P200T

K111628 · Optos Plc. · MYC · Aug 19, 2011 · Ophthalmic

Device Facts

• Record ID: K111628
• Device Name: P200T
• Applicant: Optos Plc.
• Product Code: MYC · Ophthalmic
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The P200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Device Story

P200T is a scanning laser ophthalmoscope (SLO) for wide-field retinal and autofluorescence imaging. Device uses lasers scanned in two axes across retina; returned light captured by detector, converted to electrical signal, digitized, and processed into electronic image for display on CRT or LCD. Operated by clinicians in clinical settings. Modifications from predicate include tabletop form factor, removal of powered table/headrest (replaced by handgrips), direct-drive horizontal scan mirror, optional touchscreen, and consolidated laser power monitoring/shutter system. Autofluorescence imaging achieved by switching off red laser and using fixed optical elements instead of translation stage. Output aids clinicians in diagnosing and monitoring retinal pathology.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of modifications.

Technological Characteristics

Scanning laser ophthalmoscope; lasers as light source; two-axis deflection system; electronic detector; digitized signal processing. Modifications: direct-drive horizontal scan mirror; combined laser power monitoring; single exposure shutter; fixed optical path for autofluorescence (no translation stage). Connectivity: electronic subsystem cable connection. User interface: monitor, keyboard, mouse, optional touchscreen. Patient support: face pad and handgrips.

Indications for Use

Indicated for use as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of retinal diseases or disorders in patients requiring retinal imaging.

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

• Optos Limited's Panoramic 200CAF (K100644)

Submission Summary (Full Text)

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K111628

#### Special 510k Summary

| | | AUG 1 9 2011 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|--------------------|
| Name of Device | P200T Ophthalmoscope | |
| Common or Usual Name | Scanning laser ophthalmoscope | |
| Classification Name | Scanning laser ophthalmoscope (21 C.F.R. § 866.1570) | |
| Product Code | MYC | |
| Submitter | Optos plc,<br>Queensferry House,<br>Carnegie Business Campus<br>Dunfermline,<br>Fife,<br>KY11 8GR<br>United Kingdom | |
| | Phone: | 011 44 1383 843300 |
| | Facsimile: | 011 44 1383 843333 |
| Contact Person: | Robert Tweedlie, Ph.D. | |
| Date Prepared | July 21, 2011 | |
| Predicate Device | Optos Limited's Panoramic 200CAF (K100644) | |
| Indications for Use | | |

The P200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

## Principles of Operation and Technological Characteristics

The Optos P200T is a scanning laser ophthalmoscope that 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.

### Summary of Modifications to the Predicate Device

- The scanhead used for image capture is in a different enclosure and is a table top model; .
- There is no head and chin rest, but there are external handgrips to help patient positioning; .
- There is no powered table which attaches onto the scanhead; rather, there is an electronic . enclosure that connects to the scanhead;
- The mirror used for the horizontal scan is directly connected to a motor, whereas the . horizontal scan mirror in the predicate device is motor driven via a drive bell;
- An optional touch screen monitor is used, rather than a monitor, keyboard, and mouse; .
- Combined laser power monitoring and a single exposure shutter are used, rather than . individual laser power monitoring and individual shutters for each wavelength channel;

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- The return path does not have a translation stage to move optical elements in and out of this . path;
- The autofluorescence sensor has been replaced with a new sensor with greater sensitivity; . and
- The Laser Radiation Management (LRM) firmware and capture software have minor changes . consistent with the modifications described above.

# Table of Modifications

()

| Sub-category | P200CAF | P200T |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Imaging Modes | Imaging modes are the same<br>Autofluorescence is effected by<br>laser select shutter being closed<br>and return path has optical<br>elements removed using a<br>translation stage for<br>autofluorescence. Belt drive for horizontal slow scan<br>mirror Translation stage moves optical<br>elements out of return path for<br>autofluorescence mode | Imaging modes are the same<br>Autofluorescence is effected by<br>switching off red laser and return<br>path has fixed optical elements Direct drive for horizontal slow<br>scan mirror Detector gain change for<br>autofluorescence; no translation<br>stage |
| User Interface | Scan head rests on a supporting,<br>powered table Scan head has integrated monitor Remote review/storage PC User interface:<br>- Monitor, keyboard and mouse<br>- Handheld patient capture button<br>- Handheld table up/down button | Scan head rests on a supporting<br>table Scanhead has integrated monitor Remote review/storage PC User interface:<br>- Monitor, keyboard and mouse<br>- Touchscreen optional<br>- Handheld patient capture button |
| Patient alignment<br>system (PAS) | Same for both devices | Same for both devices |
| Laser Radiation<br>Management<br>(Including safety<br>software) | Individual laser power monitoring Individual laser shutters and<br>separate exposure shutter Vertical and horizontal scan status<br>monitoring All lasers disable on failure Shutter closure on failure System lock-out on failure Exposure timing monitor Exposure rate control Dual redundancy | Combined laser power monitoring Single exposure shutter Vertical and horizontal scan status<br>monitoring R/G disable on failure Shutter closure on failure System lock-out on failure Exposure timing monitor Exposure rate control Dual redundancy |
| System<br>configuration | Scanhead attached to a powered<br>table | Scanhead connected by cable to<br>an electronic subsystem |
| Patient support | Head rest/Chin support<br>Face pad | Face pad and handgrips |

### Substantial Equivalence

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The Panoramic 200T has the same intended use and indications for use and similar principles of operation and technological characteristics as the predicate device. The minor technological differences between the Panoramic 200T and the predicate device do not raise any new questions of safety and effectiveness. Thus, the Optos Panoramic 200T Ophthalmoscope is substantially equivalent to Optos' legally marketed Scanning Laser Ophthalmoscope (SLO), the P200CAF (K100644).

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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

AUG 1 9 2011

Re: K111628

Trade Name: Optos Panoramic 2007' Scanning Laser Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulation Class: Class II Product Code: MYC Dated: July 21, 2011 Received: July 21, 2011

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tesia 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):

KIII628

Device Name: Optos Panoramic 200T Scanning Laser Ophthalmoscope Indications for Use:

The Panoramic 200T scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Prescription Use V (Per 21 C.F.R. 801.109)

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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)

Deon

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

510(k) Number K111628