(32 days)
Not Found
No
The summary describes a video ophthalmoscope with a split viewing path for direct observation and video imaging. There is no mention of AI, ML, image processing, or any algorithms that would suggest the use of such technologies for analysis or interpretation. The device appears to be a tool for visualization, not automated analysis.
No
The device is described as a viewing/examining tool (diagnostic) and does not mention any therapeutic function or intent to treat.
Yes
Explanation: The device is used to "examine the cornea, aqueous, lens, vitreous, and retina of the eye," which directly relates to assessing a patient’s health condition and making decisions about diagnosis or treatment. The act of "examining" these parts of the eye suggests an evaluative function, which is the core purpose of a diagnostic device.
No
The device description explicitly states it is a "hand held indirect and direct monocular device" with physical components like "objective lenses, relays, a beamsplitter, and eyepiece," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Vidco Ophthalmoscope is used to directly examine the internal structures of the eye within the patient's body. It's a diagnostic tool, but it's used for in vivo examination, not in vitro testing of specimens.
The description clearly states it's a device for viewing and examining parts of the eye directly. This falls under the category of an ophthalmic diagnostic device, not an IVD.
N/A
Intended Use / Indications for Use
This ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.
The Vidco Ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.
Product codes (comma separated list FDA assigned to the subject device)
HLJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea, aqueous, lens, vitreous, and retina of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 Video Ophthalmoscope (510(k) #K951210)
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.
Not Found
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).
Not Found
§ 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.
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JAN 9 2006
SECTION VII
510(k) SUMMARY
| Submitter's Name & Address: | Precision Optics Corporation, Inc.
22 East Broadway
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
Common / Usual Name – Video Ophthalmoscope
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 (301) 827-8910. 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/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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