(74 days)
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No
The summary provides no information about AI/ML, image processing, or performance studies that would typically be associated with such technologies in a medical device. The description focuses solely on the lens itself and its intended use with a scanning laser ophthalmoscope.
No
The device is described as a "scanning laser lens" indicated for use with a "wide field scanning laser ophthalmoscope," which is a diagnostic imaging tool, not a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is "indicated for use whenever a wide field scanning laser ophthalmoscope is indicated." A scanning laser ophthalmoscope is typically an imaging device used to visualize the retina, not to diagnose a condition. The provided information does not mention any diagnostic capabilities or output.
No
The device is described as a "Staurenghi Wide Field Scanning laser lens," which is a physical lens used with a scanning laser ophthalmoscope. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is for use with a scanning laser ophthalmoscope, which is used to examine the eye directly, not a specimen taken from the body.
- The description focuses on a lens for an ophthalmoscope. This is a piece of equipment used for direct examination of the eye, not for analyzing biological samples.
Therefore, the Staurenghi Wide Field Scanning laser lens, as described, falls under the category of an ophthalmic device used for in-vivo examination, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide field scanning laser ophthalmoscope is indicated.
Product codes
HJK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
4 2002 MAR
Mr. Raymond Graham Director of Engineering & Product Development Ocular Instruments, Inc. 2255 116th Ave., N.E. Bellevue, WA 98004-3039
K014170 Re:
Trade/Device Name: Staurenghi Wide Field Scanning Laser Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate Diagnostic Contact Lens Regulatory Class: II Product Code: HJK Dated: December 18, 2001 Received: December 20, 2001
Dear Mr. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 for ass bated in the encreases) it 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.
1
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,
A. Ralph 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
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Page _ of _
510 (K) Number (If Known): K014170
Device Name: Staurenghi Wide Field Scanning Laser lens
Indications for use:
The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide The Stadienthin Wide Hold Scanithing laser ophthalmoscope is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| 2-15-2002 | |
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devices | |
| 510(k) Number | K014170 |
| Prescription Use | X | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| ------------------ | --- | ---- | ----------------------------- |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)(Optional Format 1-2-96)