VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)

K993039 · Bausch & Lomb, Inc. · MRH · Jan 7, 2000 · General Hospital

Device Facts

• Record ID: K993039
• Device Name: VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
• Applicant: Bausch & Lomb, Inc.
• Product Code: MRH · General Hospital
• Decision Date: Jan 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz Millennium™ Viscous Fluid System is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgery. The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single-use accessory pack consisting of an infusion tube set, a syringe, a Cannula and instructions for use.

Device Story

The Storz Millennium Viscous Fluid Injector (VFI) system (CX5700 module) is a self-contained pump system designed for use with the Storz Millennium Microsurgical System. It facilitates the injection and aspiration of viscous fluids and Balanced Salt Solution (BSS) during posterior vitreoretinal and retinal translocation surgeries. The system utilizes disposable, single-use accessories, including an infusion tube set, syringe, and cannula. Operated by ophthalmic surgeons in a clinical/surgical setting, the device provides controlled fluid management to assist in complex retinal procedures. The system is an extension of existing microsurgical platforms, maintaining the same design, functional characteristics, and sterilization methods as the predicate device, with the added capability of administering BSS for retinal translocation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional similarity to the predicate device.

Technological Characteristics

Self-contained pump module (CX5700) for use with the Storz Millennium Microsurgical System. Includes sterile single-use accessory pack (CX5710) comprising infusion tube set, syringe, and cannula. Operates as a fluid injection/aspiration system for ophthalmic surgery.

Indications for Use

Indicated for patients undergoing ophthalmic posterior vitreoretinal and retinal translocation surgical procedures requiring injection or aspiration of viscous fluids and Balanced Salt Solution (BSS).

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Storz Millennium Viscous Fluid Injector System (K972664)

Reference Devices

• Storz Millennium Microsurgical System (K961310)
• Shillia Escalon Viscous Fluid System (K963434)
• Richard James Viscous Fluid Transfer System (K902835)
• Alcon Accurity (submission number not stated)

Submission Summary (Full Text)

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3365 Tree Court Industrial Blvd
St. Louis, MO USA 63122 6694

K993039

## 1 - 7 2000

## SUMMARY OF SUBSTANTIAL EQUIVALENCE

**BAUSCH**
**& LOMB**

Surgical

Contact Person: Vanada Johnson, Regulatory Affairs Specialist Bausch & Lomb Surgical 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 Phone [phone] Fax [phone]

Date Prepared: September 10, 1999

The Storz Millennium Viscous Fluid Injector system (VFI) is a Class II device in accordance with 21 CFR Section 880.5725. Further, the VFI and its accessories was previously cleared, via the Premarket Notification process and was assigned 510(k) file number K972664 and Classification Code 86 MRH

The VFI system module (CX5700) is a self-contained pump system used in conjunction with the Storz Millennium™ Microsurgical System (K961310). The Storz Millennium ™ Viscous Fluid Injector System (K972664) is intended for the Stort viscous fluids and Balance Salt Solution (RSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgical procedures using the Bausch & Lomb Surgical's disposable, single-use accessories .

The only difference between the proposed vs. the predicate VFI system is the inclusion of administering Balanced Salt Solution used for retinal translocation procedures. The Millennium ™ Viscous Fluid Injector System (K972664), in and of itself, will remain unchanged in that there will be no changes to the design, functional characteristics, sterilization method(s), product specifications, or intended use.

Bausch & Lomb Surgical considers the VFI system to be substantially equivalent in design and intended use in comparison to the currently marketed Viscous Fluid Injection System covered by K972664. Further, Bausch & Lomb considers the VFI system similar to the following previously cleared Storz Millennium™ Microsurgical System Shillia Escalon® Viscous Fluid System (K963434), The Richard James Viscous Fluid Transfer System (K902835) and the Alcon Accurity, The Richard Summes Viscous F

Submitted by:

A

Vanada Johnson Regulatory Affairs

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2000

Ms. Vanada Johnson Regulatory Affairs Specialist Bausch & Lomb Surgical 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694

Re: K993039 Trade Name: Viscous Fluid Injector System Module Regulatory Class: II Product Code: 86 MRH Regulation: 880.5725 Dated: December 6, 1999 Received: December 7, 1999

Dear Ms. Johnson:

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 commence prior to May 18, 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 Coscil (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 vanual regustration, 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 mail a 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 nonder the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ARolph lorentthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K993039 510(K) Number -

Device Name: Storz Millennium Viscous Fluid System

Indications for Use:

The Storz Millennium™ Viscous Fluid System is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgery. The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single-use accessory pack consisting of an infusion tube set, a syringe, a Cannula and instructions for use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-the-Counter Use

(Division Sign-Off) Dennis L. McCarthy

510(k) Number K993039

Bausch & Lomb Surgical