(316 days)
A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.
The flush device is comprised of seven small components which, when ultrasonically welded together, constitute the finished product. The device is supplied in two configurations; adult and neonate. The adult configuration differs from the neonate configuration by flow rate and color. The adult flow specification is a nominal 3 milliliters per hour (ml/hr) with a static head pressure of 250 millimeters of mercury (mmHg). The neonate flow specification is a nominal 30 ml/hr at 250 mmHg static head pressure. The device has a fast flush feature which can be momentarily actuated by squeezing the tabs on either side of the device. The fast flush feature is used to aid in filling and debubbling the pressure monitoring lines. The device has the capability of creating a momentary pressure spike to verify the frequency response of the pressure monitoring system. The pressure spike is created by pulling up and releasing (snapping) the pull tab on top of the device. The device incorporates a pressure relief capability to provide over-pressure protection to the transducer. At pressures greater than 600 mmHg (11.6 psi), the silastic control component stretches and allows fluid to by-pass the flow restrictor thereby providing over-pressure protection.
The provided text describes a 510(k) summary for a "Continuous Flush Device" by Merit Medical Systems, comparing it to predicate devices. It focuses on device specifications and functionalities rather than a study proving the device meets acceptance criteria related to AI or clinical effectiveness, as commonly requested in such prompts for medical AI devices.
Based on the provided text, here's a breakdown of the requested information, noting where the information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Predicate Device) | Merit Flush Device Performance (Reported in Submission) |
|---|---|---|
| Intended Use | For use in physiological pressure measurements which require continuous flow to maintain catheter patency. | For use in physiological pressure measurements which require continuous flow to maintain catheter patency. |
| Adult Flow Rate | $3 \pm 1$ cc/hr @ 300 mmHg (Spectramed) | |
| $3 \pm 1$ ml/hr (Baxter) | $3 \pm 1$ ml/hr @ 250 mmHg pressure | |
| Neonate Flow Rate | 30 cc/hr (Spectramed) | |
| $30 \pm 10$ ml/hr (Baxter) | $30 \pm 10$ ml/hr @ 250 mmHg pressure | |
| Fast Flush Mode | Yes | Yes |
| Bypass Pressure | Unknown bypass pressure (Spectramed) |
500 mmHg (9.7 psi) (Baxter) | >600 mmHg (11.6 psi) |
| Sterilization | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Single Use | Yes | Yes |
| Pyrogen Free | Yes | Yes |
| Packaging | Tyvek™ pouch | Tyvek™ pouch |
| Step Response Capability | Yes - by bouncing lever (Spectramed)
Yes - via the Snap-Tab™ (Baxter) | Yes - via pull tab |
| Adult Colors | Different models for adults, neonate applications (Spectramed)
Blue color (Baxter) | Adult devices supplied with squeeze tabs in white, red, blue or green. |
| Neonate Colors | Different models for adults, neonate applications (Spectramed)
Yellow color (Baxter) | Neonate devices supplied with squeeze tabs in yellow color. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to the provided document. The document describes a 510(k) submission for a physical medical device (flush device), not an AI or software as a medical device (SaMD). Therefore, there is no "test set" in the context of algorithm performance or data provenance. The comparison is based on device specifications and features against predicate devices.
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)
This information is not applicable. See the explanation for point 2. The "ground truth" here would be the physical measurements of the device's performance (e.g., flow rate, pressure relief), which are established through engineering testing, not expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. See the explanation for point 2. Adjudication methods are relevant for expert review of data, which is not described here.
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
This information is not applicable. The device is a physical medical component, not an AI or diagnostic imaging system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the engineering specifications and performance characteristics of the device, established through physical testing and measurement. For example, flow rates (ml/hr), bypass pressure (mmHg), and material compatibility (e.g., sterilization method). This is fundamentally different from clinical ground truth based on expert review or pathology.
8. The sample size for the training set
This information is not applicable. The device is a physical medical component, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. See the explanation for point 8.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).