RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04

{0}------------------------------------------------ K062612 Image /page/0/Picture/1 description: The image shows the logo for Rayner Surgical, Inc. The logo consists of the word "RAYNER" in bold, sans-serif font, with the words "Surgical, Inc." underneath in a smaller font. Above the text is a triangular shape made up of several parallel lines. The lines are oriented diagonally, creating a pattern that resembles a stylized mountain range or a series of peaks. 6654 Church Street Los Angeles, California 90042-1555 USA Telephone: 1-800-905-0143 ## DEC 1 3 2006 # 510(k) Summary ## Submitted by Rayner Intraocular Lenses Ltd. Mark Mullaney Regulatory Affairs & Quality Assurance Director Sackville Road Hove, East Sussex, BN3 7AN England Telephone # 0044-1273-205 401 Fax # 0044-1273-324 623 Summary prepared on November 10th 2006 ## Device Name - Trade/Proprietary Name: Rayner Single Use Disposable soft Tipped Injector R-INJ-04 - Common Name: Rayner Single Use Soft Tipped Injector . - Classification Name: Product Code is MSS. CRF section is TITLE 21, Part 886, Subpart E, Sec. 886.4300 . Intraocular lens guide. Device class is Class I. Classification Panel is Ophthalmic ## Information on devices to which substantial equivalence is claimed - . 510(k) Number: K052651 - Trade or Proprietary or Model Name: Rayner Single Use Disposable Injector R-INJ-02 . - . Manufacturer: Rayner Intraocular Lenses Ltd. ### Intended Use The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. Page 1 of 5 Image /page/0/Picture/23 description: The image shows a series of numbers, specifically "002000". The numbers are written in a simple, sans-serif font. The image is a close-up of the numbers, and the background is white. {1}------------------------------------------------ ### Description of the device that is subject of the application, including an explanation of how the device functions, basic scientific concepts, scientific physical and performance characteristics (design, material, physical properties) The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. INJECTOR LOADING is described as follows: aseptically transfer the injector to the sterile field by tipping it from the tray. Fully retract the plunger ensuring that the blue tip does not protrude into the loading bay. Open the loading bay flap fully to 90° and sparingly apply a commercially available viscoelastic inside the nozzle and to both grooves of the loading bay. Balanced salt solution alone should not be used as a lubricant. Carefully peel back the foil lid of the lens blister. Gently lift out the lens using parallel tipped, non-serrated forceps e.g. Kelman-McPherson. Position the lens in the loading bay in a "reverse - S" configuration. Ensure that the nearest edge of the optic is securely under the edge (lip) of the barrel. Hold open the flap and press with closed forceps to ensure the furthest edge of the optic is securely under the edge (lip) of the flap. Ensure the haptics are completely within the loading bay. While keeping the lens in position with open forceps, gently close the flaps of the injector ensuring that no part of the optic or haptics is trapped, before locking the flaps firmly together. Visually observe that the lens is symmetrically folded within the loading bay. Advance the plunger in a slow controlled manner. Anticipate an initial slight resistance could indicate a trapped lens. Observe that the lens stays symmetrically folded within the nozzle. When the lens exits the nozzle, stop depressing the plunger. The plunger is only to be depressed once. The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene. The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip. Image /page/1/Picture/7 description: The image contains the text "SC 300 '7". The text appears to be a combination of letters and numbers. The letters "SC" are followed by the number 300, and then a single quote followed by the number 7. {2}------------------------------------------------ ## Summary of how the technological characteristics of the device compare with the predicate device identified - Device comparison table: | Characteristics | Rayner Single Use Disposable<br>Injector R-INJ-02 | Rayner Single Use Soft<br>Disposable Soft Tipped Injector<br>R-INJ-04 | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Intended Use | Folds and delivers IOL into eye<br>during normal small incision<br>cataract surgery | Same | | Operating Principle | - Load IOL into the inserter<br>mechanically and insert IOL<br>into the eye<br>- IOL delivered by direct<br>forward motion applied to a<br>syringe type plunger | - Same | | Folding Operation | IOL is loaded into cartridge and<br>closed. Opposing contact edges<br>are folded towards each other | Same | | Folding Direction of the Lens | Lens decompresses in a<br>horizontal plane | Same | | Cartridge design | None | None | | Sterilization Method | EO for entire device | Same | | Materials | Polypropylene barrel, flap, bush<br>and nozzle. Polycarbonate<br>plunger with stainless steel<br>spring. | Polypropylene barrel, flap, bush<br>and nozzle. The plunger is<br>polypropylene with a<br>thermoplastic elastomer soft tip. | | Surface Treatment | None | None | | Patient contact portion of the<br>device | Nozzle and plunger tip | Same | Image /page/2/Picture/4 description: The image shows a series of six oval shapes, each resembling the letter 'O'. The ovals are arranged horizontally, with slight variations in size and spacing between them. The outlines of the ovals are somewhat rough, suggesting a hand-drawn or imperfectly printed quality. {3}------------------------------------------------ ## Non-clinical performance data - discussion and conclusions Substantial equivalence is based on the assessment of non-clinical performance data More specifically this contains the following information: - Biocompatibility testing on the injector . - Visual, optical and mechanical testing on injected IOL. . - Visual and mechanical testing on injector. . - Packaging performance testing . The performance data indicates that the Rayner Single Use Disposable Soft Tipped Injector R-INJ-04 delivers those IOL models, that allow use of this injector in their approved labeling, without significantly impacting the optical performance, the dimensions or the cosmetic appearance of the lens. The following series of tests were conducted with the injection media Balanced Salt Solution (BSS) and a viscoelastic currently approved and used on the US market. ### a) Biocompatibility testing on the injector Biocompatibility testing on the injector was undertaken on the nozzle and plunger tip as these components incorporate the materials in contact with the tissues of the injector components barrel, flap and bush are made from the same polypropylene material as the nozzle. The nozzle was tested in the previous version of the single use disposable injector (model R-INJ-02 / K052651). The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip. Using the scheme as outlined in ISO 10993-1 and the US Blue Book Memorandum G95-1 the following tests have been undertaken Cytotoxicity (Quantitative Growth Inhibition Test (ISO 10993-5), Maximization Test according to Magnusson and Kligman (ISO 10993-10) Intracutaneous Reactivity (ISO 10993-10) and Acute Systemic Toxicity (ISO 10993-11). Testing on the final packaged and terminally sterilized Single Use Disposable Soft Tipped Lens Injector (R-INJ-04) shows the materials to be biocompatible/toxicologically safe for the intended clinical application (limited exposure duration with the device in contact with a breached/comprised surface). ### b) Visual, optical and mechanical testing on injected IOL ### VISUAL TESTING Observation at magnification under optimal lighting conditions for the following: - No optic lens tears for properly loaded lenses. . - . No haptic damage. - Absence of 'Fold lines' and/or deposits/debris on the lens surface. . - Evaluation of haptic fixation recovery time, to 11 mm diameter dimension. . - OPTICAL TESTING - Modulation Transfer Function . - . Dioptric power - Spectral transmittance . MECHANICAL TESTING - Dimensions ● - Lens sagittal dimension . - Lens overall diameter . - Haptic compression force . - Dynamic fatigue durability . Page 4 of 5 {4}------------------------------------------------ - Limb/loop pull strength ● - Optic decentration . - . Optic tilt - . Axial displacement The aforementioned mechanical testing is an assessment of the haptic function. Dioptric power does not affect the property tested. Therefore testing as per FDA IOL Guidance document Oct 10th 1997, was performed on 10 lenses each of both the highest and lowest powers. Testing was carried out as per FDA guidelines in that the lens is folded for a minimum of 3 minutes. The IOL was allowed to return to its original and designed configuration. Compliance with applicable mechanical and optical requirements was demonstrated at 24+/-2 hours post folding/injection. (Reference ISO 11979-3, section 4.1 & CDRH IOL Guidance Document Oct 10th 1997). #### c) Visual and mechanical testing on the single use disposable injector VISUAL/PRODUCTION - Surface finish & dimensional check . #### MECHANICAL - Nozzle tip detachment from barrel/main body of injector . - . Tensile testing on bond of the TPE tip to the shaft of the plunger #### d) Packaging performance testing The following tests were performed: - Sterility test . - Dye penetration . - . Burst Test Page 5 of 5 {5}------------------------------------------------ Public Health Service Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 3 2006 Rayner Surgical, Inc. c/o Mr. Mark B. Mullaney Regulatory Affairs Director Sackville Road Hove East Sussex United Kingdom BN3 7AN Re: K062612 Trade Name: Rayner Single Use Soft Tipped Disposable Injector (Model R-INJ-04) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 10, 2006 Received: November 15, 2006 Dear Mr. Mullaney: We have reviewed vour 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 (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. {6}------------------------------------------------ Page 2 - Mr. Mark B. Mullaney 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. Egelman S.M.D 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 {7}------------------------------------------------ ### Indications for Use 510 (k) Number (if known) : K062612 Device Name: The disposable single-use, soft tipped injector (model number R-INJ-04) Indications For Use: The disposable single-use, soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. Over-The-Counter Use Prescription Use x x AND/OR - -(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED ) Concurrence of CDRH, Office of Device Evaluation (ODE) Paul Ormonde **510(K) Number** K062612 Page 1 of