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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.

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.

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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.

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.

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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.

This is a 510(k) summary for a minor modification to an existing device, the Navigator™ Delivery System (Navigator DS). The modification involves an "alarm modification" and does not alter the device design, intended use, or indication for use. Therefore, the information provided is limited, and many of the requested criteria for studies would not be applicable or available in this type of submission.

Here's an attempt to answer your questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance studies (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this modification was that the safety and performance of the device are not affected by the alarm modification.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "Testing of the Navigator DS was carried out, including performance testing." It does not provide details on the number of units or test scenarios.
• Data Provenance: Not specified. Given the nature of a medical device modification, it is almost certainly prospective testing conducted by the manufacturer, rather than retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided. Given that this is a performance test for a mechanical/software alarm modification, "ground truth" would likely be established by engineering specifications and direct observation/measurement of system behavior by qualified engineers/testers, rather than clinical experts.

4. Adjudication Method for the Test Set

• This information is not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for diagnostic accuracy, which is not the focus of this submission. The "adjudication" for performance testing of an alarm would be based on whether the alarm triggered correctly under expected conditions and did not trigger incorrectly.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, assessing how AI impacts human interpretation. The Navigator DS is an infusion pump, and this submission concerns a minor alarm modification, not AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This question is not applicable to this device. The Navigator DS is a physical medical device, an infusion pump, not an AI algorithm. "Standalone performance" would refer to the pump's ability to deliver fluids as intended, which was assured to be unaffected by the alarm modification.

7. The Type of Ground Truth Used

• The term "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. For performance testing of an alarm modification on an infusion pump, the "ground truth" would be the engineering specifications and design requirements for alarm behavior in various conditions (e.g., occlusion, low fluid), and the observed behavior of the device during testing.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set. The device's functionality is based on its physical and software design, not learned from data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As stated above, this device does not use a "training set" in the context of AI/machine learning.

Ask a specific question about this device

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

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.

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