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510(k) Data Aggregation
(32 days)
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR
The AMPLATZER™ TorqVue™ LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.
The provided text is a 510(k) Summary for a medical device (AMPLATZER TorqVue Low Profile Delivery Catheter). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not include information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way an AI/ML device would be evaluated.
The document is a submission to the FDA for market clearance, not a study report. It focuses on demonstrating equivalence to existing devices rather than proving novel performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of data.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes functional and safety testing as being performed and provided in cleared applications for predicate devices, implying that the current device leverages those existing approvals for its components.
- Sample sized used for the test set and the data provenance: Not applicable. The document refers to "Design Verification and Design Validation testing" performed on predicate devices, but doesn't specify test set sizes or data provenance for the current device's performance claims.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of information is not relevant for the kind of device and submission described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human assessment of outcomes for a test set.
- 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 is not an AI/ML device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical catheter, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance in a clinical setting for this type of device. The "ground truth" would be engineering specifications and safety standards for the functional components.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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(151 days)
A ST.JUDE MEDICAL COMPANY
The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
The provided document is a 510(k) summary for the ViewFlex Xtra ICE Catheter, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results with numerical performance metrics for the device itself.
Based on the provided text, a comprehensive answer to your request cannot be fully generated as the document does not include the detailed information you're looking for regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.
However, I can extract the relevant information and state what is not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The submission is for an expanded indication for use, relying on substantial equivalence to a previously cleared device.
- Reported Device Performance: Not explicitly stated with numerical metrics. The document mentions "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381)" were referenced to demonstrate the ability to image devices, but no performance metrics (e.g., sensitivity, specificity, resolution) are provided.
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: Not mentioned.
- Data Provenance: Not mentioned.
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 mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned.
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: Not mentioned. The device is a diagnostic ultrasound catheter, not an AI or image analysis algorithm that assists human readers.
- Effect Size of AI Improvement: Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a medical device for direct visualization, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not mentioned directly. The document states that "images collected during the use of the predicates for visualizing other devices within the heart" were used, implying the ground truth was visual confirmation by users of the predicate devices.
8. The sample size for the training set
- Not applicable, as this is a medical device for direct visualization, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
Overall Summary:
The 510(k) submission for the ViewFlex Xtra ICE Catheter primarily focuses on demonstrating substantial equivalence to predicate devices for an expanded indication of use (visualizing other devices within the heart). It states that the design, technological characteristics, and materials are identical to the previously cleared ViewFlex Xtra ICE Catheter (K121381). To support the expanded indication, it refers to "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381) and images collected during the use of the predicates for visualizing other devices within the heart."
The document explicitly states: "There have been no device changes and no changes to the visualization location. This submission is to expand the current indications for use to include visualizing other devices within the heart." This implies that the previous clearance (K121381) would have contained the detailed performance data, which is not included in this summary. The current submission's "proof" is the established equivalence and the prior clearance, not new, detailed performance studies.
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(112 days)
ST.JUDE MEDICAL
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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