SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE

K955869 · Scimed Life Systems, Inc. · MAV · Mar 22, 1996 · Cardiovascular

Device Facts

• Record ID: K955869
• Device Name: SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
• Applicant: Scimed Life Systems, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Encore 26 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.

Device Story

Manual balloon inflation device; consists of pressure gauge, 20cc syringe, plunger with thread lock mechanism, finger-actuated lock release, and tubing with male rotating luer. Used in clinical settings by physicians/technicians during intravascular procedures to inflate/deflate balloon dilatation catheters. Operator manually actuates plunger to generate pressure; gauge provides visual feedback of pressure levels. Advantage Kits include additional procedural accessories (insertion tool, torque device, Y-adapter). Device facilitates controlled balloon expansion for vessel dilation.

Clinical Evidence

Bench testing only. Evaluation included leak testing of the Encore 30 (encompassing Encore 26) and gauge accuracy testing for 26 and 30 atmosphere gauges. Results confirmed design meets minimum requirements and is adequate for intended use.

Technological Characteristics

Materials: Polycarbonate syringe/y-connector, nylon plunger tip, polypropylene o-rings, polyurethane tubing. Principle: Manual syringe-based hydraulic pressure generation with integrated mechanical pressure gauge. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use with balloon dilatation catheters to create, monitor, and deflate pressure during intravascular procedures.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• SCIMED Encore Inflation Device
• Merit Monarch Inflation Device
• Cordis Reusable Inflation Devices
• SCIMED Encore Advantage Kits
• ACS 20/20 Priority Pack

Reference Devices

• Avenue Insertion Tool (K922410)
• TD2 Torque Device (K922706)
• GateWay PLUS Y-Adapter (K951089)

Submission Summary (Full Text)

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K955869

510(k) Notification
SCIMED Encore Inflation Devices
Page 2

# SECTION TWO--SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
Prepared December 21, 1995

### I. General Provisions:

Submitter's Name and Address: SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311

Contact Person: Diane M. Lowe
[phone]

Classification Name: Class II, Balloon Inflation Syringe (74 MAV)

Common or Usual Name: Balloon Dilatation Pressure Gauge

Proprietary Name: SCIMED® Encore™ 26 Inflation Device
SCIMED Encore™ 30 Inflation Device
SCIMED Encore™ 26 Advantage Kit
SCIMED Encore™ 30 Advantage Kit

### II. Name of Predicate Devices:

SCIMED Encore™ Inflation Device
Merit® Monarch™ Inflation Device
Cordis® Reusable Inflation Devices
SCIMED Encore™ Advantage Kits
ACS® 20/20 Priority Pack

### III. Device Description:

The Encore 26 and Encore 30 Inflation Devices consist of a pressure gauge, a 20cc syringe, a plunger with a thread lock mechanism, a finger-actuated button for lock release and tubing with a male rotating luer for connection to a balloon dilatation catheter and an outer housing.

The Encore 26 and Encore 30 Advantage Kits consist of SCIMED's Avenue Insertion Tool (K922410), TD2 Torque Device (K922706), GateWay PLUS Y-Adapter (K951089), and the Encore 26 or Encore 30 Inflation Device.

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510(k) Notification
SCIMED Encore Inflation Devices
Page 3

## IV. Intended Use:

The Encore 26 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.

The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.

## V. Summary of Technological Characteristics:

The Encore 26 and Encore 30 Inflation Devices are similar to SCIMED's currently marketed Encore Inflation Device, except that the devices create and monitor higher pressures. The Encore 26 and Encore 30 syringe with integral y-connector is polycarbonate, the plunger tip is nylon with two polypropylene o-rings. The devices will use a solvent bond or an alternative method of insert molding to attach the polyurethane tubing to the male rotating luer and the y-connector. The Encore 26 and Encore 30 Inflation Devices are considered substantially equivalent to inflation devices currently marketed by SCIMED, Merit Medical Systems, Inc, and Cordis Corporation.

The components in the Encore 26 and Encore 30 Advantage Kits are identical to currently marketed components. The Encore Advantage Kits are considered substantially equivalent to kits currently marketed by SCIMED and ACS®.

## VI. Non-clinical Test Summary:

Testing and evaluation of the Encore 26 was encompassed in the device leak testing of the Encore 30 Inflation Device. The alternate manufacturing process of insert molding was also evaluated for leak. Gauge accuracy testing was conducted on 26 and 30 atmosphere gauges. Test results verified that the inflation devices' design meet the minimum requirements and are adequate for their intended use. The SCIMED Encore 26 and Encore 30 Inflation Devices are considered substantially equivalent to inflation devices currently marketed by SCIMED, Merit Medical Systems, Inc., and Cordis Corporation based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.

All components within the Encore 26 and Encore 30 Advantage Kits are currently marketed devices and labeled consistent with their premarket notifications; therefore, no testing of the individual devices was conducted.