AUTO SUTURE CHEMOSITE TUNNELER
Device Facts
| Record ID | K961856 |
|---|---|
| Device Name | AUTO SUTURE CHEMOSITE TUNNELER |
| Applicant | United States Surgical, A Division of Tyco Healthc |
| Product Code | LJS · General Hospital |
| Decision Date | Jul 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Indications for Use
Indicated for patients requiring subcutaneous positioning of long-term vascular access catheters and implantable drug delivery ports.
Regulatory Classification
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)
Related Devices
- K972555 — CATHETER TUNNELER · Gerard Medical, Inc. · Dec 22, 1997
- K962761 — REIGEL TUNNELING DEVICE · Cook, Inc. · Oct 11, 1996
- K964538 — R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM · Boston Scientific Corp · Mar 10, 1997
- K031844 — VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 · Boston Scientific Corp · Jul 15, 2003
- K032600 — VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 · Boston Scientific Corp · Sep 9, 2003
