Nutrifill

{0}------------------------------------------------ ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K181566 #### I. SUBMITTER - Sept 18th 2018 Date Prepared: - Name: Contamac Ltd. Address: Carlton House Shire Hill Saffron Walden Essex CB11 3AU Contact Person: Robert McGregor Managing Director Phone number: 01799 514800 Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Phone number: (503) 372-5226 #### II. DEVICE | Trade Name: | Nutrifill | |-------------------------|------------------------------------------------------------------| | Common<br>Name: | Contact Lens Insertion Solution | | Classification<br>Name: | Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918) | | Regulatory<br>Class: | Class II | | Product Code: | MRC | {1}------------------------------------------------ #### III. PREDICATE DEVICE The Nutrifill preservative free insertion solution is substantially equivalent in terms of actions and indications to the following predicate device(s): - . "LensGiene™ Sterile Saline Solution (Alternate Trade Name: ScleralFil)" By Bausch + Lomb, Inc. 510(k) number: K161622 Device Classification: II - . "Menicon Saline Rinse Solution" By Menicon Co., Ltd. 510(k) number: K151768 Device Classification: II #### DEVICE DESCRIPTION IV. The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day. #### V. INDICATIONS FOR USE The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The Nutrifill preservative free insertion solution is substantially equivalent to the predicate devices in terms of the following: - 트 Intended use - 트 Indications for use - Actions - I Classification - Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918) - 트 How supplied (sterile, single dose) - Preservative free formulation The Nutrifill preservative free insertion solution is unique from the predicate device in terms of the {2}------------------------------------------------ following: - י Nutrifill contains additional electrolytes (calcium, magnesium, potassium, phosphate) - י Nutrifill is buffered with a phosphate buffer at normal ocular pH and osmolarity The following matrix illustrates the intended use and other characteristics of the Nutrifill preservative free insertion solution, as well as the predicate device. | | Contamac, Ltd.<br>Nutrifill | Bausch + Lomb, Inc.<br>LensGiene™ Sterile Saline<br>Solution (ScleralFil) | Menicon Co., Ltd.<br>Menicon Saline Rinse<br>Solution | |------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | New Device | Predicate Device (K161622) | Predicate Device (K151768) | | Intended Use | The Nutrifill preservative free<br>insertion solution is indicated<br>as an insertion solution for<br>large diameter (scleral) and<br>hybrid contact lenses following<br>proper lens care disinfection as<br>recommended by the eye care<br>practitioner. This solution may<br>also be used for rinsing debris<br>and lens cleaners from rigid gas<br>permeable, hybrid and hard<br>contact lenses, as a rinse for<br>contact lens cases and may be<br>used as needed throughout the<br>day to rinse contact lenses. | The LensGiene™ Sterile Saline<br>Solution is indicated for use<br>following proper lens disinfection<br>as recommended by the eye care<br>practitioner. The LensGiene™<br>Sterile Saline Solution is for<br>rinsing soft (hydrophilic), rigid<br>gas permeable and hard contact<br>lenses prior to lens insertion. This<br>solution may also be used as an<br>insertion solution for large<br>diameter (scleral) contact lenses,<br>as a rinse for contact lens cases,<br>and may be used as needed<br>throughout the day to rinse<br>contact lenses. | For use following proper<br>lens disinfection as<br>recommended by the eye<br>care practitioner. The<br>Menicon Saline Rinse<br>Solution is for rinsing soft<br>(hydrophilic), rigid gas<br>permeable and hard contact<br>lenses prior to lens insertion.<br>This solution may also be<br>used as an insertion solution<br>for large diameter (scleral)<br>contact lenses, as a rinse for<br>contact lens cases, and may<br>be used as needed<br>throughout the day to rinse<br>contact lenses. | | Classification | 21 CFR 886.5918 | 21 CFR 886.5918 ; 21 CFR<br>886.5928 | 21 CFR 886.5918 ; 21 CFR<br>886.5928 | | Product Code | MRC | MRC; LPN | MRC; LPN | | Class | Class II | Class II | Class II | | Volume | 10 mL per dose | 10 mL per dose | 5 mL per dose | | Preservative Free | Yes | Yes | Yes | | Single or Multi Dose | Single Dose | Single Dose | Single Dose | | Sterility | Sterile | Sterile | Sterile | | Container | Plastic resin container with<br>twist off cap | Plastic resin container with twist<br>off cap | Plastic resin container with<br>twist off cap | | Contains Electrolytes<br>(Calcium, Magnesium,<br>Potassium, Phosphate) | Yes | No | No | {3}------------------------------------------------ #### VII. PERFORMANCE DATA ### ~ Non-Clinical Studies ~ A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate: - The Nutrifill solution is non-toxic and non-irritating - The final packaging is non-toxic and non-irritating ● ## ~ Clinical Studies ~ Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses. ## VIII. CONCLUSIONS ## Substantial Equivalence Based on the composition of the solution and results of non-clinical testing presented in this Premarket Notification, the Nutrifill preservative free insertion solution is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication. {4}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a lighter blue. October 22, 2018 1 Contamac Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068 Re: K181566 Trade/Device Name: Nutrifill Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: September 18, 2018 Received: September 21, 2018 Dear Bret Andre: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {6}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, 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