(63 days)
For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses
Not Found
The provided document is a 510(k) premarket notification decision letter from the FDA to UNILENS Corporation, USA. It concerns the conversion of soft (hydrophilic) daily wear contact lenses to parametric release from moist heat sterilization.
This document does not contain the information requested regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter acknowledges the submission and clarifies regulatory aspects but does not include the detailed study results or performance metrics one would expect in a clinical study report or verification and validation documentation. It lists numerous previously cleared products and their approval numbers but does not delve into the studies supporting the parametric release change.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alan J. Frazer Director Quality Assurance UNILENS Corporation, USA 10431 72nd Street North Largo, FL 33777
APR 2 0 2511
Re: K110452 - Bundled Special 510 (k) for Parametric Release from Moist Heat Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002. P880101, P880102, K940777, K941836, K942372, K942494. K960926, K961428, K965012, K971647, K000529, K002408, K041608, K050743, K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: March 23, 2011 Received: March 25, 2011
Dear Mr. Frazer:
We have reviewed your Special 510(k) premarket notification of intent to market the device referenced above which requests conversion to parametric release from moist heat sterilization of referenced hydrophilic contact lenses of 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Keoia Alexander
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Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Unilens Corp., USA Bundled Special 510(k)
Indications for Use
510(k) Number (if known): J K110452
Device Name: See Attached
Indications for Use:
For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses
Over-The-Counter Prescription Use Use × -- AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aura Postap
ision Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110452
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| Status | Trade Names | ApprovalNumber | ClearedDate | CommonName | DeviceClass | Panel | ProductCode |
|---|---|---|---|---|---|---|---|
| 510(k) | Sof-Form II | P820005 | 06/01/82 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Unilens, Unisite,Simulvue | P850002 | 02/28/86 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Aquaflex | P880101 | 2/10/89 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | LL-38 | P880102 | 08/11/89 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | BayVueAquaflex MTO | K940777 | 4/12/1994 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Unilens 38, Unisoft | K941836 | 07/07/94 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Simulvue 38LLBI 2 | K942372 | 07/07/94 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Xtra, 4Vue | K942494 | 09/08/94 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | SoftSITE, EMA | K960926 | 04/10/96 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Soft-55 DW | K961428 | 05/21/96 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | MV2 | K965012 | 03/11/97 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | LL Bifocal | K971647 | 07/15/97 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | MVt Toric Bifocal | K000529 | 02/16/00 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE 55 | K002408 | 10/17/00 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE 55 ToricMultifocal | K041608 | 07/07/04 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Aquaflex 2 | K050743 | 4/13/2005 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE Advanced | K082393 | 9/11/2008 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE AdvancedDefinitiveC-VUE AdvancedHydraVUE | K100456 | 10/28/2010 | Daily Wear Soft(hydrophilic)Contact Lens | II | Ophthalmic | LPL |
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§ 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.