(51 days)
The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
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The provided text is a 510(k) premarket notification letter from the FDA to FCI Ophthalmics, Inc., regarding several ophthalmic devices: Disposable Vitrectomy Lenses, Disposable Infusion Cannula, and Surgical Knife.
This document confirms substantial equivalence of these devices to previously marketed predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative notification of regulatory clearance, not a performance study report.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on:
- Regulatory Clearance: Granting permission to market the devices based on substantial equivalence.
- Device Classification: Class II, Class I, and Class I for the respective devices.
- Indications for Use: Describing the intended purpose of each component within the vitrectomy set.
- General Regulatory Requirements: Reminding the manufacturer of ongoing obligations like registration, labeling, and good manufacturing practices.
Crucially, there is no mention of specific acceptance criteria (metrics, thresholds), study designs, sample sizes, expert ground truth establishment, or any performance data that would answer the questions posed.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus with three wavy lines representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
FCI Ophthalmics, Inc. c/o Hillard W. Welch U.S. Representative for FCI 344 Annabelle Point Road Centerville, MA 02632-2402
Re: K030054
Trade/Device Name: Disposable Vitrectomy Lenses Disposable Infusion Cannula Surgical Knife Regulation Number: 21 CFR 886.1385; 21 CFR 886.4350 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II; Class I; Class I Product Code: HJK; HMX; HMX; HNN Dated: December 31, 2002 Received: January 6, 2003
Dear Mr. Welch:
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.
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Page 2 - Hillard W. Welch
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 Kalgi korenthal
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
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K030054 510(k) Number (if known):
Disposable Vitrectomy Set Disposable Vitrectomy Lenses
Device Name:
Indications for Use:
The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jake W. Brown, Ph.D.
Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K030054
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.