POLAROID CONTACTSPOD

{0}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) — K131783 For the Contactspod #### 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. . Submitter's Name: Viopti Ltd #### Submitter's Address: Polaroid Building Vale of Leven Industrial Estate Dumbarton G82 3PW Telephone +44 (0) 1389 714021 Establishment Registration Number: Still to be established Contact Person: Edwin Lindsay : .. :: ﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ - > ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------: ・ > > . ! : . ... : រ -. .............................................................................................................................................................................. Page 1 of 7 > ・ . Telephone +44 (0) 7917 134922 . Date Prepared: 13" January 2014 {1}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) - K131783 For the Contactspod #### Device Classification Information: | Regulation<br>Number | Device | Device<br>Class | Product<br>Code | Classification<br>Panel | |----------------------|--------------------|-----------------|-----------------|-------------------------| | 886.5928 | Case, contact lens | Class 2 | LRX | Ophthalmic | #### Device Trade Name: Polaroid Contactspod (and other non-Polaroid branded versions) Device Common Name: Contactspod #### Intended/ Indications Use: The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime. It is a clear solution and should not be used, if cloudy or discoloured. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT. #### Summary of Substantial Equivalence: The Viopti Device is substantially equivalent to WatchDog Group LC - Flip N Slide Contact Lens Case (K130753). The predicate device table has been prepared to compare the Contactspod with other medical devices already on the market | Property | New Device:<br>Contactspod | Predicate 1 | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Manufacturer | Viopti Ltd | WatchDog Group LC | | Device Trade Name | Contactspod | Flip N Slide Contact Lens Case | | 510(K) Number | K131783 (Pending) | K130753 | | Property | New Device:<br>Contactspod | Predicate 1 | | Device Common Name | Polaroid Contactspod | Flip N Slide Contact Lens Case | | Device Product Code | LRX | LRX | | Device Classification<br>FDA | Class II | Class II | | Intended/ Indications Use | The Contactspod is a sterile<br>single-use temporary storage<br>case and contains multi-purpose<br>solution for use with soft contact<br>lenses. | Intended for the storage of soft<br>(hydrophilic), rigid gas<br>permeable (RGP), or hard<br>contact lenses during chemical<br>disinfection. For use in storage<br>during chemical disinfection only.<br>Do not use during heat<br>disinfection. | | Storage case material | Medical grade Polypropylene | Medical grade Polypropylene | | Peel off lid material | Aluminium / PE heatseal<br>laminate | Screw Tops Caps | | Fluid used for storage of contact lenses | Multi-Purpose Solution- a<br>buffered aqueous solution<br>containing disinfectants /<br>preservatives, buffers, a<br>surfactant, a chelating agent,<br>other ancillary agents and<br>purified water. | Not Supplied with Contact Lens<br>Case | | Preservative used | Polyhexamethylene Biguanide<br>(0.0001%) | Not Supplied with Contact Lens<br>Case | | Volume of liquid for storage of each<br>lens. | 2.5ml | Not Supplied with Contact Lens<br>Case | | Method of Sterilization | Gamma Irradiation | Non Sterile | | SAL level | 10-6 or better | Non Sterile | | Intended storage of lenses | Up to 24 hours (temporary<br>storage) | Not Specified | | Property | New Device: | Predicate 1 | | Intended number of uses | Single use | Re-usable<br>Replace case at least every month | | OTC or Prescription Device | OTC | OTC | | Device Description | The Contactspod is a sterile<br>single use temporary storage<br>case and contains multi-purpose<br>contact lens solution for use with<br>soft contact lenses.<br><br>The Contactspod comprises an<br>injection mouided medical grade<br>polypropylene case and medical<br>grade TPE basket seal. The<br>contactspod is pre filled with 5ml<br>of multi-purpose solution.<br><br>The MPS solution is supplied<br>inside the moulded PP case with<br>an aluminium / PE heatseal<br>which is removed by the user.<br><br>Once lenses are inserted into the<br>solution a secondary seal is<br>used to seal the case. | The contact lens cases are<br>designed for storage of contact<br>lenses.<br><br>The Colour Contact Lens Case<br>has 2 adjoining wells that have<br>screw top caps. The Flip N Slide<br>contact lens case model has 2<br>adjoining wells with integral<br>hinged, self-sealing caps in<br>which contact lenses are<br>immersed.<br><br>The devices are not sterile and<br>are not sterile and are not for<br>heat disinfection. They are made<br>of polypropylene plastic.<br><br>The volume capacity is 5.91ml<br>on each well of both les cases | Page 2 of 7 . {2}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) — K131783 For the Contactspod Page 3 of 7 , . .. . {3}------------------------------------------------ - - - # Viopti Ltd. Traditional 510(k) — K131783 For the Contactspod . Page 4 of 7 > · ・・ . ' : ... ´ ` ... .. , : : : !! :・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ : : : . ﺑ {4}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) - K131783 For the Contactspod #### Device Description: The Polaroid Contactspod is a single use, pre-filled contact lens storage case. The product comprises four components: - . A polypropylene storage case, an aluminium foil seal, two TPE baskets and contact lens solution. The hinged polypropylene case contains the multipurpose contact lens solution stored under an aluminium foil primary seal. Inside the foil seal are two compartments (one for left lens storage and one for right lens storage). Each compartment has a min 2.4ml of contact lens solution and a TPE basket. The TPE basket has two purposes. The first is to safely hold the lens in the soft TPE material. The second is to provide the secondary seal when the lid is hinged closed and locked with the latch. The Polaroid Contactspod are sold both as an individual unit and also packaged in conjunction with other eye care and travel products. Image /page/4/Picture/8 description: The image shows a contact lens case. The case is open, revealing two compartments labeled "L" and "R" for left and right lenses, respectively. A lens is visible in one of the compartments, and a package of lens solution is partially opened next to the case. Page 5 of 7 {5}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) - K131783 For the Contactspod #### Technological Characteristics: A comparative review of the Contactspod with the predicate devices found that the materials/solution used in the Viopti Contactspod for the temporary storage of Contact Lenses have similar principles of operation and technological characteristics as the previously cleared predicates and thus do not raise any new questions with regards to safety or efficacy. ## Performance/Physical Data: . . The Contactspod was tested to ensure performance of the system, to verify and validate the product design and to characterize the performance and safety of the Contactspod. ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ The table outlines the features of the system that were evaluated through testing completed by Viopti. | Test Name | Test Description | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Stand Alone Report | The aim of this study was to investigate the sterility and possible antimicrobial<br>activity in a shelf life study of six different lots of the Contactspods prefilled with<br>Multifunctional Solution and radiated by gamma sterilization.<br><br>The products were tested in the lab using established tests and also by challenging with a standard inoculum of a representative range of microorganisms according to EN-ISO 14729:2001. | | Design Verification<br>Testing | The aim of this was to carry out various tests on the Contactspod to verify and<br>validate the product design and to characterize the performance of the Contactspod<br><br>This included hinge flexing tests, negative air pressure tests to simulate aircraft<br>cabin pressure on both the primary foil seal and the secondary TPE seal, use of<br>product at extremes of indicated temperature, latch opening force both with the foil<br>removed (correct operation) and with the foil in place (misuse), crush force testing of<br>secondary seal, crush force puncture resistance testing with the foil in place,<br>temporary storage of contactspod at extremely high and low temperature. | | Microbial load<br>comparison between<br>contact lens cases | Study of the effectiveness of various contact lens cases and concluded that the<br>Contactspod would be an effective one use storage environment for contact lenses. | | Review of ISO 14534 -<br>Ophthalmic Optics-<br>Contact lenses and<br>contact lens care<br>products | A review of ISO 14534 - Ophthalmic Optics- Contact lenses and contact lens care<br>products - Fundamental requirements was performed with regards to the<br>Contactspod to ensure compliance. All aspects of the standards were addressed/<br>reviewed and Contactspod is deemed to be compliant, with the sections applicable<br>to the Contactspod. | Page 6 of 7 {6}------------------------------------------------ ## Viopti Ltd. Traditional 510(k) – K131783 For the Contactspod | Test Name | Test Description | |-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Usability - ISO 62366:<br>2008/ IEC 62366:2007 -<br>Application of Usability<br>Engineering to Medical<br>Devices | The Contactspod was assessed with regards to usability for compliance with ISO<br>62366: 2008/ IEC 62366:2007 - Medical devices - Application of usability engineering<br>to medical devices | In addition, testing and analysis of the Contactspod has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance on selection of tests and Design Verification Testing was performed to verify the Contactspod. #### Safety and Effectiveness: e 7 of 7 The Contactspod utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the Contactspod indicated no adverse indications or results. It is our determination that the Contactspod is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 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. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 21, 2014 Viopti Ltd. % Mr. Edwin Lindsay, Quality & Regulatory Consultant Polaroid Building Vale of Leven Industrial Estate Dumberton G82 3PW United Kingdom Re: K131783 Trade/Device Name: Contactspod Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: December 30, 2013 Received: January 8, 2014 Dear Mr. Lindsay: 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. 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 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. {8}------------------------------------------------ Page 2 - Mr. Edwin Lindsay 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safety/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/ResourcesforYou/Industry/default.htm. Sincerely yours. Kesia Y. Alexander -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K131783 Device Name Contactspod Indications for Use (Describe) The Contactspod is a sterile single-use temporary storage case and contains multipurpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and disinfecting care regimen. It is a clear solution and should not be used if cloudy or discolored. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT. Type of Use (Select one or both, as applicable) [ Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Joseph C. 2014.02.11 14:19 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {10}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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