(71 days)
LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.
LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear
The provided text is a 510(k) clearance letter from the FDA for a contact lens device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges the trade name "LL Bi-Focal, Soft (hydrophilic) Contact lens for Daily Wear" and states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, I would need a document detailing the specific study conducted for the device's clearance, including acceptance criteria, study design, results, and statistical analysis.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human profiles facing right, with flowing lines above them, resembling a flag or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Hahn Director of Regulatory Affairs Lombart Lenses Division of Biocompatibles, Inc. 1215 Boissevain Ave. Norfolk, VA 23507
JUL 1 5 1997
Re: K971647
Trade Name: LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: May 1, 1997 Received: May 5, 1997
Dear Ms. Hahn:
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.
{1}------------------------------------------------
Page 2 - Ms. Lisa Hahn
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 Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Biocompatibles Eyecare Inc.
510(K) Number (if known) 4911641 LL BI-FOCAL SOFT (HYDROPHILIC) CONTACT LENSES Device Name___________________________________________________________________________________________________________________________________________________________________ Indications For Use
LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by INDICATIONS (USES): presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.
(PLEASE DO NOT - WRITE BELOW THIS LINE - CONTINUE ON ANTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use __
Daniel W. C. Brown P.H.D
(Optional Format 1-2-96)
510(k) Number
§ 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.