramic 200A and the predicate devices do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200A 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OC1 7 - 2004

Optos PLC c/o Hogan and Hartson, LLP Attn: Mr. Howard M. Holstein 555 Thirteenth Street, N.W. Columbia Square Washington, D.C. 20004

Re: K042001 RC: K042001
Trade/Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation: Ophthalmoscope, AC powered Regulatory Class: II Product Code: HLI Dated: July 26, 2004 Received: July 26, 2004

Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to conniner of provises that have been reclance with the provisions of the Federal Food, Drug, de nees may been robat 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 I ou may, ateres, and server 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 such 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); 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.

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Page 2- Mr. Howard M. Holstein

This letter will allow you to begin 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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,

A halyi Rosenthal

A. Ralph Rosenthal, 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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Statement for Indication for Use

510(k) Number (if known): K042001

Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope

Indications for Use:

This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the

retina.

Prescription Use __ (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ada C. Callaway

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K072001

Page 210 of 230

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.