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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Storz Millennium™ High Speed Vitrectomy System:

Summary of Acceptance Criteria and Study Information:

This 510(k) submission, K980488 for the "Storz Millennium™ High Speed Vitrectomy System," is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about specific performance acceptance criteria for the new device as a standalone product, nor does it detail a study that directly proves specific numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is implied through the comparison of characteristics and specifications against these predicates. This is a common approach for 510(k) submissions, where the new device is not required to meet novel performance criteria but rather to demonstrate it is as safe and effective as a legally marketed device.

Therefore, the table below will reflect the comparison of characteristics rather than specific "acceptance criteria" and "reported device performance" in the traditional sense of a clinical or analytical study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device "Performance" (as presented in the 510(k) for substantial equivalence):

Characteristic / "Acceptance Criteria" (Implied)	Storz Millennium™ High Speed Vitrectomy System (Reported "Performance")	Predicate Devices (Comparative Data)
Storz CX5800 Millennium™ High Speed Vitrectomy Module
Intended Use	Posterior segment ophthalmic surgery.	Storz Millennium™ Microsurgical System: Anterior & posterior segment ophthalmic surgery. Alcon Accurus™ Vitreoretinal Surgical System, Promex Vitrectomy System, Scieran Technologies Vit Commander System: Posterior segment ophthalmic surgery.
Modular Design	Yes.	Storz Millennium™ Microsurgical System: Yes. Alcon Accurus™ Vitreoretinal Surgical System, Promex Vitrectomy System: No. Scieran Technologies Vit Commander System: Yes.
Ophthalmic Features	Vitrectomy.	Storz Millennium™ Microsurgical System: Viscous fluid injection/aspiration, Irrigation/aspiration, phacoemulsification/ fragmentation, vitrectomy, scissors, bipolar, illumination, & IOP control. Alcon Accurus™: Viscous fluid injection/aspiration, Irrigation/aspiration, fragmentation, vitrectomy, scissors, bipolar, illumination, & IOP control. Promex: Vitrectomy, aspiration. Scieran: Irrigation/aspiration, vitrectomy, bipolar.
Programmable For Multiple Surgeons	Yes.	Storz Millennium™ Microsurgical System, Alcon Accurus™: Yes. Promex, Scieran: No.
Disposable Accessories	Yes.	All listed predicates: Yes.
User Interface	Foot pedal & touch screen.	Storz Millennium™ Microsurgical System, Alcon Accurus™: Foot pedal & touch screen. Promex, Scieran: Foot pedal & control knobs.
Foot Controller - Dual Linear	Yes.	Storz Millennium™ Microsurgical System: Yes. Alcon Accurus™, Promex, Scieran: No.
Storz CX5810 High Speed Vitrectomy Handpiece
Intended Use	Posterior Vitreous Removal.	Storz MicroVit® Vitrectomy Probe, Alcon Accurus™ InnoVit™ Probe, Promex Vitrectomy System, Scieran Technologies Vit Commander System: Posterior Vitreous Removal.
Cuts Per Minute (CPM)	(Not explicitly listed in the table provided for the new handpiece, but generally expected to be comparable to predicates)	Storz MicroVit®: 30 - 750 cpm. Alcon Accurus™ InnoVit™: 100-1200 cpm. Promex Vitrectomy System: up to 2000 cpm. Scieran Technologies Vit Commander System: 400-2500 cpm.
Sterilization	Single use Disposable.	Storz MicroVit®, Alcon Accurus™ InnoVit™: Single use Disposable. Promex, Scieran: Autoclavable handpiece with disposable tip.
Handpiece Body Material	Plastic.	Storz MicroVit®, Alcon Accurus™ InnoVit™: Plastic. Promex: Stainless steel and aluminum. Scieran: Titanium.
Type of Handpiece Drive	Pneumatic.	Storz MicroVit®, Alcon Accurus™ InnoVit™: Pneumatic. Promex, Scieran: Electric.
Associated Aspiration System	Venturi.	Storz MicroVit®, Alcon Accurus™ InnoVit™, Promex: Venturi. Scieran: Diaphragm.
Cutting Action	Guillotine.	All listed predicates: Guillotine.
Storz CX4804 High Speed Vit Cutter Pack
Pack Components	High speed vitrectomy cutter with aspiration tubing.	Storz DP4801: Vit cutter, aspiration tubing, collection cassette. Alcon Accurus™ Total Plus™ Pak: Cassette with drain bag, vitrectomy probe, fiber optic illuminator probe, aspiration tubing, infusion spike, infusion cannula. Promex Pack: High speed vitrectomy cutter with aspiration tubing.
Applicable Ophthalmic Surgical Unit	Storz Millennium Microsurgical System.	Storz DP4801: Storz Millennium Microsurgical System, Storz Premiere Microsurgical System. Alcon Accurus™ Total Plus™ Pak: Alcon Accurus Vitreoretinal Surgical System. Promex Pack: Promex Vitrectomy System.
Provided Sterile	Yes.	All listed predicates: Yes.
Labeled For Single Patient Use	Yes.	All listed predicates: Yes.
Patient Contact Material	AISI 304 stainless steel with anti-reflective steel.	Storz DP4801, Promex Pack: AISI 304 stainless steel. Alcon Accurus™ Total Plus™ Pak: Stainless steel.
Packaging	Sealed Tyvek trays. Six trays/box.	Storz DP4801: Sealed Tyvek trays. Six trays/box. Alcon Accurus™ Total Plus™ Pak, Promex Pack: Unknown.

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

This 510(k) submission does not refer to a "test set" or a formal clinical study with human subjects designed to evaluate the performance of the new device.
The data provenance is based on published information and specifications of legally marketed predicate devices, as maintained by the manufacturers and available to the FDA through previous 510(k) clearances (e.g., K961310, K961078, K961738). There is no mention of country of origin for specific "data," as it's a comparison of specifications.
The approach is a retrospective comparison against existing predicate device characteristics, not a prospective study.

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

Given that no "test set" or clinical study for the new device is described, no experts were used to establish ground truth in this context.
The "ground truth" here is effectively the accepted specifications and intended uses of the predicate devices as cleared by the FDA.

4. Adjudication Method for the Test Set:

Not applicable. No test set was described.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance, which is not applicable to a vitrectomy system.

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

Not applicable. The device is a surgical instrument and system; it is not an algorithm, and the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence relies on the established specifications, intended uses, and safety/effectiveness profiles of the identified legally marketed predicate devices, as detailed in their respective 510(k) clearances. There is no external clinical ground truth (like pathology or outcomes data) directly generated for this new device's submission.

8. The Sample Size for the Training Set:

Not applicable. This device is a vitrectomy system, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set mentioned, no ground truth needed to be established for one.

Summary

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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

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Storz CX5800 Millennium™ High Speed Vitrectomy Module Device Comparison Chart

DeviceDescription	Storz CX5800High SpeedVitrectomyModule	StorzMillenniumTMMicrosurgicalSystem	Alcon AccurusTMVitreoretinalSurgical System	PromexVitrectomy System	Scieran Technologies VitCommander System	DeviceDescription	StorzMicroVit®VitrectomyProbe	Alcon Accurus™InnoVit™Probe	Promex VitrectomySystem	Scieran TechnologiesVit CommanderSystem
510(k)	current	K961310	unknown	K961078	K961738	510(k)	K954816 K961310	unknown	K961078	K961738
Intended Use	Posterior segmentophthalmicsurgery.	Anterior & posteriorsegment ophthalmicsurgery.	Posterior segmentophthalmic surgery.	Posterior segmentophthalmic surgery.	Posterior segment ophthalmicsurgery.	Intended Use	Posterior VitreousRemoval	Posterior VitreousRemoval	Posterior VitreousRemoval	Posterior VitreousRemoval
ModularDesign	Yes.	Yes.	No.	No.	Yes.	Cuts Per Minute	30 - 750 cpm	100-1200 cpm	up to 2000 cpm	400-2500 cpm
OphthalmicFeatures	Vitrectomy	Viscous fluidinjection/aspiration,Irrigation/aspiration,phacoemulsification/ fragmentation,vitrectomy, scissors,bipolar,illumination, & IOPcontrol.	Viscous fluidinjection/aspiration,Irrigation/aspiration,fragmentation.vitrectomy, scissors,bipolar,illumination, & IOPcontrol.	Vitrectomy,aspiration.	Irrigation/aspiration,vitrectomy, bipolar.	Sterilization	Single useDisposable	Single useDisposable	Autoclavablehandpiece withdisposable tip	Autoclavablehandpiece withdisposable tip
ProgrammableFor MultipleSurgeons	Yes.	Yes.	Yes.	No.	No.	Handpiece Body	Plastic	Plastic	Stainless steel andaluminum	Titanium
DisposableAccessories	Yes.	Yes.	Yes.	Yes.	Yes.	Type ofHandpiece Drive	Pneumatic	Pneumatic	Electric	Electric
User Interface	Foot pedal &touch screen.	Foot pedal & touchscreen.	Foot pedal & touchscreen.	Foot pedal & controlknobs.	Foot pedal & control knobs.	AssociatedAspiration system	Venturi	Venturi	Venturi	Diaphragm
FootController -Dual Linear	Yes.	Yes.	No.	No.	No.	Cutting Action	Guillotine	Guillotine	Guillotine	Guillotine

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Storz CX5810 High Speed Vitrectomy Handpiece Device Comparison Chart

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Storz CX4804 High Speed Vit Cutter Pack Device Comparison Chart

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DeviceDescription	Storz CX4804High SpeedVit CutterPack	StorzDP4801VitrectomyProbe Pack	Alcon Accurus™ Total Plus™ Pak	Promex Pack
510(k)	current	K954816 K961310	unknown	K961078
Pack Components	High speed vitrectomycutter with aspirationtubing.	Vit cutter, aspirationtubing, collectioncassette.	Cassette with drain bag, vitrectomy probe,fiber optic illuminator probe, aspirationtubing, infusion spike, infusion cannula.	High speed vitrectomycutter with aspirationtubing.
ApplicableOphthalmicSurgical Unit	Storz MillenniumMicrosurgical System.	Storz MillenniumMicrosurgical System.Storz PremiereMicrosurgical System.	Alcon Accurus Vitreoretinal SurgicalSystem.	Promex Vitrectomy System.
Provided Sterile	Yes.	Yes.	Yes.	Yes.
Labeled ForSingle Patient Use	Yes.	Yes.	Yes.	Yes.
Patient ContactMaterial	AISI 304 stainless steelwith anti-reflective steel	AISI 304 stainlesssteel.	Stainless steel	AISI 304 stainless steel.
Packaging	Sealed Tyvek trays.Six trays/box.	Sealed Tyvek trays.Six trays/box.	Unknown	Unknown

ど .

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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.

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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

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Storz Millennium™High Speed Vitrectomy System Premarket Notification

INDICATIONS FOR USE

Device Name:

Storz Millennium™ High Speed Vitrectomy System

Indications for Use:

Prescription USE ✓

Dennis L. McCarthy

vision Sign-Off)

L. vision of Ophthalmic Devices 510(k) Number_K 960 488 stice Cou

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.