(72 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 disposable cassette, a reusable cassette housing, disposable vial clamps, per-patient disposable handpiece and tubing, 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.
This 510(k) submission (K124053) for the Navigator DS Next Generation Disposables is a Special 510(k) which does not include a traditional study with acceptance criteria and device performance as typically expected for new device submissions or AI/ML-driven devices. Instead, it focuses on demonstrating that a modification to an already cleared device (Navigator DS, K122215) maintains the same safety and performance profile.
Therefore, many of the typical elements of a study with acceptance criteria and a table of performance are not explicitly present in the provided document. The submission argues for substantial equivalence based on the preservation of technological characteristics, intended use, and performance characteristics of the predicate device, rather than new quantitative performance metrics.
Here's an analysis based on the provided text, addressing the requested information where applicable, and noting where information is not available due to the nature of a Special 510(k) for a device modification:
1. A table of acceptance criteria and the reported device performance
Given the nature of this Special 510(k) for a modification (next-generation disposables), specific quantitative performance acceptance criteria and reported device performance in a table format, as one might find for an entirely new device or AI algorithm, are not explicitly provided or required. The acceptance criteria are implicitly that the modified device's performance, safety profile, and intended use are not altered compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological aspects are preserved. | "All technological aspects of the Navigator DS device are preserved." |
| Intended use is not altered. | "The Navigator DS intended use and performance characteristics are not altered by this modification." "The indication for use, intended use...have not been altered." |
| Performance characteristics are not altered. | "The Navigator DS intended use and performance characteristics are not altered by this modification." "Performance Data: Testing of the Navigator DS was carried out, including performance testing and human factors evaluations. All data demonstrated that the safety and performance of the Navigator DS is not affected by the modification." "The system has been demonstrated to provide the same level of performance as the predicate device." |
| Safety profile is acceptable and not negatively impacted. | "A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance and human factors testing." "The next-generation disposables do not raise any new questions of safety or effectiveness and the system has been demonstrated to provide the same level of performance as the predicate device." "The Navigator DS next-generation disposables... do not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale." |
| No new questions of safety or effectiveness are raised. | "The next-generation disposables do not raise any new questions of safety or effectiveness..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not specify a "test set" in the context of clinical data or algorithm validation with a specific sample size. The performance testing and human factors evaluations mentioned are engineering and usability tests, not a clinical study on a patient cohort. Therefore, information on patient sample size, data provenance, or retrospective/prospective nature is not applicable and not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. Since there is no clinical "test set" or diagnostic algorithm requiring ground truth establishment by experts, this detail is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the same reasons as #3.
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
An MRMC comparative effectiveness study is typically performed for AI or imaging devices where human interpretation is involved. This device (an infusion pump with disposables) is a mechanical system, not an AI/imaging device requiring human interpretation, nor does it incorporate AI assistance for human readers. Therefore, no MRMC study was performed, and this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an AI algorithm directly. The Navigator DS is an infusion pump, a hardware device, not an AI algorithm. Therefore, no standalone algorithm performance study was done, and this information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. As noted, there's no clinical "test set" requiring ground truth for a diagnostic purpose. The "ground truth" here is effectively the accepted performance and safety profile of the predicate device, against which the modified device's engineering and human factors performance were compared.
8. The sample size for the training set
This information is not applicable and not provided. The Navigator DS is a mechanical infusion pump, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as #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).