P200MAAF

K102492 · Optos Plc. · MYC · Sep 30, 2010 · Ophthalmic

Device Facts

• Record ID: K102492
• Device Name: P200MAAF
• Applicant: Optos Plc.
• Product Code: MYC · Ophthalmic
• Decision Date: Sep 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The P200MAAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Device Story

P200MAAF is a scanning laser ophthalmoscope (SLO) using blue, red, and green lasers to scan the retina in two dimensions. A rotating polygon and motor-driven mirror deflect the laser beam; reflected light is captured by discrete detectors (red/green channels). The device generates digital images for clinician review on a display. Imaging modes include standard composite, separate red/green channels, autofluorescence (using green laser illumination), and angiography (using blue laser illumination for fluorescein dye). The system includes a scanhead on an adjustable table for patient positioning. Clinicians use the output to visualize retinal structures and pathology, aiding in diagnosis and monitoring of retinal diseases. The device is intended for clinical use.

Clinical Evidence

Bench testing only. Compliance with electrical safety, EMC, laser radiation management, and biocompatibility standards was verified. No clinical data provided.

Technological Characteristics

Scanning laser ophthalmoscope; uses blue, red, and green lasers. Two-axis deflection via rotating polygon and motor-driven mirror. Discrete light detectors for red/green channels. Digital image reconstruction. Table-mounted scanhead with height adjustment. Compliant with electrical safety and laser radiation standards.

Indications for Use

Indicated for patients requiring wide-field retinal imaging, including fluorescence and autofluorescence, to aid in diagnosis and monitoring of retinal diseases or disorders.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Panoramic 200MA (K060424)
• Panoramic 200CAF (K100644)

Submission Summary (Full Text)

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K102492

Special 510k Summary-Optos P200MAAF

| Name of Device | P200MAAF Ophthalmoscope | | | SEP 30 2010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Common or Usual Name | Scanning laser ophthalmoscope | | | |
| Classification Name | Scanning laser ophthalmoscope<br>(per 21 C.F.R. § 866.1570) | | | |
| Product Code | MYC (Class II) | | | |
| Submitter | Optos plc,<br>Queensferry House,<br>Carnegie Business Campus<br>Dunfermline,<br>Fife,<br>KY11 8GR<br>United Kingdom<br><br>Phone: [phone]<br>Facsimile: 011 44 1383 843333 | | | |
| Contact Person: | Robert Tweedlie Ph.D. | | | |
| Date Prepared | August 31st, 2010 | | | |
| Predicate Device | Optos Limited's Panoramic 200MA (K060424) and<br>Optos Limited's Panoramic 200CAF (K100644) | | | |

#### Indications for Use

The P200MAAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

### Technological Characteristics

The P200MAAF is a conventional scanning laser ophthalmoscope (SLO), which uses a low power laser beam to scan in two dimensions over the retina. The reflected (or returned) light is detected and used to generate a digital image with a computer or electronic imaging device.

The blue, red and green lasers and their corresponding wavelengths are the same in the The blac, Tou and groom as The other predicate, the P200CAF does not have the Opted i zoom it does not have an angiographic mode but it does have the exact same red and green lasers in terms of type and wavelength.

The generation of the image is performed in the conventional manner using light detectors, the generation of the mitized, and the data collected in a computer for reconstruction, the balput of which is ages on the beams on the two axes is done using a

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conventional rotating polygon for the fast vertical scan and a motor driven mirror for the slower horizontal scan. An alignment pattern helps ensure that the patient's eye is correctly positioned.

The reflected energy from the retinal surface is passed back through the device to an array of two discrete detectors (effectively a red and a green channel). For the P200MAAF, P200MA, and the P200CAF, in standard imaging mode, the images produced can be viewed either as a composite image (red and green images combined) or separate as a green channel and a red channel image. The P200MAAF and P200CAF can also generate an alternate red channel image that shows the natural fluorescence (autofluorescence) of the eye. In this imaging mode, the retina is illuminated using the green laser, while the red laser optical path is blocked by a shutter. In this imaging mode, the red channel image now displays the naturally occurring fluorescent material of the retina, such as lipofuscin. The signal strength varies as the laser beam is scanned across the eye, allowing an image to be created and recorded, revealing the variation in its constituent material and structures.

The Panoramic P200MAAF and the P200MA also have an angiographic mode where the red and green lasers are blocked and only the blue laser illuminates the retina. The blue laser causes the fluorescence of an injected contrast media (or dye), fluorescein. Fluorescein absorbs in the blue and emits in the green part of the visible spectrum. In this imaging mode, the green channel now displays the flow (and possible leakage) of the dye through the blood vessels of the eye.

This scanning function is housed in the 'scanhead,' which is seated on a table that can move up and down and this affords a height adjustment to achieve correct patient positioning.

The P200MAAF, P200MA, and P200CAF capture one image at a time and can present each image as a thumbnail sketch. If more than one image is captured, all three devices display a series of thumbnail sketches in the order in which they were scanned. The P200MAAF, like the P200MA and P200CAF, allows the user to view one or more images of the eye.

## Principles of Operation:

The P200MAAF, P200MA, and the P200CAF have very similar principles of operation. Each device uses 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 digitized and used to build up an electronic picture in a computer and displayed either on a cathode ray tube or a liquid crystal display.

### Performance Testing:

Compliance to electrical safety (including EMC), light emitting products, programmable devices and biocompatibility standards are met. Each device is tested for electrical safety, laser power output and correct functioning of the laser radiation management system against set criteria and limits.

## Substantial Equivalence

The P200MAAF has no new intended use, similar principles of operation, and similar The P200MAAT Than ho rice in the predicate devices, the P200MA and the P200CAF. The technological characteristios as the prodicate devices do not raise any new

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questions of safety and effectiveness. Thus, the Optos P200MAAF Ophthalmoscope is substantially equivalent to Optos' legally marketed Scanning Laser Ophthalmoscopes (SLO), the P200MA (K060424) and the P200CAF (K100644).

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Image /page/3/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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Optos PLC c/o Mr. Howard M. Holstein Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K102492

Trade Name: Panoramic 200MAAF Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulation Class: Class II Product Code: MYC Dated: August 31, 2010 Received: August 31, 2010

# Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Costietic Act (110.) that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercedes, market the de 100, belyer to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Tease note: ODICP abos not be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (see above) into inamajor regulations affecting your device can be filly be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I edelar regariting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a backannal equirements of the requirements of the Act

SEP 3.0. 2010

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Page 2 - Mr. Howard M. Holstein

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

- http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological 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): K102492 Device Name: Optos P200MAAF Scanning Laser Ophthalmoscope Indications for Use:

The P200MAAF scanning laser ophthalmoscope is indicated for use as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest 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)

9/30/2010
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102492

SEP 3 0 2010

102492