(337 days)
The Bridge Sentry™ System is intended for the infusion (or administration) of fluids of medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal medications. It is not intended for use with blood, blood products or lipids.
The Bridge Sentry™ Bedside Unit. The Bridge Sentry Pharmacy Utility and the Bridge Sentry™ Administration Sets are collectively referred to as the Sentry System. The Sentry System includes an electrical, external, volumetric drug compounder and infusion pump. The administration sets contain a dedicated cassette that is compatible with the Bridge Seotry Bedside Unit. The Sentry is an electro-mechanical device incorporating a sterile disposable cassette with ancillary fluid delivery tubing and components. The Sentov stores drug delivery preset information for reconstitution, dilution and delivery. These presets are based on industry standards derived from drug labeling. The preset information is downloaded into each Sentry device. The Sentry requires identification of the patient, the user, the drug, and the dillo oching part of the setup operation. The identification may be accomplished via bar code scan or menu selection. The Sentry uses the identification information in conjunction with the pharmacy presets to minimize emars and capture drig event information. The Sentry System provides accurate and continuous flow of fluids to the patient. The device operates using a proprietary Acoustic Volume Sensor, a form of actuation pressure and a precision fluid impedance in the set to for a closed loop flow control system. The system detect occlusions in the patient line downstream and determines if sufficient fluid can be drawn from an upstream source to continue patient delivery. The system also detects air in line and when possible eliminates the air. The administration sets are sterile, and for single patient use. The Administration Sets are composed of a unique cassette and various combinations of other standard administration set components including tubing, filters, spikes, drip chambers, injection sites, clamps, caps or protectors, and luer connectors. The Sentry Cassette contains 10 valves to control fluid flow, a precision control orifice for flow control, a front cover, rear cover, mid-body, an inlet port, outlet port, a luer connection, and three drug vial spikes. The Sentry device contains a System Management Module, a Fluid Delivery Module, bar code scanner, infusion stand base and pole(s), vial attachment mechanism, battery, pharmacy utility, air in line sensor, and a data acquisition computer.
Here's a breakdown of the acceptance criteria and study information for the Bridge Sentry™ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reconstitution | Manual reconstitution methods according to drug manufacturers' guidelines are used as the control to show that the Sentry System is equivalent or better. | Equivalent |
| Mixing | Concentration consistency is within 10 percent throughout a 50 ml mix cycle and mass balance of drug is ≥ 95 percent. | Equivalent |
| Delivery | The Sentry will conform to the ANSI/AAMI ID26-1992 specification, which is equivalent or better than the delivery performance of the predicates: Horizon Nxt and the OmniFlow 4000. | Equivalent |
| Rinse/Flush | Reduction in concentration is ≥ 97 percent. | Equivalent |
| Solution Materials Contact | Acceptable results from standard tests (ISO10993 Standard Physicochemical Tests: Elastomers and Plastics). | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test sets for each performance test (Reconstitution, Mixing, Delivery, Rinse/Flush, Solution Materials Contact). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, it refers to "manual reconstitution methods according to the drug manufacturers' guidelines" as the control for reconstitution, and standards like ANSI/AAMI ID26-1992 for delivery.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The tests appear to rely on objective measurements against specified standards or comparative performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the device's technical performance against established standards and predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the studies described are standalone performance tests of the device itself (the "Sentry System"), without human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
The ground truth or reference standards used are:
- Reconstitution: Drug manufacturers' guidelines for manual reconstitution methods.
- Mixing: USP Drug Assay High Performance Liquid Chromatography (HPLC) to measure concentration accuracy.
- Delivery: ANSI/AAMI ID26-1992 guidelines for infusion devices, and comparison to predicate devices (Horizon Nxt and OmniFlow 4000).
- Rinse/Flush: USP Trace Drug Assay High Performance Liquid Chromatography (HPLC) to measure residual drug concentration.
- Solution Materials Contact: ISO10993 Standard Physicochemical Tests for Elastomers and Plastics.
8. The Sample Size for the Training Set
The document does not discuss a "training set" in the context of machine learning or AI. The Sentry System is an electro-mechanical device with preset information downloaded into it, which is based on "industry standards derived from drug labeling." It uses this information in conjunction with identification data to minimize errors. This does not align with a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, this question is not applicable. The device's "presets" are based on "industry standards derived from drug labeling."
§ 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).