SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT

K964450 · Pilling Weck Group · HET · Jan 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964450
• Device Name: SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
• Applicant: Pilling Weck Group
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

Device Story

Manual surgical instrument; used in endoscopic abdominal and thoracic surgery. Device consists of secondary trocar with stainless steel pyramidal tip, polymer handle/shaft, and threaded polymer sleeve with insufflation port. Cap assembly includes universal adapter seal and reducer to minimize pneumoperitoneum leakage. Physician inserts trocar through abdominal/thoracic wall to create access port; trocar removed; sleeve remains in place. Sleeve serves as conduit for endoscopic instruments, laparoscopes, and probes. Device facilitates minimally invasive surgical access; maintains pneumoperitoneum during procedure.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through comparison of technological characteristics and intended use with predicate devices.

Technological Characteristics

Materials: stainless steel (tip), polymer (handle, shaft, sleeve). Components: pyramidal trocar, threaded sleeve with insufflation port, cap assembly with universal adapter seal and reducer. Manual operation; no energy source. Dimensions: proportionally sized.

Indications for Use

Indicated for use in endoscopic abdominal and thoracic surgery to provide incision and peritoneal access for the positioning of a hollow sleeve to facilitate the introduction of surgical instruments, endoscopes, and probes.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. 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 preheater, light source and cables, and component parts.

Predicate Devices

• Core Dynamics Entree II
• Access Surgical Access Single Use Trocar and Sleeve
• United States Surgical Acute Suture Surgiport Disposable Surgical Trocar and Cannula with Insufflation Port
• Karl Stortz Trocars and Cannula with Insufflation Ports

Submission Summary (Full Text)

{0}

K964450
P192

# Pilling Weck
510(k) Summary

## 1. Submitter Name, Address, and Date of Submission:

Miss Karenann J. Brozowski
Group Regulatory Affairs Director
Pilling Weck Group
Tall Pines Park
Jaffrey, NH 03452
JAN 10 1997

Telephone: [phone]

Contact: Same as above.

## 2. Names of the Device, Common, Proprietary(if Known), and Classification.

Classification Name: Secondary Trocar with Sleeve
Common Name: Secondary Trocar and Sleeve with Insufflation Port

## 3. Identification of the legally marketed device to which the submitter claims equivalence.

The Pilling Weck Secondary Trocar and Sleeve with Insufflation Port are substantially equivalent to the Core Dynamics Entree II, Access Surgical Access Single Use Trocar and Sleeve, United States Surgical Acute Suture Surgiport™ Disposable Surgical Trocar and Cannula with Insufflation Port, and Karl Stortz Trocars and Cannula with Insufflation Ports.

## 4. Description of the Device:

The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft.

A Teleflex Company
One Weck Drive, P.O. Box 12600
Research Triangle Park, North Carolina 27709
[phone]

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K964450
p292

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The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port. There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.

## 5. Intended Use of the Device:

The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.

Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

The usage of this product is identical to previous devices, which have the same technological characteristics.

## 6. Summary of Technological Characteristics:

The following technological characteristics are the same or equivalent as predicate devices:

The Trocar, consisting of a hub with a stainless steel tip are equivalent to the predicates.

The sleeve with insufflation port and cap assembly, which has the port of entry for the surgical instrument and has a threaded shaft, is used with the Trocar, which is equivalent to the predicates.

The Cap Assembly is contains the seal, which is used to minimize the leakage from the pneumoperitoneum, which is equivalent to the predicates.

sum11mm