PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM

K962226 · Johnson & Johnson Medical, Inc. · FOZ · Dec 23, 1996 · General Hospital

Device Facts

• Record ID: K962226
• Device Name: PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The PROTECTIV 2000 IV Catheter Safety System is a needle safety feature for an IV catheter.

Device Story

Device consists of needle safety mechanism integrated with IV catheter; designed to reduce needle stick injuries. Operates via one-finger push activation; features include tactile and audible click upon locking; irreversible safety mechanism; gasket wipes blood from cannula; covered needle tip. Used by clinicians in clinical settings during IV access procedures. Provides secure handling via grips. Benefits patient and clinician by preventing accidental needle sticks.

Clinical Evidence

Bench testing only. Testing included cannula security, force to advance/lock, safety mechanism efficacy, tip protector security, cannula orientation, FIPG efficacy, and biocompatibility per ISO 10993. Simulated clinicals performed. All tests passed minimum requirements.

Technological Characteristics

Needle safety system for IV catheters. Features: one-finger push activation, audible/tactile locking, blood-wiping gasket, needle tip cover. Sterilization: EtO. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for use as an IV catheter safety system to reduce needle stick injuries during catheterization.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• PROTECTIV I.V. Catheter Safety System (K962226)
• PROTECTIV Plus IV Catheter Safety System (K962226)

Submission Summary (Full Text)

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DEC 23 1996
K 962226

# 510(k) Summary of Safety and Effectiveness

# PROTECTIV* 2000 IV CATHETER SAFETY SYSTEM

Company Name & Address:

Johnson & Johnson Medical Incorporated
2500 East Arbrook Boulevard
Arlington, Texas 76004-3130

Identification of the Legally Marketed Device:

PROTECTIV IV Catheter Safety System and the PROTECTIV Plus IV Catheter Safety System

Description of the Device:

The PROTECTIV 2000 IV Catheter Safety System is a needle safety feature for an IV catheter. The IV catheter portion of the system is the same product that is currently marketed by JJMI. The PROTECTIV 2000 IV Catheter Safety System is designed to reduce needle stick injuries. The PROTECTIV 2000 IV Catheter Safety System is being provided on a variety of IV catheters.

Comparison Information

| FEATURE | PROTECTIV I.V. AND PROTECTIV PLUS | PROTECTIV 2000 |
| --- | --- | --- |
| Flash back visualization | Close to catheter hub | Close to catheter hub |
| Locking as part of threading action | yes | yes |
| Tactile feel of locking | yes | yes |
| Audible click upon locking | yes, single click | yes, single click |
| Prevents needle sticks | yes | yes |
| Irreversible safety mechanism | yes | yes |
| Covered needle tip | yes | yes |
| Gasket wipes blood from cannula | yes | yes |
| One finger push to activate | yes | yes |
| Grips for secure handling | yes | yes |
| EtO sterilized | yes | yes |
| Single sterile wrapped | yes | yes |
| Designed to prevent needle sticks | yes | yes |
| Preloaded | yes | yes |

*Trademark

4(a)

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# Discussion of Tests/Studies with Conclusions:

The Safety system has passed all tests for safety and effectiveness (i.e. biocompatibility, sterility and system performance). The testing and conclusions are summarized below;

| Test | Conclusion |
| --- | --- |
| Cannula Security | Passed the minimum requirement |
| Force to Advance/Lock | Passed the minimum requirement |
| IVC Safety Mechanism Efficacy | Passed the minimum requirement |
| Tip Protector/Primary Member Security | Passed the minimum requirement |
| Cannula Orientation | Passed the minimum requirement |
| FIPG Efficacy | Passed the minimum requirement |
| Biocompatibility Per ISO 10993 | Passed |
| Simulated Clinicals | Passed |
| Sterilization | Passed |

4(b)