SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR

K962683 · Deknatel, Inc. · HIF · Jan 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K962683
• Device Name: SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
• Applicant: Deknatel, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a CO2 tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient’s abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.

Device Story

Device provides intra-abdominal distention for laparoscopic surgery; utilizes CO2 gas. Features include software-controlled flow rates, pressure settings, and automatic venting of excess abdominal pressure. Includes CO2 warmer and video interface for parameter display. Operated by surgical staff in OR. Provides continuous monitoring of patient abdominal pressure; optimizes pneumoperitoneum maintenance. Benefits include improved performance and user convenience during laparoscopic procedures.

Clinical Evidence

Bench testing only. Includes software verification and validation, UL 544 certification, and EMI/EMC testing (VDE 0871/0876/0877, CISPR 11:1990/EN55011). Device conforms to ECRI Test Criteria for High-flow Laparoscopic Insufflators.

Technological Characteristics

Software-controlled laparoscopic insufflator. Features CO2 warmer, video interface, and pressure monitoring. Electrical safety: UL 544. EMI/EMC: VDE 0871/0876/0877, CISPR 11:1990/EN55011. Connectivity: Video screen interface for parameter display.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring intra-abdominal distention via pneumoperitoneum.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• Snowden-Pencer Computerized High Flow Insufflator (K920986)

Reference Devices

• WISAP Flow Therme Insufflator (K952508)

Submission Summary (Full Text)

{0}

JAN 10 1997
K962683
P172

# 510(k) SUMMARY

for

DSP Worldwide's

Snowden-Pencer Computerized High Flow Insufflator

## 1. DATE PREPARED

July 9, 1996

## 2. SPONSOR INFORMATION

Address: DSP Worldwide
600 Airport Road
Fall River, MA 02720-4740

Contact: Timothy N. Thomas
Phone: [phone]
FAX: [phone]

## 3. DEVICE NAME

Proprietary Name: Snowden-Pencer Computerized High Flow Insufflator
Common/Usual Name: Insufflator
Classification Name: Laparoscopic Insufflator

## 4. DEVICE DESCRIPTION AND INTENDED USE

The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a $\mathrm{CO}_{2}$ tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient’s abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.

DSP Worldwide - 510(k)
Snowden-Pencer Computerized High Flow Insufflator
7/9/96
Page E-1

{1}

K962683
P292

# 5. COMPARISON TO PREDICATE DEVICES

The Snowden-Pencer Computerized High Flow Insufflator is similar in design, function, and intended use to other high flow insufflators currently in commercial distribution in the United States. The predecessor Snowden-Pencer Computerized High Flow Insufflator (K920986) had many of the identical features to the current model device with the exception of the continuous monitoring of patient pressure, the $\mathrm{CO}_{2}$ warmer, and the video interface. These three new features have been added to the device in order to improve device performance and user convenience. Other electronic high flow insufflators, such as the WISAP Flow Therme Insufflator (K952508) also include a $\mathrm{CO}_{2}$ heater.

# 6. DEVICE TESTING

Performance testing conducted on the Snowden-Pencer Computerized High Flow Insufflator includes software verification and validation, UL 544 testing and certification, VDE 0871/0876/0877 and CISPR 11:1990/EN55011 testing/certification for radiated emissions (EMI/EMC). The device was also tested by the Emergency Care Research Institute (ECRI) and conforms to the ECRI Test Criteria for High-flow Laparoscopic Insufflators.

DSP Worldwide - 510(k)
Snowden-Pencer Computerized High Flow Insufflator
7/9/96
Page E-2