KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

K032087 · Keeler Instruments, Inc. · HLJ · Nov 26, 2003 · Ophthalmic

Device Facts

• Record ID: K032087
• Device Name: KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
• Applicant: Keeler Instruments, Inc.
• Product Code: HLJ · Ophthalmic
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

Device Story

Hand-held monocular indirect ophthalmoscope; used by trained personnel in medical or school settings. Device utilizes filament lamp, condensing system, and mirror assembly (two full mirrors, one semi-reflector) to illuminate and view patient eye. Condensing lenses image lamp filament onto patient cornea; light stops trap corneal reflections to provide reflex-free retinal images. Provides larger field of view than conventional direct ophthalmoscopes; produces erect, un-reversed retinal image. Enables thorough retinal examination while minimizing exam/exposure time. Practitioner views retina directly through eyepiece; output facilitates clinical diagnosis of ocular structures.

Clinical Evidence

No clinical trials; effectiveness established via physician assessments. Development teams conducted assessments with practicing physicians using the subject device and competitor models. Results indicated the device meets practitioner needs and performs in an equivalent or better manner than existing monocular indirect ophthalmoscopes.

Technological Characteristics

Monocular indirect ophthalmoscope; 3.5V power source; Xenon lamp illumination; glass viewing optics. Dimensions: 190mm x 120mm x 45mm; weight: 300g. Complies with EN ISO 15004 for electrical safety and UV/IR filtering. Non-corrosive materials. Manual operation; no software or connectivity.

Indications for Use

Indicated for examination of the cornea, aqueous, lens, vitreous, and retina of the eye by trained personnel in medical or school environments.

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 11800 Ophthalmoscope

Submission Summary (Full Text)

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# NOV 2 6 2003

## K032087

### "510(k) SUMMARY" Summary of Safety and Effectiveness

# Submitter's Name & Address:Keeler Instruments Inc. 456 Parkway Broomall, PA. 19008

Contact Person & Telephone: Eugene R. VanArsdale (610)-353-4350

| Date Summary Prepared: | July 2, 2003 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Classification Name - Indirect Ophthalmoscope<br>Common/Usual Name - Ophthalmoscope<br>Proprietary Name - Keeler Wide Angle Ophthalmoscope |
| Predicate Device: | Welch Allyn 11800 Ophthalmoscope |

#### Device Description, Intended Use & Effectiveness:

The Keeler Wide Angle Ophthalmoscope is a hand held indirect monocular device for use by trained personnel for viewing the cornea and retina of a patient. The viewing path in conjunction with the large solid angle projection of the illumination path provides two angles of view which provides larger fields of view than attainable with a conventional direct ophthalmoscope. The viewing optical system composes of two objective lenses, relay components and eyepiece provide an erect, un-reversed image of the patients retina to the doctor.

The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil.

Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

This instrument with it two larger field of views and increased ease of entry allows for a more thorough examination of the retina while minimizing the exam and exposure time to the patient. The effectiveness of the Keeler Wide Angle Ophthalmoscope is the same as current monocular indirect ophthalmoscopes already on the market.

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Technological Characteristics:

| Criteria | Keeler Wide Angle Ophthalmoscope | |
|-----------------|----------------------------------|--|
| | Model No: 1130-P-5004 | |
| Type: | Monocular Indirect | |
| Power Source: | 3.5 volts | |
| Illumination: | Xenon lamp | |
| Viewing Optics: | Glass | |
| Image Position: | Right Side Up | |
| Size: | 190mmL x 120mmH, x 45mmW | |
| Weight | 300 grams | |
| Date Introduced | 2003 | |

| Safety: | An abundance of safety areas were investigated and reviewed from the<br>Risk Analysis stage, right through the project to ensure that the Keeler<br>Wide Angle Ophthalmoscope is as safe as or safer than existing similar<br>devices already in the market place. The specific safety areas considered<br>are as follows: |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Toxicity - | Materials used are neither toxic nor known to create significant allergic<br>reactions when used as intended by the manufacturer. |
| Electrical - | External test house approval to EN ISO 15004 |
| Light - | Light output levels are consistent to similar devices in the field, UV and<br>IR filtering complies with EN ISO-15004. |
| Corrosion - | Device is non-corrosive |
| Explosion - | Highly unlikely; manufactured of non-explosive materials. Uses approved<br>medical grade power supplies already on the market. |
| Surface -<br>Temperature | All surfaces have been evaluated for practitioner and patient contact. |
| Fire Hazard - | Probability extremely low. This system is illuminated by a xenon lamp,<br>which draws a maximum of 2.6 watts of power. |
| Mechanical - | The instrument has been designed to ensure that the risk of physical injury<br>when performing the intended function(s) has been reduced as much is<br>practicable. |

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#### Product Risk Assessment to EN1441, Risk Analysis, Verification and Design validation were conducted on this device.

# Summary of Effectiveness:

The determination of device effectiveness was co-coordinated in the following manner.

The Keeler Wide Angle Ophthalmoscope development teams conducted assessments of the device with practicing physicians in an effort to establish if the device met all of the practitioner's needs.

The evaluating physicians were also users of either the Keeler Ophthalmoscope or a competitor's model (all have the same intended use). The results of the assessments indicated that the Keeler Wide Angle Ophthalmoscope performs the needs of the documentation procedure in an equivalent or better manner of effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by a staff with two snakes entwined around it, topped with a set of three human profiles facing to the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2003

Keeler Instruments Inc. % Mr. Eugene R. VanArsdale Marketing Manager 456 Parkway Broomall, PA 19008-4295

Re: K032087

Trade/Device Name: Keeler Wide Angle Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: October 20, 2003 Received: October 21, 2003

Dear Mr. VanArsdale:

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, 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 - Mr. Eugene R. VanArsdale

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/dsma/dsmamain.html

Sincerely yours,

A. Palgi Rosenthal

A. Ralph Rosenthal, 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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#### Intended Use:

Applicant: Keeler Instruments Inc.

510(k) Number (if known): `K032087

Device Name: Keeler Wide Angle Ophthalmoscope

Indications for Use:

The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

| Prescription Use | V |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Optional Format 1-2-96)

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

> ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

> > (Per 21 CFR 801.109)

Callaway

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

K032087 510(k) Number _

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