KSEA THERMOFLATOR (MODEL 26 4320 20)

K955073 · KARL STORZ Endoscopy-America, Inc. · HIF · Dec 6, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K955073
• Device Name: KSEA THERMOFLATOR (MODEL 26 4320 20)
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Dec 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO₂ gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures

Device Story

KSEA Thermoflator (model 26 4320 20) is a microprocessor-based laparoscopic insufflator; delivers CO₂ gas to peritoneal cavity; user-adjustable flow rates (0-30 L/min) and pressure (0-30 mmHg); used in clinical settings by surgeons; provides rapid insufflation and maintenance of distention; includes pressure and flow-sensing technology; incorporates safety features to monitor gas delivery; assists surgeons in maintaining surgical field visibility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-based system; CO₂ gas delivery; pressure and flow-sensing technology; user-adjustable flow (0-30 L/min) and pressure (0-30 mmHg) controls.

Indications for Use

Indicated for patients undergoing Ob/Gyn laparoscopic surgical and diagnostic procedures requiring peritoneal cavity distention via CO₂ insufflation.

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.

Submission Summary (Full Text)

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Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CRF 807.92. All data included in this documents are accurate and complete to the best of KSEA's knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]
DEC - 6 1996

**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs

**Device Identification:**
Common Name
Laparoscopic Insufflator
Trade Name (optional)
KSEA Thermoflator (model 26 4320 20)

**Indication:**
This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO₂ gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures

**Device Description:**
The KSEA Thermoflator (model 26 4320 20) is a microprocessor-based system, with gas output that is user adjustable from 0-30 liters/minute, and pressure that is user adjustable from 0-30 mmHg. The unit uses contemporary technology in pressure and flow-sensing, and incorporates a wide variety of safety features.

**Substantial Equivalence:**
The KSEA Thermoflator (model 26 4320 20) is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermoflator (model 26 4320 20) and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.

Signed: Betty M. Johnson
Manager, Regulatory Affairs

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