Who is the manufacturer of STORZ MILLENNIUM VISCOUS FLUID SYSTEM?

Storz Instrument Co. filed the 510(k) submission for STORZ MILLENNIUM VISCOUS FLUID SYSTEM (K972664).

What is the FDA product code for STORZ MILLENNIUM VISCOUS FLUID SYSTEM?

MRH. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for STORZ MILLENNIUM VISCOUS FLUID SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STORZ MILLENNIUM VISCOUS FLUID SYSTEM?

Storz Millennium™ Microsurgical System (K961310); Escalon® Viscous Fluid System (K963434); Richard James Viscous Fluid Transfer System (K902835); Escalon® Fluid Delivery Pack (K963434).

Who can help prepare an FDA 510(k) submission like STORZ MILLENNIUM VISCOUS FLUID SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STORZ MILLENNIUM VISCOUS FLUID SYSTEM

K972664 · Storz Instrument Co. · MRH · Oct 10, 1997 · General Hospital

Device Facts

Record ID	K972664
Device Name	STORZ MILLENNIUM VISCOUS FLUID SYSTEM
Applicant	Storz Instrument Co.
Product Code	MRH · General Hospital
Decision Date	Oct 10, 1997
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 a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal 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.

Device Story

System comprises Storz CX5700 module and CX5710 disposable injection pack; used during posterior vitreoretinal surgery. Module integrates with Storz Millennium™ Microsurgical System to inject/aspirate viscous fluids (e.g., silicone oil) for retinal tamponade. Operated by surgeon via foot pedal and touch screen interface. System provides dual linear foot control for pressure/vacuum regulation (0-70 PSI injection; 0-600 mmHg aspiration). Disposable pack includes tubing, syringe, and needle assembly. Output allows surgeon to manipulate intraocular fluid dynamics to fixate retinal tears/detachments.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Modular pump system; AISI 303 stainless steel patient contact materials; dual linear foot controller; touch screen interface; sterile, single-use disposable accessory packs; packaged in Tyvek® pouches.

Indications for Use

Indicated for injection and aspiration of viscous fluids (e.g., silicone oil) during posterior ophthalmic vitreoretinal surgery to act as a tamponade for retinal tears and detachments.

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™ Microsurgical System (K961310)
Escalon® Viscous Fluid System (K963434)
Richard James Viscous Fluid Transfer System (K902835)
Escalon® Fluid Delivery Pack (K963434)

Reference Devices

Alcon Accurus™ Vitreoretinal Surgical System

Related Devices

K993039 — VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) · Bausch & Lomb, Inc. · Jan 7, 2000
K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM · Storz Instrument Co. · Mar 23, 1998
K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) · Bausch and Lomb, Incorporated · Mar 25, 2026
K082473 — BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM · Bausch & Lomb, Inc. · Jan 5, 2009
K213467 — EVA NEXUS Ophthalmic Surgical System · D.O.R.C. Dutch Ophthalmic Research Center (International) · Jun 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ K972664 Image /page/0/Picture/1 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and bold. There is a registered trademark symbol in the upper right corner of the image. The background is a rounded rectangle. Storz Millennium™ Viscous Fluid System Premarket Notification 0CT 1 0 1997 #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is submitted in accordance with the requirements of 21 CFR 807.92: Contact Person: Patrick G. Balsmann, Regulatory Affairs Associate Storz, 3365 Tree Court Industrial Bldv., St. Louis, MO 63122-6694 Phone: (314) 225- 5051, ext. 5538. Date Prepared: July 15, 1997 Proprietary Name: Storz Millennium™ Viscous Fluid System Common/Usual Name: Viscous Fluid Injection/Aspiration System(s). Classification Name: Infusion Pump, 86 MRH; 21CFR §880.5725. Device Description/Intended Use: The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module. Predicate Device: The Storz CX5700 Millennium™ Viscous Fluid System Module is similar in design and function to the Storz Millennium™ Microsurgical System (K961310), Escalon® Viscous Fluid System (K963434), the Richard James Viscous Fluid Transfer System (K902835), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5710 Viscous Fluid Injection Pack is similar in design, composition, and function to the Escalon® Fluid Delivery Pack (K963434.) Predicate Comparison: A chart comparing characteristics of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack to those of the predicate devices is attached. **Submitted by:** Robert H. Johnson Patrick G. Balsmann Regulatory Affairs 1 × 4 {1}------------------------------------------------ #### Storz CX5700 Millennium™ Viscous Fluid System Module Device Comparison Chart ( ( | Device Description | Storz CX5700 Viscous Fluid System | Storz Millennium™ Microsurgical System | Alcon Accurus™ Vitreoretinal Surgical System | Escalon® Viscous Fluid System | Richard James Viscous Fluid Transfer System | |----------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | 510(k) | current | K961310 | unknown | K963434 | K902835 | | Intended Use | Posterior segment ophthalmic surgery - injection & aspiration of viscous fluids. | Anterior & posterior segment ophthalmic surgery. | Posterior segment ophthalmic surgery. | Posterior ophthalmic surgery - injection & aspiration of viscous fluids. | Posterior ophthalmic surgery - injection & aspiration of viscous fluids. | | Modular Design | Yes | Yes. | No. | No. | No. | | Ophthalmic Features | Viscous fluid injection/ aspiration. | Irrigation/aspiration, phacoemulsification/ fragmentation, vitrectomy, scissors, bipolar, illumination, & IOP control. | Viscous fluid injection/aspiration, Irrigation/aspiration, fragmentation, vitrectomy, scissors, bipolar, illumination, & IOP control. | Viscous fluid injection/aspiration. | Viscous fluid injection/aspiration. | | Programmable For Multiple Surgeons | Yes. | Yes. | Yes. | No. | No. | | Device Description | Storz CX5700 Viscous Fluid System | Storz MillenniumTM Microsurgical System | Alcon AccurusTM Vitreoretinal Surgical System | Escalon® Viscous Fluid System | Richard James Viscous Fluid Transfer System | | 510(k) | current | K961310 | unknown | K963434 | K902835 | | Disposable Accessories | Yes. | Yes. | Yes. | Yes. | Yes. | | Viscous Fluid User Interface | Foot pedal & touch screen. | Foot pedal & touch screen. | Foot pedal & touch screen. | Foot pedal & control knob. | Foot pedal & control knob. | | Foot Controller - Dual Linear | Yes | Yes. | No. | No. | No. | | Viscous Fluid Injection, Pressure Range | 0 - 70 PSI | Not Applicable. | 0 - 80 PSI. | 0 - 70 PSI. | 0 - 70 PSI. | | Viscous Fluid Injection, Aspiration Range | 0 - 600 mmHg. | Not Applicable. | 0 - 600 mmHg. | 0 - 600 mmHg. | 0 - 650 mmHg. | ﻟ {2}------------------------------------------------ # Storz CX5700 Millennium™ Viscous Fluid System Module Comparison ( ﺴﺮ ﻣ {3}------------------------------------------------ #### Storz CX5710 Viscous Fluid Injection Pack Device Comparison Chart ﻟﻤﺴﺘﻌﻤﺎ - | Device Description | Storz CX5710 Viscous Fluid Injection Pack Escalon® Fluid Delivery Pack | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | current K963434 | | Pack Components | Modified hose barb, tubing, male luer with locking nut, filter, 10cc syringe adaptor, 10cc modified piston, needle/cover assembly, 10cc standard piston, & 10cc syringe assembly. Hose barb, tubing, male luer with locking nut, filter, 10cc syringe adaptor, 10cc modified piston, needle/cover assembly, 10cc standard piston, & 10cc syringe assembly. | | Applicable Ophthalmic Surgical Unit | Storz Millennium™ Microsurgical System Escalon® Viscous Fluid System | | Provided Sterile | Yes. Yes. | | Labeled For Single Patient Use | Yes. Yes. | | Patient Contact Material | AISI 303 stainless steel. AISI 303 stainless steel. | | Packaging | Sealed Tyvek® pouches. 10 packs/box. Sealed Tyvek® pouches. 10 packs/box. | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern. OCT 10 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Patrick G. Balsmann Domestic Regulatory Affairs Associate Storz Instrument Company 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122-6694 Re: K972664 > Trade Name: Storz Millennium™ Viscous Fluid System Regulatory Class: II Product Code: 86 MRH Dated: July 15, 1997 Received: July 16, 1997 Dear Mr. Balsmann: 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. {5}------------------------------------------------ Page 2 - Mr. Patrick G. Balsmann 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. Roepke Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for Storz. The logo is in black and white and features the word "storz" in a stylized font. The word is set against a black background with rounded corners. There is a registered trademark symbol to the right of the word. ## Storz Millennium™ Viscous Fluid System Premarket Notification ### INDICATIONS FOR USE Device Name: Storz Millennium™ Viscous Fluid System Indications for Use: The Storz Millennium™ Viscous Fluid System is a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal 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. Enette TK Beers ivision of Ophthalmic 510(k) Number **Prescription Use** **(Per 21 CFR 801.109)** (114