(158 days)
The OptiVantage DH Injector System with Enhanced Communication 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 Injector System with Enhanced Communication 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 DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device:
- 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 knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives 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 DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.
The provided text is a 510(k) summary for the OptiVantage DH Injector System with Enhanced Communication. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.
The document is a submission to the FDA for market clearance, focusing on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K042744). The comparison table highlights features that are identical between the new device and the predicate. The "enhancement" mentioned is an additional layer of enforcement for existing safety features, rather than a new performance characteristic requiring a new clinical performance study with acceptance criteria.
Therefore, many of the requested details about performance studies, data provenance, expert ground truth, etc., are not present in this 510(k) summary document.
Here's a breakdown of what is and is not available in the provided text:
1. Table of acceptance criteria and reported device performance:
- Not available. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy or pressure limits) against which a study's results would be measured. It rather lists specifications and features that are identical to the predicate device.
2. Sample size used for the test set and the data provenance:
- Not available. No performance study or test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. Not applicable as no performance study with ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available. Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This device is a power injector for contrast media, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not available. No standalone performance study is mentioned. The device's performance is implicit in its specifications, which are deemed substantially equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not available. Not applicable.
8. The sample size for the training set:
- Not available. Not applicable as no machine learning algorithm development is described.
9. How the ground truth for the training set was established:
- Not available. Not applicable.
What can be extracted from the document related to "performance" and "criteria":
The document relies on substantial equivalence to a predicate device (OptiVantage DH Power Injection System, K042744). The "acceptance criteria" are implicitly that the new device performs identically or acceptably compared to the predicate for all relevant functions.
Reported Device Performance (based on comparison to predicate):
| Feature | OptiVantage DH Injector System with Enhanced Communication (New Device) |
|---|---|
| Intended Use | Identical to predicate |
| Multi-phasic Injections | 6 phases per protocol (Identical to predicate) |
| OptiBolus | Yes (Identical to predicate) |
| Protocol Storage | 40 protocols (Identical to predicate) |
| Syringe Sizes | All Mallinckrodt 125-ml, Liebel-Flarsheim 200 ml (Identical to predicate) |
| Single or Dual Syringe Modality | Single syringe and Dual syringe (Identical to predicate) |
| Syringe Drive System | Electromechanical (Identical to predicate) |
| Syringe Heater | Yes (Built-in, Powerhead controlled) (Identical to predicate) |
| Syringe Fill Rate | 2 to 15 ml/sec (Identical to predicate) |
| Flow Rate | 0.1 to 10 ml/sec (Identical to predicate) |
| Max Pressure Limit | 325 psi (Identical to predicate) |
| Pressure Limit Control | User-settable or automatic 25 psi increments (Identical to predicate) |
| Flushing System | Manual or via injector (Identical to predicate) |
| Remote Start | Yes (Identical to predicate) |
| Scan Delay | 0-600 seconds (Identical to predicate) |
| Phase Delays | 0-600 seconds plus Pause (Identical to predicate) |
| Console Controls | Touch screen Color LCD (Identical to predicate) |
| Power head Controls | Touch screen Color LCD (Identical to predicate) |
| Post Injection Readout | Yes (Identical to predicate) |
| OEM Interface | Relays & Optical Couplings/Serial (CAN) (Identical to predicate) |
| Safety Stop Mechanism | Electrical Stop when injection parameters are out of specifications (Identical to predicate) |
| Remote Check for Air | Yes (Identical to predicate) |
| Volume Remaining Display | Displayed on Power Head and Console (Identical to predicate) |
| Used Syringe Detection | Yes (with Enhanced Communication) (New enhancement, assumed to meet safety/function criteria) |
§ 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.