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 200MA and the predicate device are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. Both devices use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina 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 computer and displayed either on a cathode ray tube or a liquid crystal display.

AI/ML Overview

The provided text describes a 510(k) submission for the Optos Panoramic 200MA Ophthalmoscope, asserting its substantial equivalence to a predicate device (Optos Panoramic 200A). This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel devices or AI-powered diagnostics.

Therefore, the information required to populate the table and answer the subsequent questions regarding acceptance criteria, study design, and ground truth establishment, as typically understood in the context of an AI/ML device, is not present in the provided document.

Here's why and what can be inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The submission focuses on compliance with standards (IEC, EN, UL, CAN/CSA) and the device's functional equivalence to the predicate.
Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device against specific clinical criteria. The performance is implicitly deemed acceptable because it is "substantially equivalent" to the predicate device.

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

Not Applicable: There is no mention of a "test set" in the context of evaluating diagnostic performance from data. The submission is about the physical device and its operational characteristics being similar to the predicate.

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

Not Applicable: No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set:

Not Applicable: No test set or corresponding adjudication is mentioned.

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: This is not an AI/ML device, and no MRMC study is mentioned.

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

No: This is not an AI/ML device.

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

Not Applicable: There is no ground truth used in the context of evaluating a diagnostic algorithm's performance against clinical findings. The "ground truth" for this 510(k) submission is that the device's physical and operational characteristics comply with regulations and are equivalent to the predicate, and that the predicate itself is legally marketed and generally accepted as safe and effective for its intended use.

8. The sample size for the training set:

Not Applicable: This is not an AI/ML device.

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

Not Applicable: This is not an AI/ML device.

Summary based on the provided document:

The submission for the Optos Panoramic 200MA Ophthalmoscope relies on demonstrating substantial equivalence to a previously cleared predicate device (Optos Panoramic 200A). The "acceptance criteria" are primarily related to:

Identical Intended Use and Indications: Both devices are "intended to examine the retina and are indicated to aid in the diagnosing and monitoring disease and disorders that manifest in the retina" and "for imaging the fluoresced ocular vasculature."
Similar Principles of Operation and Technological Characteristics: Both are Scanning Laser Ophthalmoscopes (SLO) using lasers, a defiance system, and light detectors to generate digital images. The document states, "The detailed technological differences do not raise any new questions of safety or effectiveness."
Compliance with Recognized Standards: The device complies with various international and national safety and electrical standards (e.g., 21 C.F.R., Parts 1010 and 1040, EN 60825:2001, IEC 60601-1, UL60601-1, CAN/CSA-C22.2 No.601.1-M90).

The "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, which presents arguments and evidence for substantial equivalence, focusing on the lack of new safety or effectiveness concerns due to minor technological differences from the predicate. No independent diagnostic accuracy study comparing the device's clinical performance against a gold standard or human readers is detailed, as it's not typically required for this type of submission.

Summary

{0}------------------------------------------------

MAR 1 7 2006

Image /page/0/Picture/1 description: The image contains a sequence of numbers and letters. The sequence is 'K060424'. The characters are written in a bold, sans-serif font.

Attachment 2: Special 510k Summary-Optos Panoramic 200MA

Name of Device	Panoramic 200MA Angiograph Ophthalmoscope
Common or Usual Name	Scanning laser ophthalmoscope
Classification Name	Ophthalmoscope, AC powered(per 21 C.F.R. 866.1570)
Product Code	MYC
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	8th February, 2006
Predicate Device
Trade Name	Manufacturer	510(k)
Panoramic 200A	Optos	K042001

Intended Uses

Optos plc's ("Optos") Panoramic 200MA has the same intended use and same indications as the Optos predicate device, the Panoramic 200A. Both devices are intended to examine the retina and are indicated to aid in the diagnosing and monitoring disease and disorders that manifest in the retina. Additionally, the Panoramic 200MA and Panoramic 200A are indicated for imaging the fluoresced ocular vasculature. Thus, the Panoramic 200MA Ophthalmoscope has the same intended use and same indications as the predicate device.

Page 45 of 145

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K060424'. The characters are written in a handwritten style.

Principles of Operation and Technological Characteristics

The above principle of operations holds for imaging the retina or a fluoresced retina. The detailed technological differences do not raise any new questions of safety or effectiveness.

Performance Standards

The Optos Panoramic 200MA Ophthalmoscope is a Class 1 laser device. This device complies with 21 C.F.R., Parts 1010 and 1040 (and also EN 60825:2001). The Optos Panoramic 200MA 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;
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.

95000 66198/0001 2263650 |

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K060424'. The characters are handwritten in a clear, legible style. The numbers are easily distinguishable, and the letter 'K' is written in uppercase.

Conclusion

The Panoramic 200MA has the same intended use, the same indications and very similar principles of operation and technological characteristics as the predicate device. The minor technological differences between the Panoramic 200MA and the predicate devices do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200MA Ophthalmoscope is substantially equivalent to Optos` legally marketed Scanning Laser Ophthalmoscopes (SLO), the P200A (K042001)

Page 47 of 145

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2006

Optos PLC % Hogan & Hartson, LLP 555 Thirteenth St. N.W. Columbia Square Washington, DC 20004 Attn: Howard M. Holstein

Re: K060424

Trade/Device Name: Panoramic, Model 200MA Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: February 17, 2006 Received: February 17, 2006

Dear Mr. Holstein:

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 application (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 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.

{4}------------------------------------------------

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) 827-8910. 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/cdrl/industry/support/index.html.

Sincerely yours,

MB. Eychhaus - MD

Malvina B. Eydelman, M.D Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K060424

Statement for Indication for Use

510(k) Number (if known): KOGOYZY

Device Name: Optos Panoramic 200A Scanning Laser Ophthalmoscope 200 HA

Indications for Use:

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)

Clay P. Buttner

(Division Sign-Off)
Division of thalmic Ear,
Nose and Thuat Devises

510(k) Number.

WDC - 66148880001 - 22636511 1

Page 133 of 145

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.