EVS

K963886 · Applied Medical Resources · DYB · Apr 24, 1997 · Cardiovascular

Device Facts

• Record ID: K963886
• Device Name: EVS
• Applicant: Applied Medical Resources
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Indications for Use

The Applied Medical EVS is a single-use sheath intended for percutaneous access to the peripheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation.

Device Story

Single-use vascular access sheath; facilitates placement/removal of therapeutic instrumentation. Components: sheath with deployable mesh funnel, obturator with deployable mesh umbrella, hemostasis valve with luer port. Used for percutaneous insertion (eliminates 'cut down') or insertion into exposed vessels; compatible with standard 9F vascular introducer sheaths. Operated by clinicians in vascular procedures. Provides access channel for instruments; hemostasis valve prevents blood loss. Benefits: minimally invasive access, reduced tissue trauma compared to cut down.

Clinical Evidence

Bench testing only; mechanical, safety, and biocompatibility testing performed to verify functional safety, structural integrity, and material safety.

Technological Characteristics

Single-use catheter introducer; includes deployable mesh funnel and umbrella mechanisms. Features hemostasis valve with luer port. Materials biocompatibility verified per standard safety testing.

Indications for Use

Indicated for percutaneous access to the peripheral vascular system to assist in the placement and removal of therapeutic instrumentation in patients requiring vascular access.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Applied Medical Catheter Introducer Sheath (K890766)
• Hemostasis valve (K895214)

Submission Summary (Full Text)

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K963886
April 24, 1997

# APPENDIX IX

## 510(k) SUMMARY

### 510(k) NUMBER: PENDING

### SUBMITTED BY:
Applied Medical Resources Corporation
26051 Merit Circle, Unit #103
Laguna Hills, California 92653
[phone] EXT. 310

### CONTACT PERSON:
Howard V. Rowe

### DATE OF PREPARATION:
September 21, 1996

### NAME OF DEVICE:
Applied Medical Expanding Vascular Sheath.

### CLASSIFICATION NAME:
Catheter introducer

### TRADE NAME:
Expanding Vascular Sheath

### SUMMARY STATEMENT:

The Applied Medical EVS is a single-use sheath intended for percutaneous access to the peripheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation. The device consists of three major components: a sheath with deployable mesh funnel, an obturator with deployable mesh umbrella and a hemostasis valve with luer port.

Since the EVS is designed for percutaneous insertion, patient “cut down” is unnecessary. Percutaneous insertion may be accomplished with or without the use of a standard 9F vascular introducer sheath. The EVS may also be inserted into an exposed vessel.

The EVS is substantially equivalent to the Applied Medical “Catheter Introducer Sheath” covered by K890766. The hemostasis valve portion of this product was previously approved under K895214.

Mechanical, safety and biocompatibility tests were performed to verify functional safety, structural integrity and material safety. All testing demonstrated that the AMR EVS is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.