(86 days)
To allow communication between a personal computer and the CADD-Prizm™ Ambulatory Infusion Pump, Model 6100, or pump-to-pump, either remotely or locally via a modem over telephone lines.
The PC-Communications System ("PC System") and Pump Communications System ("Pump System") are two products that will be used with CADD-Prizm™ Model 6100 Ambulatory Infusion Pumps. The PC System and the Pump System products are substantially equivalent to Sabratek's MediVIEW™ Software Package used with their Homerun™ Model 6060 Ambulatory Infusion Pump and the current Modem used with SIMS Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion Pump. The products allow communications between a personal computer and an ambulatory infusion pump, either locally or remotely via modem over telephone lines and allow the clinician and patient to converse during PC to pump, or pump-to-pump communications, respectively.
This document describes a 510(k) submission for the PC-Communication and Pump Communications System used with the CADD-Prizm™ Model 6100 Ambulatory Infusion System. The submission aims to demonstrate substantial equivalence to existing devices rather than prove clinical efficacy against specific acceptance criteria. Therefore, many of the requested details about acceptance criteria for device performance, ground truth, and clinical study specifics are not applicable or detailed in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for device performance in terms of accuracy, sensitivity, specificity, or other typical performance metrics for AI/CAD devices. Instead, it relies on feature-by-feature comparison for substantial equivalence.
| Feature/Function | Acceptance Criteria (Implied) | Reported Device Performance (Deltec PC System with CADD Prizm™ Pump) |
|---|---|---|
| IBM compatible PC software program. | Must have this capability. | Yes |
| Allows direct PC to pump cable | ||
| connection. | Must have this capability. | Yes |
| Allows connection to pump via modem | ||
| and telephone lines. | Must have this capability. | Yes |
| Program uses modem with | ||
| simultaneous voice and data feature. | Must have this capability. | Yes |
| User reviews and controls pump via | ||
| image of pump on the PC screen. | Must have this capability. | Yes |
| User can monitor pump via image of | ||
| pump on the PC screen. | Must have this capability. | Yes |
| User can retrieve reports from pump. | Must have this capability. | Yes |
| User can view, print and save reports to | ||
| disk. | Must have this capability. | Yes |
| User can retrieve, view, print reports | ||
| previously saved to disk. | Must have this capability. | Yes |
| User can capture patient data to | ||
| formulate outcomes management | ||
| database. | Must have this capability (for the new device). | Yes |
| Program documents "before and after" | ||
| snapshot of the pump's program in a | ||
| communications log. | Must have this capability (for the new device). | Yes |
| Program can retrieve information on | ||
| what accessories are attached to pump, | ||
| e.g. AC adapter, air detector, cassette, | ||
| etc. | Must have this capability (for the new device). | Yes |
| Kit contains separate analog phone | Not applicable to the new device; predicate's feature. | (Does not apply to Deltec PC System) |
| Kit contains analog simultaneous voice | ||
| data modem that plugs directly into | ||
| clinician's and patient's own phone | Must have this capability (for the new device). | (Does not apply to Deltec PC System, but to new ASVD Modem) |
| Patient and clinician can voice | ||
| communicate during communication | ||
| setting | Must have this capability (for the new device's modem component). | (Does not apply to Deltec PC System, but to new ASVD Modem) |
Note: The "acceptance criteria" here are implied by the substantial equivalence comparison table. The new device is considered to "meet" these criteria if it possesses the enumerated features, especially those present in the predicate devices. For features specific to the new device (e.g., "capture patient data to formulate outcomes management database"), the implication is that these are additional positive features that do not negatively impact safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Clinical studies were not deemed necessary regarding the use of the PC -Communications System and Pump Communications System with the CADD-Prizm™ Ambulatory Infusion System, Model 6100."
Therefore, there is no test set in the context of clinical performance evaluation, and thus no sample size or data provenance information available for such a test set. The evaluation was based on functional testing (see point A in "SUMMARY OF STUDIES V.")
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As clinical studies were not performed, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical features and functional testing, not on comparative effectiveness for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is a communication system, not an AI or algorithm-based diagnostic tool. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of AI/CAD devices. The "standalone" evaluation would be the functional testing of the communication system itself, ensuring it performs its intended communication tasks. The provided document mentions "Functional Testing A. Test plans associated with the validation of software controlled interface functions," which serves this purpose.
7. The Type of Ground Truth Used:
For the functional testing, the "ground truth" would be the expected behavior and output of the communication system, verified against its design specifications and industry standards for data transmission and software functionality. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather engineering and software validation.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 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).