(290 days)
The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.
The ANT Inflation Device Compact Pack:
-ANT Inflation Device: See description above.
-ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use during vascular procedures in conjunction and/or diagnostic device (e.g., balloon dilatation catheters, artherectorny devices, sent delivery systems, intravascular ultrasound devices.)
ANT Inflation Device is a single-use, sterile device used in cardiovascular procedures to inflate and deflate balloon catheters. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure up to 30 ATM.
ANT Inflation Device Accessory Compact Pack contains a hemostasis valve, a torque device, and a guide wire introducer. The hemostasis valve is designed to provide a port for interventional system. The guide wire introducer is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.
This document describes the ANT Inflation Device and ANT Inflation Device Compact Pack, which are intended for use during vascular procedures to create and monitor pressure in balloon catheters. The submission includes performance tests, biocompatibility tests and comparison to a predicate device to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy of pressure gauge | Pressure readings comparable to a calibrated pressure gauge | Accurately pressurized to 4ATM, 16ATM, 27ATM, with readings comparable to the calibrated gauge. Results comparable to other commercially available devices. |
| Leak test | No leakage at tested pressures | No bubbles observed when immersed in water after being pressurized with water at 1ATM, 15ATM, 30ATM, and maintained for 2 minutes. Shows connection is comparable to other commercially available devices. |
| Competence test | Proper functioning with a legally marked catheter | Monitored pressure accurately during inflation and deflation with a legally marked catheter. Results comparable to other commercially available devices. |
| Biocompatibility | Meet ISO 10993-1:2003 requirements | Meets biocompatibility requirements of ISO 10993-1:2003 for both the Inflation Device and Accessory Pack components (as an external communicating device). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact number of test samples used for each performance test (Accuracy of pressure gauge, Leak test, Competence test). It generally states "Completely packaged devices are chosen as the test samples" for the accuracy test and "Test samples were pressurized" for the leak test. The data provenance is not explicitly stated as retrospective or prospective, but these appear to be internal laboratory tests conducted by the manufacturer (Shenzhen ANT Hi-Tech Industrial Co., Ltd, China) for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are objective performance measurements against established physical standards (calibrated pressure gauge) or pass/fail criteria (leakage, functional competence according to the device's design). No human expert interpretation of device output for medical diagnosis or treatment decisions was involved in establishing ground truth for these tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements and do not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a medical instrument (balloon inflation device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manually operated mechanical instrument, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance tests consists of:
- Calibrated Measurement: For the accuracy of the pressure gauge, the ground truth was established by a "calibrated pressure gauge."
- Objective Criteria: For the leak test, the ground truth was the observable presence or absence of bubbles, indicating leakage. For the competence test, it was the observable proper functioning of the device during inflation and deflation when attached to a legally marked catheter.
- Established Standards: For biocompatibility, the ground truth was compliance with the requirements of ISO 10993-1:2003, as assessed through specific tests outlined in the standard (e.g., ISO 10993-5, 10993-10, 10993-11, 10993-4).
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this device does not involve AI/machine learning, there is no training set or associated ground truth for it.
§ 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.