(127 days)
The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens
This document is a marketing authorization for a contact lens and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the regulatory approval process for the Continental 45 Toric (hefilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample size used, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
- Information about MRMC studies, standalone performance, or the ground truth used for such studies.
- Sample size for a training set or how ground truth for a training set was established.
The document is a regulatory approval letter and an "Indications For Use" statement. It does not detail the technical performance or validation studies of the contact lens.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed to the right of the department's name. The department's name is written in a circular fashion around the left side of the caduceus. The text reads, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1999
Mr. Kim McQuarrie, President Continental Soft Lens, Inc. 10 Glenview Drive Littleton, CO 80123
Re: K990011
Trade Name: Continental 45 Toric (hefilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: April 19, 1999 Received: April 21, 1999
Dear Mr. McQuarrie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Kim McQuarrie, President
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) K990011 Continental 45 Toric
April 19, 1999
INDICATIONS FOR USE
The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over the Counter Use
Myra Smith
Division Sign-Off)
Division of Ophthalmic Devices
K990011 «k) Number __
(Optional Format 1-2-96)
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.