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510(k) Data Aggregation
(268 days)
Reprocessed BRK Transseptal Needle
The Reprocessed BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
The reprocessed BRK Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical transseptal introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of a St. Jude Medical transseptal introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and/or guidewire insertion (0.014" maximum guidewire diameter for an 18 gauge needle). The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within the dilator. The reprocessed needle is available in various useable lengths and distal curve configurations.
This looks like a 510(k) summary for a reprocessed medical device, specifically a transseptal needle. For reprocessed devices, the acceptance criteria and supporting studies are focused on demonstrating that the reprocessed device is as safe and effective as the original, legally marketed predicate device. The information provided does not describe an AI/ML-based device or a comparative effectiveness study involving human readers with and without AI assistance. Therefore, many of the requested categories related to AI/ML performance, ground truth, and reader studies are not applicable to this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Reprocessed BRK Transseptal Needle) |
|---|---|
| Technological Characteristics Equivalence | The purpose, design, materials, function, and intended use are identical to the predicate device. No changes to claims, clinical applications, patient population, performance specifications, or method of operation. |
| Biocompatibility | Bench and laboratory testing conducted to demonstrate performance. (Details of specific criteria and results are not provided in this summary.) |
| Cleaning Validation | Bench and laboratory testing conducted to demonstrate performance. (Details of specific criteria and results are not provided in this summary.) |
| Sterilization Validation | Bench and laboratory testing conducted to demonstrate performance. (Details of specific criteria and results are not provided in this summary.) |
| Functional Testing | Bench and laboratory testing conducted to demonstrate performance, including: |
| Visual Inspection | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Dimensional Verification | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Simulated Use | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Leak Testing | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Mechanical Characteristics | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Corrosion Resistance | Performed. (Details of specific criteria and results are not provided in this summary.) |
| Packaging Validation | Bench and laboratory testing conducted to demonstrate performance. (Details of specific criteria and results are not provided in this summary.) |
| Reprocessing Cycle Limit | Reprocessed no more than one (1) time. Device serialized and tracked. |
| Reprocessor Exclusivity | Reprocessing performed only by Innovative Health, excluding devices previously reprocessed by other reprocessors. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "test set" in terms of number of reprocessed needles used for each test. The studies mentioned are bench and laboratory tests, not clinical trials or studies with human subjects that would typically have data provenance from specific countries or be retrospective/prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is not an AI/ML diagnostic tool requiring expert review for ground truth establishment. The "ground truth" for a reprocessed device is its ability to meet specified performance characteristics identical to the original device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed via objective bench and laboratory testing.
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. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed.
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 an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance specifications and characteristics of the original, legally marketed predicate device (St. Jude Medical BRK Transseptal Needle). The reprocessed device aims to demonstrate equivalence to these established standards through various bench and laboratory tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
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