(176 days)
The "Microjet Crono K" and "Crono go" ambulatory infusion pump device has been designed 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 K, 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 K 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 K 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 K 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 K is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
Here's an analysis of the provided information regarding the Microjet Crono K and Crono go ambulatory infusion pumps, focusing on acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided document is a 510(k) summary from 2002, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results with detailed performance metrics and statistical analyses as might be found in a more recent PMA or extensive clinical study report. Therefore, some of the requested information (like specific effect sizes for MRMC studies or detailed ground truth methodologies) is not explicitly present in this type of submission.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily demonstrates substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838) by comparing characteristics and showing that the new device is as safe and effective. It does not explicitly list quantified acceptance criteria with specific performance thresholds (e.g., a "must achieve X% accuracy"). Instead, "acceptance criteria" are implied by the comparison to the predicate device, where the new device must perform at least as well as or similarly to the predicate device in aspects like safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance ("Microjet Crono K" & "Crono go") |
|---|---|---|
| Intended Use | Subcutaneous and intravenous infusion of prescribed liquid medicines (as per predicate's relevant uses) | Subcutaneous and intravenous only |
| Safety | As safe as the predicate device | Bench, EMC, and user testing indicate safety comparable to predicate. |
| Effectiveness | As effective as the predicate device | Bench, EMC, and user testing indicate effectiveness comparable to predicate. |
| Technological Differences | Minor differences that do not raise new questions of safety or effectiveness | Few technological differences (e.g., battery type, size, weight, capacity, warranty) and no new indications for use. |
| Flow/Infusion Control | Reliable infusion without frequent occlusions, or with effective occlusion management (implied by predicate's function) | Particular mechanism for high thrust force (up to 3x higher) to address catheter occlusion; innovative infusion control system to proceed automatically after occlusion is eliminated. Infusion up to 3x more fractionated (22 ml per impulse for 10/20ml syringe) for better absorption. |
| Patient Experience/Usability | User-friendly, portable (implied to avoid "refuse of therapy") | Compact size (3" x 1.85" x 1.14", 4.0 oz) due to special syringe; fitted with LCD showing delivery time and battery status. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the implied acceptance criteria for substantial equivalence consists of bench testing, EMC (Electromagnetic Compatibility) testing, and user testing.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the bench testing, EMC testing, or user testing. These are typically internal validation studies that are summarized to support the 510(k) rather than detailed clinical trial reports with specific patient numbers.
- Data Provenance: The studies were conducted by CANÉ S.r.l. (the manufacturer) in Rivoli-Cascine Vica (Torino), Italy. The data is retrospective in the sense that these tests were performed and summarized to support the 510(k) submission. It's not a prospective, multi-center clinical trial report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not provide details on the number of experts, their qualifications, or how ground truth was established specifically for the test sets (bench, EMC, user testing). Such information is generally not required for a 510(k) summary demonstrating substantial equivalence for this type of device. The "user testing" would likely involve medical professionals and/or patients, but their expert role in establishing a formal "ground truth" (as in diagnostic accuracy studies) is not described.
4. Adjudication Method for the Test Set:
- The document does not describe any formal adjudication method for the test sets (bench, EMC, user testing). Adjudication methods like '2+1' or '3+1' are typical in diagnostic imaging studies where consensus among multiple readers is needed to define a ground truth for ambiguous cases. This is not applicable to the types of tests mentioned (bench, EMC, user testing) for an infusion pump.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. This is not relevant for an infusion pump.
6. Standalone (Algorithm Only) Performance Study:
- While the device itself is an "algorithm" in the sense that it controls infusion, no separate "standalone" algorithm-only performance study (without human-in-the-loop performance), as understood in AI/ML medical devices (e.g., an automated diagnostic algorithm without human oversight), was conducted or reported. The device's performance inherently involves its interaction with a user (loading medication, setting parameters) and patient (receiving infusion). The "bench testing" would evaluate the device's mechanical and electrical functions in a controlled environment, which could be considered an "algorithm-only" performance aspect to some extent, but not in the context of an AI-driven diagnostic or interpretative algorithm.
7. Type of Ground Truth Used:
- For bench testing: The "ground truth" would be established by engineering specifications, known physical principles, and validated measurement techniques. For example, flow rate accuracy would be compared against a known standard, occlusion detection against intentionally induced blockages, and battery life against expected draw under defined conditions.
- For EMC testing: The "ground truth" is established by adherence to international standards and regulatory limits for electromagnetic emissions and immunity (e.g., IEC 60601-1-2 or similar).
- For user testing: The "ground truth" or validation would be based on observed functional success, ease of use, and user feedback compared to the predicate device or established usability principles. This is not a pathology or outcomes data type of ground truth.
8. Sample Size for the Training Set:
- Not applicable / Not specified. This device is an infusion pump, not an AI/ML-based system that uses a "training set" in the computational learning sense. The device's design and functionality are based on engineering principles and prototypes, not on a machine learning training dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the concept of a "training set" for an AI/ML model does not apply here, there is no ground truth established for such a set. The "ground truth" for the device's design and engineering would be based on fundamental scientific and engineering principles, functional requirements, and safety standards.
§ 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).