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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Storz Millennium™ Viscous Fluid System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or performance study report would for an AI/ML device.

Therefore, many of the requested points regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on predicate comparison to establish substantial equivalence.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implied by demonstrating similar design, intended use, and operational characteristics to these predicates.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Storz CX5700 Viscous Fluid System)
Intended Use	Posterior segment ophthalmic surgery - injection & aspiration of viscous fluids (matching predicates like Escalon and Richard James)	Posterior segment ophthalmic surgery - injection & aspiration of viscous fluids
Modular Design	Yes (matching Storz Millennium™ Microsurgical System, different from some other predicates)	Yes
Ophthalmic Features	Viscous fluid injection/aspiration (matching Escalon, Richard James)	Viscous fluid injection/aspiration
Programmable For Multiple Surgeons	Yes (matching Storz Millennium™ Microsurgical System, Alcon Accurus™)	Yes
Disposable Accessories	Yes (matching all predicates listed)	Yes
Viscous Fluid User Interface	Foot pedal & touch screen (matching Storz Millennium™, Alcon Accurus™)	Foot pedal & touch screen
Foot Controller - Dual Linear	Yes (matching Storz Millennium™ Microsurgical System, different from some other predicates)	Yes
Viscous Fluid Injection, Pressure Range	0 - 70 PSI (matching Escalon, Richard James; similar to Alcon Accurus™ at 0-80 PSI)	0 - 70 PSI
Viscous Fluid Aspiration, Range	0 - 600 mmHg (matching Escalon; similar to Alcon Accurus™ at 0-600 mmHg and Richard James at 0-650 mmHg)	0 - 600 mmHg

2. Sample Size Used for the Test Set and Data Provenance:

This is a premarket notification for a medical device (a pump system for ophthalmic surgery), not an AI/ML diagnostic or prognostic tool. Therefore, there is no "test set" or "data provenance" in the context of evaluating algorithm performance on a dataset of patient cases. The evaluation is based on comparing the device's design and functional specifications to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no "ground truth" establishment in the context of a dataset for an AI/ML device. The "truth" for this submission is based on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method as described for AI/ML performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this is not an AI/ML device requiring an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm. It's a medical pump system.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The submission essentially argues that the new device is sufficiently similar to these predicates that it can be considered equally safe and effective.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set or ground truth in the context of AI/ML for this device.

Summary

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K972664

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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

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Storz CX5700 Millennium™ Viscous Fluid System Module Device Comparison Chart

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DeviceDescription	Storz CX5700Viscous FluidSystem	StorzMillennium™MicrosurgicalSystem	Alcon Accurus™VitreoretinalSurgical System	Escalon® ViscousFluid System	Richard JamesViscous FluidTransfer System
510(k)	current	K961310	unknown	K963434	K902835
Intended Use	Posterior segmentophthalmicsurgery - injection& aspiration ofviscous fluids.	Anterior & posteriorsegment ophthalmicsurgery.	Posterior segmentophthalmic surgery.	Posterior ophthalmicsurgery - injection& aspiration ofviscous fluids.	Posterior ophthalmicsurgery - injection &aspiration of viscousfluids.
ModularDesign	Yes	Yes.	No.	No.	No.
OphthalmicFeatures	Viscous fluidinjection/aspiration.	Irrigation/aspiration,phacoemulsification/fragmentation,vitrectomy, scissors,bipolar, illumination,& IOP control.	Viscous fluidinjection/aspiration,Irrigation/aspiration,fragmentation,vitrectomy, scissors,bipolar, illumination,& IOP control.	Viscous fluidinjection/aspiration.	Viscous fluidinjection/aspiration.
ProgrammableFor MultipleSurgeons	Yes.	Yes.	Yes.	No.	No.
DeviceDescription	Storz CX5700Viscous FluidSystem	StorzMillenniumTMMicrosurgicalSystem	Alcon AccurusTMVitreoretinalSurgical System	Escalon® ViscousFluid System	Richard JamesViscous FluidTransfer System
510(k)	current	K961310	unknown	K963434	K902835
DisposableAccessories	Yes.	Yes.	Yes.	Yes.	Yes.
Viscous FluidUser Interface	Foot pedal &touch screen.	Foot pedal & touchscreen.	Foot pedal & touchscreen.	Foot pedal &control knob.	Foot pedal & controlknob.
FootController -Dual Linear	Yes	Yes.	No.	No.	No.
Viscous FluidInjection,PressureRange	0 - 70 PSI	Not Applicable.	0 - 80 PSI.	0 - 70 PSI.	0 - 70 PSI.
Viscous FluidInjection,AspirationRange	0 - 600 mmHg.	Not Applicable.	0 - 600 mmHg.	0 - 600 mmHg.	0 - 650 mmHg.

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Storz CX5700 Millennium™ Viscous Fluid System Module

Comparison

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Storz CX5710 Viscous Fluid Injection Pack Device Comparison Chart

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Device Description	Storz CX5710 Viscous Fluid Injection PackEscalon® Fluid Delivery Pack
510(k)	currentK963434
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 SystemEscalon® 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.

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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.

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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

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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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).