CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY

Q: Who is the manufacturer of CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY?

Valleylab, Inc. filed the 510(k) submission for CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY (K964601).

Q: What is the FDA product code for CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY?

LFL. as a Class U device in the SU panel.

Q: What is the regulatory pathway for CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K964601 · Valleylab, Inc. · LFL · Jan 16, 1997 · SU

Device Facts

Record ID	K964601
Device Name	CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
Applicant	Valleylab, Inc.
Product Code	LFL · SU
Decision Date	Jan 16, 1997
Decision	SESE
Submission Type	Traditional
Device Class	Class U
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.

Indications for Use

Indicated for patients undergoing laparoscopic or thoracoscopic surgery requiring fragmentation, emulsification, and aspiration of soft tissue.

Related Devices

K190180 — CUSA Clarity Ultrasonic Surgical Aspirator System · Integra LifeSciences Corporation · Apr 1, 2019
K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System · Integra LifeSciences Corporation · Jul 11, 2023
K981262 — CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM · Valleylab, Inc. · Jul 6, 1998
K221763 — CUSA Clarity Ultrasonic Surgical Aspirator System · Integra LifeSciences Corporation · Jul 15, 2022
K161882 — CUSA Clarity Ultrasonic Surgical Aspirator System · Integra LifeSciences Corporation · Oct 14, 2016

Submission Summary (Full Text)

{0} 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.