Contact Lens Case, Model: A-1, B-1

{0}------------------------------------------------ November 30, 2017 P L Overseas Limited % Rain Yip Official Correspondent Feiying Drug & Medical Consulting Technical Service Group Rm. 3005 Area B. Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, Guangdong 518000 P.R. China Re: K172925 Trade/Device Name: Contact Lens Case, Model: A-1, B-1 Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: September 16, 2017 Received: September 25, 2017 Dear Rain Yip: 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality svstems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Denise L. Hampton -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172925 Device Name Contact Lens Case Indications for Use (Describe) For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. # Date: 16/09/2017 #### I. Submitter P L Overseas Limited RM.A 4/F Alexandra Indl. Bldg. Blk.A, 1064-1066 Tung Chau West ST., Cheung Sha Wan, Kowloon, HongKong Phone: 00852 2959 3013 Tax: 00852 2959 0930 Maggie Li Tel: 86 138 2888 2233 Email: maggie@mghkltd.com # II. Device Name of Device: Contact Lens Case Common or Usual Name: Contact Lens Case Classification Name: Case, Contact Lens Regulatory Class: II Product Code: LRX Regulation Number: 21 CFR 886.5928 # III. Predicate Device - 1 ) The predicate devices are listed as below: | Manufacturer | Predicate Device | 510(k) Number | Approval Date | |--------------------------------------------------|-------------------|---------------|--------------------| | Ningbo<br>Yinzhou<br>Zonghai Artware Co.,<br>Ltd | Contact Lens Case | K162869 | December 9, 2016 | | MACA Plastics Inc | Contact Lens Case | K140488 | September 10, 2014 | 2 ) No reference devices were used in this submission. # IV. Device Description {4}------------------------------------------------ The Contact Lens Case is a lens case product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. The Case is to be designed during chemical disinfection only. No designed for heat disinfecting system. The Contact Lens Case includes A-1 and B-1 two models. Both have adopted the same structure design, consisting of two parts: holder and cover. The holder is based with adjoining dual wells for the containment of fluid, and two covers are designed for screwing. At the same time, the bottom of each well is marked with L (left) and R (right) letters, and the covers are also labeled with L (left) and R (right) letters. The Contact Lens Case is simple with a well volume of 4.2mL ±0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning. # V. Indications for Use For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection. # VI. Comparison of Technological Characteristics With the Predicate Device The Contact Lens Case is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance. 1) K1628690, "Contact Lens Case", manufactured by "Ningbo Yinzhou Zonghai Artware Co., Ltd" in Zhejiang, China 2) K140488, "Contact Lens Case", manufactured by "MACA Plastics Inc" in Ohio, U.S.A The following table shows similarities and differences of use, design, material, safety and effectiveness between the subject device and predicate devices. | Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | 1.Classification | | | | | | Device Name | Contact Lens Case | Contact Lens Case<br>K162869 | Contact Lens Case<br>K140488 | | | Classification Name | Case, Contact Lens | Case, Contact Lens | Case, Contact Lens | | | Classification Advisory<br>Committee | Ophthalmic | Ophthalmic | Ophthalmic | | | Class | II | II | II | | | Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | | | Regulation Number | 21CRF 886.5928 | 21CRF 886.5928 | 21CRF 886.5928 | | | Product Code | LRX | LRX | LRX | | | Comparison<br>Statement | The subject device has the same classification as the predicate devices. | | | | | 2. Intended Use | | | | | | Intended Use | For storage of soft<br>(hydrophilic), hard and<br>rigid gas permeable<br>(RGP) contact lenses<br>during chemical<br>disinfection.<br>Use for storage during<br> | For storage of soft<br>(hydrophilic), hard and<br>rigid gas permeable<br>contact lenses during<br>chemical disinfection.<br>Use for storage during<br>chemical disinfection<br>only. DO NOT USE<br>WITH HEAT. | For storage of soft<br>(hydrophilic), hard and<br>rigid gas permeable<br>contact lenses during<br>chemical disinfections.<br>Use for storage during<br>chemical disinfection<br>only. Do not use heat<br>disinfection. | | | Comparison<br>Statement | The subject device has the same intended use as the predicate devices. | | | | | 3.Design/Material | | | | | | Disinfection Type | Chemical Disinfection<br>Not heat-Disinfection | Chemical Disinfection<br>Not heat-Disinfection | Chemical Disinfection<br>Not heat-Disinfection | | | Sterilization | Not sold sterile | Not sold sterile | Not sold sterile | | | Design | Holder with two wells<br>to hold fluid and two<br>covers for the Left and<br>Right eyes of contact<br>lenses<br>The covers are<br>designed for screwing. | Shaped base with two<br>wells to hold fluid and<br>two screw lids for the<br>Left and Right eyes of<br>contact lenses | Two adjoining<br>chambers with screw<br>top into which contact<br>lenses are immersed. | | | Dimension (L*W*H) | A-1<br>B-1 | 64*31*16mm<br>65*31*15mm | 63*32*16mm | Unknown | | Volume (Each well) | | 4.2mL $\pm$ 0.15 | 4.8mL | Over 3.0mL | | Materials | A-1 | Holder:<br>Polypropylene | BASE: Polypropylene<br>(PP) | Polypropylene (PP)<br>and Arcylonitrile- | | Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | | | | (PP)<br>Cover: High-<br>density<br>Polyethylene<br>(HDPE) | LID: Polyethylene<br>(PE) | Butadiene-Styrene<br>copolymer (ABS) | | | | B-1<br>Acrylonitrile-<br>Butadiene-<br>Styrene<br>copolymer<br>(ABS) | | | | | Comparison<br>Statement | The subject device has a similar product design as the predicate device. The<br>minor difference is material and appearance, which will be discussed and<br>demonstrated in "Safety Elements" below. | | | | | 4.Effectiveness | | | | | | Effectiveness | The capacity is<br>sufficient for contact<br>lens to be fully<br>immersed under use<br>condition. | The capacity is<br>sufficient for contact<br>lens to be fully<br>immersed under use<br>condition. | The capacity is<br>sufficient for contact<br>lens to be fully<br>immersed under use<br>condition. | | | Comparison<br>Statement | The subject device has the same performance effectiveness as the predicate<br>devices. | | | | | 5.Safety Elements | | | | | | Biocompatibility | Complying with ISO<br>10993-1:<br>-Cytotoxicity<br>(ISO10993-5)<br>-Skin Sensitization<br>(ISO10993-10)<br>-Ocular Irritation<br>(ISO10993-10)<br>-Systematic Toxicity<br>(ISO10993-11) | Complying with<br>ISO10993-1:<br>-Cytotoxicity<br>(ISO10993-5)<br>-Skin Sensitization<br>(ISO10993-10)<br>-Ocular Irritation<br>(ISO10993-10)<br>-Systematic Toxicity<br>(ISO10993-11) | Unknown | | | Leakage Test | No Leakage | No Leakage | Unknown | | | Comparison<br>Statement | The A-1 Model of the subject device is made of similar materials as the<br>Predicate Device 1 and B-1 Model of the subject device is made of the same<br>material as the Predicate Device 2. Meanwhile, the subject device was<br>tested relevant biocompatibility tests in accordance with Product Guidance<br>and ISO10993 standards as recognized by FDA; the test results met all | | | | | Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | | | | relevant requirements in test standards, and are comparable to the predicate device. | | | | | | The subject device has the same performance effectiveness as the predicate devices. | | | | ## Comparison Table {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## VII.Performance Data The following performance data were provided in support of the substantial equivalence determination. ## Non-Clinical Data: ## 1) Biocompatibility Testing The biocompatibility evaluation for the Contact Lens Case was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing included the following tests: - > ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity - > ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization - > ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Ocular Irritation - > ISO 10993-11:2006/(R)2010, Biological Evaluation of Medical Devices -Par t 11: Tests for Systemic Toxicity All tests were passed. ## 2) Leakage Testing Leakage testing was conducted to the Contact Lens Case samples. 120 combinations of different tops and bottoms were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the test were repeated 3 times. None of the tested contact lens cases showed any leakage and all passed the leakage tests successfully. The test results show the Contact Lens Case complies with the requirement as defined. ## Clinical Data Clinical studies were unnecessary for this application. Lens case solutions used with this contact lens case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses. {8}------------------------------------------------ #### Summary Based on the above performance as documented in this application, Contact Lens Case was found to have a safety and effectiveness profile that is similar to the predicate device. #### Conclusions VIII. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Contact Lens Case is to be concluded substantial equivalent to its predicate devices.