K Number
K961310
Device Name
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
Date Cleared
1996-06-27

(84 days)

Product Code
Regulation Number
886.4670
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anterior and Posterior Segment Ophthalmic Surgeries
Device Description
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. 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 occupving 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 Vitrectorny module. e. Irrigation, Venturi aspiration, and Vitrectorny 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.
More Information

K894278, K921460, K946227, K952213, K925828, DP8020, DP7020, DP4800, DP4310, DP9404, D8204, S2070 C

Not Found

No
The summary describes a modular ophthalmic microsurgical system with various functional modules and peripherals. There is no mention of AI, ML, image processing, or any data-driven algorithms that would indicate the use of AI/ML technology.

Yes
The device is designed for ophthalmic surgeries, which are medical procedures performed to treat conditions and restore function, hence it is a therapeutic device.

No

The device description indicates it is a "modular ophthalmic microsurgical system" designed for "Anterior and Posterior Segment Ophthalmic Surgeries", listing modules like "Phacoemulsification" and "Vitrectorny". These are surgical functions, not diagnostic ones.

No

The device description clearly outlines a physical ophthalmic microsurgical system with multiple hardware components, including a computer unit, ophthalmic unit with various modules, and peripherals. It is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is for "Anterior and Posterior Segment Ophthalmic Surgeries." This describes a surgical procedure performed directly on the patient's eye.
  • Device Description: The description details a modular ophthalmic microsurgical system with various functional modules (e.g., Air/Fluid Exchange, Bipolar Coagulation, Illumination, Irrigation, Vitrectomy, Phacoemulsification). These are all tools used during surgery on a living patient.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The description of the Storz PREMIERE II does not mention any such function or the analysis of biological samples.

Therefore, the Storz PREMIERE II is a surgical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Ophthalmic surgical system for cataract and vitro retinal surgery.
Anterior and Posterior Segment Ophthalmic Surgeries

Product codes

886.4670, 886.4150, 886.4100

Device Description

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.
  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 occupving 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 Vitrectorny module.
    e. Irrigation, Venturi aspiration, and Vitrectorny 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ophthalmic / Anterior Segment / Posterior Segment

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K894278, K921460, K946227, K952213, K925828, DP8020, DP7020, Grieshaber MPC, PSS, ErgoTec, DP4800, DP4310, DP9404, D8204, S2070 C

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.4670 Phacofragmentation system.

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

0

Image /page/0/Picture/0 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and have a rounded appearance. The word is enclosed in a rounded rectangle, and there is a registered trademark symbol in the upper right corner of the rectangle. The image has a slightly distressed or worn appearance, with some areas of the black background appearing faded or scratched.

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 L. Swearingen

JUN 2 7 1998

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

1 : Blad

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 fotlowing classification names:

    1. Phacofragmentation system, 21 CFR §886.4670;
    1. Vitreous Aspirating and Cutting Device, 21 CFR §886.4150; and
    1. 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.

1

    1. 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 occupving 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:
    • Air/Fluid Exchange and Scissors/Forceps module. a.
    • b. Bipolar Coagulation module.
    • Illumination module. C.
    • ರ. Irrigation, Scroll Aspiration, and Vitrectorny module.
    • Irrigation, Venturi aspiration, and Vitrectorny module. e.
    • f. Phacoemulsification and Phacofragmentation module.
    • ರು. Phaco module.
    • ﻏ Frag module.
    1. 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:

  • CX4310 Deluxe Scroll Phaco Pack. 1.
    1. CX4800 Deluxe Scroll Posterior Vitrectomy Pack.
    1. CX9404 Bipolar Adaptor; CX9400, CX9420, CX9430 Bipolar Cords.
  • র্ব CX7000 Phaco Handpiece and CX7050 Frag Handpiece.
    1. 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:

2

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:

1 1992

The Storz CX4800 Deluxe Scroll Posterior Vitrectorny 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.

3

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

| Device Name /
Manufacturer | Storz PREMIERE II
Microsurgical Systems | 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 |
| 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 TXRT™ 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 |

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