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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

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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The BRKTM Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

The St. Jude Medical BRKTM 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 the 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.
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 BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This device is a modification of the predicate device (BRK™ Transseptal Needle (K072278)) due to an adhesive change. The study conducted for this device was a non-clinical study involving bench testing and biocompatibility testing to verify the device modification. The study aimed to demonstrate substantial equivalence to the predicate device and ensure the modification did not adversely affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical bench testing and biocompatibility testing. It does not specify a sample size for a "test set" in the context of clinical data or patient studies. The testing was performed on the device itself.

Data provenance: The testing was described as "bench testing and biocompatibility testing," implying laboratory-based testing rather than human clinical data. No country of origin for data or retrospective/prospective nature is applicable in this context.

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

This information is not applicable as the study was non-clinical (bench and biocompatibility testing). Ground truth, in the context of expert review, typically refers to clinical diagnosis or assessment.

4. Adjudication Method for the Test Set

This information is not applicable as there was no test set requiring expert adjudication for clinical outcomes. The evaluation involved direct product testing against specifications and standards.

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 performed. This device is a medical needle, and the study was focused on the impact of a material change (adhesive) through non-clinical testing, not on human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical instrument, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study was established by product specifications, intended use, and international standards (ISO 10993-1 for biocompatibility). The performance was measured against these established engineering and safety criteria, not against clinical outcomes or pathology from patients.

8. The Sample Size for the Training Set

This information is not applicable as there was no "training set" in the context of machine learning or AI. The study involved non-clinical testing of a physical medical device.

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

This information is not applicable as there was no "training set" or AI component involved in this device's evaluation.

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The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

The St. Jude Medical 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 the 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 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.

The provided 510(k) summary for the BRK™ Transseptal Needle does not contain detailed information regarding acceptance criteria or the specifics of a study proving the device meets those criteria in the way typically expected for complex diagnostic or AI-driven devices.

The submission focuses on establishing substantial equivalence based on performance requirements for a medical instrument rather than a "device" in the context of diagnostic algorithms or imaging. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth for training) are not applicable or not provided in this type of submission.

Here's an attempt to address the request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary broadly states that "Bench testing of the BRK™ Transseptal Needle was performed to support substantial equivalence. Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements."

Specific acceptance criteria and quantitative performance metrics are not detailed in this summary. For a device like a transseptal needle, these typically involve:

• Mechanical Strength: Withstand forces during insertion and manipulation.
• Dimensional Accuracy: Meet specified outer diameter, length, and curve.
• Material Biocompatibility: Non-toxic and compatible with human tissue.
• Sterility: Absence of viable microorganisms.
• Functionality: Smooth stylet/guidewire passage, effective puncture capability, secure stopcock.
• Tip Integrity: No damage or dulling after puncture.

Since the document provided is a summary, the detailed test reports outlining these specific criteria, methods, and acceptance ranges would be in the full submission, but are not included here.

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

The summary mentions "Bench testing of the BRK™ Transseptal Needle." This implies a series of laboratory tests on physical samples of the device.

• Sample Size for Test Set: Not specified. Testing would likely involve multiple units manufactured to ensure consistency.
• Data Provenance: The testing was "bench testing," meaning in a laboratory environment, likely at St. Jude Medical's facilities (United States, given the submitter address). It is a prospective test in the sense that the new device's performance was evaluated against pre-defined criteria. It is not clinical data from patients or retrospective patient data.

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

This concept is not relevant for a physical medical instrument like a transseptal needle. "Ground truth" (in the context of expert review) is typically for diagnostic assessments (e.g., interpreting images). For a physical device, performance is measured against engineering specifications and functional benchmarks, not expert-established ground truths.

4. Adjudication Method for the Test Set

Not applicable. This is typically used in clinical trials or diagnostic studies involving human interpretation. Bench testing results are usually objective measurements against engineering specifications.

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

Not applicable. MRMC studies are for evaluating diagnostic accuracy, especially when comparing human readers with and without AI assistance on a set of cases. This device is a physical instrument, not a diagnostic algorithm.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Not applicable. This refers to the performance of an AI algorithm independently. The BRK™ Transseptal Needle is a manual surgical instrument.

7. The Type of Ground Truth Used

The "ground truth" for a physical medical device's performance is its adherence to engineering specifications, design requirements, and recognized industry standards for safety and efficacy. This is established through objective measurements and validated test methods. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." Its design is based on engineering principles and existing predicate devices.

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

Not applicable, as there is no "training set" for this type of device.

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