Who is the manufacturer of E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH?

Valleylab, Inc. filed the 510(k) submission for E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH (K970140).

What is the FDA product code for E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH?

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

What are the predicate devices for E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH?

Laparoscopic Pencil Grip Handset (K904560); Laparoscopic Pistol Grip Handset (K925647); Laparoscopic Cord (Preamendments Device).

Who can help prepare an FDA 510(k) submission like E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH?

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.

E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH

K970140 · Valleylab, Inc. · GEI · Mar 28, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970140
Device Name	E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH
Applicant	Valleylab, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.

Device Story

Accessory system for monopolar electrosurgery; consists of sterile, single-use switch and cord. Switch features female connector for instrument attachment and male connector for cord; adhesive button allows user-selected placement on instrument. System connects standard electrosurgical generator to laparoscopic/thoracoscopic instruments. Operator (surgeon) depresses switch button to activate generator coagulation output. Used in OR setting; facilitates remote control of RF current delivery during minimally invasive procedures.

Clinical Evidence

Bench testing only. Tested per IEC 601-1 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF18 (1993). Biocompatibility testing not pertinent as device is non-patient contact.

Technological Characteristics

Monopolar electrosurgical accessory; includes switch and cord. Energy source: RF current from standard electrosurgical generator. Connectivity: electrical connectors for instrument and generator interface. Standards: IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18. Non-patient contact.

Indications for Use

Indicated for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures requiring handswitching of instruments (e.g., scissors, graspers).

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Laparoscopic Pencil Grip Handset (K904560)
Laparoscopic Pistol Grip Handset (K925647)
Laparoscopic Cord (Preamendments Device)

Related Devices

K200455 — Trigger Switch and Cord · New Deantronics Taiwan , Ltd. · Mar 31, 2020
K060117 — BOVIE BUTTON REMOTE HAND SWITCH · Aaron Medical Industries · Feb 22, 2006
K203603 — Monopolar Hook · Human Xtensions , Ltd. · Feb 1, 2021
K201833 — BiPad Hand Activated, Disposable Bipolar Electrocautery Cords · Bipad Surgical, Inc. · Jul 31, 2020
K133167 — MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD · Intuitive Surgical, Inc. · Jan 7, 2014

Submission Summary (Full Text)

{0} SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE TRIGGER SWITCH AND CORD K970/40 MAR 28 1997 The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired. The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument. The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator. The Trigger Switch and Cord are non-patient contact accessories, thus, biocompatibility testing is not pertinent. The Trigger Switch and Cord have been tested in accordance with the following standards: - IEC 601-1 (1988), Medical Electrical Equipment Part 1: General Requirements for Safety - IEC 601-2-2 (1991), Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment - ANSI/AAMI HF18 (1993), Electrosurgical Devices The Trigger Switch and Cord accessories are substantially equivalent in function and intended use to the following legally marketed devices: E2750, Laparoscopic Pencil Grip Handset (K904560); E2751, Laparoscopic Pistol Grip Handset (K925647); and E0510 Laparoscopic Cord (Preamendments Device). The Trigger Switch and Cord are substantially equivalent to the above devices in that all of the devices are accessories which are used to deliver RF current from a standard electrosurgical generator to the surgical site during laparoscopic or thoracoscopic procedures. Both the trigger switch and the laparoscopic handsets provide a switching mechanism for output control.