(50 days)
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No
The summary describes a disposable vitrectomy lens, a passive optical device, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "Disposable Vitrectomy Lens" used to visualize ocular structures during surgery. Its function is to aid visualization, not to directly treat or prevent a disease or condition.
No
The device is described as a "Disposable Vitrectomy Lens" primarily for "visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery." Its function is to allow the surgeon to see, which is an aid to a medical procedure, not a diagnostic act in itself. It does not analyze data or provide a diagnosis.
No
The device description explicitly states "Disposable Vitrectomy Lens," which is a physical hardware component used during surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery." This describes a device used during a surgical procedure to aid the surgeon's vision.
- Device Description: The device is a "Disposable Vitrectomy Lens." This is a physical tool used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such function. It is a surgical instrument.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.
Product codes
HJK
Device Description
Disposable Vitrectomy Lens
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
ocular fundus, vitreous, and retinal structures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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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§ 886.1385 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2001
Ocular Instruments, Inc. c/o Mr. Raymond Graham Director of Engineering & Product Development 2255 116th Ave., N.E. Bellevue, WA 98004-3039
Re: 510(K) Number: K012096 Trade/Device Name: Disposable Vitrectomy Lens Regulation Number: 21 CFR 886.1385 Regulatory Class: Class II Product Code: HJK Dated: July 3, 2001 Received: July 5, 2001
Dear Mr. Graham:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becamed the device is substantially equivalent (for the indications for use above and we and oure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the enorthere) (Device Amendments, or to devices that have been reclassified in enacificant anie of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general controls provisions of the Act. The general chercedes, mailier the device as lude 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarited i Ipproval), it the Code of Federal Regulations, Title 21, Parts 800 to ancecing your don't lee can valent determination assumes compliance with the Current Good 099. It substantially of of a quirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponesis) with the GMP regulation may result in regulatory action. In addition, FDA may collips " will one of comments concerning your device in the Federal Register. Please note: publication and caremarket notification submission does not affect any obligation you this response to your premation of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Raymond Graham
This letter will allow you to begin marketing your device as described in your 510(k) premarker notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The PDF mically of casswation 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 II you distre specific at not ro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please 571-6115. Italiaonal), roompliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information " Misoranonig by reletence to prematics nounceaver (2) virision of Small Manufacturers On your responsibilities and and and and are (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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
2
510(k) Number KOJ 2096
DEVICE NAME Disposable Vitrectomy Lens
INDICATIONS FOR USE
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use __ X
Over-The Counter-Use _ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel W.C. Brown, Ph.D.
ivision of Ophthalmic Devices K012096 510(k) Number