Search Results
Found 3 results
510(k) Data Aggregation
(68 days)
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 ("ViewFlex™ Catheter") is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.
Here's a breakdown of the acceptance criteria and the study information for the ViewFlex™ Xtra ICE Catheter, based on the provided document:
This document is a 510(k) clearance letter and a summary of the special 510(k) submission for the ViewFlex™ Xtra ICE Catheter's compatibility with the ViewMate™ Multi Ultrasound System. It describes the testing performed to ensure the updated device (the ViewFlex™ Xtra ICE Catheter when used with the new ViewMate™ Multi Ultrasound System) does not raise new questions of safety or effectiveness compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Design verification activities were performed with their respective acceptance criteria to ensure that the use of the ViewFlex™ Xtra ICE Catheter in conjunction with the ViewMate™ Multi Ultrasound System does not affect the safety or effectiveness of the device. All testing performed met the established performance specifications."
While specific, granular acceptance criteria values are not explicitly listed in this summary, the general acceptance criteria are implicitly that the device, when used with the new console, performs safely and effectively within established performance specifications, and meets relevant industry standards.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Ensure safety and effectiveness when used with ViewMate™ Multi Ultrasound System | "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-2-37 (basic safety & essential performance of ultrasonic medical diagnostic and monitoring equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1-2 (electromagnetic compatibility) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| No new or increased hazards identified as a result of modifications | "There were no new or modified hazards identified as a result of the proposed modifications. Abbott has reviewed the applicable risk management documentation... and determined that the changes... do not increase existing risks or create new risks to the user or patient, and that the residual risk remains acceptable following verification and validation activities." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set in terms of number of patients, cases, or images. The testing described is primarily non-clinical design verification and validation testing rather than clinical performance testing with patient data.
The data provenance is for non-clinical testing (bench testing, performance evaluations) related to device compatibility and adherence to standards. It does not involve human patient data from a specific country, nor is it described as retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this submission. The ground truth for this type of special 510(k) submission for device compatibility is established through objective engineering and performance testing, comparing the device's output and safety metrics against predefined specifications and industry standards, rather than expert interpretation of clinical data to establish a "ground truth" diagnosis.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the testing focuses on technical performance and compliance with standards, there is no need for expert adjudication in the traditional sense of resolving discrepancies in diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic performance of an AI-powered device or a new imaging modality and compare it to existing methods or human readers. The ViewFlex™ Xtra ICE Catheter is a diagnostic intravascular catheter, and this particular submission focuses on its compatibility with a new ultrasound console, not on comparing its diagnostic performance or an AI component to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The ViewFlex™ Xtra ICE Catheter is a medical device (a catheter with an ultrasound transducer) that requires a human operator and an ultrasound console to function. It is not an AI algorithm or a standalone diagnostic tool in that sense. The device's performance is inherently tied to its use by a human and with supporting equipment.
7. The Type of Ground Truth Used:
The ground truth used for this type of non-clinical testing is based on established engineering specifications, industry standards, and validated test methods. For example, measuring a deflection angle would use a calibrated measurement system (engineering ground truth), or testing electrical safety complies with specific limits defined in the referenced standards (standard-based ground truth).
8. The Sample Size for the Training Set:
Not applicable. This submission is for a medical device (a catheter) and its compatibility with an ultrasound system. It does not involve machine learning or AI algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm in this submission.
Ask a specific question about this device
(151 days)
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.
Ask a specific question about this device
(30 days)
The ViewFlex™ Xtra ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow 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 and ViewMate Z ultrasound consoles.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific, quantifiable acceptance criteria in the traditional sense of a performance study (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various non-clinical tests.
The criteria can be inferred from the "Comparison to Predicate Devices" and "Summary on Non-Clinical Testing" sections.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Same intended use and fundamental scientific technology as the predicate device. | "The ViewFlex™ Xtra ICE Catheter has the same intended use and fundamental scientific technology as the predicate device." |
| Technological Equivalence: Technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent to the predicate device. | "The technological characteristics of the ViewFlex™ Xtra ICE Catheter are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling." |
| Safety and Effectiveness (Design Modifications): Design modifications do not adversely affect safety and effectiveness. | "Through biocompatibility and bench performance testing it was demonstrated that the design modifications do not adversely affect the safety and effectiveness." |
| Performance Specifications (Bench Testing): Device meets established performance specifications. | "The results of bench testing demonstrated that the device meets the established performance specifications." |
| Biocompatibility Specifications: Modified design meets specifications in accordance with ISO 10993-1. | "The results of biocompatibility testing demonstrated that the modified design meets specifications in accordance with ISO 10993-1." |
| Overall Substantial Equivalence: Based on the above, the device is substantially equivalent to the predicate. | "Based on this and the data provided in this pre-market notification, the subject device and predicate device has been shown to be substantially equivalent." (FDA's letter further confirms this determination). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (bench testing and biocompatibility testing). There is no mention of a clinical test set involving human patient data being used to establish the device's performance regarding its primary indication (visualizing cardiac structures and blood flow). Therefore, there is:
- No sample size for a clinical test set.
- No data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As there was no clinical test set described for the primary indication of visualizing cardiac structures and blood flow, this information is not applicable or provided. The "ground truth" for the non-clinical tests would be established by the physical and chemical properties measured during bench and biocompatibility testing, compared against predetermined engineering specifications and ISO standards, respectively.
4. Adjudication Method for the Test Set
Again, since no clinical test set for diagnostic performance is described, an adjudication method is not applicable or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study, nor does it address human reader improvement with or without AI assistance. This device is an imaging catheter, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is an intracardiac ultrasound catheter, a direct imaging device, not an algorithm or AI system for which standalone performance would be applicable. Its "performance" is its ability to acquire images, which is assessed through bench testing and its similarity to the predicate device.
7. The Type of Ground Truth Used
For the non-clinical testing described:
- Bench Testing: Engineering specifications and performance metrics derived from the device's design and intended function (e.g., deflection capabilities, ultrasound signal quality, physical dimensions).
- Biocompatibility Testing: Compliance with ISO 10993-1 standards for biological evaluation of medical devices.
- Substantial Equivalence: Comparison to the established characteristics and performance of the predicate device (ViewFlex Plus Catheter (K101239)).
8. The Sample Size for the Training Set
Not Applicable. This is a hardware device (an intracardiac ultrasound catheter), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As no training set is relevant for this type of device.
Ask a specific question about this device
Page 1 of 1