(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.
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K 121878
NOV 2 2012
510(k) Summary
General Information l.
Submitter Information a.
| Submitter's Name and Address | |
|---|---|
| Medtronic, Inc. | |
| Medtronic Cardiovascular | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 |
Contact Person
Kari Christianson Senior Regulatory Affairs Specialist Tel: 763-514-9529 FAX: 763-526-8377 Email: kari.j.christianson@medtronic.com
Date of Summary
June 27, 2012
Cardioblate CryoFlex Surgical Ablation System Proprietary Name of Device
Common/Usual Name Cryosurgical System
Classification Name
Classification
Class II, per 21 CFR 878.4350
Product Code:
Predicate Device
OCL
SurgiFrost 7cm, 10cm Cryosurgical Devices (K053436)
Surgical Device, for Ablation of Cardiac Tissue
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Device Description II.
System and Components a.
The Medtronic Cardioblate® CryoFlex® Surgical Ablation Probes, Console, and accessories are used together as a system. The system is composed of the following components:
| Components | Model number |
|---|---|
| Cardioblate CryoFlex Console | 65CS1 |
| Cardioblate CryoFlex Console, Refurbished | R65CS1 |
| Cardioblate CryoFlex 7cm Probe | 60SF7 |
| Cardioblate CryoFlex 10cm Probe | 60SF2 |
| Cardioblate CryoFlex 10S Probe | 60SF3 |
| Tank Carrier | 65TC1 |
| Tank Regulator | 65RAXNA |
| Tank Regulator, Refurbished | R65RAXNA |
| Pressure Transducer Cable, 6ft. (1.8m) | 67PS6 |
| Gas Hose, 8ft (2.4m) | 67H08 |
| Power Cord, North American. | 671PCNA |
b. System Overview
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.
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Special 510(k): Modification to K053436 Medtronic . -
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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. Note that once the probe is connected to the control panel, it should not be disconnected until the end of the procedure because it cannot be reconnected. The probe is disabled once it is disconnected.
Indications for Use 111.
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.
There is no change to the indications for use as compared to the predicate device.
IV. Comparison to Predicate Devices
The Medtronic Cardioblate CryoFlex Surgical Ablation system is substantially equivalent to the predicate surgical ablation system, has the same intended use and the same design with the exception of an alternate insulative sheath component on the 7cm, 10cm and 10S models (60SF7, 60SF2, and 60SF3, respectively), and a modified heat exchange component on the 10S model (60SF3).
Summary of Performance Data V.
Verification and validation testing has demonstrated that the Medtronic CryoFlex Surgical Ablation System is substantially equivalent to the predicates.
VI. Conclusion
Based on the accumulated technical information, intended use, verification tests and performance data provided, the Cardioblate CryoFlex Surgical Ablation disposable probes and console are substantially equivalent to the currently marketed predicate devices.
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Special 510(k): Modification to K053436 Medtronic ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Inc. c/o Mr. Kari Christianson Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE, Mail Stop MVS83 Mounds View, MN 55112
NOV. 2 2012
Re: K121878
Trade Name: Cardioblate CryoFlex Surgical Ablation Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: June 27, 2012 Received: June 28, 2012
Dear Mr. Christianson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Kari Christianson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
15 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 121878
Indications for Use
510(k) Number (if known):
Device Name: Cardioblate CryoFlex Surgical Ablation System
Indications For Use: 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.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off) vision of Cardiovascular Devices
510(k) Number K121878
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Special 510(k): Modification to K053436 Medtronic Confidential
§ 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.