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510(k) Data Aggregation
(143 days)
The Dib UltraNav Transseptal Catheter System is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal puncture.
The Dib UltraNav Transseptal Catheter System is a single-use, dual lumen, non-steerable intravascular catheter and handle to be used during a percutaneous procedure to support visualization and puncture of the septum. It is to be used to cross the interatrial septum and enable placement of a guidewire into the left side of the heart. The UltraNav catheter system is used with off-the-shelf transseptal needles and ultrasound catheters (not provided).
The provided text describes a medical device, the Dib UltraNav Transseptal Catheter System, and its acceptance criteria as well as the studies conducted to demonstrate its safety and substantial equivalence to existing predicate devices. However, the document does not contain a specific table of acceptance criteria with corresponding device performance metrics in the format requested. It outlines the types of tests performed and states that "All test requirements were met."
Therefore, I will extract the available information and structure it as best as possible to answer your questions.
Here's the information regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document states that "All test requirements were met" for the mechanical, biocompatibility, sterilization, packaging, and animal testing. However, it does not provide specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it lists the types of tests conducted and implies that the performance met regulatory and internal requirements.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Performance | All test requirements were met in compliance with ISO 10555-1: 2013 and Dib UltraNav Medical, LLC internal requirements. Tests included: Freedom from leakage (air and liquid), Tensile strength, Radiopacity, Visual inspection, Dimensional testing, Luer connection testing, Kink resistance/bend testing, Torque testing, Push transmittance, Simulated use, and Handle performance related tests. |
| Biocompatibility | All test requirements were met in accordance with ISO 10993-1: 2018 and FDA guidance. Tests included: Cytotoxicity, Acute Systemic Toxicity, Irritation, Pyrogenicity, Sensitization, ASTM Hemolysis, Complement Activation, Partial Thromboplastin Time, Platelet and Leukocyte Count Assay, and In Vivo Thrombogenicity. |
| Sterilization Validation | Sterilization validation was completed in accordance with ISO 11135-1, effective in providing a sterility assurance level (SAL) ≥ 10⁻⁶. |
| Packaging Validation | Packaging validation was performed to ensure product and packaging integrity after shipping and distribution simulation, in accordance with ISO 11607 (Parts 1 and 2). |
| Animal Testing (In Vivo Safety & Performance) | The study demonstrated safety, ability to facilitate an accurate puncture of the septum, and ability to reliably deliver a guidewire to the left side of the heart. (Compared to a reference device). |
| Usability Assessment (Human Factors) | The study demonstrated that the UltraNav could be used without operator use errors that lead to serious adverse events. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical, Biocompatibility, Sterilization, and Packaging Tests: The document does not specify general sample sizes for these tests. It only lists the types of tests performed and the standards followed. The provenance is internal company testing and compliance with international standards.
- Animal Testing: The test set for the animal study consisted of eight canines. The document does not specify the country of origin of this data, but it was an acute GLP (Good Laboratory Practice) animal study, implying prospective data collection under controlled conditions.
- Usability Assessment: The test set involved two independent users.
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)
- For the animal study, the "ground truth" (assessment of safety, accurate septum puncture, and guidewire delivery) was established through observation and measurement during the study. While experts (e.g., veterinary surgeons, clinicians) would have been involved in conducting and evaluating the animal study, the document does not specify the number or qualifications of these experts explicitly for establishing ground truth, beyond indicating it was a GLP study.
- For the usability assessment, the "ground truth" (absence of operator use errors leading to serious adverse events) was established by two independent users, who evaluated the device. Their specific qualifications are not detailed beyond being "independent users" likely qualified to operate medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe a formal "adjudication method" in the context of expert consensus (like 2+1 or 3+1) for establishing ground truth from human readers. The tests performed are primarily laboratory-based or direct observation (animal study, usability).
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical catheter system, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical, Biocompatibility, Sterilization, Packaging: Ground truth for these studies is based on quantifiable measurements against established engineering standards (ISO standards, internal requirements) and biological compatibility assay results.
- Animal Testing: Ground truth was established through direct observation and measurement during an acute GLP animal study, comparing the device's performance (safety, septum puncture accuracy, guidewire delivery) to a reference device.
- Usability Assessment: Ground truth was established by direct observation and assessment by independent users regarding the occurrence of operator use errors.
8. The sample size for the training set
- The concept of a "training set" is not applicable here as the Dib UltraNav Transseptal Catheter System is a physical medical device, not an AI/ML algorithm. Therefore, no training set was used.
9. How the ground truth for the training set was established
- As there was no training set, this question is not applicable.
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(113 days)
The St. Jude Medical ACross™ Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.
The St. Jude Medical ACross™ Transseptal Access System consists of three main components; ( ) ) a radiopaque sheath, (2) a radiopaque dilator, (3) a transseptal luminal stainless steel needle (1) a factopaque sheam; (2) a factopaque on has a specially curved distal portion to with a sond stanness stool as the atrial septum. The proximal ends of each component interlock to form a handle. The product is also packaged with a compatible guidewire.
The sheath is fitted with a seal to provide hemostasis during catheter introduction and/or I the sitean is thited with a soar to provith a side-port and three-way stopcock to provide for aspiration, fluid infusion, blood sampling, and pressure monitoring. The transseptal needle aspiration, that mitasion, oroca sampling, as accommodate positioning in the cardiac contisis of a Drockenbrough style carreng for air aspiration, fluid infusion, blood sampling, and pressure monitoring.
The provided document is a 510(k) summary for the ACross™ Transseptal Access System. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain any information about specific acceptance criteria, device performance metrics, or the details of a study that proves the device meets such criteria.
The summary states:
"Non-clinical testing of the ACross™ Transseptal Access System includes in vitro bench testing, animal preclinical, biocompatibility testing, shelf-life and packaging testing, and sterilization. The total of the testing demonstrates that the ACross™ Transseptal Access System design meets product specifications and intended uses."
This general statement indicates that testing was performed, and the device met its specifications. However, it does not provide specific details on:
- Acceptance criteria and reported device performance: No table or description of quantitative or qualitative acceptance criteria and corresponding performance results is given.
- Sample size, data provenance: No information on the sample sizes for any tests (bench, animal) or the origin/type of data (retrospective/prospective, country of origin).
- Number/qualifications of experts, adjudication method: These pertain to studies involving human interpretation or expert review, which are typically not relevant for a device like a transseptal access system where performance is measured through physical properties and safety.
- MRMC comparative effectiveness study: Not applicable, as this is a device for physical access, not an imaging or diagnostic AI tool.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth: Not applicable in the traditional sense for a physical device. Performance is measured against engineering specifications and safety standards.
- Training set sample size and ground truth establishment: Not applicable, as this device does not involve a "training set" in the context of AI or machine learning. Development would involve engineering design, prototyping, and testing against design specifications.
Conclusion:
Based on the provided 510(k) summary, it is not possible to extract the requested information regarding specific acceptance criteria, device performance data, study details, expert involvement, or ground truth establishment. The document only provides a high-level overview of the types of non-clinical testing performed, stating that the device "meets product specifications and intended uses." To obtain the detailed information you requested, one would typically need to refer to the full 510(k) submission and its accompanying technical reports, which are not included in this summary.
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(112 days)
The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.
The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the heart. The inner diameter measures 10F. The distal tips of the introducers are available in a variety of curve configurations to meet physician preferences for accessing different parts of the cardiac anatomy. Each introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheaths contain radiopaque materials for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducers and are designed to facilitate the introduction and passage of the introducer through the vasculature.
This 510(k) summary (K061015) describes the Fast-Cath Hemostasis Introducer and Fast-Cath Transseptal Introducer, which are catheter introducers used for introducing various catheters into the heart. The submission asserts substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K061015 summary, explicit acceptance criteria and corresponding reported device performance metrics are not detailed. The summary states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench/Performance | Not explicitly stated in quantitative terms. | "Testing has demonstrated that the new devices are substantially equivalent to the predicate devices." |
| Design/Material | "similar design, materials, and technical requirements as the predicate devices." | "The catheters have similar design, materials, and technical requirements as the predicate devices." |
| Intended Use | Match or be substantially equivalent to predicate. | "The proposed modification is equivalent to the predicate with respect to intended use..." |
| Safety/Functionality | Implied to be equivalent to predicate. | "The proposed modification is equivalent to the predicate with respect to...performance specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any specific information about the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective or prospective). The summary merely states "Summary of Testing" and "Testing has demonstrated...", without elaborating on the nature or scope of this testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
There is no mention of experts or ground truth establishment in the context of clinical or performance data for either the test set or training set. Since the submission relies on substantial equivalence to predicate devices and likely refers to bench testing, expert review to establish ground truth as one might see in diagnostic AI studies is not applicable or detailed here.
4. Adjudication Method for the Test Set
As no specific test set involving human interpretation or performance evaluation is described, adjudication methods are not applicable or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described. This type of study is typically relevant for diagnostic devices involving human interpretation of data, often comparing AI-assisted vs. unassisted human performance. This submission is for a medical device (catheter introducer), not a diagnostic algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study, in the context of an algorithm's performance without human intervention, was not applicable and not performed or described. The device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
Given the nature of the device (catheter introducer) and the type of submission (510(k) for substantial equivalence to predicate devices), the "ground truth" used for testing would most likely relate to engineering specifications, material properties, mechanical performance, and biocompatibility standards. It would not be clinical outcomes data, pathology, or expert consensus in the same way as for diagnostic devices. These would be assessed through bench testing and possibly animal studies (though not detailed here) comparing the device's physical and functional characteristics to established standards and predicate devices.
8. Sample Size for the Training Set
There is no mention of a "training set" in this 510(k) summary. The concept of a training set is relevant for machine learning algorithms, which are not described as part of this device. The testing described would be focused on verifying physical and functional equivalence, not training a model.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, the method for establishing its ground truth is not applicable or mentioned.
In summary, the provided 510(k) summary for K061015 is a standard submission for a physical medical device (catheter introducer) seeking substantial equivalence to predicate devices. It relies on a comparison of design, materials, intended use, and general performance specifications to existing, legally marketed devices. It does not provide the detailed information (such as explicit acceptance criteria, sample sizes for test/training sets, expert involvement, or adjudication methods) that would typically be associated with performance studies for diagnostic algorithms or devices where clinical efficacy and human interpretation are key endpoints. The "study" mentioned is general "testing" to demonstrate substantial equivalence, rather than a detailed clinical trial or AI performance study.
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