(29 days)
the Crono Super PID has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Crono Super PID is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion. Crono Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities. Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration. Crono Super PID administers 22 µl per impulse. In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. Crono Super PID is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
The provided text describes a 510(k) premarket notification for the Crono Super PID ambulatory infusion pump, establishing its substantial equivalence to a predicate device (Crono, K041414). This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table between the predicate device (Crono - K041414) and the new device (Crono Super PID) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially the performance characteristics of the predicate device that the new device must match or improve upon to be considered substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Device Crono - K041414) | Reported Device Performance (Crono Super PID) | Met? |
|---|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME | YES |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm). | SAME | YES |
| Weight | 4.0 oz (115 g) (battery included). | SAME | YES |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME | YES |
| Infusion per impulse | 22 µl. | SAME | YES |
| Flow rate accuracy | +/-2%. | SAME | YES |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | SAME | YES |
| Capacity | 10 or 20 ml. | SAME | YES |
Note: The phrase "SAME" in the "Reported Device Performance" column signifies that the Crono Super PID meets or matches the specified characteristic of the predicate device.
2. Sample size used for the test set and the data provenance
The document states, "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." However, specific sample sizes for these tests are not provided. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for the bench, EMC, and user testing is not explicitly stated. Given that CANE S.r.l. is an Italian company, it's highly probable that some or all of the testing was conducted in Italy, but this is an inference, not stated fact.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable or not specified. For a 510(k) submission demonstrating substantial equivalence for an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy) would typically be established through instrumental measurements and engineering verification, not through expert consensus on medical images or clinical outcomes. The document does not mention the involvement of medical experts in establishing ground truth for the technical performance parameters.
4. Adjudication method for the test set
Not applicable or not specified. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of subjective data (e.g., radiological images) where discrepancies between expert readers need to be resolved. This is not relevant for the type of bench and user testing described for an infusion pump, which focuses on objective physical and functional characteristics.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI algorithms, where the performance of human readers (e.g., radiologists) is augmented by AI. The Crono Super PID is an ambulatory infusion pump, not a diagnostic device, and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Crono Super PID is a physical medical device (an infusion pump), not an algorithm. Its performance is inherent to its mechanical and electronic function, not an algorithm's output separate from human interaction in a diagnostic or interpretive context.
7. The type of ground truth used
The ground truth for the performance characteristics of the Crono Super PID would be established through objective engineering measurements and verification. For example:
- Flow rate accuracy: Measured against a calibrated standard using laboratory equipment.
- Max. Occlusion pressure: Measured using pressure sensors.
- Size and Weight: Measured using standard measuring tools.
- Infusion per impulse: Verified through precise volume measurement.
The phrase "bench, EMC, and user testing" suggests these types of objective measurements were performed.
8. The sample size for the training set
Not applicable / Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models. The Crono Super PID is a physical device, and its development and testing do not involve a training set in the AI sense. Its design and manufacturing are based on engineering principles and quality control.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of this device's development as described. The performance data is derived from direct physical and functional testing.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).