Search Results

Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.

This document, K060288, describes the Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The key performance claim for these devices is the silver coating's ability to reduce bacterial surface colonization for up to two months.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the reduction of bacterial surface colonization, the document refers to a published clinical study by Bambauer et al. (2001). The sample size and specific details of the test set for this study are not provided in the submission itself, but would be found in the referenced publication. The data provenance is implied to be clinical, but the country of origin is not specified in this document. It is a retrospective reference to existing literature.

For frictional resistance, silver coated catheters and uncoated catheters were compared. The document doesn't specify the exact number of catheters in the test set, but states "Tests were conducted at several different normal load conditions" and "All measurements were conducted in the dry state." This was a prospective in-vitro bench test.

For silver elution rates, "segments were cut from the shafts of silver coated catheters" and "Tests were performed in triplicate for periods ranging from 1 day to 8 weeks." This was a prospective in-vitro bench test with a sample size of at least three per time point.

For equivalent flows and mechanical properties, these were compared to predicate devices. The document does not specify the sample size but implies an in-vitro equivalence study.

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

For the reduction of bacterial surface colonization, the information is based on a referenced clinical study. The number and qualifications of experts involved in establishing the ground truth (e.g., diagnosing infections, culturing bacteria) for that study are not provided in this 510(k) submission.

For the in-vitro tests (frictional resistance, silver elution rates, flows, mechanical properties), "experts" in the traditional sense of medical diagnoses were not involved. The ground truth was established through laboratory measurement protocols and analyses by qualified technical personnel within Spire Biomedical or a contract lab.

4. Adjudication Method for the Test Set

Given the nature of the evidence provided (reference to a clinical study for bacterial colonization, and in-vitro bench testing for other characteristics), there is no mention of an adjudication method (like 2+1 or 3+1 consensus) in this submission. This type of adjudication is typically relevant for studies involving human interpretation of medical images or symptoms, which is not the primary focus of the performance data presented here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this submission. The device is a physical medical device (catheter), and its performance data focuses on material properties, bacterial colonization rates, and mechanical equivalence, rather than human interpretation or diagnostic aid. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable to this device. The RetrO Silver™ and XpressO Silver™ catheters are physical medical devices, not AI algorithms. Their performance is described in a standalone manner, entirely independent of human-in-the-loop performance in the context of interpretation or decision-making.

7. Type of Ground Truth Used

• Reduction of Bacterial Surface Colonization: The ground truth for this claim is based on clinical testing from referenced literature. This would typically involve microbiological culture results or clinical infection rates.
• Frictional Resistance: The ground truth was established through direct physical measurement using a test rig platform.
• Silver Elution Rates: The ground truth was established through chemical analysis (measuring silver concentration in solution) in laboratory immersion studies.
• Equivalent Flows and Mechanical Properties: The ground truth was established through physical measurements and engineering tests to compare the coated catheters to their non-coated predicate devices.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable. The performance data is derived from direct testing of the physical device or references to clinical studies, not from a model trained on data.

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

As there is no training set for this physical medical device, this question is not applicable.

Ask a specific question about this device

The 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm can be used for femoral insertion.

55cm Pourchez RetrO™ Silicone Twin Lumen Chronic Device Hemodialysis Catheter with Separated Tips. The 55cm Pourchez RetrO catheter uses the exact same materials of construction.

The provided text is a 510(k) summary for a medical device, the "55cm Pourchez RetrO Kit" or "Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a study involving human-in-the-loop or standalone AI performance.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through engineering and bench testing, rather than extensive clinical trials with human readers or AI.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

   This document does not specify quantitative acceptance criteria. Instead, it asserts that "A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." The "reported device performance" is essentially that these tests did demonstrate substantial equivalence or conformance.

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices (K022000) for mechanical and physical properties.	Demonstrated via mechanical and physical tests (tensile and flow).
   Conformance to established ISO standards for hemodialysis catheters.	Demonstrated via mechanical and physical tests (tensile and flow).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not applicable. The "tests" mentioned are mechanical and physical bench tests, not clinical studies with patients or data sets in the typical sense for AI/human performance. No sample size for a test set (e.g., patient data) is provided, nor is data provenance.

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)

   Not applicable. Ground truth for device performance in this context would be physical measurements from the aforementioned mechanical and physical tests, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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

   Not applicable. No MRMC study was performed, as this device (a catheter) is 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 physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   The "ground truth" for the performance claims appears to be derived from objective measurements from mechanical and physical bench tests, and conformance to ISO standards for hemodialysis catheters.

8. The sample size for the training set

   Not applicable. This is a physical medical device; there's no "training set" in the context of an AI algorithm.

9. How the ground truth for the training set was established

   Not applicable, as there is no training set mentioned in the context of AI. For the manufacturing and quality control of the physical device, ground truth would be established through engineering specifications and industry standards.

Ask a specific question about this device