(127 days)
Not Found
No
The description focuses on the mechanical and cryoablative aspects of the device, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is intended for the treatment of cardiac arrhythmias by creating cryonecrosis, which aligns with the definition of a therapeutic device.
No
The device is described as a "cryoablative surgical device" used for the "cryosurgical treatment of cardiac arrhythmias," which involves freezing target tissue to block electrical conduction pathways. Its primary function is therapeutic (ablation), not diagnostic. While it has an integrated thermocouple for monitoring temperature, this is for controlling the ablation process, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components including probes, a console, tank carrier, tank regulator, cables, and a power cord, indicating it is a hardware-based system with potential software control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias." This describes a surgical intervention performed directly on the patient's body.
- Mechanism of Action: The device "freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis." This is a therapeutic action performed on living tissue within the body.
- Device Description: The description details a "cryoablative surgical device" used in the "cryosurgical treatment of cardiac arrhythmias." This reinforces its role as a surgical tool.
- Anatomical Site: The anatomical site is "cardiac tissue," which is within the patient's body.
- Intended User / Care Setting: The intended users are "surgeon, operating room nurse," and the setting is an operating room, consistent with a surgical procedure.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's heart tissue during surgery.
N/A
Intended Use / 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.
Product codes
OCL
Device Description
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 |
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing has demonstrated that the Medtronic CryoFlex Surgical Ablation System is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 . -
2
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 ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or progress.
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.
4
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
5
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)
Page 1 of __
Division Sign-Off) vision of Cardiovascular Devices
510(k) Number K121878
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Special 510(k): Modification to K053436 Medtronic Confidential