(170 days)
The portable Crono infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono H, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono H allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a iron chelation therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono H has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono H makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono H is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
This document is a 510(k) summary for the Microjet Crono H ambulatory infusion pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a study involving AI/machine learning performance assessment).
Here's what can be extracted from the document based on the provided format, with explanations where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria for performance metrics (e.g., accuracy, precision of infusion) in a quantitative sense with corresponding reported performance values. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Microjet Crono H) |
|---|---|---|
| Intended Use | Intravenous, Intra-arterial, Subcutaneous, Intraperitoneal, Epidural, Intrathecal (Predicate) | Subcutaneous and intravenous only |
| Power Source | 2 AA alkaline batteries, AC Adapter (Predicate) | Lithium battery (3V) of the 123 A type |
| Size | 4.4 x 3.8 x 1.6 x in (112x 95x41 mm) (Predicate) | 3" x 1.85" x 1.14" (77 x 47 x 29 mm) |
| Weight | 13.8 oz (392 grams) (Predicate) | 4.0 oz (115 g) (battery included) |
| Capacity | 10 ml (Predicate) | 10 or 20 ml |
| Warranty | 1 year (Predicate) | 2 years |
| Safety & Effectiveness | Safety and effectiveness comparable to predicate device in bench, EMC, and user testing. | "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." "After analyzing both bench and user testing data, it is the conclusion... that the Microjet Crono is as safe and effective as the predicate device..." |
2. Sample size used for the test set and the data provenance
The document mentions "bench, EMC, and user testing" but does not specify sample sizes for any of these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The testing described is for a medical device (infusion pump) and does not involve "ground truth" derived from expert consensus in the way a diagnostic imaging AI algorithm would.
4. Adjudication method for the test set
Not applicable, as the evaluation type does not involve an adjudication process as described (e.g., for expert consensus on images).
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 such study was mentioned. The device is an ambulatory infusion pump, 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
This information is not applicable. The device is a physical infusion pump, not a standalone algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically applied to AI/machine learning data sets (e.g., expert consensus, pathology, outcome data) is not relevant here. The evaluation relies on engineering tests (bench testing, EMC testing) and user testing to assess the device's functional performance, safety, and effectiveness in comparison to a predicate device.
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI/machine learning model submission where a "training set" would be used.
9. How the ground truth for the training set was established
Not applicable.
Summary of the K013855 Submission's Approach to Demonstrating Safety and Effectiveness:
The K013855 submission for the Microjet Crono H ambulatory infusion pump focuses on demonstrating substantial equivalence to a previously legally marketed device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838). The primary method for proving this is through a detailed comparison of characteristics and results from "bench, EMC, and user testing," which reportedly showed the new device to be "as safe and effective as the predicate device."
The document does not detail acceptance criteria in a quantitative, performance-metric-based fashion. Instead, the "acceptance criterion" is implicitly met by showing that the new device's characteristics and performance are comparable to, or better than, the predicate device across various features, particularly in its fundamental function as an infusion pump. The "study" that proves this is the collection of "bench, EMC, and user testing" data, which are not described in detail regarding methodologies, sample sizes, or specific performance outcomes.
§ 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).