REUSABLE TROCAR WITH SLEEVE (COMMON)

K963815 · Pilling Weck Group · GCJ · Nov 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963815
• Device Name: REUSABLE TROCAR WITH SLEEVE (COMMON)
• Applicant: Pilling Weck Group
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The 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

Reusable trocar and sleeve system; includes single-use disposable cap assembly with universal adapter seal. Trocar (3mm-11mm) features stainless steel shaft, pyramidal style. Sleeve constructed of polymer; threaded design. Used in endoscopic surgery (abdominal/thoracic) for incision and peritoneal access. Trocar creates entry point; sleeve maintains access port. Cap seal minimizes pneumoperitoneum leakage during instrument/laparoscope insertion. Operated by surgeons in clinical/OR settings. Benefits include maintained insufflation and secure instrument port.

Clinical Evidence

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

Technological Characteristics

Reusable trocar (3-11mm) with stainless steel shaft, pyramidal tip. Polymer sleeve with threaded design. Disposable cap assembly with universal adapter seal. Manual surgical instrument; no energy source or software.

Indications for Use

Indicated for patients undergoing endoscopic abdominal or thoracic surgery requiring incision and peritoneal access for instrument positioning.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Core Dynamics Entree II
• Apple Medical Hunt Reich Secondary Trocar
• Access Surgical Access Single Use Trocar and Sleeve

Submission Summary (Full Text)

{0}

K 96 3815

# 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

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: Reusable Trocar with Sleeve

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

The Pilling Weck Trocar and Sleeve is substantially equivalent to the Core Dynamics Entree II, Apple Medical Hunt Reich Secondary Trocar, and the Access Surgical Access Single Use Trocar and Sleeve.

4. Description of the Device:

The device consists of Reusable Trocars and Sleeves, with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.

The Reusable Trocar, sizes 3mm.-11mm., is constructed with a stainless steel shaft and is available in pyramidal style.

The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

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

{1}

Page 2

## 5. Intended Use of the Device:

The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The 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 Reusable Trocar, consisting of a hub with a stainless steel shaft is equivalent to the predicates.

The sleeve used with the Trocar is treaded, 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.

sum5mm