PANORAMIC200 OPTHALMOSCOPE

K983999 · Optos Plc. · HLI · Feb 3, 1999 · Ophthalmic

Device Facts

• Record ID: K983999
• Device Name: PANORAMIC200 OPTHALMOSCOPE
• Applicant: Optos Plc.
• Product Code: HLI · Ophthalmic
• Decision Date: Feb 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

Optos plc's ("Optos") Panoramic200 and Odyssey Optical System's S2LO ("the Odyssey SLO") and G. Rodenstock Instruments GmbH Scanning Laser Ophthalmoscopes ("the 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 and disorders that manifest themselves in the posterior pole of the eye.

Device Story

Scanning Laser Ophthalmoscope (SLO) for retinal examination; uses laser light source scanned across retina in two axes; returned light converted to electrical signal by detector; signal digitized to generate electronic color image; displayed on CRT or LCD monitor. Used by clinicians to diagnose/monitor posterior pole diseases. Differences from predicates include wider imaging angle, higher resolution, lack of infrared laser, and specific deflection system/display format. Benefits include wide-field visualization of retinal pathology to aid clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only. Device complies with BS EN 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, BS EN 60825-1, UL2601, CAN/CSA-C22.2 No.601.1-M90, AS 3200.1/NZ 6150, and JIST 1001/1002 standards.

Technological Characteristics

Scanning Laser Ophthalmoscope (SLO); laser light source; two-axis deflection system; light detector; digitizer; PC-based image processing; CRT/LCD display. Class I laser device. Complies with 21 C.F.R. 1010/1040 and various electrical safety standards (BS EN 60601 series, UL2601, CSA 601.1).

Indications for Use

Indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders manifesting in the posterior pole of the eye.

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

• S2LO (K981640)
• Scanning Laser Ophthalmoscope (SLO) (K882517)
• Scanning Laser Ophthalmoscope (SLO) (K871268)

Submission Summary (Full Text)

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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<br>(per 21 C.F.R. 866.1570) |
| Product Code | HLI |
| Submitter | Optos plc<br>16 Comely Park,<br>Dunfermline,<br>Fife,<br>Scotland<br>United 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 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.

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. General<br>requirements for safety; |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN 60601-1-1:1993 | Medical electrical equipment. General<br>requirements for safety. Collateral standard. Safety<br>requirements for medical electrical systems; |
| BS EN 60601-1-2:1993 | Medical electrical equipment. General<br>requirements for safety. Collateral standard.<br>Electromagnetic compatibility |

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| BS EN 60601-1-4:1997 | Medical electrical equipment. General<br>requirements for safety. Collateral standard.<br>General requirements for programmable electrica<br>medical systems. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN 60825-1:1994<br>AMD2 | Safety of laser products. Part 1. Equipment<br>classification, requirements and user's guide. |
| UL2601:1994 | Medical electrical equipment. General<br>requirements for safety. |
| CAN/CSA-C22.2<br>No.601.1-M90 | Medical electrical equipment. General<br>requirements for safety. |
| AS 3200.1:1990/<br>NZ 6150:1990 | Medical electrical equipment. General<br>requirements for safety. |
| JIST 1001/1002:1992 | Medical electrical equipment. General<br>requirements 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

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)