(87 days)
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.
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.
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.
§ 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.