(198 days)
The BD Intelliport System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of medications to patients.
The BD Intelliport System allows the clinician to record anesthesia related medication events in the pre-op, intra-op, and PACU areas. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The BD Intelliport System is used for automated documentation of medication, concentration, dose, volume and time of each IV injection for when intravenous bolus injections of medication are given to a patient.
During treatment, the clinician connects an intelligent injection port, called the Intelliport device, to a patient's fluid-delivery line and performs standard drug-delivery activities. The health practitioner injects the drug; the Intelliport reads the 2-D barcode adhered to the syringe containing the drug such as Becton Dickinson syringe K110771. This barcode contains the drug name and concentration. As the drug is injected, the Intelliport measures the volume of the injected drug and the time the drug was administered. Once the drug has been administered, the Intelliport transmits all of the information to an electronic record maintained by the Computer.
The provided text describes the BD Intelliport System, its indications for use, and a comparison to a predicate device (DocuSys Anesthesia Information and Digital-Drug Management System) to establish substantial equivalence. It also mentions performance testing. However, it does not provide a detailed study report that proves the device meets specific acceptance criteria with the level of detail requested in the prompt.
Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will extract the information that is present and note where details are missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Explicitly Stated for Intelliport) | Reported Device Performance (BD Intelliport System) |
|---|---|---|
| Accuracy of Drug Delivery | Not explicitly stated as "acceptance criteria", but compared to predicate and manual activation. | ± 5% for bolus volumes > 1.0 mL to 55 mL |
| ± 20% for bolus volumes of 0.4 to 1.0 mL | ||
| Additional Functional Features (Implied Acceptance by presence) | ||
| Automated record keeping system | Present | Present |
| Patient safety features aligned with hospital records/protocols | Present | Present |
| Identification, measurement, alerting, documentation of medication administration | Present | Present |
| Record anesthesia related events (pre-op, intra-op, PACU) | Present | Present |
| Use by healthcare professionals in hospital/medical center | Present | Present |
| Facilitate documentation of manually administered bolus IV injections | Present | Present |
| Measures volume of injected drug | Present | Uses ultrasonic sensor |
| Allergy data notification | Present | Provides notice of patient allergies |
| Medication history record | Present | Provides a record of drug delivery related events |
| Drug formulary | Present | Provides drug formulary to select drugs |
| Narcotics tracking | Present | Provides database for tracking narcotics |
| External data interface | Present | Provides interface to hospital information system |
| Provides ability to edit drug formulary | Present | Provides ability to edit drug formulary |
Note: The document explicitly states the accuracy of the BD Intelliport System, but it doesn't frame it as a "pre-defined acceptance criterion" in the same way a study protocol would. Instead, it justifies this performance by comparison to the predicate's reported accuracy (with a clarification on calculation methods) and manual syringe activation.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "performance testing for the BD Intelliport System includes software unit testing and code reviews (verification), system validation testing, and testing to compliance standards for electrical and electromagnetic safety."
- Sample Size: Not specified for any specific test set.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). The tests likely occurred in a lab or simulated environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not specified in the provided text. The performance testing described appears to be technical in nature (software, electrical, volumetric accuracy) rather than requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
Not specified.
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
Not applicable. This device is an automated record-keeping system with measurement capabilities, not an AI-assisted diagnostic tool that would typically involve human "readers" or interpretations. The comparison is between the BD Intelliport System and a predicate system, both of which are automated.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The accuracy testing for drug delivery (± 5% for bolus volumes > 1.0 mL to 55 mL and ± 20% for bolus volumes of 0.4 to 1.0 mL) can be considered standalone performance, as it quantifies the device's measurement capability independent of a human's interpretation of that measurement. The device itself is designed to automate aspects of medication administration documentation, which is inherently a "standalone" function in terms of data capture and measurement.
7. The Type of Ground Truth Used
For the accuracy testing of drug delivery, the ground truth would likely be established by controlled laboratory measurements using highly accurate reference instruments or gravimetric methods to determine the actual volume delivered, against which the BD Intelliport System's reported volume is compared. This is implied by the statement "Testing of the BD Intelliport System syringe delivery is conducted in accordance with the bolus delivery requirements as defined in IEC 60601-2-24 (Particular requirements for the safety of infusion pumps and controllers)."
8. The Sample Size for the Training Set
Not applicable/Not specified. The BD Intelliport System is described as a system for identification, measurement, alerting, and documentation of medications. It is not presented as an AI/ML device that requires a "training set" in the context of learning algorithms. Its functionality is based on predefined logic, sensors (ultrasonic for volume), and barcode scanning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/ML model is indicated.
§ 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).