(113 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (K191526 vs. K123733) |
|---|---|
| Same intended use | Yes |
| Same technological characteristics | Yes |
| Same shelf life | Yes |
| Same operating principle | Yes |
| Substantially equivalent material | Yes (except for connector, which is new but stated as substantially equivalent) |
| Substantially equivalent design features | Yes (internal design unchanged, external design changed for easier handling) |
| Facilitates pneumatic connection to the console | Yes |
| Secures the electrical connection of the probe's thermocouple to the console | Yes |
| Argon gas transferred from console through pneumatic stem into probe for cooling | Yes |
| Same console connection port | Yes |
| Connection to console | Yes |
| Pneumatic stem locks into female quick disconnect fitting on console | Yes |
| Connectors pushed onto console to form connection, pin removed prior to use | Yes |
| External Pull Pin mechanism (predicate only) | Yes (predicate had it, new device does not as mechanism is changed) |
| Connector removed by two hands (predicate only) | Yes (predicate only) |
| Connector removed by one hand via button (new device only) | Yes (new device only) |
| Connector appearance (blue) | Yes |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.