← Product Code LFL · K964601

# CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY (K964601)

_Valleylab, Inc. · LFL · Jan 16, 1997 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K964601

## Device Facts

- **Applicant:** Valleylab, Inc.
- **Product Code:** LFL
- **Decision Date:** Jan 16, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.

## Device Story

Ultrasonically vibrating surgical device; utilizes irrigation and aspiration to fragment, emulsify, and remove soft tissue. CUSA Lap™ Accessory enables laparoscopic/thoracoscopic use; includes extended life tip, flue, sterilizer case, torquing wrench, and soft start circuit board. Optional CUSA Electrosurgical Module (CEM) provides electrosurgical cutting or coagulation current through the tip. Operated by surgeons in OR settings. Provides tissue removal and hemostasis; benefits include precise tissue management during minimally invasive procedures.

## Clinical Evidence

Bench testing only. Reliability testing included dielectric withstand (60 Hz) and trocar insertion/extraction capability. Biocompatibility testing confirmed materials are equivalent to legally marketed devices.

## Technological Characteristics

Ultrasonic surgical fragmentation/emulsification system. Components: Extended Life Tip, Laparoscopic Flue, Soft Start circuit board. Materials: Biocompatible, equivalent to predicate. Energy: Ultrasonic vibration; optional electrosurgical (CEM) module for cutting/coagulation. Connectivity: Standalone system. Sterilization: Not specified.

## Submission Summary (Full Text)

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JAN 6 1997

K 964601

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR

CUSA System 200 with Soft Start, and CUSA Lap™ Accessory

## Intended Use

The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.

## Product Description

The CUSA System 200 is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The CUSA Lap™ Accessory can be used only with CUSA 200 Systems equipped with Soft Start circuitry and currently available CUSA handpieces. The Accessory consists of a Laparoscopic Extended Life Tip, Laparoscopic Flue, Laparoscopic Sterilizer Case and Tray, Laparoscopic Extended Life Tip Torquing Socket wrench, and Soft Start Circuit Board with External Activation Switch. The CUSA System 200 with soft start and the CUSA Lap™ Accessory may be used with the CUSA Electrosurgical Module (CEM), which will provide electrosurgical capability. This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA tip to the surgical site.

## Safety and Performance

The CUSA System 200 with soft start and the CUSA Lap™ Accessory have been tested and shown to meet the following requirements:

### Reliability Testing:

* Dielectric withstand (60 Hz) of the flue
* Trocar insertion/extraction capability

### Biocompatibility Testing:

Patient contact materials of the CUSA handpiece and CUSA Lap™ Accessory have been shown to be biocompatible and remain the same as those of legally marketed products.

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**Source:** [https://fda.innolitics.com/device/K964601](https://fda.innolitics.com/device/K964601)

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