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For models 60SF2, 60SF3, and 60SF7:
The Cardioblate CryoFlex surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

For model 60CM1:
The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp and Surgical Ablation Probe and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The Medtronic Cardioblate™ CryoFlex™ Surgical Ablation System is an argon based cryosurgical system intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate™ CryoFlex™ 7 cm, 10 cm, and 10-S probes, the Cardioblate™ CryoFlex™ clamp, and the Cardioblate™ CryoFlex™ Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. The system utilizes an argon-based cryogen for fast, controlled freezing.

The Cardioblate™ CryoFlex™ clamp and surgical ablation probes are single use, disposable cryoablation probes that are designed for use with the Cardioblate™ CryoFlex™ surgical ablation system. The probes include integrated thermocouple for monitoring temperature at the ablation segment. The clamp and surgical ablation probes are supplied sterile and cannot be reused or re-sterilized.

The probe's shaft and ablation segment are made of specially heat-treated stainless steel. The shaft is designed with enough malleability that the surgeon can shape it, while still maintaining enough stiffness to ensure its stability in the operating field.

The malleable ablation segment has a bellows configuration, which provides kink resistance and thermal performance. A moveable insulative sleeve on the shaft allows the surgeon to vary the size of the ablation zone.

The probe has a 3-m (10 ft) connection hose which is to be handed out of the sterile field to an operating room nurse for connection to the control panel.

This document is a 510(k) premarket notification for the Cardioblate CryoFlex Surgical Ablation System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K123733), specifically regarding an updated connector design. As such, it does not describe a clinical study to establish performance against acceptance criteria in the context of disease diagnosis or treatment effectiveness. Instead, the "study" described is a comparison of device characteristics to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a modification (updated connector design) to a previously cleared device, the "acceptance criteria" are based on demonstrating that the modified device maintains the same fundamental characteristics and performance as the predicate. The performance is reported in terms of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

No test set in the traditional sense of patient data is described. The "test" is a comparison of the modified device's technical specifications and functionality to the predicate device. The provenance of this comparison data is from the manufacturer, Medtronic, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There is no "ground truth" related to disease diagnosis or treatment outcome established by experts in this submission. The ground truth for the comparison is the existing design and performance of the predicate device, against which the modified device is assessed.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical trial or expert review of cases described to require an adjudication method. The assessment is a direct comparison of engineering and design characteristics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a 510(k) submission for a device modification, not an AI-based diagnostic or therapeutic aid requiring MRMC studies to assess human reader improvement.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a surgical ablation system, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established performance and safety profile of the legally marketed predicate device (K123733). The submission aims to demonstrate that the modified device's characteristics are "substantially equivalent" to this existing ground truth.

8. Sample Size for the Training Set

Not applicable. This is a hardware modification submission, not an AI algorithm development. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the Clamp and Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The Medtronic Cardioblate® CryoFlex® Surgical Ablation Probes, Console, and accessories are used together as a system. The system is composed of the Cardioblate CryoFlex Console, Cardioblate CryoFlex Console, Refurbished, Cardioblate CryoFlex 7cm Probe, Cardioblate CryoFlex 10cm Probe, Cardioblate CryoFlex 10S Probe, Cardioblate CryoFlex Clamp with 10cm Probe, Tank Carrier, Tank Regulator, Tank Regulator, Refurbished, Pressure Transducer Cable, 6ft. (1.8m), Gas Hose, 8ft (2.4m), and Power Cord, North American. The Medtronic Cardioblate CryoFlex Surgical Ablation System is a cryoablative surgical device that is used in the cryosurgical treatment of cardiac arrhythmias. The system utilizes an argon-based cryogen for fast, controlled freezing. The Cardioblate CryoFlex probes are single use, disposable cryoprobes that are designed for use with the system. Each probe has an integrated thermocouple for monitoring temperature at is ablation segment. The probes are supplied sterile, cannot be reused or re-sterilized, and are available in 7cm, 10cm, 10-S (slightly stiffer), and clamp with 10cm probe versions. The probes shaft and ablation segment are made of specially heat-treated stainless steel. The shaft was designed with enough malleability that the surgeon can easily shape it while still maintaining enough stiffness to ensure its stability in the operating field. The maileable ablation segment has a bellows configuration, which provides kink resistance and thermal performance. A movable insulative sleeve on the shaft allows the surgeon to vary the size of the ablation zone. The probe has a 3m (10ft) connection hose which is to be handed out of the sterile field to an operating room nurse for connection to the control panel.

The provided text describes a 510(k) premarket notification for the Medtronic Cardioblate CryoFlex Surgical Ablation System. This is a submission for regulatory clearance, not a study evaluating device performance against specific acceptance criteria in the manner typically found in clinical trials or performance studies for diagnostic AI devices.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for many medical devices. The "performance data" mentioned refers to verification and validation testing to ensure the new device meets its design specifications and functions as intended, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested categories (e.g., acceptance criteria, reported device performance metrics in a table, sample size for test set, ground truth by experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or explicitly stated in this type of regulatory submission.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

Acceptance Criteria and Study for Medtronic Cardioblate CryoFlex Surgical Ablation System (K123733)

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

• Not explicitly stated in this document in the format of specific acceptance criteria (e.g., "sensitivity > 90%") and reported performance metrics.
• The document states: "Verification and validation testing has demonstrated that the Medtronic Cardioblate CryoFlex Surgical Ablation System is substantially equivalent to the predicates." This implies that the device met internal design specifications and functions comparably to the predicate, which would be the "acceptance criteria" from a regulatory perspective for substantial equivalence. However, no specific performance values are given.

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

• Not specified. The document mentions "verification and validation testing" but does not detail the sample sizes, data provenance, or study design (retrospective/prospective) of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not specified. This type of information is relevant for studies evaluating diagnostic accuracy or clinical effectiveness, often involving human interpretation. This submission focuses on the safety and functional equivalence of a surgical ablation device. "Ground truth" in this context would likely refer to engineering specifications and physical performance measurements (e.g., temperature, ablation size), rather than expert medical interpretation.

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

• Not applicable / Not specified. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not mentioned for the verification and validation tests for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a cryosurgical ablation system, not a diagnostic AI device requiring human reader interpretation or assistance. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

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

• Not applicable. This device is a surgical instrument, not an algorithm, so standalone algorithm performance is not relevant.

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

• Not explicitly stated for the "verification and validation testing." For a surgical device, ground truth would likely be based on engineering specifications, physical measurements (e.g., temperature achieved, lesion size in in-vitro or animal models), and compliance with material and safety standards.

8. The sample size for the training set

• Not applicable / Not specified. This device is hardware for surgical ablation, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable. As the device is not an AI algorithm, there is no training set or corresponding ground truth establishment process relevant to AI.

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