(93 days)
The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.
The main components of the PRESS DUO elite and PRESS DUO elite AG are the Console, Powerhead and Main Control Unit. The basic confiqurations of the PRESS DUO elite and PRESS DUO elite AG are a pedestal, ceiling mount or table mount configuration. With any configuration, the three main components are most often contained in the angiographic suite and normally near the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the graphical user interface with touchscreen input. The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (like that used with laptop computers) and communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection by driving the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe. The only difference between the PRESS DUO elite and PRESS DUO elite AG is the availability of the CT Mode. The PRESS DUO elite provides both an Angiographic Mode and CT Mode of operation whereas the PRESS DUO elite AG has the CT Mode of operation turned off in the software and cannot be turned on by the user. All other software, hardware and mechanical aspects of the PRESS DUO elite and PRESS DUO elite AG are identical.
The provided text describes the Nemoto Kyorindo Co., Ltd.'s PRESS DUO elite and PRESS DUO elite AG contrast delivery systems and their clearance through the FDA 510(k) process. This is a medical device, and the information available focuses on demonstrating substantial equivalence to predicate devices and performance testing to meet specifications, rather than clinical efficacy studies often associated with AI/ML devices. Therefore, many of the requested points related to AI/ML studies (like MRMC studies, training/test set sample sizes with ground truth, expert opinions for ground truth, etc.) are not applicable here.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims the device met specifications, but specific quantitative acceptance criteria for each measurement are not explicitly listed as numerical targets. Instead, the document states that tests verified the device's ability to "accurately achieve these the substantial equivalence claims" and that "all pressure readings were within the allowable specifications," "flow rate measured within the allowable ranges of the specification," and "successfully delivered the volumes within the allowable specifications."
The table below summarizes the claimed performance relative to the specifications mentioned in the "SUMMARY OF PERFORMANCE TESTING" section. It's important to note that the specific numerical thresholds for "allowable specifications" are not provided in this document.
| Performance Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Volume Delivered | Within allowable specifications for programmed volumes | Successfully delivered volumes within allowable specifications. |
| Flow Rate | Within allowable ranges of the specification for non-pressure limited injections | Measured within allowable ranges of the specification for non-pressure limited injections. Pressure-limited injections automatically reduce flow rate to maintain constant pressure. |
| Pressure | Within allowable specifications | All pressure readings were within the allowable specifications and compared to displayed values and product specifications. |
| Manual Control Speeds | Within allowable specification range | Confirmed to be within the allowable specification range. |
| EMC, Electrical, Mechanical, and Thermal Safety | Compliance with relevant standards | Performed using a prototype device with no electrical, safety, or structural mechanical differences from the final device. Ferrite bead included. |
2. Sample size used for the test set and the data provenance
- Sample Size: "a single unit of the justification for testing only a single unit is based upon our long history of the PRESS DUO in the Japanese market."
- Data Provenance: The justification references "our long history of the PRESS DUO in the Japanese market for approximately 5 years," implying previous market experience. The testing itself was performed on a prototype, but the location of this specific performance testing is not explicitly stated, although the company is based in Tokyo, Japan. The mention of "prototype device" suggests the testing was likely prospective for this specific submission, even if drawing on prior experience.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a contrast delivery system, not an AI/ML device requiring expert ground truth for image or clinical interpretation. Performance testing involved direct measurement of physical parameters like volume, flow rate, and pressure.
4. Adjudication method for the test set
- Not applicable. As above, this is performance testing of a physical device, not an AI/ML diagnostic or prognostic tool requiring adjudication of clinical interpretations.
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 is a medical device for injecting contrast media, not an AI-assisted diagnostic or prognostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm. The performance testing was for the device itself.
7. The type of ground truth used
- The ground truth for the performance testing was based on direct physical measurements of the device's output (flow rate, volume, pressure, manual speeds) compared against pre-defined engineering specifications. This is a form of engineering ground truth.
8. The sample size for the training set
- Not applicable. This device does not involve a training set in the context of AI/ML or statistical modeling. The "long history of the PRESS DUO in the Japanese market for approximately 5 years" provides historical data and experience, but not a "training set" in the computational sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set in the AI/ML context.
§ 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.