Search Results

The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

The blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance of the blood tubing sets. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the non-clinical bench testing.
• Data Provenance: The testing was "Non-Clinical Test/Performance Testing - Bench" conducted by NxStage Medical, Inc. This indicates it was internal, prospective bench testing. The country of origin for the data is not specified beyond being generated by the submitter (NxStage Medical, Inc. in Lawrence, MA, USA, with manufacturing sites in Mexico and Thailand, and sterilization sites in the USA).

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

Not applicable. This device is a blood tubing set, and the evaluation is based on non-clinical bench testing, not image analysis or diagnostic performance requiring human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable, as ground truth derived from human experts is not relevant for this type of device evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a medical device for blood transport, not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the functional performance and safety characteristics of the blood tubing sets as demonstrated through validated non-clinical bench testing, showing they meet design specifications and are comparable to the predicate device. It's based on engineering and performance specifications/standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning model requiring a training set.

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

Not applicable.

Ask a specific question about this device

The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.

The provided document (K080807) for the NxStage Medical, Inc. Blood Tubing Sets is a Special 510(k) Device Modification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with detailed performance metrics. As such, information regarding acceptance criteria, specific device performance numbers, and detailed study parameters (like sample sizes for test and training sets, expert qualifications, MRMC studies, or standalone performance) are not detailed in this type of submission.

The document indicates "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, it does not present the specific acceptance criteria or the reported performance data from these tests.

Based on the provided text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document states that "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, the specific acceptance criteria and the numerical results of these tests are not disclosed in this summary. The goal was to demonstrate substantial equivalence, implying that the modified device met performance expectations similar to the predicate.

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

Not explicitly provided. The document states that "Performance, verification and validation testing was conducted," but it does not specify the sample sizes used for these tests. The nature of this 510(k) being a "Special 510(k) Device Modification" suggests that the testing likely focused on bench testing to confirm the modified device's performance against the predicate, rather than large-scale clinical trials. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

Not applicable. This type of submission relies on bench testing and comparison to a predicate device for substantial equivalence, not typically on expert-established ground truth for a test set in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

Not applicable. As above, a formal adjudication method for establishing ground truth from experts is not described for this type of device and submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe a MRMC comparative effectiveness study. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a blood tubing set re-submission.

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

Not applicable. This submission pertains to a physical medical device (blood tubing sets), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

Not applicable in the traditional sense. For a physical device like blood tubing sets, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., flow rates, pressure resistance, sterility). The document implies that the device's performance was characterized against a "basis of comparison to the predicate device," meaning the predicate's established performance served as a de-facto ground for equivalence.

8. The Sample Size for the Training Set

Not applicable. This submission relates to a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.

Ask a specific question about this device