(211 days)
Injection of contrast media into the heart, great vessels, and coronary arteries, to study the heart and vessels by x-ray photography
The Oz Power Syringe consists of a 35cc syringe that is manually powered by a lever arm which attaches to a base. As the lever arm is raised, the synnge is titled with the distal tip plyoting on a pin while the plunger filts to a higher angle. The mechanism is designed to stop the plunger as the lever arm is raised to pull the plunger back in the synnge barrel to 35cc. At this position, the lever arm is approximately at a 45 degree angle from the base and the syringe is titled to help produce power as the lever arm will be pushed downward to deliver the contrast media in the syringe. The operator loads the syringe by pulling back on the plunger to draw in the contrast, then pushes the plunger forward to remove air, as is done with a traditional manual syringe. To deliver contrast media, the operator presses down on the lever handle. The operator can easily adjust the delivery pressure in response to fluoroscope or x-ray imaging, or in response to patient comfort levels, by simply adjusting the manual force applied to the lever. The Oz Power Syringe allows the operator to produce more pounds per square inch pressure than normal synnge use. By applying 80-70 pounds of downward pressure on the lever, the operator can easily achieve a 200-350 psl delivery prossure. It is easy to load and inject. It is easy to control and requires much less space than electrically driven power injector equipment. This device enables the operator to produce sufficient pressures to achieve proper contrast delivery, while maintaining control throughout the delivery process. It is very important that the proper amount of contrast media, as well as the pressure and rate at which it is delivered, be controlled for safe and desirable results to both the operator and the patient.
The Oz Power Syringe is a manually powered syringe system intended for injecting contrast media into the heart, great vessels, and coronary arteries for x-ray photography. The summary of safety and effectiveness indicates that the device's performance was established by comparing it to predicate devices through a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by conducting comparative non-clinical tests against predicate devices. The "reported device performance" is essentially that the Oz Power Syringe passed these tests, demonstrating substantial equivalence. The document does not provide specific quantitative acceptance criteria values (e.g., "pressure must be X psi +/- Y") or direct quantitative performance results for the Oz Power Syringe for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria (Inferred from Test Types) | Reported Device Performance |
|---|---|
| Ability to generate and withstand pressure (closed system) | "Pressure through system directly into pressure gauge (closed)" passed. |
| Ability to deliver pressure through catheters (open system) | "Pressure through system flowing through catheters (open)" passed. |
| Compatibility with existing power injector systems (open system) | "Pressure through present power injector system (open)" passed. |
| Ability to maintain Luer suction | "Luer suction test" passed. |
| Resistance to high-pressure leakage | "High pressure leakage" test passed. |
| Resistance to high-pressure burst | "High pressure burst" test passed. |
| Functionality of Luer connections | "Luer test" passed. |
| Mechanical strength/durability | "Break testing" passed. |
| Integrity of product packaging | "Packaging Integrity" passed. |
| Comparable performance to predicate devices (MedRad Mark V Angiographic Injector & Sherwood Medical Monoject 35cc Syringe) across various parameters (intended use, operating principle, materials, dimensions, weight, volume, flow rate, injection pressure, packaging, labeling, expiration date). | The device was found "substantially equivalent" to predicate devices based on the comparison and non-clinical testing. |
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical laboratory testing. Therefore, there is no "test set" in the sense of patient data. The sample size for the physical devices tested (e.g., number of syringes subjected to burst pressure) is not specified. The data provenance is from non-clinical bench testing. Specific country of origin for the testing is not mentioned, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. For non-clinical bench testing of a physical device like a syringe, "ground truth" is established by measurements against specified engineering and performance criteria, not by expert interpretation of medical images or data.
4. Adjudication Method for the Test Set:
This information is not applicable as the study involved non-clinical bench testing, not human-based assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a 510(k) submission for a physical medical device (syringe/injector) based on non-clinical testing and substantial equivalence to predicate devices. It is not an AI-assisted diagnostic tool, so an MRMC comparative effectiveness study is not relevant or included.
6. Standalone Performance Study:
Yes, in a way. The "Non-Clinical Testing" detailed in the document serves as the standalone performance study for the Oz Power Syringe. These tests were conducted on the device itself to verify its functional and safety characteristics, confirming its ability to perform its intended use and withstand operational stresses. The comparison to predicate devices also implicitly supports its standalone performance by demonstrating it behaves similarly to currently marketed devices.
7. Type of Ground Truth Used:
The ground truth for this device's performance is based on engineering specifications and measurements from physical testing. For example, a pressure gauge provides the "ground truth" for pressure output, and direct observation or measurement determines leakage or burst points. The "ground truth" for proving safety relies on meeting established industry standards for such devices and demonstrating equivalence to legally marketed predicates.
8. Sample Size for the Training Set:
This information is not applicable. The development and testing of this device do not involve machine learning or AI models with "training sets."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for an AI model.
§ 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.