← Product Code [LJS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS) · K961856

# AUTO SUTURE CHEMOSITE TUNNELER (K961856)

_United States Surgical, A Division of Tyco Healthc · LJS · Jul 18, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K961856

## Device Facts

- **Applicant:** United States Surgical, A Division of Tyco Healthc
- **Product Code:** [LJS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS.md)
- **Decision Date:** Jul 18, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5970
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The Auto Suture* Chemosite* Tunneler** is indicated for use with implantable drug delivery ports and catheters and for use in the subcutaneous positioning of long-term vascular access catheters and subcutaneous ports.

## Device Story

The Auto Suture Chemosite Tunneler is a surgical instrument used for the subcutaneous placement of long-term vascular access catheters and implantable drug delivery ports. The device consists of an angled stainless steel shaft. It is used by surgeons in a clinical or operating room setting to create a subcutaneous tunnel through which the catheter or port system is passed. By facilitating the placement of these access devices, it enables long-term therapeutic delivery for the patient.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Angled stainless steel shaft; biosafe materials; manual surgical instrument; non-powered; sterile.

## Regulatory Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

## Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

## Predicate Devices

- Cook™ Trocar Tunnelator™
- Davol® Tunneler

## Reference Devices

- Auto Suture* Chemosite* Implantable Drug Delivery System ([K952748](/device/K952748.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
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K961856

United States Surgical Corporation
510(k) Premarket Notification
Auto Suture* Chemosite* Tunneler**

JUL 18 1996

# SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

As is evident in the submitted information on design, indications, materials and method of use, the Auto Suture* Chemosite* Tunneler** is substantially equivalent to the Cook™ Trocar Tunnelator™, the Davol® Tunneler and other currently marketed devices by United States Surgical Corporation.

- Both the Auto Suture* Chemosite* Tunneler** and the Davol® Tunneler have similar indications, namely, for use with implantable drug delivery ports and catheters and for use in the subcutaneous positioning of long-term vascular access catheters and subcutaneous ports.
- Both the Auto Suture* Chemosite* Tunneler** and the Cook™ Trocar Tunnelator™ are comprised of biosafe materials, such as stainless steel.
- Both the Auto Suture* Chemosite* Tunneler** and the Cook™ Trocar Tunnelator™ are composed of an angled stainless steel shaft.
- Both the Auto Suture* Chemosite* Tunneler** and Auto Suture* Chemosite* Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are manufactured in similar facilities, using similar materials and process methods and controls.
- Both the Auto Suture* Chemosite* Tunneler** and the Auto Suture* Chemosite* Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are packaged in similar facilities, with the same materials and with the same process methods and controls.
- Both the Auto Suture* Chemosite* Tunneler** and the Auto Suture* Chemosite* Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are sterilized in similar facilities, with the same materials and with the same process methods and controls.

* Trademark of United States Surgical Corporation.
** Trademark name not yet determined.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K961856](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K961856)

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