Search Results

The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

BIOTRONIK's Selectra lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit.

The Selectra Accessory Kit includes the following components in a single sterile package:

• 1 Selectra Slitter Tool
• 1 quide wire
• 2 7F Transvalvular Insertion Tools (TVI)
• 1 syringe
• 1 torque tool
• 2 check valves
• 2 stopcocks
• 1 Tuohy Borst Adapter (TBA)

The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a medical device clearance (K192996) for Biotronik's Selectra Catheters, Accessory Kit, and Slitter Tool. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel effectiveness. Therefore, the information provided is not a study proving de novo performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product.

The document states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." This indicates that extensive clinical studies, including those typically associated with AI/SaMD performance validation (like MRMC studies, standalone AI performance, expert ground truth establishment for AI training/testing), were not performed or required for this particular device clearance.

Instead, the performance data provided supports the substantial equivalence to a previously cleared predicate device (BIOTRONIK's Selectra 5F and 7F Catheters, Selectra Accessory Kit and Selectra Slitter Tool - K183265). The tests conducted were primarily engineering and quality control tests to confirm that minor modifications to the device and manufacturing processes did not negatively impact its performance or safety compared to the predicate.

Therefore, many of the requested criteria for AI/SaMD performance studies cannot be extracted from this document because they are not applicable to the type of device and clearance pathway described.

However, I can extract the available information as it pertains to the "acceptance criteria" and "study" for this specific device clearance, acknowledging that it's about substantial equivalence and not AI performance.

Acceptance Criteria and Device Performance (as reported for K192996 clearance)

Since this is a 510(k) for minor modifications to an existing device, the "acceptance criteria" and "performance" are implicitly defined by demonstrating that the modified device performs equivalently to the predicate device and meets established safety and functionality standards for a percutaneous catheter system.

1. Table of Acceptance Criteria & Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of devices tested for each category. These types of tests are typically done on a representative sample size determined by engineering and quality assurance protocols (e.g., ISO standards, internal validation plans) to ensure statistical confidence, but the specific numbers are not public in a 510(k) summary.
• Data Provenance: The tests were conducted by Biotronik, presumably at their facilities or certified labs. The location of the company is Lake Oswego, Oregon, USA. The data would be prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the modified device.

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

• Not Applicable / Not Mentioned. This type of "expert ground truth" for a test set is typically relevant for interpretative devices (e.g., AI for diagnostics). For a percutaneous catheter system, "ground truth" relates to quantifiable physical and material properties and functional performance, verified through engineering and bench testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set:

• Not Applicable / None. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, particularly for AI validation. This device's testing involves objective measurements and standards, not subjective interpretation requiring adjudication.

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

• No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." MRMC studies are clinical studies involving human readers, and none were performed.

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

• Not Applicable / No. This device is a physical medical instrument (catheter system), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance validation is based on engineering specifications, material science standards, established functional parameters, and safety benchmarks (e.g., biocompatibility standards, sterility assurance levels). It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be. The performance of the modified device was compared against the known, established performance of the predicate device.

8. Sample Size for the Training Set:

• Not Applicable. This is a hardware device, not an AI model that requires a "training set."

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

• Not Applicable. As explained above, there is no AI training set for this device.

Ask a specific question about this device

The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.

The provided document describes modifications to medical devices—the Selectra Accessory Kit and Selectra Slitter Tool—and their clearance through a Special 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove efficacy against specific acceptance criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance through clinical studies.
• Sample sizes used for test sets, data provenance, or details about training sets.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or associated effect sizes.
• Standalone (algorithm-only) performance.
• The type of ground truth used in a new clinical study.
• How ground truth for a training set was established.

Instead, the submission demonstrates substantial equivalence primarily through non-clinical testing and a comparison of technological characteristics between the modified devices and their predicate devices.

Here's the information that is available:

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

The document provides a table outlining the technical specifications of the predicate and proposed devices, demonstrating that the proposed device maintains similar functionality, or improvements that do not raise new questions of safety or effectiveness. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Study that proves the device meets the acceptance criteria:

The "study" conducted for this 510(k) submission is a series of non-clinical tests designed to validate the safety and performance of the modified devices and to justify the shelf-life extension and new packaging. These tests implicitly serve as "acceptance criteria" for demonstrating substantial equivalence. The document states:

"Summary of Non-Clinical Testing: The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:

• Comparison of the attributes and specifications of the subject and predicate devices -
• Subject device risk analysis
• Subject device validation testing which includes the following testing:"

Non-Clinical Validation Testing Performed:

For the New TVI Tool:

• Cytotoxicity
• Sensitization Local Lymph Node Assay (LLNA)
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity in the Mouse with 4 Extracts
• Material Mediated Pyrogenicity Rabbit Pyrogen Test
• Hemocompatibility Evaluation
• Compendium of Biological Evaluation
• EtO Residual Gas Analysis
• Environmental Preconditioning
• Release of Particulate Matter
• Tests After Environmental Preconditioning and Shelf Life (25 months)
• Labeling on Sales / Sterile Package Accompanying Documentation

For the Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:

• Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of Unit
• Inspection of Seldinger Guide Wire
• Inspection of Syringe
• Inspection of Check Valve, Stop-Cock, and Sealing Caps
• Inspection of TVI and slitter tool
• Proof of Sterilization after Accelerated Aging of 25 Months

For the New Sterile Packaging for the Selectra Slitter Tool:

• Labelling on Sales / Sterile Package Accompanying Documentation
• Environmental Preconditioning
• Determination of Shelf Life (25 months) and Integrity of Sterile Packaging
• EtO Sterilization Cycle Product Adoption
• Tests after Environmental Preconditioning and Accelerated Aging (25 Months)

2. Sample sized used for the test set and the data provenance: Not applicable. These are non-clinical (laboratory/mechanical/biological) tests, not human studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission for device modifications.

4. Adjudication method for the test set: Not applicable. See above.

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. This device is a catheter accessory, not an AI or imaging device involving human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See above.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests is based on established scientific and engineering standards, and documented test methods to verify material properties, sterility, mechanical integrity, and biological compatibility.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is relevant here.

9. How the ground truth for the training set was established: Not applicable. See above.

Ask a specific question about this device