(84 days)
Ophthalmic surgical system for cataract and vitro retinal surgery.
Anterior and Posterior Segment Ophthalmic Surgeries
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.
This is a 510(k) summary for a medical device called the "Storz PREMIERE II Microsurgical System," and it does not contain information about studies proving the device meets acceptance criteria in the manner you've described for AI/ML device evaluations.
The document is a submission to the FDA for substantial equivalence, a regulatory pathway for devices that are "as safe and effective as" a legally marketed predicate device. This process primarily relies on comparing the new device's technological characteristics and intended use to those of existing, legally marketed devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, or AI/MRMC study results because this document is describing a traditional hardware medical device and not an AI/ML device that would undergo such evaluation.
The tables in the document compare the Storz PREMIERE II system to predicate devices based on general information (like intended use, presence of real-time display, modular design, power requirements, operating temperature, and humidity) rather than performance metrics from a clinical study against specific acceptance criteria.
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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.
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:
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- Phacofragmentation system, 21 CFR §886.4670;
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- Vitreous Aspirating and Cutting Device, 21 CFR §886.4150; and
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- 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:
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- 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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- 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.
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- 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.
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- CX4800 Deluxe Scroll Posterior Vitrectomy Pack.
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- CX9404 Bipolar Adaptor; CX9400, CX9420, CX9430 Bipolar Cords.
- র্ব CX7000 Phaco Handpiece and CX7050 Frag Handpiece.
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- 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:
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.
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Storz PREMIERE II Ophthalmic Microsurgical System Substantial Equivalence Comparison - General Information
| Device Name /Manufacturer | Storz PREMIERE IIMicrosurgical Systems | Storz PREMIERE®Microsurgical System510(k) K894278,K921460, K946227Storz Instrument Co. | Alcon System 20000®Legacy™Microsurgical System510(k) K952213Alcon Surgical, Inc. | SITE TXR™ System510(k) K925828SITE MicrosurgicalSystems, Inc. | ChironCATALYST™Microsurgical System510(k) unknownChiron Corp |
|---|---|---|---|---|---|
| Intended Use | Anterior and PosteriorSegment OphthalmicSurgeries | Anterior and PosteriorSegment OphthalmicsSurgeries | Anterior SegmentOphthalmic Surgery | Anterior and PosteriorSegment OphthalmicSurgeries | Anterior SegmentOphthalmic Surgery |
| Real-Time Display | Yes | Yes | Yes | Yes | Yes |
| ConfigurationsAvailable | Anterior/Posterior/Both | Anterior/Posterior/Both | Anterior | Anterior/Both | Anterior |
| Modular Design | Yes | No | No | Yes | No |
| Programmable forMultiple Surgeons | Yes | Yes | Yes | Unknown | Yes |
| Remote Control | Yes | Yes | Yes | No | Yes |
| Multi-function FootControl | Yes | Yes | Yes | Yes | Yes |
| Self-Diagnostics | Yes | Yes | Yes | No | Unknown |
| Error Processing | Yes | Yes | Yes | Yes | Unknown |
| On-LineInformation | Yes | Yes | Yes | No | No |
| DisposableAccessories | Yes | Yes | Yes | Yes | Unknown |
| Automated IV Pole | Yes | Yes | Yes | No | Yes |
| Device Name / Manufacturer | Storz PREMIERE IIMicrosurgical SystemsStorz Instrument Co. | Storz PREMIERE®Microsurgical System510(k) K894278,K921460, K946227Storz Instrument Co. | Alcon System 20000®Legacy™Microsurgical System510(k) K952213Alcon Surgical, Inc. | SITE TXRT™ System510(k) K925828SITE MicrosurgicalSystems, Inc. | ChironCATALYST™Microsurgical System510(k) unknownChiron Corp. |
| Electrical PowerRequirements | 100-120V220-240V50/60 Hz | 100-120V220-240V50/60 Hz | 100-120V220-240V47/63 Hz | Unknown | 120V240V60 Hz |
| OperatingTemperature | 10°-40° C | 10°-35° C | 10°-35° C | 10°-43° C | Unknown |
| MaximumHumidity | 98% non-condensing | 90% non-condensing | 95% non-condensing | Unknown | 44% non-condensing |
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이트 대 .
§ 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.