(82 days)
The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.
The CADD-Legacy™ PCA Model 6300 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-PCA® Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6300 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one delivery application. The delivery application resident in the Model 6300 pump and the subject of this 510(k) Notification is the continuous infusion with bolus (PCA) delivery application.
The provided 510(k) summary for the CADD-Legacy™ PCA Model 6300 Ambulatory Infusion System primarily focuses on demonstrating substantial equivalence to predicate devices through functional testing, rather than reporting on specific acceptance criteria and a detailed study proving performance against those criteria. Clinical studies were explicitly stated as "not deemed necessary."
Therefore, it is not possible to extract all the requested information, particularly regarding specific numerical acceptance criteria, device performance metrics, sample sizes for test/training sets, expert details, or comparative effectiveness studies, as these were not conducted or reported in this 510(k) summary.
However, based on the provided text, here is what can be inferred and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Verification (Software) | Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified. This implies the device met predefined functional requirements, though specific numerical performance metrics (e.g., accuracy of infusion rate, bolus delivery precision) are not specified. |
| Safety (Overinfusion, Under-infusion, No Infusion) | The summary acknowledges these as "potential adverse effects" common to infusion pumps and implies that functional testing and substantial equivalence demonstrate the device mitigates these risks to an acceptable level as compared to predicate devices. No specific quantitative criteria or performance data for these risks are provided. |
| Substantial Equivalence | The device was found substantially equivalent to the CADD-PCA® Ambulatory Infusion Pump and CADD-Prizm® VIP Model 6100 Ambulatory Infusion System. This is the overarching acceptance criterion and performance metric for this submission. |
Explanation: The document does not define specific, quantifiable acceptance criteria like "infusion accuracy within X% of programmed rate" or "alarm activation within Y seconds of occlusion." Instead, the acceptance is based on the successful completion of "functional testing" and a determination of "substantial equivalence" to existing, legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The summary only mentions "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified." This typically refers to internal test cases and scenarios, not a patient-based test set.
- Data Provenance: Not applicable in the context of clinical data for this 510(k). The testing described is functional and software validation, likely performed internally by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the functional tests would be the device's adherence to its design specifications and validated software functionality. This is typically assessed by engineers and quality assurance personnel, not clinical experts for ground truth in the sense of disease diagnosis or outcome.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a human-centric "test set" requiring adjudication in the context of clinical performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ PCA Model 6300 Ambulatory Infusion System."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the traditional sense of an "algorithm only" device. This is an infusion pump, and its "performance" is inherently tied to its mechanical and software functionality, which always involves human interaction (programming, setup) and often human monitoring. The described "functional testing" is essentially a standalone performance evaluation of the device's technical specifications.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the functional testing, the "ground truth" would be the device's adherence to its engineering design specifications, software requirements, and validated functional outputs. This is not ground truth in the context of pathology, outcomes data, or expert consensus on clinical findings.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is an infusion pump, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The software and hardware were developed and validated, not "trained."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned for this device.
In summary: The 510(k) submission for the CADD-Legacy™ PCA Model 6300 Ambulatory Infusion System relies on demonstrating substantial equivalence to predicate devices through functional and software validation testing. It does not involve clinical studies with human subjects, complex AI algorithms, or the kind of detailed performance metrics and ground truth establishment typically associated with such studies.
§ 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).