(57 days)
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
The OptiVantage DH Injection System delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage is made up of the following major components:
- Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
- Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc).
- Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer.
- Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.
The provided document is a 510(k) summary for a medical device called the "OptiVantage DH Injection System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
However, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to clinical performance, diagnostic accuracy, or similar aspects that would typically involve statistical metrics (like sensitivity, specificity, AUC) and expert review.
Instead, the document focuses on design and functional equivalence to a predicate device. The "features" table (sections 8 and 9) compares technical specifications and functionalities of the new device against the predicate. The "study" referenced implicitly in this context is the comparison to the predicate device itself, aiming to demonstrate that the new device performs similarly or offers enhancements without raising new questions of safety or effectiveness.
Therefore, many of the requested fields cannot be directly answered from the provided text because such information is not present. Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, there are no explicit "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output or clinical outcome. The document focuses on demonstrating substantial equivalence to a predicate device by comparing technical features. The "acceptance criteria" can be inferred as matching or improving upon the predicate device's functional specifications without introducing new safety/effectiveness concerns.
| Feature / Criteria (Inferred from Predicate Comparison) | Acceptance Criteria (Implicit) | Reported Device Performance (OptiVantage DH) |
|---|---|---|
| Intended Use | Same as predicate | Intended to be used for injecting radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with CT equipment. (Matches predicate) |
| Multi-phasic Injections | At least 4 phases per protocol (predicate performance) | 6 phases per protocol (Improvement over predicate) |
| OptiBolus | Yes (Matches predicate) | Yes (Matches predicate) |
| Protocol Storage | At least 12 protocols (predicate performance) | 40 protocols (Improvement over predicate) |
| Syringe Sizes | Accommodate Mallinckrodt 125-ml contrast syringes & Liebel-Flarsheim 200 ml empty syringe (Matches predicate) | Accommodates all pre-filled volumes of Mallinckrodt 125-ml contrast syringes & Liebel-Flarsheim 200 ml empty syringe (Matches predicate) |
| Single or Dual Syringe Modality | Single syringe and Dual syringe (when interfaced) (predicate performance) | Single syringe and Dual syringe capability (Improvement/simplification over predicate, as dual syringe is inherent) |
| Syringe Drive System | Electromechanical (Matches predicate) | Electromechanical (Matches predicate) |
| Syringe Heater | Yes (Matches predicate) | Yes (Matches predicate) |
| Syringe Fill Rate | 2 to 15 ml/sec (Matches predicate) | 2 to 15 ml/sec (Matches predicate) |
| Flow Rate | 0.1 to 9.9 ml/sec (predicate performance) | 0.1 to 10 ml/sec (Slight improvement/expansion of range) |
| Max Pressure Limit | 325 psi (Matches predicate) | 325 psi (Matches predicate) |
| Pressure Limit Control | User-settable (predicate performance) | User-settable or automatic (Improvement over predicate) |
| Pressure Control Increments | 25 psi increments (Matches predicate) | 25 psi increments (Matches predicate) |
| Flushing System | Manual or via injector (with interface) (predicate performance) | Manual or via injector (simplification over predicate, as dual syringe is inherent) |
| Scan Delay | 0 - 500 seconds (predicate performance) | 0 - 600 seconds (Improvement over predicate) |
| Phase Delays | 0 - 254 seconds plus Pause (predicate performance) | 0 - 600 seconds plus Pause (Improvement over predicate) |
| Console Controls | Touch screen Color LCD (Matches predicate) | Touch screen Color LCD (Matches predicate) |
| Power Head Controls | Keypad (predicate performance) | Touch screen Color LCD (Improvement over predicate) |
| Safety Stop Mechanism | Electrical Stop when injection parameters are out of specifications (Matches predicate) | Electrical Stop when injection parameters are out of specifications (Matches predicate) |
| Volume Remaining Display | Displayed on Power Head and Console (Matches predicate) | Displayed on Power Head and Console (Matches predicate) |
| Used Syringe Detection | Yes (Matches predicate) | Yes (Matches predicate) |
| Target Population | Humans (Matches predicate) | Humans (Matches predicate) |
| Sterility | Injectors are not sterile products; syringes and disposables are provided sterile. (Matches predicate) | Injectors are not sterile products. Syringes and Disposables are provided sterile. (Matches predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a 510(k) submission based on substantial equivalence to a predicate device, focusing on design and functional comparisons. It does not refer to a clinical study with a test set of data points or patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As above, no clinical test set or ground truth establishment by experts is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate device based on its design and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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 power injector, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware with software control; it's not an algorithm meant for standalone performance in the diagnostic sense. Its operation is "standalone" in that it performs its injection function without continuous human intervention during the injection process itself, once programmed. However, this is not the typical meaning of "standalone" in the context of diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) pertains to the safety and effectiveness profile of the predicate device (CT9000ADV / OptiBolus Injection System, K031339). The new device demonstrates substantial equivalence by showing that its design, materials, and operational parameters are either identical or offer improvements that do not introduce new risks, aligning with the already-cleared predicate.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI models that require a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.
§ 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.