RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06

{0}------------------------------------------------ K081455 6654 Church Street Los Angeles, California 90042-1555 USA Telephone: 1-800-905-0143 ### SEP - 5 2008 # 510(k) Summary ## Submitted by Rayner Intraocular Lenses Ltd. Andrew Wells Quality Assurance & Regulatory Affairs Manager Sackville Road Hove, East Sussex, BN3 7AN England Telephone # 0044-1273-205 401 Fax # 0044-1273-324 623 Summary prepared on May 12th 2008 ## Device Name - Trade/Proprietary Name: Rayner Single Use Small Incision Disposable Injector R-INJ-06 ● - Common Name: Rayner Single Use Small Incision 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: K062512 ● - Trade or Proprietary or Model Name: Rayner Single Use Soft Tipped Disposable Injector R-INJ-04 � - . Manufacturer: Rayner Intraocular Lenses Ltd. ## Intended Use The single-use small incision disposable injector (model number R-INJ-06) is intended 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/22 description: The image shows the number 000017. The number is written in a simple, sans-serif font. The digits are evenly spaced and clearly visible. The number is likely a serial number, code, or identifier. {1}------------------------------------------------ Description of the device that is subject to of the application, including an explanation of how the device functions, basic scientific concepts, scientific physical and performance characteristics (design, material, physical properties) The single-use small incision disposable injector (model number R-INJ-06) is intended 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 sterile field by tipping it from the tray. Fully retract the plunger ensuring that the tip does not protrude into the loading bay. Open the loading bay fialy 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. Rinse the IOL with sterile balanced salt solution. 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 down on lens 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, Excessive 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 is only to be depressed once. The small incision injector (model number R-INJ-06) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white. {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>Soft Tipped Injector R-INJ-04 | Rayner Single Use Small<br>Incision Disposable Injector<br>R-INJ-06 | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | 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. The plunger is<br>polypropylene with a<br>thermoplastic elastomer soft tip. | Polypropylene barrel, flap, bush,<br>nozzle and sleeve. The plunger is<br>polycarbonate. | | Surface Treatment | None | None | | Patient contact portion of the<br>device | Nozzle and plunger tip | Same | {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. t - Visual and mechanical testing on injector. - Packaging performance testing . The performance data indicates that the Rayner Single Use Disposable Soft Tipped Injector R-INJ-06 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, bush and sleeve are made from the same polypropylene material as the nozzle was tested in a previous version of the single use disposable injector (model R-INJ-02 / K052651). The plunger is a polycarbonate material which was tested in a previous version of the single use disposable injector (model R-INJ-02 / K052651. The injector is transparent and the plunger is white. 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 Injector shows the materials to be biocompatible/toxicologically safe for the intended clinical application (limited exposure duration with the device in contact with a breached/compromised 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. - t 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 Page 4 of 5 000020 {4}------------------------------------------------ - . Dynamic fatigue durability - 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 . #### d) Packaging performance testing The following tests were performed: - Sterility test . - Dye penetration . - Burst Test . {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 2008 Rayner Surgical, Inc. c/o Mr. Andrew Wells Rayner Intraocular Lenses 6654 Church Street Los Angeles, CA 90042-1555 Re: K081455 Trade/Device Name: Rayner Single Use Small Incision Disposable Injector R-INJ-06 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: MSS Dated: August 8, 2008 Received: August 13, 2008 Dear Mr. Wells: 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. 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 (2 ) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electromic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egleston, 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}------------------------------------------------ Rayner Surgical Inc. ### 510k submission # Indications for Use 510(k) Number (if known): K 08 14 5 5 Device Name Rayner Single Use Small Incision Disposable Injector R-INJ-06 - ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Indications For Use: ## Statement of Indications for use "The single-use small incision disposable injector (model number R-INJ-06) 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 " Prescription Use \ / Yes (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No. No. -(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Widnets Virran 9/3/08 Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic Ear, Division Throat Devises 510(k) Number_KO&THE 5 Page 1 of 1 May 12th 2008 000016