SYNERGIST POWER PACK

K960414 · Chiron Vision Corp. · HQC · Apr 24, 1996 · Ophthalmic

Device Facts

• Record ID: K960414
• Device Name: SYNERGIST POWER PACK
• Applicant: Chiron Vision Corp.
• Product Code: HQC · Ophthalmic
• Decision Date: Apr 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.

Device Story

Synergist™ Power Pack is an accessory for existing Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. It replaces the host console's ultrasonic handpiece to provide load-compensating ultrasonic power and Tmesis™ multi-function handpiece capability. The system comprises a console, cables, Tmesis™ handpiece, footswitch, and Ultra Tip™ packs. It operates by measuring the host console's handpiece output signal and replicating that power level for the connected handpiece, maintaining displayed power levels and energy summations. It uses an independent power supply rather than drawing from the host console. Used in surgical settings by ophthalmologists to facilitate cataract removal; benefits include precise tissue removal and compatibility with existing surgical consoles.

Clinical Evidence

Bench testing only.

Technological Characteristics

External module for Phaco Emulsifier systems. Operating frequency: 40 kHz. Independent power supply. Impedance-matched ultrasonic handpiece. Materials: standard materials used in Phaco Emulsifier aspirator consoles and handpieces. No software or firmware.

Indications for Use

Indicated for patients undergoing cataract surgery or other ophthalmic surgical procedures requiring precision tissue removal.

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

• Phacotron™ Gold Multifunction Ultrasonic (Tmesis™) Handpiece (K925631)

Submission Summary (Full Text)

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K960414
2960414
APR 24 1996

# SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter’s name, address, telephone number, contact person, and date summary prepared;

a. Chiron Vision Corporation
555 West Arrow highway
Claremont, CA 94711

b. Contact Person: Judy F. Gordon, D. V. M.
Vice President, Scientific Affairs


c. Date Summary Prepared: January 26, 1996

2. Name of device, including trade name and classification name:

a. Trade/Proprietary Name: Synergist™ Power Pack
b. Classification Name: Phacofragmentation System

3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company: Chiron Intraoptics
Device: Phacotron™ Gold Multifunction Ultrasonic (Tmesis™) Handpiece
510(k): K925631
Date Cleared: July 29, 1993

064

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4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multi-function handpiece capability.

The Synergist™ Power Pack consists of:

- Power Pack Console
- Connector Cables
- Tmesis™ multi-function handpiece,
- Adjunct Footswitch
- Ultra Tip™ Pack in various configurations

The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.

5. Statement of intended use:

The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.

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6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

| Characteristic | Synergist™ Power Pack | Phacotron™ Gold Multifunction Handpiece |
| --- | --- | --- |
| Intended use | Cataract/ophthalmic surgery | Cataract/ophthalmic surgery |
| Operating principle | Equivalent to US handpiece impedance matched | Equivalent to US handpiece impedance matched |
| | Console controlled via standard footswitch | Console controlled via standard footswitch |
| | External module | Internal module |
| | Independent power supply | Phaco console power supply |
| | Operating frequency-40khz | Operating frequency-40kHz |

The operating principals listed above compare the principles of operation of the system with the module contained within the host console (predicate 510(k)) and with the module contained in an external housing (subject 510(k)). The characteristics of the multifunction handpiece vs. predicate devices is set forth in the 510(k) for the Phacotron™ Gold Multifunction Handpiece, a copy of which is provided in Section 11.

| Materials | Standard materials used in Phaco Emulsifier | Standard materials used in Phaco Emulsifier |
| --- | --- | --- |
| | Aspirator consoles and handpieces | Aspirator consoles and handpieces |