(8 days)
Not Found
No
The summary describes a standard direct ophthalmoscope and does not mention any features related to image processing, AI, or ML. The performance studies compare it to legally marketed ophthalmoscopes based on clarity of view and ability to visualize abnormalities, which are typical metrics for this type of device.
No.
The descriptions indicate its use for examination and viewing, rather than treatment or therapy.
Yes
The device is intended to be used by trained professionals to 'examine the fundus or the inside of the back of the eye' and to 'visualise abnormalities that may be indicative of medical conditions', which directly relates to the process of diagnosing conditions.
No
The device description explicitly states it is a "compact battery-powered handheld direct ophthalmoscope," indicating it is a hardware device.
Based on the provided information, the Optyse™ Lens Free Ophthalmoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Optyse™ function: The Optyse™ is a direct ophthalmoscope used to visually examine the inside of the back of the eye (fundus). It does not perform tests on samples taken from the body. It is a tool for direct observation.
Therefore, the Optyse™ falls under the category of a medical device used for examination and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HLJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus or the inside of the back of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel, trained professionals
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Ophthalmos Ltd. Optyse™ USA 510(k) Submission
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K061278'. The characters are written in a bold, dark font, and they are slightly uneven in size and spacing. The background of the image is plain white.
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: +44 1799 532777 Fax: +44 1799 532701
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight, stacked on top of each other.
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 (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/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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Device Evaluation (ODE)
Stenia L. McCarthy
Division of t Nosa and
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