STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM

{0}------------------------------------------------ K980488 MAR 2 3 1998 #### Storz Millennium™ High Speed Vitrectomy System Premarket Notification #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is submitted in accordance with the requirements of 21 CFR 807.92: Contact Person:Gary Rauvola, Regulatory Affairs Group Manager Bausch & Lomb Surgical, Storz Products 3365 Tree Court Industrial Blvd. St. Louis. MO 63122-6694 Phone: (314) 225- 5051, ext. 5340. Date Prepared: February 4, 1998 Proprietary Name: Storz Millennium™ High Speed Vitrectomy System Common/Usual Name: Automated Vitrectomy Device Classification Name: Vitreous Aspiration & Cutting Instrument, 86 HQE; 21CFR \$886.4150. Device Description/Intended Use: The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack. Predicate Devices: The Storz CX5800 Millennium™ System High Speed Vitrectomy module is substantially equivalent in design and function to the Storz Millennium™ Microsurgical System (K961310), Promex Vitrectomy System (K961078), Scieran Technologies VIT Commander System (K961738), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5810 Millennium™ High Speed Vitrectomy handpiece is substantially equivalent to the Storz Micro Vit Vitrectomy Probe (K954816 and K961310), Promex Vitrectomy handpiece (K961078), Alcon Accurus InnoVit Probe, and the Scieran Vit Commander System handpiece (K961738). The Storz CX4804 High Speed Vitrectomy pack is similar in design, composition, and function to the Storz DP4801 Vitrectomy Probe pack (K954816 and K961310), the Promex vitrectomy cutter pack (K961078), and the Alcon Accurus Total Plus Pak. Predicate Comparisons: Charts comparing characteristics of the Storz CX5800 Millennium™ High Speed Vitrectomy module, Storz CX5810 Millennium™ High Speed Vitrectomy handpiece, and the Storz CX4804 pack to those of the predicate devices are attached. Submitted by: Gary Rauvole Gary Rauvola Regulatory Affairs Group Manager {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white halftone pattern. The pattern is arranged in a semi-circular shape, with the dots becoming smaller and more sparse towards the edges of the semi-circle. The dots are densely packed in the center of the semi-circle, creating a darker area. The overall effect is a gradient from dark to light, with the darkest area in the center and the lightest areas at the edges. ## Storz CX5800 Millennium™ High Speed Vitrectomy Module Device Comparison Chart | Device<br>Description | Storz CX5800<br>High Speed<br>Vitrectomy<br>Module | Storz<br>MillenniumTM<br>Microsurgical<br>System | Alcon AccurusTM<br>Vitreoretinal<br>Surgical System | Promex<br>Vitrectomy System | Scieran Technologies Vit<br>Commander System | Device<br>Description | | Storz<br>MicroVit®<br>Vitrectomy<br>Probe | Alcon Accurus™<br>InnoVit™<br>Probe | Promex Vitrectomy<br>System | Scieran Technologies<br>Vit Commander<br>System | |------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------|---------------------------------|--|-------------------------------------------|-------------------------------------|--------------------------------------------------|--------------------------------------------------| | 510(k) | current | K961310 | unknown | K961078 | K961738 | 510(k) | | K954816<br>K961310 | unknown | K961078 | K961738 | | Intended Use | Posterior segment<br>ophthalmic<br>surgery. | Anterior & posterior<br>segment ophthalmic<br>surgery. | Posterior segment<br>ophthalmic surgery. | Posterior segment<br>ophthalmic surgery. | Posterior segment ophthalmic<br>surgery. | Intended Use | | Posterior Vitreous<br>Removal | Posterior Vitreous<br>Removal | Posterior Vitreous<br>Removal | Posterior Vitreous<br>Removal | | Modular<br>Design | Yes. | Yes. | No. | No. | Yes. | Cuts Per Minute | | 30 - 750 cpm | 100-1200 cpm | up to 2000 cpm | 400-2500 cpm | | Ophthalmic<br>Features | Vitrectomy | Viscous fluid<br>injection/aspiration,<br>Irrigation/aspiration,<br>phacoemulsification<br>/ fragmentation,<br>vitrectomy, scissors,<br>bipolar,<br>illumination, & IOP<br>control. | Viscous fluid<br>injection/aspiration,<br>Irrigation/aspiration,<br>fragmentation.<br>vitrectomy, scissors,<br>bipolar,<br>illumination, & IOP<br>control. | Vitrectomy,<br>aspiration. | Irrigation/aspiration,<br>vitrectomy, bipolar. | Sterilization | | Single use<br>Disposable | Single use<br>Disposable | Autoclavable<br>handpiece with<br>disposable tip | Autoclavable<br>handpiece with<br>disposable tip | | Programmable<br>For Multiple<br>Surgeons | Yes. | Yes. | Yes. | No. | No. | Handpiece Body | | Plastic | Plastic | Stainless steel and<br>aluminum | Titanium | | Disposable<br>Accessories | Yes. | Yes. | Yes. | Yes. | Yes. | Type of<br>Handpiece Drive | | Pneumatic | Pneumatic | Electric | Electric | | User Interface | Foot pedal &<br>touch screen. | Foot pedal & touch<br>screen. | Foot pedal & touch<br>screen. | Foot pedal & control<br>knobs. | Foot pedal & control knobs. | Associated<br>Aspiration system | | Venturi | Venturi | Venturi | Diaphragm | | Foot<br>Controller -<br>Dual Linear | Yes. | Yes. | No. | No. | No. | Cutting Action | | Guillotine | Guillotine | Guillotine | Guillotine | {2}------------------------------------------------ ## Storz CX5810 High Speed Vitrectomy Handpiece Device Comparison Chart 1. 1. 1. 1. 1. 1. ಕ್ಷಗಳ ੂ ్లు : ई {3}------------------------------------------------ # Storz CX4804 High Speed Vit Cutter Pack Device Comparison Chart 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | Device<br>Description | | Storz CX4804<br>High Speed<br>Vit Cutter<br>Pack | Storz<br>DP4801<br>Vitrectomy<br>Probe Pack | Alcon Accurus™ Total Plus™ Pak | Promex Pack | |-------------------------------------------|--|------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | 510(k) | | current | K954816<br>K961310 | unknown | K961078 | | Pack Components | | High speed vitrectomy<br>cutter with aspiration<br>tubing. | Vit cutter, aspiration<br>tubing, collection<br>cassette. | Cassette with drain bag, vitrectomy probe,<br>fiber optic illuminator probe, aspiration<br>tubing, infusion spike, infusion cannula. | High speed vitrectomy<br>cutter with aspiration<br>tubing. | | Applicable<br>Ophthalmic<br>Surgical Unit | | Storz Millennium<br>Microsurgical System. | Storz Millennium<br>Microsurgical System.<br>Storz Premiere<br>Microsurgical System. | Alcon Accurus Vitreoretinal Surgical<br>System. | Promex Vitrectomy System. | | Provided Sterile | | Yes. | Yes. | Yes. | Yes. | | Labeled For<br>Single Patient Use | | Yes. | Yes. | Yes. | Yes. | | Patient Contact<br>Material | | AISI 304 stainless steel<br>with anti-reflective steel | AISI 304 stainless<br>steel. | Stainless steel | AISI 304 stainless steel. | | Packaging | | Sealed Tyvek trays.<br>Six trays/box. | Sealed Tyvek trays.<br>Six trays/box. | Unknown | Unknown | ど . {4}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 3 1998 Mr. Gary Rauvola Regulatory Affairs Group Manager Bausch & Lomb Surgical, Storz Products 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 Re: K980488 > Trade Name: Storz Millennium Microsurgical System High Speed Vitrectomy Regulatory Class: II Product Code: 86 HQE Dated: February 4, 1998 Received: February 9, 1998 Dear Mr. Rauvola: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. Image /page/4/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. {5}------------------------------------------------ Page 2 - Mr. Gary M. Rauvola This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A Ralph Rosenthal A. Ralph Rosenthal, M.I Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Storz Millennium™High Speed Vitrectomy System Premarket Notification ## INDICATIONS FOR USE Device Name: Storz Millennium™ High Speed Vitrectomy System Indications for Use: The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack. Prescription USE ✓ Dennis L. McCarthy vision Sign-Off) L. vision of Ophthalmic Devices 510(k) Number_K 960 488 stice Cou