(211 days)
The portable Crono infusion device has been designed only for use in subcutaneous infusion of prescribed liquid medicines.
The Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Cane s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, 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 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 liquid medicine 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 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 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 is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
The provided text describes a 510(k) summary for the Microjet Crono Ambulatory Infusion Pump. It does not contain information typically found in acceptance criteria and study designs for evaluating device performance against specific metrics like sensitivity, specificity, or image quality, which are more common in studies for diagnostic devices or AI algorithms.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump) by comparing general characteristics and safety/effectiveness conclusions based on "bench, EMC, and user testing."
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I answer questions related to sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of studies were not conducted or described in the provided submission for this device.
The "acceptance criteria" in this context are implicitly the characteristics listed in the "Substantial Equivalence Chart" and the general safety and effectiveness claims.
Here's a breakdown of what can be extracted based on the provided text, addressing only the relevant points:
1. A table of (implicit) acceptance criteria and the reported device performance
The acceptance criteria here are based on similarity to the predicate device and the successful completion of specified tests.
| Characteristic / Acceptance Criterion | Reported Microjet Crono Performance |
|---|---|
| Intended Use | Subcutaneous only |
| Physical characteristics: | |
| Power Source | Lithium battery (3V) of the 123 A type |
| Size | 3" x 1.85" x 1.14" (77 x 47 x 29 mm) |
| Weight | 4.0 oz (115 g) (battery included) |
| Capacity | 10 or 20 ml |
| Warranty | 2 years |
| Safety and Effectiveness | Results of bench, EMC, and user testing indicate safety and effectiveness. |
| Technological Differences | Few technological differences compared to the predicate. |
| New Indications for Use | No new indications for use. |
2. Sample sized used for the test set and the data provenance: Not applicable. The document mentions "bench, EMC, and user testing" but does not specify sample sizes for these tests or the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are not described.
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 device is not an AI-powered diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an infusion pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense. The "ground truth" for this submission is implicitly established by the performance of the predicate device and the successful completion of engineering and usability tests.
8. The sample size for the training set: Not applicable. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set for an algorithm.
§ 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).