REUSABLE TROCAR WITH SLEEVE (COMMON)

K964123 · Pilling Weck Group · GCJ · Dec 12, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K964123
• Device Name: REUSABLE TROCAR WITH SLEEVE (COMMON)
• Applicant: Pilling Weck Group
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures 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 system; consists of reusable stainless steel trocars (pyramidal or conical tips) and polymer sleeves with insufflation ports; includes single-use disposable cap assemblies with universal adapter seals. Used in OR by surgeons for laparoscopic/thoracic procedures. Trocar creates incision/access; sleeve maintains pneumoperitoneum via cap seal; allows passage of endoscopic instruments/probes. Benefits include secure port of entry and minimized gas leakage during surgery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable stainless steel trocar shafts; polymer sleeves; single-use disposable cap assemblies with universal adapter seals. Features insufflation ports and threaded cannula design. Manual operation; no energy source or software.

Indications for Use

Indicated for use in endoscopic surgery, including gynecologic, general, thoracic, and other laparoscopic procedures, to provide 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
• Access Surgical Access Single Use Trocar and Sleeve
• Mahe Reusable Standard Trocar and Trumpet Valve Cannula
• Mahe Safety Trocar

Submission Summary (Full Text)

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PillingWeck
510(k) Summary
K964123

# 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

DEC 12 1996

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 Trocars and Cannula with Insufflation Port

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

The Pilling Weck Trocars and Cannula with Insufflation Port are substantially equivalent to the Core Dynamics Entree II, Access Surgical Access Single Use Trocar and Sleeve, Mahe Reusable Standard Trocar and Trumpet Valve Cannula, Mahe Safety Trocar.

# 4. Description of the Device:

The device consists of Reusable Trocars and Cannula with Insufflation Port 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 Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip.

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

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

## 5. Intended Use of the Device:

The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures 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 Trocars, consisting of a hub with a stainless steel shaft are equivalent to the predicates.

The cannula with insufflation ports 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.

sum10mm