CONTACT LENS CASE

{0}------------------------------------------------ ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92. The Assigned 510(k) Number is: ## 1. Date of Submission: Nov 28, 2006 ## Applicant Device Information 2. Trade/Proprietary Name: Contact Lens Case (Multiple Brand Names) Common Name: Contact Lens Case Classification Name: Case, Contact Lens Device Class: Jly F Product Code: LRX Regulation Number: 886.5928 Intended Use: The Applicant contact lens case is a fens care product to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection. ## 3. Submitter Information Manufacturer Name: Ningbo Kaida Rubber & Plastic Technology Co., Ltd. No.1 Qinggang Industrial Park, Mou Shan Town, Yu Yao City, Zhejiang Province, China ## Contact Person of the Submission: Ms. Diana. Hong Mr. Eric. Chen Shanghai Mid-link Consulting Co., Ltd. Suite 8D, Zhongxin Zhongshan Building, Lane 999, Zhongshan No.2 Road (S), Shanghai 200030 China Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 {1}------------------------------------------------ Premarket Notification 510(k) Submission-510(k) Summary Report No.: A20060121 Email: Diana.hong@mid-link.net ## Predicate Device 4. The Legally Marketed Contact Lens Case as predicate devices is identified as followings: 1) i-Promotions Contact Lens Case (K042578) Manufactured by: i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123 ## Device Description 5. applicant device of Contact Lens Case is a device intended to be used The by the contact lens wearer or practitioner for storing contact lenses while not being worn. The applicant device is not sterile and not for heat-disinfection. Applicant Device Variants: SL-295, SL-298, SL-326, SL-338, SL-316, SL-511, SL-800, SL-863, SL-884, SL-886, SL-869, SL-876, SL-880, SL-899 All the variant models as mention above follow the same design principle with the same intended use. The only difference is the dimension and appearance of each model, which do no effect on the usage and intended use and just for commercial purpose. The applicant device of Contact Lens Case consists of 2 parts: case body and case cover. The case body is based with adjoining dual wells for the containment of fluid, and the cap is designed for screwing. All the variant models of the applicant device have a capacity of over 1.5 ml in each case well. And the inner height of the all well exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition. The applicant device of Contact Lens Case made of 2 types of material of Polypropylene (PP) and Acrylonitrile - butadiene - styrene copolymer (ABS) for each variant model. {2}------------------------------------------------ Premarket Notification 510(k) Submission—510(k) Summary Report No.: A20060121 ## Substantially Equivalence Determination 6. # Comparison Table of the Applicant Device and Predicate Device of Single Lumen | Comparison Elements | Applicant Device | Predicated Device | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Multiple Brand Names | 2) i-Promotions Contact Lens Case (K042578) | | Classification Name | Contact Lens Case | Contact Lens Case | | Product Code | LRX | LRX | | Comparison Statement | The applicant device has same classification information as the predicate device. | | | Intended Use | The Applicant contact lens case is a lens care product to be<br>used by the contact lens wearer or practitioner for storing contact<br>lenses while not being worn. The applicant device is not designed<br>for heat disinfecting system. Use only with chemical disinfection. | i-Promotions Contact Lens Case is intended for storage<br>during disinfection of soft, rigid gas permeable or hard<br>contact lenses. Not to be used with heat disinfection. Use<br>only with chemical disinfection. | | Indications | Storage and Disinfection of Soft, Rigid Gas Permeable<br>or Hard | Storage and Disinfection of Soft, Rigid Gas Permeable<br>or Hard | | Comparison Statement | The applicant device has same indications and intended use as the predicate device. | | | Disinfection Type | Chemical Disinfection<br>Not Heat-Disinfection | Chemical Disinfection<br>Not Heat-Disinfection | | Design | Two adjoining Wells Screwed with Screw Top<br>into Which | Two adjoining Wells Screwed with Integral Hinged Cap into Which<br>Respective Lenses are Immersed | | Main Material | SK Corporation Polypropylene (PP) R370Y with<br>certificated quality | Dow Chemical Company Low Density Polyethene Dow<br>Product | | | Acrylonitrile - butadiene - styrene copolymer (ABS) PA -<br>757K | #9931 See 510(k) (K993486) | | | Carbazole violet (Pigment Violet 23) (CAS Reg. No.<br>6358-30-1, Color Index No. 51319) | | | Comparison Statement | | The applicant device has similar product design as the predicate device. The only difference is the ABS material | X3 {3}------------------------------------------------ | | Effectiveness Elements | | | | |----------------------|----------------------------------|----------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------| | | | Two adjoining Wells Screwed with Integral Hinged Cap into Which | | | | | | Respective Lenses are Immersed | | | | Comparison Statement | | The applicant device has same performance effectiveness as the predicate device. | | | | Safety Elements | | Polypropylene (PP) R370Y | Low Density Polyethene Dow Product #9931 | | | | <i>In Vitro</i> Cyto-toxicity | No Cyto-toxicity | <i>In Vitro</i> Cyto-toxicity | No Cyto-toxicity | | | Delayed-type<br>Hypersensitivity | No delayed dermal contact<br>sensitization | Delayed-type Hypersensitivity | No delayed dermal contact sensitization | | | Eye Irritation | No intracutaneous reactivity | Eye Irritation | No intracutaneous reactivity | | | Systemic Toxicity | No systemic toxicity | Systemic Toxicity | No systemic toxicity | | | | Acrylonitrile - butadiene - styrene copolymer (ABS) | | | | | | PA - 757K | | | | | <i>In Vitro</i> Cyto-toxicity | No Cyto-toxicity | | | | | Delayed-type<br>Hypersensitivity | No delayed dermal contact<br>sensitization | | | | | Eye Irritation | No intracutaneous reactivity | | | | | Systemic Toxicity | No systemic toxicity | | | | | | Polypropylene (PP) R370Y with colorant of Carbazole violet | | | | | <i>In Vitro</i> Cyto-toxicity | No Cyto-toxicity | | | | | Delayed-type<br>Hypersensitivity | No delayed dermal contact<br>sensitization | | | | | Eye Irritation | No intracutaneous reactivity | | | | | Systemic Toxicity | No systemic toxicity | | | | Comparison Statement | | The applicant device has same performance safety as the predicate device | | | Premarket Notification 510(k) Submission—510(k) Summary X4 {4}------------------------------------------------ rket Notification 510(k) Submission-510(k) Summission-510(k) Summit No.: A20060121 ## SULT OF COMPARIS same performano The applican device has same classion information, same intended use, similar product design, ## Conclusion The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore is applicant device in the spelicant device in the {5}------------------------------------------------ ## Effectiveness and Safety Considerations 7. ## Effectiveness: All the variant models of the applicant device have a capacity of over 1.5 ml in each case well. And the inner height of the all well exceeds 8.5 mm. With regard to the Center Thickness the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, of the capacity is sufficient for contact lens to be fully immersed under use condition. ## Safety Considerations: The test results of biocompatibility of Polypropylene (PP) contact lens (SL-884 is sampled for the test) are presented as Table IV-5 for the consideration of Biological Specifications. The test results of biocompatibility of Acrylonitrile - butadiene - styrene copolymer (ABS) contact for the test) are presented as Table IV-6 for the lens case (SL-800 is sampled consideration of Biological Specifications The test results of biocompatibility Polypropylene (PP) contact lens case with colorant Carbazole is sampled for the test) are presented as (SL-295 vjolet (Pigment Violet 23) IV-7 for the consideration of Biological Specifications. Table Per 21 CFR 73.3107, Carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Color Index No. 51319) is exempt from the certification requirement of 721(c) of FD&C Act. Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness. {6}------------------------------------------------ Public Health Service Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ningbo Kaida Rubber and Plastic Technology Co., Lt c/o Marc M. Mouser Underwriters Laboratories, Inc. Laboratory and Testing 2600 NW Lake Rd. Camas, WA 98607 MAY - I 2007 Re: K071081 Trade/Device Name: Contact Lens Case (Multiple Brand Names) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: March 1, 2007 Received: April 17, 2007 Dear Mr. Mouser: 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. {7}------------------------------------------------ ## Page 2 - Marc M. Mouser 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, M.B. Eichelman, M.D. Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use ා දූ Pending KO7/08) 510(k) Number:________________________________________________________________________________________________________________________________________________________________ Device Name: _Contact Lens Case ## Indications for Use: The Applicant contact lens case is a lens care product to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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) (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | 510(k) Number | K071081 | Page 1 of 1 | |---------------|---------|-------------| |---------------|---------|-------------| YI