(260 days)
The Lockbox is intended to hold a Perfusor® Space PCA Infusion Pump and provide reasonably secure access to the medication syringe contained within.
The Lockbox is a lockable, clear plastic enclosure designed to house a B. Braun Perfusor® Space PCA Syringe Infusion Pump and secure it onto a vertical IV pole. The Lockbox consists of a two part polycarbonate enclosure consisting of a front housing and a rear housing. The rear housing has two guide rails which position the pump in the Lockbox. The left guiderail contains a detent which serves to hold the pump in place. The rear housing contains three openings, one to allow for the release of the pump from the detent in the left guide rail, one that allows for connection of the power and PCA cables, and slotted openings allowing for alarms to be heard while the infusion pump is in the Lockbox. A front housing is connected to the rear case by means of a full length hinge designed into the polycarbonate material. When closed, the Lockbox is secured by a keyed lock preventing access to the syringe contents contained within the infusion pump. A cut-out in the front housing provides a clinician direct access to the user interface keys and display screen. An aluminum pole clamp, designed to operate with a vertical IV pole is attached to the Lockbox. Once attached to the IV pole, the pole clamp can be locked to prevent the Lockbox from being removed from the pole.
The provided text describes a 510(k) summary for a medical device called the "Lockbox for the Perfusor® Space PCA Infusion Pump." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to AI or comparative effectiveness with human readers) are not applicable as this submission is for a Class II medical device, an "Infusion Pump Accessory," which emphasizes functional and safety testing to ensure it performs as intended and is substantially equivalent to existing devices.
However, I can extract the general acceptance criteria inferred from the performance testing summary and provide what information is available.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document states that "In all testing, the pre-determined acceptance criteria were met." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance is reported qualitatively as meeting these unspecified criteria.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Pass visual inspection. | Pre-determined acceptance criteria were met. |
| Withstand specified drop test parameters without compromising functionality or integrity. | Pre-determined acceptance criteria were met. |
| Permit visual and audible indicators of the pump to be perceived. | Pre-determined acceptance criteria were met. |
| Demonstrate resistance to drops and tampering, maintaining security. | Pre-determined acceptance criteria were met. |
| Demonstrate functional and reliable operation of the pole clamp, including lock, latch, and knob mechanisms. | Pre-determined acceptance criteria were met. |
| Withstand a specified number of door opening/closing cycles without failure. | Pre-determined acceptance criteria were met. |
| Maintain integrity and functionality after exposure to specified chemicals (cleaning and disinfection agents). | Pre-determined acceptance criteria were met. |
| Maintain integrity and functionality after simulated distribution/shipping (according to ASTM D4169-16). | Pre-determined acceptance criteria were met. |
| Mitigate identified risks to an acceptable level as per ISO 14971:2007. | Pre-determined acceptance criteria were met. |
| Maintain reasonably secure access to the medication syringe contained within. (Overall intended use) | Results demonstrate the proposed device meets its intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the performance tests. The data provenance is internal B. Braun Medical Inc. testing, as these are non-clinical (engineering/functional) tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" concept is typically relevant for diagnostic or AI-driven devices where decisions are compared against expert consensus or pathological findings. For this device (an infusion pump accessory/lockbox), validation involves engineering and functional testing against design specifications and relevant standards, not expert interpretations of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. Adjudication methods are used to establish a consensus ground truth when multiple experts provide differing interpretations, which is not the case for functional and physical testing of a lockbox.
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
This question is not applicable. An MRMC study is relevant for diagnostic imaging devices, especially those incorporating AI assistance. The device in question is a physical lockbox for an infusion pump, which does not involve "human readers" or "AI assistance" in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm or an AI-driven system. It is a mechanical accessory.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is implied by the design specifications, engineering standards (e.g., ASTM D4169-16, ISO 14971:2007), and the intended functionality (e.g., the lock working, the material not degrading, the pump fitting). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense usually applied to diagnostic devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
§ 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).