STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)

K961310 · Storz Instrument Co. · HQC · Jun 27, 1996 · Ophthalmic

Device Facts

• Record ID: K961310
• Device Name: STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz PREMIERE II is a modular ophthalmic microsurgical system which is designed to be configured by Storz for use in anterior segment surgery only, posterior segment surgery only, or both.

Device Story

Modular ophthalmic microsurgical system for anterior and posterior segment surgery. System comprises computer unit with embedded PC/display, base unit, power supply, and interchangeable functional modules (phacoemulsification, vitrectomy, irrigation/aspiration, bipolar coagulation, illumination). Operated by surgeons in clinical settings via foot control or remote. System provides real-time display, self-diagnostics, and error processing. Modular design allows configuration for specific surgical needs. Benefits include integrated control of multiple surgical modalities, automated IV pole, and programmable settings for multiple surgeons.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design verification, and comparison of technical specifications and functional capabilities against predicate devices.

Technological Characteristics

Modular ophthalmic microsurgical system. Components: embedded PC, display console, power supply, and functional modules (phaco, vitrectomy, irrigation/aspiration, coagulation, illumination). Connectivity: foot control, remote control. Power: 100-120V/220-240V, 50/60 Hz. Operating environment: 10°-40° C, up to 98% humidity. Features: self-diagnostics, error processing, automated IV pole, programmable surgeon settings.

Indications for Use

Indicated for patients undergoing anterior segment, posterior segment, or combined ophthalmic microsurgical procedures.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• Storz PREMIERE Microsurgical System (K894278, K921460, K946227)
• Alcon Series 20000 Legacy Microsurgical System (K952213)
• SITE TXR System (K925828)
• Chiron CATALYST Microsurgical System
• Storz DP8020 Phaco Handpiece
• Storz DP7020 Frag Handpiece
• Grieshaber MPC Microscissors
• Grieshaber PSS Microscissors
• Storz ErgoTec Vitreoretinal Instrument System
• Storz DP4800 Posterior Vitrectomy Pack
• Storz DP4310 Deluxe Phaco Pack
• Storz DP9404 Bipolar Adaptor
• Storz D8204 Reusable Bipolar Cable
• Storz S2070 C Disposable Bipolar Cable

Submission Summary (Full Text)

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K961310

# 510(k) Summary of Safety and Effectiveness

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

## Submitted by:

Audrey G. Swearingen
Storz Instrument Company
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
314/225-5051, extension 5821

## Contact Person:

Michael H. Southworth
Regulatory Affairs Manager

## Date Prepared:

April 1, 1996

## Proprietary Name:

This device has been tentatively named the Storz PREMIERE II Microsurgical System. The proprietary name may be changed prior to distribution.

## Common/Usual Name:

Ophthalmic surgical system for cataract and vitro retinal surgery.

## Classification Name:

The device system is a Class II ophthalmic microsurgical system, Class II medical device, which is a combination of the following classification names:

1. Phacofragmentation system, 21 CFR §886.4670;
2. Vitreous Aspirating and Cutting Device, 21 CFR §886.4150; and
3. Radiofrequency Electrosurgery cautery Apparatus, 21 CFR §886.4100.

## Device Description/ Intended Use:

The Storz PREMIERE II is a modular ophthalmic microsurgical system which is designed to be configured by Storz for use in anterior segment surgery only, posterior segment surgery only, or both. The modular design allows user configuration of the system.

The PREMIERE II system is divided into the following functional sections:

1. Computer Unit. This unit will sit upon the PREMIERE II Ophthalmic Unit and is composed of an embedded PC and a display console.

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2. Ophthalmic Unit. This unit is comprised of a base unit, a power supply module, and up to five selected ophthalmic modules. The base unit is the primary housing for the system ophthalmic instrumentation, and is designed to facilitate front loading and unloading of up to six modules. The power supply module is the power source for the remaining five modules occupying the base unit. The ophthalmic modules are functional units, each of which contain the necessary components to interface the module with the Ophthalmic Base Unit or Ophthalmic Expansion Unit. The ophthalmic modules which will be available at product introduction are:

a. Air/Fluid Exchange and Scissors/Forceps module.
b. Bipolar Coagulation module.
c. Illumination module.
d. Irrigation, Scroll Aspiration, and Vitrectomy module.
e. Irrigation, Venturi aspiration, and Vitrectomy module.
f. Phacoemulsification and Phacofragmentation module.
g. Phaco module.
h. Frag module.

3. Peripherals. The following peripheral devices will be available at product introduction: Instrument Cart with automated IV pole, Ophthalmic Expansion Unit for additional modules, Remote Control Unit, and Foot Control.

New accessory devices to be marketed for use with the Storz PREMIERE II system. These include the following:

1. CX4310 Deluxe Scroll Phaco Pack.
2. CX4800 Deluxe Scroll Posterior Vitrectomy Pack.
3. CX9404 Bipolar Adaptor; CX9400, CX9420, CX9430 Bipolar Cords.
4. CX7000 Phaco Handpiece and CX7050 Frag Handpiece.
5. CX7100 Vertical Cut Microscissors and CX7150 Proportional Cut Microscissors Handpieces with Storz and ErgoTec® detachable tips.

Several existing Storz accessory devices will also be compatible with the Storz PREMIERE II System.

**Predicate Devices:** The Storz PREMIERE II Ophthalmic Microsurgical System and accessories are substantially equivalent to the following predicate devices:

The Storz PREMIERE II Microsurgical System is substantially equivalent to the Storz PREMIERE® Microsurgical System, the Alcon Series 20000® Legacy™ Microsurgical System, the SITE TXR™ System, and the Chiron CATALYST™ Microsurgical System;

The Storz CX7000 Phaco and CX7050 Frag Handpieces are substantially equivalent to the Storz DP8020 Phaco and DP7020 Frag Handpieces;

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The Storz CX7100 and CX7150 Microscissors with detachable ErgoTec™ tips are substantially equivalent to the Grieshaber MPC and PSS Microscissors, and the Storz ErgoTec™ Vitreoretinal Instrument System;

The Storz CX4800 Deluxe Scroll Posterior Vitrectomy Pack and Storz CX4310 Deluxe Scroll Phaco Pack are substantially equivalent to the Storz DP4800 Posterior Vitrectomy Pack and the Storz DP4310 Deluxe Phaco Pack, respectively;

The Storz CX9404 Bipolar Coaxial Adaptor is substantially equivalent to the Storz DP9404 Bipolar Adaptor;

The Storz CX9430 and CX9400 Reusable Bipolar Cables are substantially equivalent to the Storz D8204 Reusable Bipolar Cable, and the Storz CX9420 Disposable Bipolar Cable to the Storz S2070 C Disposable Bipolar Cable.

**Predicate Comparison:** Charts comparing the PREMIERE II System and accessories listed above to their respective predicate devices, demonstrating substantial equivalence, are attached.

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# Storz PREMIERE II Ophthalmic Microsurgical System
## Substantial Equivalence Comparison - General Information

| Device Name / Manufacturer | Storz PREMIERE II Microsurgical Systems
Storz Instrument Co. | Storz PREMIERE® Microsurgical System 510(k) K894278, K921460, K946227
Storz Instrument Co. | Alcon System 20000® Legacy™ Microsurgical System 510(k) K952213
Alcon Surgical, Inc. | SITE TXR™ System 510(k) K925828
SITE Microsurgical Systems, Inc. | Chiron CATALYST™ Microsurgical System 510(k) unknown
Chiron Corp. |
| --- | --- | --- | --- | --- | --- |
| Intended Use | Anterior and Posterior Segment Ophthalmic Surgeries | Anterior and Posterior Segment Ophthalmics Surgeries | Anterior Segment Ophthalmic Surgery | Anterior and Posterior Segment Ophthalmic Surgeries | Anterior Segment Ophthalmic Surgery |
| Real-Time Display | Yes | Yes | Yes | Yes | Yes |
| Configurations Available | Anterior/Posterior/Both | Anterior/Posterior/Both | Anterior | Anterior/Both | Anterior |
| Modular Design | Yes | No | No | Yes | No |
| Programmable for Multiple Surgeons | Yes | Yes | Yes | Unknown | Yes |
| Remote Control | Yes | Yes | Yes | No | Yes |
| Multi-function Foot Control | Yes | Yes | Yes | Yes | Yes |
| Self-Diagnostics | Yes | Yes | Yes | No | Unknown |
| Error Processing | Yes | Yes | Yes | Yes | Unknown |
| On-Line Information | Yes | Yes | Yes | No | No |
| Disposable Accessories | Yes | Yes | Yes | Yes | Unknown |
| Automated IV Pole | Yes | Yes | Yes | No | Yes |

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| Device Name / Manufacturer | Storz PREMIERE II Microsurgical Systems
Storz Instrument Co. | Storz PREMIERE® Microsurgical System 510(k) K894278, K921460, K946227
Storz Instrument Co. | Alcon System 20000® Legacy™ Microsurgical System 510(k) K952213
Alcon Surgical, Inc. | SITE TXR™ System 510(k) K925828
SITE Microsurgical Systems, Inc. | Chiron CATALYST™ Microsurgical System 510(k) unknown
Chiron Corp. |
| --- | --- | --- | --- | --- | --- |
| Electrical Power Requirements | 100-120V
220-240V
50/60 Hz | 100-120V
220-240V
50/60 Hz | 100-120V
220-240V
47/63 Hz | Unknown | 120V
240V
60 Hz |
| Operating Temperature | 10°-40° C | 10°-35° C | 10°-35° C | 10°-43° C | Unknown |
| Maximum Humidity | 98% non-condensing | 90% non-condensing | 95% non-condensing | Unknown | 44% non-condensing |