(117 days)
Not Found
No
The description focuses on the mechanical and cryoablative aspects of the device, with no mention of AI or ML capabilities.
Yes
The device is described as "intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias" and that it "freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis." This indicates a direct impact on the body to treat a condition.
No
The device is described as a cryoablative surgical device used for the treatment of cardiac arrhythmias by freezing target tissue to block electrical conduction pathways. Its function is therapeutic (ablation), not diagnostic (identifying or characterizing disease).
No
The device description explicitly lists multiple hardware components including probes, a console, a clamp, a tank carrier, a tank regulator, cables, and a power cord, all of which are integral to the system's function.
Based on the provided information, 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 tissue.
- Mechanism of Action: The device works by "freeze[ing] target tissue and block[ing] the electrical conduction pathways by creating an inflammatory response and cryonecrosis." This is a physical action on the tissue, not an analysis of a sample taken from the body.
- Device Description: The description details a surgical ablation system with probes, a console, and accessories used for cryosurgical treatment. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly treats tissue within the body.
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 CryoFlex 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 |
| Cardioblate CryoFlex Clamp with 10cm Probe | 60CM1 |
| Tank Carrier | 65TC1 |
| Tank Regulator | 67RAXNA |
| Tank Regulator, Refurbished | R67RAXNA |
| 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 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. 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 tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive cardiac surgical procedures. Intended user appears to be a surgeon or other medical professional in an operating room setting.
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 Cardioblate CryoFlex Surgical Ablation System is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cardioblate® CryoFlex® Surgical Ablation System (K121878)
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
K123733 1/3
510(k) Summary
APR 0 1 2013
General Information l.
Submitter Information a.
| Submitter's Name and
Address | Medtronic, Inc.
Medtronic Cardiovascular
8200 Coral Sea Street NE, MVS83
Mounds View, MN 55112 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kari Christianson
Senior Regulatory Affairs Specialist
Tel: 763-514-9529
FAX: 763-367-9827
Email: kari.j.christianson@medtronic.com |
Date of Summary
December 04, 2012
Cryosurgical System
Proprietary Name of Device
Cardioblate CryoFlex Surgical Ablation System
Surgical Device, for Ablation of Cardiac Tissue
Common/Usual Name
Classification Name
Class II, per 21 CFR 878.4350
OCL .
Product Code:
Classification
Predicate Device
Cardioblate® CryoFlex® Surgical Ablation System (K121878)
1
II. Device Description
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 |
| Cardioblate CryoFlex Clamp with 10cm Probe | 60CM1 |
| Tank Carrier | 65TC1 |
| Tank Regulator | 67RAXNA |
| Tank Regulator, Refurbished | R67RAXNA |
| 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 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.
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 III.
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.
Comparison to Predicate Devices IV.
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 the addition of an alternate insulative sheath component on the 7cm, 10cm and 10S probes (Models 60SF7, 60SF2, and 60SF3, respectively) and on the clamp with 10cm probe (Model 60CM1).
Summary of Performance Data V.
Verification and validation testing has demonstrated that the Medtronic Cardioblate 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 system is substantially equivalent to the currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is printed in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2013
Medtronic Inc. c/o Ms. Kari Christianson Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE, Mail Stop MVS83 Mounds View, MN 55112
Re: K123733
Trade/Device Name: Cardioblate CryoFlex Surgical Ablation System Regulation Number: 21 CFR 870.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: OCL Dated: February 6, 2013 Received: February 8, 2013
Dear Ms. 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 – Ms. 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 (OS) 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.
Bram D厚ùlokerman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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 CryoFlex 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)
Bram D. Zuckerman
2013.04.01 15:17:16
-04'00'
Page 1 of