(93 days)
The NavigatorTM 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Navigator™ Delivery System (Navigator DS):
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission is for a minor modification to an already cleared device, the Navigator DS (K120830). The modification involves "modified resistance thresholds." The core approach to acceptance criteria is demonstrating that this minor change does not negatively impact safety or performance and that the device remains substantially equivalent to the predicate.
Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Summary) |
---|---|---|
Safety | Acceptable risk profile after modification. | Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing. |
Performance | Performance of the Navigator DS is not affected by the modification (modified resistance thresholds). Device provides the same level of performance as the predicate. | All data demonstrated that the safety and performance of the Navigator DS is not affected by the modification. |
Functional Equivalence | Indication for use, intended use, technological characteristics, principles of operation, and performance are not altered. No new questions of safety or effectiveness. | The Navigator DS, as modified, maintains its indication for use, intended use, technological characteristics, principles of operation, and performance, and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical study or a distinct, statistically powered performance test with a specific sample size. Instead, it refers to "Performance Data: Testing of the Navigator DS."
- Sample Size for Test Set: Not explicitly stated. The nature of the testing implies engineering/performance testing rather than a patient-based clinical study.
- Data Provenance: Not specified. Given it's a device modification, the testing would likely be internal to the manufacturer (Carticept Medical, Inc.). It is not stated whether this was retrospective or prospective data, but "testing" generally implies prospective data generation. There is no information about the country of origin for the data beyond the manufacturer's location in Alpharetta, GA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the context of this submission. The submission is for a minor device modification and relies on engineering performance testing and risk analysis, not on expert-adjudicated ground truth derived from clinical data (e.g., radiologist reviews of images).
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since there's no mention of a human-reviewed test set or clinical study requiring adjudication, this concept does not apply to the provided data.
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 type of study would involve human readers evaluating cases, which is not relevant for this device modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Navigator DS. The Navigator DS is an "Infusion Pump, External" and not an AI or algorithm-based diagnostic device. The performance data discussed refers to the physical and functional performance of the infusion pump itself (e.g., pressure thresholds, fluid delivery mechanics), not a standalone algorithm's accuracy.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance specifications and safety requirements for an infusion pump, and the demonstrated functional equivalence to its predicate device. This is based on:
- Engineering specifications and test methods: To verify the modified resistance thresholds meet the intended design and function.
- Risk analysis (Safety Case and Hazard Analysis): To ensure the device's operation remains safe within defined parameters.
- Comparison to predicate device performance: The predicate (K120830) itself would have had its performance and safety verified against established standards. This submission states "the system has been demonstrated to provide the same level of performance as the predicate device."
8. The Sample Size for the Training Set
This information is not applicable or not provided. The Navigator DS is a hardware device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided 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).