(142 days)
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Not Found
No
The description focuses on the optical and mechanical components of a traditional ophthalmoscope and does not mention any computational or algorithmic features indicative of AI/ML.
No
The device is intended for examination and viewing purposes, not for treating conditions or ailments.
Yes
The device is used to examine structures of the eye (cornea, aqueous, lens, vitreous, and retina), which is a diagnostic activity to evaluate for abnormalities or conditions.
No
The device description explicitly details physical components such as objective lenses, relay components, eyepiece, filament lamp, condensing system, and mirrors, indicating it is a hardware device.
Based on the provided information, the Keeler Wide Angle Ophthalmoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Keeler Wide Angle Ophthalmoscope is to examine the structures within the eye (cornea, aqueous, lens, vitreous, and retina) directly on the patient.
- The device description details an optical system for direct visualization. It describes how light is projected into the eye and how the image of the eye's internal structures is viewed by the practitioner. This is a direct examination method, not an in vitro test.
- There is no mention of analyzing biological samples. The device does not process blood, urine, tissue, or any other specimen taken from the patient.
Therefore, the Keeler Wide Angle Ophthalmoscope is a medical device used for direct examination of the eye, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
HLJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cornea, aqueous, lens, vitreous, and retina of the eye
Indicated Patient Age Range
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Intended User / Care Setting
trained personnel within a medical or school environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Welch Allyn 11800 Ophthalmoscope
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 886.1570 Ophthalmoscope.
(a)
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.(b)
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.
0
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 |
| Common/Usual Name - Ophthalmoscope | |
| 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.
1
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
Risk Analysis stage, right through the project to ensure that the Keeler
Wide Angle Ophthalmoscope is as safe as or safer than existing similar
devices already in the market place. The specific safety areas considered
are as follows: |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Toxicity - | Materials used are neither toxic nor known to create significant allergic
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
IR filtering complies with EN ISO-15004. |
| Corrosion - | Device is non-corrosive |
| Explosion - | Highly unlikely; manufactured of non-explosive materials. Uses approved
medical grade power supplies already on the market. |
| Surface -
Temperature | All surfaces have been evaluated for practitioner and patient contact. |
| Fire Hazard - | Probability extremely low. This system is illuminated by a xenon lamp,
which draws a maximum of 2.6 watts of power. |
| Mechanical - | The instrument has been designed to ensure that the risk of physical injury
when performing the intended function(s) has been reduced as much is
practicable. |
2
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.
3
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.
4
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
5
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 _
1-1