(39 days)
The LockBox is a plastic enclosure designed to hold a CADD®-Solis infusion pump and a medication reservoir or syringe.
The LockBox is an accessory to the CADD® -Solis ambulatory infusion pump. It is a plastic enclosure for the CADD®-Solis ambulatory infusion pump when it is attached to commercially available medication rescrvoir. The reservoir may be a flexible IV bag up to 500 mL in size or a syringe up to 60 mL. The Lockbox may be attached to a CADD-Prizm Polcmount Bracket.
The provided text describes a medical device called "LockBox for CADD®-Solis Ambulatory Infusion Pump," an accessory designed to enclose an infusion pump and its medication reservoir. This submission for 510(k) premarket notification does not include a study proving device performance against specific acceptance criteria in the typical sense of a clinical or analytical study with quantitative metrics.
Instead, the submission states:
"The LockBox was subjected to verification and validation testing as well as human factors usability testing. All tests performed demonstrate the LockBox meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications."
This indicates that the device met internal acceptance criteria defined in its own specifications through a process of verification, validation, and human factors testing. However, the details of these internal acceptance criteria and the results of these tests are not provided in the document.
Therefore, many of the requested details cannot be filled from the given text.
Here's a breakdown of what can be extracted and what cannot:
| Information Category | Details from Provided Text |
|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | |
| Acceptance Criteria | Not explicitly detailed. The text states: "meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications." These specifications are not provided. |
| Reported Device Performance | Not explicitly detailed with quantitative metrics. The text states: "All tests performed demonstrate the LockBox meets the acceptance criteria..." |
| 2. Sample size and data provenance for test set | Not specified. |
| 3. Number and qualifications of experts for ground truth | Not applicable, as no external expert-based ground truth was established from clinical studies. |
| 4. Adjudication method for test set | Not applicable. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. Clinical studies were "deemed not necessary." |
| 6. Standalone (algorithm only without human-in-the-loop) performance study | Not applicable. This is a physical accessory device, not an algorithm. |
| 7. Type of ground truth used | Ground truth for safety and performance was established through verification, validation, and human factors usability testing against internal specifications. No external "clinical" ground truth (e.g., pathology, outcomes data) was used or required. |
| 8. Sample size for the training set | Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set. |
| 9. How ground truth for the training set was established | Not applicable. |
§ 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).