MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE

{0}------------------------------------------------ MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES K101782 # 510(k) SUMMARY | Submitter Information | STAAR Surgical Company<br>Contact: Jack Coggan<br>Director of Regulatory Affairs<br>1911 Walker Avenue<br>Monrovia, California 91016<br>Phone: 626.303.7902 ext 2616<br>Fax: 626.303.2962 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Registration Number | 2023826 | | Submission Correspondent | STAAR Surgical Company<br>Contact: Jack Coggan<br>Director of Regulatory Affairs<br>1911 Walker Avenue<br>Monrovia, California 91016<br>Phone: 626.303.7902 ext 2616<br>Fax: 626.303.2962 | | Date Summary Prepared | January 4, 2011 | | Classification Name | Lens, Guide, Intraocular<br>(Class I) - KYB 21 CFR 886.4300<br>Folders and Injectors, Intraocular Lens (IOL)<br>(Class I) - MSS 21 CFR 886.4300 | | Common/Usual Name | Intraocular Lens Injector Cartridge | | Device Trade Name | MicroSTAAR™ MSI Injector System<br>Models: CQ, SFC 25, SFC 45 | The primary devices used for comparison in this summary are: Epiphany Injector System (K090161) and MicroSTAAR™ Indigo Injector System (K073586). #### Intended Use The MicroSTAAR MSI Injector System is intended to fold and insert STAAR Surgical Company Collamer phakic and aphakic 1-piece and 3-piece Collamer® intraocular lenses for surgical placement in the human eye. The MSI Cartridges in this submission are just one component of the MicroSTAAR MSI Injector System. The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). 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The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile. ## Technological Characteristics The MicroSTAAR™ MSI injector System Cartridge has substantially equivalent technological characteristics to the predicate device. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, specifications and materials. | | MicroSTAAR Injector System<br>K940593, K980696, K073586 | Epiphany Injector System<br>K090161<br>Epiphany | MicroSTAAR MSI Injector<br>System Cartridges | Substantially<br>Equivalent | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Product<br>Description | System is designed to facilitate<br>the loading, folding and<br>delivery of an intraocular lens<br>(IOL) into the human eye<br>through a small incision. | System is designed to facilitate<br>the loading, folding and<br>delivery of an intraocular lens<br>(IOL) into the human eye<br>through a small incision. | System is designed to facilitate<br>the loading, folding and<br>delivery of an intraocular lens<br>(IOL) into the human eye<br>through a small incision. | Same | | Intended Use | Intended to fold and insert<br>STAAR Surgical Company 1-<br>piece or 3-piece Collamer<br>intraocular lenses for surgical<br>placement in the eye. | Intended to fold and insert<br>STAAR Surgical Company 3-<br>piece Silicone intraocular<br>lenses for surgical placement in<br>the eye. | Intended to fold and insert<br>STAAR Surgical Company 1-<br>piece and 3-piece Collamer<br>intraocular lenses for surgical<br>placement in the eye. | Same | | Design | Single cartridge to be used in<br>conjunction with appropriate<br>injector system and 1-piece or<br>3-piece Collamer lenses for<br>surgical placement of lens into<br>eye. | A single component medical<br>device used in conjunction with<br>3-piece silicone lenses for<br>surgical placement in the eye. | Single cartridge to be used in<br>conjunction with appropriate<br>injector system and 1-piece or<br>3-piece Collamer lenses for<br>surgical placement of lens into<br>eye. | Same | | Materials | Cartridge is manufactured from<br>Polypropylene purchased from<br>US Supplier. | Cartridge is manufactured from<br>Polypropylene MG05 and<br>Polypropylene MG03<br>purchased from Japan Supplier. | Cartridge is manufactured from<br>Polypropylene MG05 and<br>Polypropylene MG03<br>purchased from Japan Supplier. | Same | | Mechanical<br>Safety | | | | | | Manufacturing | Utilization of contract<br>manufacturers and in-house<br>processing at Monrovia facility | Utilization of contract<br>manufacturers and in-house<br>processing at the STAAR Japan<br>facility | Utilization of contract<br>manufacturers and in-house<br>processing at the STAAR Japan<br>facility, while molding process<br>is still done by a US contractor. | Similar | # Comparison Analysis {3}------------------------------------------------ ### MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES | 510(k) | MicroSTAAR Injector System<br>K940593, K980696, K073586 | Epiphany Injector System<br>K090161<br>Epiphany | MicroSTAAR MSI Injector System Cartridges | Substantially Equivalent | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Operating<br>Principle | The IOL is placed into the<br>loading area and folded shut or<br>gently pressed towards tip.<br>Then cartridge is loaded onto<br>the injector. | The cartridge is part of the<br>Epiphany Injector. The lens is<br>loaded into the cartridge,<br>snapped shut, and pushed into<br>pre-operative position. | Depending on the cartridge<br>type, the IOL is either placed<br>into the loading area and folded<br>shut, or it is pressed forward<br>towards the tip. Then cartridge<br>is loaded onto the injector. | Same | | Packaging | Cartridge is placed in tray,<br>sealed with Tyvek lid and<br>labeled. Tray is placed in Kraft<br>paper pouch and then a foil<br>pouch, and labeled again. US<br>Packaging Supplier. | The Epiphany injector is placed<br>into a tray, which is labeled.<br>This unit is placed inside a<br>pouch which is sealed. The<br>sealed pouch is then put into a<br>box with a package insert.<br>Japanese Packaging Supplier. | Cartridge is placed in tray,<br>sealed with Tyvek lid and<br>labeled. Tray is placed in Kraft<br>paper pouch. Japanese<br>Packaging supplier. | Similar | | Sterility | Sterile Ethylene Oxide (EtO)<br>by Subcontractor | Sterile Ethylene Oxide (EtO)<br>by STAAR Japan | Sterile Ethylene Oxide (EtO)<br>by STAAR Japan | Same | | Manufacturer | STAAR Surgical | STAAR Japan | STAAR Japan | Same | 8 . Table 1 – Summary of Design comparison for 21 CFR § 807.87(f) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 FEB - 7 2011 STAAR Surgical Company c/o Mr. Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016 Re: K101782 Trade/Device Name: MicroSTAAR Injector System Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserve Product Code: MSS Dated: December 2, 2010 Received: December 6, 2010 Dear Mr. Coggan: This letter corrects our substantially equivalent letter of December 22, 2010. We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocasined 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 commerce provided to May 20, 1977, the oncordance with the provisions of the Federal Food, Drug, devices that have occh require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the devices subject to eno gements for annual registration, listing of devices, controls provisions of the frect merade song prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (000 as ) Existing major regulations affecting your device can be may be subject to additions, 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 Please be advised that I DA s issuated or wouldevice complies with other requirements of the Act that I DA has made a acterimansions administered by other Federal agencies. You must of any I cuthal saltutes and regulations and limited to: registration and listing (21 Comply with an the For 8 requirements (01); medical device reporting (reporting of medical {5}------------------------------------------------ #### Page 2 - Mr. Jack Coggan 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Kesia Alexander Image /page/5/Picture/7 description: The image shows a handwritten word, "for", in cursive script. The letter "f" is elongated with a large loop extending below the baseline, and the letters "o" and "r" are connected in a fluid, continuous stroke. The writing appears to be done with a pen or marker, and the ink is dark and bold. Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K101782 Device Name: MicroSTAAR™ Injector System Cartridge Indications For Use: The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye. Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jennifer Brown Page 1 of (Division Sign Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K101782