OPTYSE OPHTHALMOSCOPE

K061278 · Ophthalmos , Ltd. · HLJ · May 16, 2006 · Ophthalmic

Device Facts

• Record ID: K061278
• Device Name: OPTYSE OPHTHALMOSCOPE
• Applicant: Ophthalmos , Ltd.
• Product Code: HLJ · Ophthalmic
• Decision Date: May 16, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

Device Story

Optyse™ is a compact, battery-powered, handheld direct ophthalmoscope. Device uses internal illumination source to allow trained professionals to view patient's retina/fundus. Operation involves manual positioning by clinician to visualize internal eye structures; provides reversed image of retina. Used in clinical settings for routine eye examinations. Benefits include portability and ease of use for visualizing abnormalities indicative of medical conditions. No complex processing or digital output; device is purely optical/mechanical.

Clinical Evidence

No clinical trials required. User studies comparing Optyse™ to legally marketed ophthalmoscopes demonstrated equivalent performance in clarity of view and ability to visualize abnormalities. Bench testing confirmed compliance with ISO 10942 (Ophthalmic Instruments – Direct Ophthalmoscopes) and IEC 60601-1 (Medical Electrical Equipment Safety).

Technological Characteristics

Handheld, battery-powered (alkaline) direct ophthalmoscope. Features include illumination source, optical viewing system, and carrying case. Complies with ISO 10942 and IEC 60601-1. No software or digital connectivity.

Indications for Use

Indicated for use by trained professionals to examine the fundus or the inside of the back of the eye in patients.

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

• Uni II (K925756)

Submission Summary (Full Text)

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Ophthalmos Ltd. Optyse™ USA 510(k) Submission

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## SECTION 6: 510(K) SUMMARY

510(k) Summary of Safety and Effectiveness as required per 21 CFR 807.92. April 15, 2006

- (1) Submitter Details:
Ophthalmos Ltd Abbey Barns Duxford Road Ickleton Cambridge CB10 1SX United Kingdom

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Contact: Laura Garcia Position: Chief Executive Officer Phone: [phone] Fax: [phone]

Date of submission: April 15, 2006

#### (2) Device Name and Classification

Device name: Optyse™ Device Common Name: Ophthalmoscope

#### Classification, product code (3)

| Class: | II |
|---------------|---------------------------------|
| Product Code: | HLJ |
| CFR: 886.1570 | Ophthalmoscope, battery-powered |

#### (4) Predicate Device Information

The device has been compared to the following cleared device:

| Company | Device | 510(k) |
|---------------------|--------|---------|
| Rudolf Riester GMBH | Uni II | K925756 |

#### (5) Device Description

The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.

#### (6) Intended Use

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

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#### (7) Technological Characteristics

The Optyse™ is very similar in design to commercially available hand-held ophthalmoscopes including the named predicate device, the Reister Uni II ophthalmoscope (510 (k) # K925756). The Optyse™ and the Uni II are both considered to be pocket sized, simple direct ophthalmoscopes having the same intended use. The viewing systems use similar sources of illumination, are powered by alkaline batteries and provide a reversed image of the patient's retina to the trained personnel. Both kits are provided with simple carrying cases for storage when the ophthalmoscope is not in use.

#### (8) Performance Data

#### a. Non-clinical tests

The Optyse™ has been compared with legally marketed devices and has been tested according to the standards listed below.

### ISO 10942

Compliance testing of the Optyse™ device to ISO 10942:1998 Ophthalmic Instruments – Direct Ophthalmoscopes has been conducted and a declaration of conformity provided.

### IEC 60601-1

Compliance testing of the Optyse™ device to IEC 60601-1:1988 Medical Electrical Equipment - Part 1 Requirements for Safety (General) has been conducted and a declaration of conformity provided.

#### b. Clinical performance data for equivalence

Clinical trials were not required, however, user studies comparing the effectiveness of the Optyse™ with legally marketed ophthalmoscopes by practising optometrists demonstrated equivalent performance in clarity of view and ability to visualise abnormalities that may be indicative of medical conditions.

### Summary

The comparison of intended use and technological features of the Optyse™ device with the cleared device taken together with the safety and effectiveness tests and other information in this submission indicate the device is substantially equivalent in safety, effectiveness and intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ophthalmos Ltd c/o Mr. Neil E. Devine Intertek Testing Services 2307 East Aurora Rd. Twinsburg, OH 44087

Re: K061278

MAY 16 2006

. Trade/Device Name: Optyse™ Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HLJ Dated: May 4, 2006 Received: May 8, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encreations of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, as excerdance with the provisions of the Federal Food, Drug, de necs that have been recised in at require approval of a premarket approval application (PMA). and Costinetter (110.) that to novice, subject to the general controls provisions of the Act. The I ou may, dicrorore, mains of the Act include requirements for annual registration, listing of general voltaren profissioning 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 If your de ree 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. Neil E. Devine

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

MB Eychhus - MD

Malvina B. Eydelman, 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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## INDICATIONS FOR USE

Indications for Use

510(k) Number (if known):

K061278 (k)

Device Name:

Optyse TM Ophthalmoscope

Indications For Use:

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used to examine the fundus or the inside of the back of the eye

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Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Division of t Nosa and

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