SAFETY TROCER WITH SPRINGLOADED OBDURATOR

K960347 · Spiess Design, Inc. · HET · Jul 1, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960347
• Device Name: SAFETY TROCER WITH SPRINGLOADED OBDURATOR
• Applicant: Spiess Design, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jul 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Our SHIELDED Trocar establishes and maintains surgical access to the intra-abdominal cavity. It allows CO₂ insufflation and surgical Endoscopy identically to other, older trocars, with no difference in Effectiveness.

Device Story

SHIELDED Trocar; surgical instrument for intra-abdominal access. Features spring-loaded blunt obturator covering sharp cutting edge; automatically shields edge upon entry into body cavity to prevent accidental injury. Used in operating room by surgeons. Enables CO2 insufflation and endoscopic procedures. Design includes trocar sheath, housing, CO2 valve, stopcock, and sealing cap. Provides safety mechanism similar to Veress needles while maintaining functionality of traditional trocars. Disassembly required for cleaning/sterilization.

Clinical Evidence

Comparative bench testing with animal tissue; performance and effectiveness identical to older trocar models.

Technological Characteristics

Mechanical trocar with spring-loaded blunt obturator; sharp cutting edge; trocar sheath; housing; CO2 valve; stopcock; sealing cap. Manual operation. Sterilizable.

Indications for Use

Indicated for establishing and maintaining surgical access to the intra-abdominal cavity for CO2 insufflation and surgical endoscopy.

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.

Submission Summary (Full Text)

{0}

Subject: SHIELDED Trocar with springloaded Obturator
510(k) # K960347
JUL - 1 1996
K960347

# A. Summary of Safety and Effectiveness:

1. Our "SHIELDED Trocar" was in detail compared to other, older Trocars and we concluded that our device provides safety for patients and operating room personnel. The cutting edge of our trocar is never exposed at any time.

2. Our SHIELDED Trocar establishes and maintains surgical access to the intra-abdominal cavity. It allows CO₂ insufflation and surgical Endoscopy identically to other, older trocars, with no difference in Effectiveness.

# B. Parts of finding Substantial Equivalence:

1. The Intended Use and the Indications for Use are identical for our SHIELDED Trocar and the other, older Trocar versions.

2. The Design Engineering of our Trocar and older versions is identical in almost all components:

They all have:
1. A sharp cutting edge
2. A Trocar Sheath
3. Trocar Housing
4. A valve to minimize CO₂ loss
5. A Stopcock for CO₂ insufflation
6. A Sealing Cap

{1}

C. Descriptive Information

1. Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immediately re-enters it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator.

While assembled this new Trocar never allows accidental cutting of a patient or operating room personnel. Disassembly of this instrument is only required for cleaning and sterilization.

2. Our SHIELDED Trocar represents a combination between common old Trocars and the SHIELDING function of Veress needles: A springloaded blunt Obturator device always covers the sharp cutting edge.

D. Performance Testing

Comparative Bench testing with animal tissue enabled us to conclude that the performance and effectiveness of our SHIELDED Trocar is identical to older Trocar models.

E. Adverse Health Effects

We were not able to determine any adverse health effects with our SHIELDED Trocar and we cannot imagine any possibility of this kind.