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The lead delivery system, consisting of Selectra catheters in conjunction with the Selectra Accessory Kit, is used to facilitate implantation of leads in the heart chambers or in the coronary veins via the coronary sinus.

Selectra 3D catheters are also indicated to facilitate Solia S lead implantation in the left bundle branch area to achieve left bundle area pacing (LBBAP).

BIOTRONIK's Selectra 3D 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 3D lead introducer system consists of several individually available quiding catheters with various 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 facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided FDA 510(k) summary describes the acceptance criteria and study for the Selectra 3D Lead Delivery System. However, it's important to note that this document is for a medical device (lead delivery system), not an AI/software device. Therefore, many of the typical acceptance criteria and study design elements requested for AI/software (e.g., test set sample size, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in this context.

The study presented focuses on the physical device's safety and effectiveness for lead implantation, particularly for left bundle branch area pacing (LBBAP).

Here's a breakdown based on the provided text, highlighting what is applicable and what is not for an AI/software device:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: 157 patients were enrolled. This serves as the study population for evaluating the device's safety and effectiveness.
• Data Provenance:
  • Country of Origin: "ten investigational sites across Europe, Asia, and Australia."
  • Retrospective or Prospective: Prospective study.

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)

• Number of Experts: An "Endpoint Adjudication Committee" determined the relatedness of SADEs to the Selectra 3D catheter. The exact number of experts and their qualifications beyond being part of this committee are not specified in the provided text.
• Ground Truth for Effectiveness: "Successful His bundle or left bundle branch area pacing was determined by the implanting physician." The qualifications of these physicians are not detailed, but they are implied to be specialists performing these cardiac procedures.

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

• Adjudication Method: For the primary safety endpoint, an "Endpoint Adjudication Committee" assessed the relatedness of SADEs. The specific method (e.g., consensus, majority vote) is not detailed in this summary. For effectiveness, the implanting physician made the determination, which does not involve a multi-expert adjudication among different readers of an image, for example.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This study is for a physical medical device, not an AI/software product, so the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Standalone Performance: No, a standalone performance study (in the context of an algorithm) was not done. This device is a tool used by a human implanter, not an algorithm.

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

• Ground Truth for Safety: Expert consensus/adjudication by an "Endpoint Adjudication Committee" for SADE relatedness.
• Ground Truth for Effectiveness: Clinical determination by the "implanting investigator" regarding the success and stability of lead implantation for conduction system pacing. This is an outcome evaluated by the treating physician in real-time or soon after implantation.

8. The sample size for the training set

• Training Set Sample Size: This study describes the evaluation of a physical medical device. There is no concept of a training set in the context of this type of clinical study for a traditional device. The study uses a prospective cohort to gather safety and effectiveness data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device study.

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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.

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

BIOTRONIK's Selectra lead introducer system is a combination of quiding 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, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. 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.

This document is a 510(k) summary for the BIOTRONIK Selectra Lead Introducer System. The submission, K183265, seeks to demonstrate substantial equivalence to previously cleared predicate devices.

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

The document explicitly states: "Performance data was not required to support this submission because no design change has been made." Therefore, there are no specific acceptance criteria for performance or reported device performance in this 510(k) summary. The submission is based on the premise that the device's technological characteristics are identical to the predicate devices.

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. No performance data was required or provided in this submission because no design change was made.

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. No performance data was required or provided.

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

Not applicable. No performance data was required or provided.

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 medical instrument (lead introducer system), not an AI-assisted diagnostic or interpretative system.

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

Not applicable. This device is a medical instrument, not an algorithm.

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

Not applicable. No performance data was required or provided.

8. The sample size for the training set

Not applicable. No new performance data was generated or analyzed as part of this submission. The device is a physical medical instrument, not a learned algorithm.

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

Not applicable. No new performance data was generated or analyzed as part of this submission.

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The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

BIOTRONIK's Selectra CS lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the coronary venous system for suitable leads and catheters. The Selectra CS 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 guide wire, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescope system, and allow probing of the ostium of the coronary sinus, access to the coronary sinus, introduction of contrast media for angiography, and positioning of left ventricular leads, also called coronary sinus (CS) leads. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a 510(k) premarket notification for the BIOTRONIK Selectra CS Lead Introducer System. This document focuses on the substantial equivalence of the device to previously cleared predicate devices and does not contain information about the performance of an AI/ML device. Therefore, it is impossible to describe the acceptance criteria and study as requested in the prompt for an AI/ML device.

The information present in the document can be summarized as follows:

Device Description:
The Selectra CS lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the coronary venous system for suitable leads and catheters. It consists of individually available guiding catheters with various curve shapes and the Selectra accessory kit. The catheters are available as inner (5F) and outer (7F) catheters that form a telescope system.

Indications for Use:
The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Comparison with Predicate Device:
The subject device has minor modifications compared to the predicate device, including:

• Additional models with shorter overall working length and same diameter.
• A modified blister package.
• A longer shelf life.
• Manufacturing changes without affecting performance criteria.
• Stopcock produced from a different polycarbonate material.
• Updated labeling for inventory management, UDI compliance, and international standards.

Performance Data and Acceptance Criteria:
The performance testing aimed to demonstrate that the modified catheters meet the same performance criteria as the predicate devices. The following tests were conducted using the same test methods and acceptance criteria as for the predicate devices:

Missing Information (as this is not an AI/ML device submission):

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth
• Qualifications of those experts
• Adjudication method
• MRMC comparative effectiveness study or human reader improvement with AI
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

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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.

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The Selectra accessory kit 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 Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package. The Selectra accessory kit includes the following components: 1 Selectra Slitter Tool, 1 Seldinger Guide Wire, 4 Transvalvular Insertion (TVI) Tools, 1 Syringe, 1 Torquer, 2 Stopcocks, 2 Check valves, 2 Sealing caps, 1 Technical Manual. The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with specific acceptance criteria in the way a clinical trial would. Therefore, many of the requested elements pertaining to clinical performance, ground truth, expert opinions, and AI effect sizes are not applicable here.

Here's a breakdown of what can be extracted from the provided text:

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

Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily based on ensuring the modified device maintains the same characteristics and performance as the predicate device. The document explicitly states:

• Acceptance Criteria: The usage, indications for use, contraindications, and function of the Selectra accessory kit must remain unchanged compared to the predicate device (ScoutPro ACS accessory kit, K101776). The changes are "minor component modifications."
• Reported Device Performance: The document implicitly states that the device meets these criteria by asserting, "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k)."

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. This submission is for a device modification (Special 510(k)) and is based on maintaining substantial equivalence to a predicate device, not on specific clinical trial data with a test set in the traditional sense. The evidence provided typically involves engineering and bench testing to demonstrate that the minor component modifications do not alter the safety or effectiveness of the device. There's no mention of a clinical "test set" from patients.

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. As noted above, this is not a study requiring expert-established ground truth on patient data.

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

• Not Applicable. No test set or human adjudication process for clinical data is described.

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 component kit for a lead introducer system; it does not involve AI or human readers for diagnostic interpretation.

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

• Not Applicable. This device is a physical medical accessory kit, not an algorithm.

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

• Not Applicable. The "ground truth" for this type of submission is the documented performance and characteristics of the legally marketed predicate device. The new device is compared against the predicate's established performance through engineering and design verification.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of device modification for substantial equivalence.

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

• Not Applicable. There is no training set.

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