PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS

K053425 · Precision Optics Corp. · HLJ · Jan 9, 2006 · Ophthalmic

Device Facts

• Record ID: K053425
• Device Name: PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
• Applicant: Precision Optics Corp.
• Product Code: HLJ · Ophthalmic
• Decision Date: Jan 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.

Device Story

Handheld indirect and direct monocular video ophthalmoscope; used by trained personnel for eye examinations. Device utilizes objective lenses, relays, and a beamsplitter to provide an erect, un-reversed image of the retina. Beamsplitter enables simultaneous direct viewing by the clinician and video imaging on a monitor for local or remote (telemedicine) viewing. Output allows clinicians to visualize ocular structures to assist in diagnosis and patient assessment.

Clinical Evidence

Bench testing only. Compliance with international standards for electrical safety (IEC 60601-1) and optical radiation (ISO 10942 and ISO 10943) was verified. Maximum device temperatures were measured below 33°C.

Technological Characteristics

Handheld monocular ophthalmoscope; includes objective lenses, relays, and beamsplitter. Complies with IEC 60601-1, ISO 10942, and ISO 10943. Battery powered. No software-based automated analysis or algorithm described.

Indications for Use

Indicated for use by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina 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

• Welch Allyn Video Ophthalmoscope (K951210)

Submission Summary (Full Text)

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K053425

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JAN 9 2006

## SECTION VII

### 510(k) SUMMARY

| Submitter's Name & Address: | Precision Optics Corporation, Inc.<br>22 East Broadway<br>Gardner, MA 01440 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Erwin E. Heider |
| Telephone: | 978-630-1800 x 155 |
| Telefax: | 978-630-1487 |
| Date Summary Prepared: | July 29, 2005 |
| Device Name: | Classification Name - Direct and Indirect Ophthalmoscope<br>Common / Usual Name – Video Ophthalmoscope<br>Model Number - 2500-VOS |
| C.F.R. Section: | 886.1570 |
| Product Code: | HLJ |
| Device Class: | II |
| Classification Panel: | Ophthalmic (Battery Powered) |
| Predicate Device: | Welch Allyn Video Ophthalmoscope (510(k) #K951210) |

#### Device Description:

The Precision Optics Corporation Video Ophthalmoscope is a hand held indirect and direct monocular device for use by trained personnel for viewing / examining the cornea, agueous, lens, vitreous, and retina of the patient's eye(s). The viewing path is split in two via a beamsplitter to provide for direct viewing by the trained personnel as well as simultaneous video imaging on a monitor either near or at the patient or at a remote site via telemedicine techniques. The viewing system is comprised of objective lenses, relays, a beamsplitter, and eyepiece and provides an erect, un-reversed image of the patient's retina to the trained personnel.

#### Intended Use:

This ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.

## Technological Characteristics & Comparison to Predicate Device:

The Precision Optics Corporation video ophthalmoscope is very similar in design and performance to the Welch Allyn video ophthalmoscope (510(k) #K951210). The design and construction of the beamsplitter portion as well as most technical parameters are identical. Minor differences exist in the illumination controls, number of apertures, number of filters, specific diopter settings and shape of handle, but these differences are not critical to performance Page 07-02

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### SECTION VII

in general use. The Maximum Device Temperatures of the Welch Allyn video ophthalmoscope were not known, but those measured for the Precision Optics video ophthalmoscope were all below 33 ℃. Also, tests performed to determine electrical and optical radiation safety of the Welch Allyn video ophthalmoscope were unknown. The Precision Optics Corporation video ophthalmoscope complies with international standards for electrical safety (IEC 60601-1) and optical radiation (ISO 10942 and ISO 10943 - Section 5.5).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 9 2006

2006

Precision Optics Corporation c/o Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Rd. Boxborough, MA 01719

Re: K053425

Trade/Device Name: Precision Optics Corporation Video Ophthalmoscope, Model 2500-VOS Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: December 28, 2005 Received: December 29, 2005

Dear Mr. Devinc:

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 ass suited in also encreated 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.

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Page 2 - Neil E. Devine, Jr.

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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/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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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SECTION III

# Indications for Use

510(k) Number (if known):

510(k) Number (if known):

Device Name: Precision Optics Corporation Video Ophthalmoscope (2500-VOS)

Indications For Use: The Vidco Ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OBE)

Evenett R. Burns

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

510(k) Number K05342

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