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 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.

AI/ML Overview

This is a medical device, not an AI/ML device, so most of the requested information (e.g., sample size for AI/ML models, expert consensus, MRMC studies) is not applicable. However, I can provide the available information based on the provided text.

Acceptance Criteria and Device Performance for SCIMED® Encore™ 26 and 30 Inflation Devices

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device Leakage	Verified through testing of the Encore 30 Inflation Device, which also encompassed the Encore 26. The alternate manufacturing process (insert molding) was also evaluated for leak.
Gauge Accuracy	Testing conducted on 26 and 30 atmosphere gauges.
Meeting Minimum Requirements for Intended Use	Test results verified that the inflation devices' design meets the minimum requirements and are adequate for their intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It mentions "Testing and evaluation of the Encore 26 was encompassed in the device leak testing of the Encore 30 Inflation Device." This suggests a conceptual pooling of testing between the two models for certain aspects.

The data provenance is from in-vitro testing and evaluation conducted by the manufacturer, SCIMED Life Systems, Inc., presumably in the United States. The testing is prospective as it was conducted to verify the design of the new devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical medical device, not an AI/ML system that relies on expert interpretation for ground truth. The "ground truth" here is the physical performance against defined engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is a physical medical device. Performance is determined by objective measurements against established engineering specifications, not expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical medical device; there are no "readers" or "cases" in the context of an MRMC study for this type of product.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device; there is no standalone algorithm.

7. Type of Ground Truth Used

The ground truth used is based on engineering specifications, safety standards, and performance requirements for medical devices of this type. The testing was designed to verify that the physical characteristics and functionality (e.g., leak resistance, pressure gauge accuracy) meet these established standards.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device; there are no "training sets" in the context of AI/ML models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical medical device, there is no ground truth established for a training set. The "ground truth" for the device's design and performance is inherent in the engineering principles and regulatory standards governing such devices.

Summary

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K955869

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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
		(612) 494-2454
	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:

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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.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.