SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR

{0}------------------------------------------------ # Rayner ## MAR 2 7 2014 Rayner İğraocular Lenses Limited 1-2 Sacker | | | Frading Estate, Sackville Road Hove, East Sussex England BN3 7AN Telephone: 44-1273-205401 Fax: +44 (0) 1273 324623 www.rayner.com Date this summary prepared: 20th March 2013 510(k) Summary Devices 5. | Common Name: | Rayner Injectors | |--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/Proprietary names: | Single Use Soft Tipped Disposable Injector (Model R-INJ-04) and Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model R-INJ-04/18) | | CFR section: | Title 21 Part 886 Subpart E Section 886.4300 Intraocular Lens Guide | | Classification Name: | Intraocular lens guide | | Product code: | MSS | | Device Class: | Class I | | Classification Panel: | Ophthalmic | | Information on devices to which substantial equivalence is claimed | | | 510(k) number: | K091507 | | Trade/Proprietary name: | Single Use soft tipped injector R-INJ-04/18 | | Manufacturer: | Rayner Intraocular Lenses Limited, Sackville Road, Hove, East Sussex, BN3 7AN; United Kingdom | Official Correspondent: Juliette E Cook Rayner Intraocular Lenses Limited 1-2 Sackville Trading Estate, Sackville Road Hove, East Sussex BN3 7AN United Kingdom US Agent: Robert Mazzaferro RegTech Solutions LLC 11 Dellcastle Court Montgomery Village MD 20886 Phone: +44-1273-205401 Phone: 301 2162720 {1}------------------------------------------------ ## Model R-INJ-04 and Model R-INJ-04/18 #### 5.1 Intended Use The single use disposable injectors (Model R-INJ-04 and Model R-INJ-04/18) are intended to be used to compress and insert into the capsular bag only those.intraocular lenses that allow the use of these injectors in their approved labelling. #### 5.2 Description of the device that is subject of the application There are two types of Rayner disposable single use soft tipped injectors (Model R-INJ-04 and Model R-INJ-04/18). They are the same except Model R-INJ-04 has a 2.0 mm diameter nozzle and Model R-INJ-04/18 has a 1.8 mm nozzle. The size is indicated on the barrel flap of the respective injectors by 1.8 or 2.0 embossed texts. The injectors are assembled from a nozzle, barrel, flap, guide bushes and plunger components which are made of polypropylene material. The plunger has a thermoplastic elastomer soft tip at one end. The injectors are supplied sterile. #### 5.3 Comparison of technological characteristics to a predicate device The intended use of the predicate device and the Models subject of this traditional 510(k) is the same: "intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling. The predicate device applies the same operating principle to into the eye. The predicate device is similar to the modified in this submission. There is no significant difference between the devices; the predicate device has similar technical characteristics, such as design, components, materials, assembly method and intended use. The difference between the two injector models described in this submission (Model R-INJ-04/18), can be summarised as the diameter of the nozzle, 1.8mm and 2.0mm respectively and the nozzle diameter in text embossed on the barrel flap. The predicate device has a 1.8 mm nozzle. The predicate and substantially equivalent devices have passed tests in accordance with standards. Tests and studies were completed to demonstrate that lenses implanted with the Rayner injectors sustain mechanically and optically uncompromised characteristics, compared to the predicate. There are no significant differences in the features between the predicate and substantially equivalent devices that could adversely affect the safety and/or performance of the injectors or the lenses implanted with these devices. #### 5.4 Non-clinical performance data The substantial equivalence of the Rayner injectors (Model R-INJ-04 and Model R-INJ-04/18) with the predicate device is based on the assessment of the technical characteristics, such as design, components, materials, assembly method and intended use of the injectors and test results performed. {2}------------------------------------------------ The test results demonstrate that the modified Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18) deliver into the eye those lens models that allow use of these injectors in their approved labelling with no significant impact on the optical and mechanical performance or the cosmetic features of the lenses. The following paragraphs summarise the non-clinical tests that the Rayner injectors (Model R-INJ-04 and Model R-INJ-04/18) are safe, effective and perform as well as (or better than) the predicate device (CFR Part 807.92(b)(3)). The tests include: - . Injector biocompatibility tests - . Sterilisation validation - . Visual, mechanical and optical testing of the injected lens - Visual and mechanical testing of the disposable Rayner injectors ● - Packaging performance testing and stability studies ◆ These tests demonstrate that when the devices are used according to the manufacturer's instructions, the injectors perform to the pre-determined specifications. ### Injector biocompatibility tests The material of all components of the predicate device is the same polypropylene material as the polypropylene material of all components of the Rayner Injectors (Model R-INJ-04 and Model R-INJ-04/18), and it has not been changed. The points of contact with the patient are the injector nozzle and the plunger. Biocompatibility tests on these components have been carried out on the predicate device. In summary, all tests were passed and the data demonstrate that the materials of Rayner injectors (Model R-INJ-04 and Model R-INJ-04/18) are biocompatible and toxically safe to be used as intended by the manufacturer. There has been no material change to the predicate device since it was 510(k) cleared. Other components of the injector are not in contact with the patient, nor with the user. ### Sterilisation Validation The injectors are packed in the primary packaging and sterigenics UK Ltd. The sterilisation process was validated and achieved SAL 10 *. The method of ethylene-oxide (ETO) sterilisation process is the same as for the predicate device. #### Visual, mechanical and optical testing of the injectors and the injected lenses The visual, mechanical and optical criteria of the device performance, such as cosmetic defects, MTF, power, compression force, surface finish and dimensions were identified as per ISO 11997-3. These criteria were met. Pre and post injection visual, mechanical and optical tests have been completed on lenses injected using the disposable Rayner injectors (Model R-INJ-04 and Model R-INJ-04/18) with satisfactory results. Pre and post injection visual tests were carried out for: - . Optic damage or tear on lenses loaded in accordance with manufacturer's description - . Damage to the lens haptic - . Folding lines, deposits or debris transferred to the lens {3}------------------------------------------------ ## Optical test - t Modulation Transfer Function (MTF) - . Dioptric power - Mechanical testing - . Dimensions - . Lens sagittal dimension - . Lens overall diameter - . Aperture opening test - Injection force testing ● - . Visual and mechanical testing of the disposable Rayner injectors The visual, mechanical and optical criteria of the device performance, such as cosmetic defects, MTF, power, compression force, surface finish and dimensions were identified as per ISO 11997-3. These criteria were met. - . Surface finish - Cosmetic inspection . - . Nozzle-tip detachment from barrel ## Packaging performance testing and stability studies - . Sterility test - . Dye penetration - . Burst test #### 5.5 Overall conclusion of the Non-clinical performance data There are no significant differences in the features between the predicate and substantially equivalent devices that could adversely affect the safety and/or performance of the injectors or the lenses implanted with these devices. The tests carried out on the predicate device and Model R-INJ-04 and Model R-INJ-04/18 confirm that the Rayner injectors are safe and perform as intended by the manufacturer. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally in the image. There is a logo to the left of the text. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 27, 2014 Rayner Intraocular Lenses, Ltd. % Mr. Hans-Gerd Evering Lead Technical Reviewer, BSI Assurance UK Limited Kitemark Court, Davy Avenue, Knowlhill Milton Keynes, MK5 8PP, UK Re: K132002 Trade/Device Name: Single Use Soft Tipped Disposable Injector (Model R-INJ-04) and Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model R-INJ-04/18) Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lens (IOL) Regulatory Class: Class I Product Code: MSS Dated: February 28, 2014 Received: March 13, 2014 Dear Mr. Evering: 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. {5}------------------------------------------------ Page 2 - Mr. Hans-Gerd Evering 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 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. Evdelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications For Use Statement 4. 510(k) Number (if known):K132002 Device Name: Rayner Injectors Single Use Disposable Soft Tipped Injector (Model R-INJ-04) and Raysert Single Use Soft Tipped Small Incision Disposable Injector (Model R-INJ-04/18) Indications For Use: ## Statement of Indications For Use The single use disposable injectors (Model R-INJ-04 and Model R-INJ-04/18) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Tieuvi H. Nguyen -A 2014.03.21 10:41:16 -04'00' For the use of U. S. Food and Drug Administration only. This document confidential, proprietary information of Rayner Introcular Lenses Umlted. It may not be copied or reproduced without prior written permission from Rayner Intraocular Lenses Umited.