Search Results
Found 8 results
510(k) Data Aggregation
(35 days)
ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter
ViewFlex™ Xtra ICE Catheter
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.
ViewFlex™ Eco Reprocessed ICE Catheter
The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Advisor™ HD Grid Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Agilis™ NxT Steerable Introducer
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
Agilis™ NxT Steerable Introducer Dual-Reach™
The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
This FDA 510(k) clearance letter (K251211) and its accompanying 510(k) summary pertain to a change in workflow for several existing cardiovascular catheters, specifically allowing for a "Zero/Low Fluoroscopy Workflow."
The key phrase here is "Special 510(k) – Zero/Low Fluoroscopy Workflow". This type of submission is for modifications to a previously cleared device that do not significantly alter its fundamental technology or intended use, but rather introduce a change in how it's used or processed.
Crucially, this submission does NOT describe a new AI/software device that requires extensive performance testing against acceptance criteria in the manner you've outlined for AI/ML devices. Instead, it's about demonstrating that existing devices, when used with a new, less-fluoroscopy-dependent workflow, remain as safe and effective as before.
Therefore, many of the questions you've asked regarding acceptance criteria, study details, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) document. The document explicitly states:
- "Bench-testing was not necessary to validate the Clinical Workflow modifications."
- "Substantial Equivalence of the subject devices to the predicate devices using the zero/low fluoroscopy workflow has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods."
This indicates that the "study" proving the device (or rather, the new workflow) meets acceptance criteria is a summary of existing clinical data where alternative visualization methods were already employed, rather than a prospective, controlled study of a new AI algorithm.
Based on the provided document, here's what can be answered:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implicit acceptance criterion is that the devices, when used with "zero/low fluoroscopy workflow," maintain substantial equivalence to their predicate devices in terms of safety and effectiveness. This means they must continue to perform as intended for visualizing cardiac structures, blood flow, mapping, or introducing catheters.
- Reported Device Performance: The document states that "Substantial Equivalence... has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods." This implies that the performance (e.g., adequate visualization, successful mapping, successful catheter introduction) was maintained. Specific quantitative metrics of performance (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for a diagnostic AI) are not provided or applicable here as this is not an AI/ML diagnostic clearance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "a summary of clinical data across multiple studies." This suggests an aggregation of results from existing (likely retrospective) patient data where alternative visualization techniques (allowing for "zero/low fluoroscopy") were already utilized clinically. It's not a new, single, prospectively designed test set for an AI algorithm.
- Data Provenance: Not specified regarding country of origin or specific patient demographics. It is implied to be clinical data collected from studies where these types of procedures were performed using alternative visualization. The data would be retrospective as it's a "summary of clinical data" that already exists.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k). Ground truth in an AI/ML context typically refers to adjudicated labels for images or signals. Here, the "ground truth" is inferred from standard clinical practice and outcomes in the historical data summarized. There's no mention of a specific expert panel for new ground truth establishment for a diagnostic AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic outputs by multiple readers.
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. This is not an AI-assisted diagnostic device. The workflow change is about using alternative non-fluoroscopic imaging modalities (e.g., intracardiac echocardiography, electro-anatomical mapping systems), not about AI improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. The predicate devices are physical catheters.
7. The type of ground truth used:
- The "ground truth" is inferred from clinical outcomes and established clinical practice using the devices with alternative visualization methods in real-world scenarios. It's not a specific, adjudicated dataset for an AI algorithm. The performance of the devices (such as successful navigation, visualization, and mapping) under the "zero/low fluoroscopy" workflow is assumed to be equivalent to their performance under full fluoroscopy, as demonstrated by prior clinical use where such methods were employed.
8. The sample size for the training set:
- Not applicable. There is no AI model being trained discussed in this document.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
In summary:
This 510(k) is for a workflow modification for existing medical devices (catheters), not for an AI/ML diagnostic or assistive software. Therefore, the detailed data performance evaluation typically required for AI models against specific acceptance criteria (as requested in your template) is not presented or relevant in this clearance letter. The "proof" relies on the concept of substantial equivalence to previously cleared predicate devices, supported by a summary of existing clinical data that used alternative visualization methods, implying that the devices function safely and effectively even with reduced fluoroscopy.
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(151 days)
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
The Medline ReNewal Reprocessed 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 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac 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. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.
The provided text is a 510(k) summary for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a reprocessed medical device. It does not contain information about an AI/ML-driven device, nor does it specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance, are not applicable or cannot be extracted from this particular document.
However, I can extract the "performance" details in the context of the non-clinical testing conducted to prove substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)
The document primarily focuses on demonstrating that the reprocessed device performs comparably to the original predicate device through various non-clinical tests. These tests effectively serve as the "acceptance criteria" for demonstrating substantial equivalence rather than diagnostic performance in an AI/ML context.
| Acceptance Criteria (Non-Clinical Test Category) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Performance | Evaluated and found to be substantially equivalent to the predicate device. Specific tests included: |
| - Simulated use and artificial soiling | Not explicitly detailed, but implied successful equivalence. |
| - Visual inspection | Not explicitly detailed, but implied successful equivalence. |
| - Mechanical characteristics | Not explicitly detailed, but implied successful equivalence. |
| - Ultrasound transducer testing | Not explicitly detailed, but implied successful equivalence. |
| - Dimensional analysis | Not explicitly detailed, but implied successful equivalence. |
| - Electrical Safety | Not explicitly detailed, but implied successful equivalence. |
| - Dielectric and current leakages | Not explicitly detailed, but implied successful equivalence. |
| Cleaning Validation | Not explicitly detailed, but implied successful validation for reprocessing. |
| Biocompatibility | Not explicitly detailed, but implied successful validation. |
| Sterilization Validation | Not explicitly detailed, but implied successful validation. Specific tests included: |
| - Bioburden testing | Not explicitly detailed, but implied successful validation. |
| - Ethylene oxide and ethylene chlorohydrin residuals testing | Not explicitly detailed, but implied successful validation. |
| - Bacteriostasis/fungistasis | Not explicitly detailed, but implied successful validation. |
| Packaging and shelf life validation | Not explicitly detailed, but implied successful validation. |
| Product stability | Not explicitly detailed, but implied successful validation. |
| Indications for Use | Same as the predicate device: "indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart." |
| Technological Characteristics | Same as the predicate device: "To operate, the catheter is connected to a compatible intracardiac ultrasound console (View Mate II, ViewMate Z and Philips CX50) via a compatible ViewFlex Catheter Interface Module." |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a reprocessing approval based on non-clinical engineering and biological tests, not statistical analysis of patient data or diagnostic performance of an AI model. There is no "test set" in the sense of a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for this submission is established through validated scientific methods for medical device performance, safety, and equivalence.
4. Adjudication method for the test set
Not applicable. No adjudication method is described, as there is no "test set" requiring expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. This applies to AI/ML devices that assist human readers in diagnostic tasks. The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a reprocessed physical medical device, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
For this type of device (reprocessed catheter), the "ground truth" is established through:
- Validated engineering specifications: Proving the device meets its design requirements in terms of mechanical, electrical, and dimensional properties.
- Biological safety testing: Ensuring biocompatibility and effective sterilization.
- Functional performance testing: Demonstrating the device performs its intended function (e.g., ultrasound imaging capability) identically to the original device.
- Regulatory standards and guidelines: Adherence to established FDA regulations for reprocessing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML model.
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(53 days)
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
The Reprocessed 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 Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter 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 anteriorto-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.
The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of accuracy or clinical performance. The submission is for a reprocessed medical device (Intracardiac Echocardiography Catheter), and the studies described are primarily focused on demonstrating that the reprocessed device is as safe and effective as the predicate device and operates as originally intended.
Specifically, the document focuses on:
- Bench and laboratory testing: To demonstrate the performance (safety and effectiveness) of the reprocessed device.
- Comparison to a predicate device: Asserting that the reprocessed device is substantially equivalent to legally marketed predicate devices.
- Validation of reprocessing methods: Ensuring cleaning, sterilization, and functional integrity after reprocessing.
Therefore, many of the requested categories for a study demonstrating clinical performance or diagnostic accuracy are not applicable to this submission.
However, I can extract the relevant information regarding the testing performed and the general "acceptance criteria" through comparison to the predicate.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for image quality metrics) or their exact reported performance values. Instead, it states that the reprocessed device meets the functional and safety requirements to be considered equivalent to the predicate. The "performance" is implicitly "as safe and effective as the predicate" and "operates as originally intended."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated compliance. |
| Cleaning Validation | Demonstrated compliance. |
| Sterilization Validation | Demonstrated compliance. |
| Functional Performance | Operates as originally intended (includes Visual Inspection, Simulated Use, Dimensional Verification, Ultrasound Transducer Testing, Image Quality Testing, Acoustic Output Testing, Mechanical Characteristics). |
| EMC and Electrical Safety | Demonstrated compliance. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the "test set" (e.g., number of reprocessed catheters tested for each criterion). The testing would have been done on a sufficient number of reprocessed devices to validate the reprocessing methods and ensure consistency. The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions, which is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin of the data is not explicitly stated but is implied to be within the US (given FDA submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study involving diagnostic accuracy with expert-established ground truth.
4. Adjudication method for the test set
This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not conducted or described. The focus is on the substantial equivalence of the reprocessed device to its predicate through engineering and functional testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is an Intracardiac Echocardiography Catheter, not an AI algorithm. The functional testing described is effectively a standalone performance assessment of the physical device.
7. The type of ground truth used
The "ground truth" for the functional and safety testing would be:
- Engineering specifications of the original device.
- Industry standards and regulatory requirements for medical device safety and performance (e.g., biocompatibility standards, sterilization efficacy).
- The performance characteristics of the new/unreprocessed predicate device.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device submission, as it relates to a physical medical device and its reprocessing, not a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as above.
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(68 days)
ViewFlex Xtra ICE Catheter
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.
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(260 days)
Reprocessed ViewFlex Xtra ICE Catheter
The reprocessed ViewFlex™ Xtra ICE catheter is in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The Reprocessed ViewFlex™ Xtra ICE 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 Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F 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 provided text describes the regulatory clearance for a reprocessed medical device, specifically the Reprocessed ViewFlex™ Xtra ICE Catheter (K190478). This document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical performance and safety tests. It does not pertain to an AI/ML-driven device or a study involving human readers or efficacy in diagnosing conditions. Therefore, many of the requested categories in the prompt are not applicable.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document details various tests performed to ensure the reprocessed device is substantially equivalent to the original predicate device. The "acceptance criteria" are implied to be that the reprocessed device performs "as originally intended" and meets the same functional and safety characteristics as the new, original (OEM) device.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Cleaning Validation | Demonstrated appropriate functional characteristics and validated cleaning procedures. |
| Sterilization Assurance | Sterilization Verification | Validated sterilization procedures. |
| Biocompatibility | Ethylene Oxide Residual Testing (ISO 10993-7) | Confirmed acceptable residual levels. |
| Cytotoxicity | Met biocompatibility requirements per ISO 10993-1. | |
| Sensitization | Met biocompatibility requirements per ISO 10993-1. | |
| Irritation/Intracutaneous Reactivity | Met biocompatibility requirements per ISO 10993-1. | |
| Acute Systemic Toxicity | Met biocompatibility requirements per ISO 10993-1. | |
| Pyrogenicity | Met biocompatibility requirements per ISO 10993-1. | |
| Hemocompatibility | Met biocompatibility requirements per ISO 10993-1. | |
| Thrombogenicity | Met biocompatibility requirements per ISO 10993-1. | |
| Packaging & Shelf-life | Packaging Validation (ASTM D4169, ASTM F88, ASTM F2096) | Validated packaging procedures. |
| Shelf-life Validation (ASTM 1980-07) | Validated shelf-life. | |
| Functional Performance | Electrical Leakage | Performed as originally intended. |
| (Bench Testing) | Torsional Strength | Performed as originally intended. |
| Flexation Fatigue | Performed as originally intended. | |
| Fluid Integrity | Performed as originally intended. | |
| Joint Bond Strength | Performed as originally intended. | |
| Deflection Fatigue | Performed as originally intended. | |
| Stiffness | Performed as originally intended. | |
| Tip Buckling | Performed as originally intended. | |
| Transducer Sensitivity | Performed as originally intended. | |
| Ultrasound console compatibility | Compatible with listed consoles (ViewMate™ II, ViewMate™ Z, ViewMate™, Philips CX50a). | |
| Acoustic Output | Performed as originally intended. | |
| Thermistor Functionality | Performed as originally intended. | |
| Manufacturing Process | Visual and validated functional testing of all products | Included in the manufacturing process to ensure product quality. |
| Device Tracking | Reprocessed device is marked and tracked | Ensures the device is rejected from further reprocessing after one cycle, indicating control over reprocessing limits. |
| Overall Conclusion | Substantial Equivalence to Predicate Device (K133853) | Performance testing demonstrated substantial equivalence to the predicate device and did not raise different questions in safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each particular test (e.g., number of catheters tested for electrical leakage). It refers to "representative samples of reprocessed devices" for functional testing. The data provenance is implied to be from internal lab testing conducted by Sterilmed, Inc. No information on country of origin or retrospective/prospective nature of the testing is provided beyond it being part of the 510(k) submission process for a reprocessed device.
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)
This is not applicable. The study described is a non-clinical, bench-top engineering and biocompatibility study comparing a reprocessed device to a new device, not a diagnostic study requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by medical experts for a test set in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation. This document describes physical, chemical, and functional engineering tests.
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
This is not applicable. The device is an intracardiac ultrasound catheter for visualization, not an AI-driven diagnostic tool that assists human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the performance and safety specifications of the original (OEM) predicate device (ViewFlex™ Xtra ICE Catheter, K133853). The reprocessed device is tested to ensure it meets these established technical specifications and performance characteristics, demonstrating "substantial equivalence" rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This is not applicable. There is no AI/ML algorithm that requires a training set. The study involves reprocessed physical devices.
9. How the ground truth for the training set was established
This is not applicable. There is no AI/ML algorithm or training set.
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(261 days)
Reprocessed ViewFlex Xtra ICE Catheter
The Reprocessed 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 Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter 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 leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.
The provided text is a 510(k) summary for a reprocessed medical device, specifically a Reprocessed ViewFlex Xtra ICE Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria for a new AI or diagnostic device.
Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this document as it describes a reprocessed catheter and not a new diagnostic algorithm or AI system.
However, I can extract the relevant information regarding performance testing that was conducted to demonstrate the reprocessed device's safety and effectiveness.
Here's a breakdown of what can be extracted, and where limitations exist based on the document:
1. A table of acceptance criteria and the reported device performance:
The document describes the types of tests performed to demonstrate that the reprocessed device performs "as originally intended" and is "effectively identical" to the predicate. It does not provide specific quantitative acceptance criteria or detailed numerical performance results for these tests. The conclusion states the device is "at least as safe and effective as the predicate device," implying it met internal standards for each test.
| Test Category | Reported Device Performance | Acceptance Criteria (Not explicitly stated in document) |
|---|---|---|
| Biocompatibility | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involve ISO 10993 compliance) |
| Validation of Reprocessing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves demonstrating proper cleaning, disinfection/sterilization, and restoration of function) |
| Sterilization Validation | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves demonstrating sterility assurance level) |
| Functional Performance Tests | "demonstrates that Reprocessed ViewFlex device perform as originally intended." | (Not detailed, would involve specific mechanical and operational parameters) |
| Acoustic Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, would involve ultrasound image quality and output parameters) |
| Electrical Safety Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involves IEC 60601 standards) |
| Electromagnetic Compatibility Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involves IEC 60601-1-2 standards) |
| Packaging Validation | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves maintaining sterility and product integrity) |
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: Not specified. The document states "Each individual device is tested for appropriate function" during reprocessing, and that bench and laboratory testing was conducted. This implies testing on a statistically relevant sample of reprocessed devices, but the exact number isn't given.
- Data Provenance: Not applicable in the context of this device and the types of tests described. These are laboratory/bench tests, not clinical data sets 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. This document describes engineering and laboratory testing for a reprocessed catheter, not a diagnostic algorithm that requires expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for interpreting clinical data, particularly in a reader study or when establishing ground truth from multiple experts. This is not relevant for bench testing of a catheter.
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 is a reprocessed catheter, not an AI or diagnostic imaging device. No MRMC study was mentioned or would be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm; this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for these engineering tests would be established by validated test methods, adherence to specifications, and comparison to the original device's performance, as measured by calibrated equipment and documented procedures. For instance, the ground truth for electrical safety is adherence to established electrical safety standards.
8. The sample size for the training set:
- Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is involved.
Summary of the Study:
The study described is a series of bench and laboratory tests designed to confirm that the Reprocessed ViewFlex Xtra ICE Catheter is safe and effective and performs "as originally intended," thereby demonstrating substantial equivalence to the predicate device.
The tests included:
- Biocompatibility
- Validation of Reprocessing
- Sterilization Validation
- Functional Performance Tests
- Acoustic Testing
- Electrical Safety Testing
- Electromagnetic Compatibility Testing
- Packaging Validation
The specific detailed results or quantitative acceptance criteria for each test are not provided in this summary document, only the general statement that the testing "demonstrates that Reprocessed ViewFlex device perform as originally intended" and that the device is "at least as safe and effective as the predicate device." The study essentially aims to prove that the reprocessing process does not negatively impact the device's original validated performance and safety characteristics.
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(151 days)
VIEWFLEX XTRA ICE CATHETER
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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(30 days)
VIEWFLEX XTRA ICE CATHETER
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.
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