HR POLYURETHANE PICC AND MIDLINE CATHETERS

K964556 · Johnson & Johnson Medical, Inc. · LJS · Apr 16, 1997 · General Hospital

Device Facts

• Record ID: K964556
• Device Name: HR POLYURETHANE PICC AND MIDLINE CATHETERS
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.

Device Story

Polyurethane catheters for venous access/prolonged IV therapy; single or dual lumen configurations; optional flushable guidewire; sterile individual units or insertion kits. Insertion via introducer sheath. PICC tip location: superior vena cava; midline tip location: axilla. Used by clinicians in clinical settings for vascular access. Benefits: provides reliable venous access for therapy administration.

Clinical Evidence

Bench testing only. Testing included flow rate, tensile strength (body and hub), catheter stiffness, elongation, leakage, burst pressure, catheter collapse, biocompatibility (ISO 10993), and sterility (LAL procedure for non-pyrogenicity). All tests passed.

Technological Characteristics

Polyurethane catheter material; single/dual lumen; sterile, pyrogen-free; includes introducer sheath and optional flushable guidewire. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring venous access or prolonged intravenous therapy. PICC catheters are indicated for tip placement in the superior vena cava; midline catheters are indicated for tip placement below the shoulder at the level of the axilla.

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

• L-Cath PICC and midline
• One-Cath PICC and midline
• Arrow PICC
• SoloPICC and midline
• Per-Q-Cath PICC
• V-Cath PICC and midline
• SiL-Cath PICC and midline catheters

Submission Summary (Full Text)

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K96-1556
April 16, 1997

# Summary of Safety and Effectiveness Information for JJMI Polyurethane PICC and Midline Catheters

1. **Classification Name**: Percutaneous Intravascular Catheter 80 FOZ
**Common Name**: Peripherally Inserted Central Venous Catheter (PICC) and Midline catheter
**Proprietary Name**: None has been designated at this time

2. **Establishment Registration Number**: 2938241

3. **Establishment Name/Address**:
Menlo Care, Inc.
Johnson & Johnson Medical, Inc.
1350 Willow Road Suite 202
Menlo Park, CA 94025

4. **Classification**: Class II

5. **Substantially Equivalent Devices**: L-Cath PICC and midline, One-Cath PICC and midline, Arrow PICC, SoloPICC and midline, Per-Q-Cath PICC, V-Cath PICC and midline, and SiL-Cath PICC and midline catheters.

6. **Description and Device Function**: Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen configurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.

7. **Performance Standards**: No performance standards have been established by the FDA for this type of device.

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8. **Packaging and Sterilization**: These devices will be packaged in pouches and will be sterile and pyrogen-free. Insertion kits will be sterilized as well. Non-pyrogenicity will be established for each production lot by the LAL procedure.

9. **Tests/Studies with Conclusions**: The JJMI Polyurethane PICC and midline catheters have passed all tests for safety and effectiveness (i.e., biocompatibility, sterility and device performance). The testing and conclusions are summarized below.

| Test | Conclusion |
| --- | --- |
| Flow rate | Passed |
| Tensile strength of body | Passed |
| Tensile strength of catheter to hub | Passed |
| Catheter stiffness | Passed |
| Catheter elongation | Passed |
| Leakage at hub joint | Passed |
| Burst pressure (positive pressure) | Passed |
| Catheter collapse (negative pressure) | Passed |
| Biocompatibility per ISO 10993 | Passed |
| Sterilization | Passed |