(173 days)
The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.
Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery status.
The provided text describes the Microjet Crono PCA ambulatory infusion pump and its substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics with numerical targets, details about a test dataset (sample size, provenance, ground truth establishment), expert qualifications, or MRMC study results.
Instead, the document focuses on:
- Device Identification: Name, classification, and common use.
- Equivalent Legally Marketed Devices: Comparison to a predicate device (Cadd-Legacy PCA Model 6300).
- Indications for Use: Intravenous or subcutaneous infusion of medicines for pain management.
- Description of the Device: Physical characteristics, features like microprocessor control, patient bolus button, safety system, and occlusion detection.
- Safety and Effectiveness, comparison to predicate device: States that "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device."
- Substantial Equivalence Chart: Compares functional and physical characteristics with the predicate device.
Given that this is a 510(k) summary, it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data like a novel device might. The "acceptance criteria" here are implicitly tied to demonstrating equivalence to the predicate device's safety and effectiveness.
Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from the provided text.
Here is what can be inferred or directly stated based on the text (with many fields unanswerable):
Acceptance Criteria and Reported Device Performance
The document does not explicitly list numerical acceptance criteria. Instead, the "acceptance criterion" is implicitly demonstrating that the Microjet Crono PCA is "as safe and effective" as the Cadd-Legacy PCA Model 6300, based on "bench, EMC, and user testing." The comparison chart provides the basis for this claim of equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Microjet Crono PCA) |
|---|---|---|
| Intended Use | Designed for use in intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, intrathecal infusion of medicines for pain management. | Intravenous or subcutaneous only. (Note: This is a more limited intended use, which can support substantial equivalence as it doesn't introduce new risks.) "Designed for use in intravenous or subcutaneous infusion of medicines for pain management." |
| Safety & Effectiveness | As safe and effective as the Cadd-Legacy PCA Model 6300. | "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 of CANÈ S.r.1. that the Microjet Crono PCA is as safe and effective as the predicate device, has few technological differences, and has no new indications for use..." |
| Power Source | 2 AA alkaline batteries, AC Adapter | Lithium battery (3V) of the 123 A type |
| Size | 4.4 x 3.8 x 1.6 in (112x 95x41 mm) | 3" x 1.85" x 1.14" (77 x 47 x 29 mm) (Smaller) |
| Weight | 13.8 oz (392 grams) | 4.0 oz (115 g) (battery included). (Lighter) |
| Capacity | 50 or 100 ml | 10 or 20 ml (Smaller capacity) |
| Warranty | 1 year | 2 years (Longer) |
| Technological Features | Basic PCA pump functionality | Microprocessor-controlled, patient bolus button, screen for infused volume/bolus count, keyboard lock, occlusion detection/continuation. (These are described as innovative/outstanding technology, implying they meet or exceed predicate features.) |
The "study" refers to "bench, EMC, and user testing." No specific details about the methodology, sample sizes, or results of these tests beyond the general conclusion are provided.
Unanswerable Information (Based on provided text):
- Sample size used for the test set and the data provenance: Not specified. The document mentions "bench, EMC, and user testing" but no details on sample size (e.g., number of devices tested, number of users, number of cases/simulations). Data provenance is not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is not a diagnostic device or a study involving expert interpretation of data. The "ground truth" for a pump's function typically comes from engineering specifications and objective measurements (bench testing) and user feedback/performance in simulated or actual (but controlled) use.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/specified.
- 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 is not a diagnostic device involving human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its function involves both the device itself and human interaction (programming, patient use of bolus). The "bench" testing could be considered "standalone" in a technical sense, but it's not specific to an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a device like an infusion pump, "ground truth" would likely involve engineering specifications, calibration standards, and objective measurements (e.g., flow rate accuracy, occlusion pressure thresholds, battery life, structural integrity). For "user testing," ground truth would relate to usability and performance as expected by users and design requirements. The document does not specify.
- The sample size for the training set: Not applicable/specified. This is not a machine learning or AI-based device that typically has a "training set."
- How the ground truth for the training set was established: Not applicable/specified.
§ 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).