(59 days)
The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.
The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record. Qualified ultrasound imaging units include the SonoSite M-Turbo and SonoSite M-MSK, (configuration part numbers L05323 and L05600, respectively).
This document describes the 510(k) submission for the Navigator™ Delivery System (Navigator DS) with added image integration capability. The submission asserts that this modification does not introduce new safety or effectiveness concerns, and thus, a full clinical evaluation was not required. The study focuses on demonstrating that the added image integration feature does not negatively impact the device's original safety and performance.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Validation | All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. |
| Electrical Testing of Connected Devices | All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. |
| Simulated Use Testing | All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. |
| Acceptable Risk Profile (based on design-based risk mitigation) | A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set for evaluating an algorithm's performance on patient data. Instead, it appears the "test set" refers to the device itself and its interaction with the added feature. Therefore, there is no mention of sample size for patient data or data provenance (e.g., country of origin, retrospective/prospective). The testing described focuses on the device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an engineering and functional performance evaluation of a device modification, not an assessment of an AI's diagnostic or predictive capabilities requiring expert-established ground truth on medical data.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a human-in-the-loop diagnostic task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved." This indicates the focus was not on comparing human reader performance with or without AI assistance but rather on the safety and functionality of the device with a new feature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary focus of this submission is a device modification. The "image integration capability" described is about displaying treatment information from the Navigator DS on an ultrasound screen and printing ultrasound images on patient treatment records. It does not appear to be an AI algorithm with standalone diagnostic or predictive performance. Therefore, a standalone algorithm performance study as typically understood for AI-driven devices was not conducted. The "software validation" mentioned would cover the functionality of this integration.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context refers to the expected functional performance and safety of the device. This was established through:
- Software Validation: Ensuring the software for image integration works as intended.
- Electrical Testing: Verifying safe electrical operation of connected devices.
- Simulated Use Testing: Confirming the device performs safely and effectively in simulated scenarios.
- Safety Case and Hazard Analysis: Identifying potential risks and ensuring mitigation measures are effective.
These are engineering and safety benchmarks, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The described image integration is a functional modification to a device and does not involve an AI algorithm that would typically require a "training set" of medical data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 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).