(127 days)
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, 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 crvoablative 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, and 10-S (slightly stiffer) 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 malleable 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.
Here's a breakdown of the acceptance criteria and study information for the Cardioblate CryoFlex Surgical Ablation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "device must achieve an ablation temperature of X within Y seconds"). Instead, it focuses on demonstrating substantial equivalence to a predicate device through verification and validation testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (SurgiFrost 7cm, 10cm Cryosurgical Devices - K053436) | "Verification and validation testing has demonstrated that the Medtronic CryoFlex Surgical Ablation System is substantially equivalent to the predicates." |
| No Change to Indications for Use | "There is no change to the indications for use as compared to the predicate device." |
| Functional equivalence with alternate insulative sheath component (7cm, 10cm, 10S models) | Verified through "Verification and validation testing." (Specific results not detailed in this summary.) |
| Functional equivalence with modified heat exchange component (10S model) | Verified through "Verification and validation testing." (Specific results not detailed in this summary.) |
| Ability to freeze target tissue and block electrical conduction pathways by creating an inflammatory response and cryonecrosis, as per Indications for Use. | Implied by "substantial equivalence" to a device already cleared for this function. Specific studies demonstrating this mechanism for this modified device are not detailed in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Verification and validation testing has demonstrated that the Medtronic CryoFlex Surgical Ablation System is substantially equivalent to the predicates." However, it does not provide details on:
- The specific sample size used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided document does not specify the use of experts or the establishment of ground truth in this manner for the verification and validation testing. The focus is on technical and functional equivalence, not on diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
As there's no mention of expert review or ground truth establishment based on expert consensus for the test set, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or AI devices that augment human interpretation. The Cardioblate CryoFlex is a surgical ablation device, and its performance is evaluated differently.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical surgical tool (a cryosurgical system) and not an algorithm or AI product. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device requires human operation during a surgical procedure.
7. The Type of Ground Truth Used
The "ground truth" for a surgical device like this is primarily its functional performance and safety in achieving its intended therapeutic effect. This would be assessed through:
- Engineering tests (e.g., temperature control, freezing rate, probe malleability, kink resistance, thermal performance).
- Biocompatibility and sterilization validation.
- Potentially, animal or cadaveric studies to demonstrate tissue ablation characteristics, although this summary does not specifically detail such studies for this modification.
- The ultimate "ground truth" for its therapeutic efficacy is based on the predicate device's established performance in "freezing target tissue and block[ing] the electrical conduction pathways by creating an inflammatory response and cryonecrosis."
8. The Sample Size for the Training Set
The concept of a "training set" is relevant to machine learning and AI algorithms. Since the Cardioblate CryoFlex Surgical Ablation System is a physical medical device and not an AI or machine learning product, there is no training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable.
§ 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.