KSEA CULDOCENTESIS SET

K962881 · Karl Storz Endoscopy · HEW · Oct 22, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962881
• Device Name: KSEA CULDOCENTESIS SET
• Applicant: Karl Storz Endoscopy
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Oct 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2

Indications for Use

The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.

Device Story

Manual reusable surgical device; includes two single-use disposable components. Used by surgeons or physicians for peritoneal fluid collection. Device facilitates fluid aspiration; minimizes complications associated with conventional culdocentesis. Clinical utility involves fluid sampling for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual reusable surgical device. Body contact materials: surgical grade stainless steel, PTFE, polyurethane. Non-body contact materials: silicone, polyolefin, PVC.

Indications for Use

Indicated for use by qualified surgeons or physicians for the collection of peritoneal fluid.

Regulatory Classification

Identification

A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

Submission Summary (Full Text)

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Karl Storz Endoscopy

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K962881

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 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

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

**OCT 22 1996**

**Contact:**
Kevin Kennan
Regulatory Affairs Specialist

**Device Identification:**
Common Name: Culdocentesis Set
Trade Name: (optional)
KSEA Culdocentesis Set

**Indication:** The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.

**Device Description:** The KSEA Culdocentesis Set are manual reusable surgical devices (with two single-use disposable components). The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis. The body contact materials are surgical grade stainless steel, PTFE, and polyurethane. The non-body contact materials of the Culdocentesis Set are silicone, polyolefin, and PVC.

**Substantial Equivalence:** The KSEA Culdocentesis for collection of peritoneal fluid are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Culdocentesis Set and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

Signed:
Kevin Kennan
Regulatory Affairs Specialist

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