(113 days)
Not Found
No
The description focuses on the physical mechanism of cryoablation and temperature monitoring, with no mention of AI or ML.
Yes
The device is intended for "treatment of cardiac arrhythmias" by freezing "target tissue and block[ing] the electrical conduction pathways," which directly addresses and treats a medical condition.
No
The device is described as a surgical ablation system intended to block electrical conduction pathways by creating cryonecrosis, which is a treatment, not a diagnostic function. While it monitors temperature, this is for controlling the ablation process, not for diagnosing a condition.
No
The device description explicitly details hardware components such as probes, a clamp, a console, and a connection hose, 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 cardiac tissue.
- Device Description: The device is a "surgical ablation system" that "freeze[s] target tissue and block[s] the electrical conduction pathways." This is a therapeutic action performed on the patient's body.
- Anatomical Site: The anatomical site is "cardiac tissue," which is within the patient's body.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status. This device operates in vivo (within the body) to treat a condition.
N/A
Intended Use / Indications for Use
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.
Product codes
OCL
Device Description
The Medtronic Cardioblate™ CryoFlex™ Console, Cardioblate™ CryoFlex™ surgical ablation probes, and accessories are used together as a system. The system is comprised of the following components:
K123733 - 65CS1 Cardioblate™ CryoFlex™ Surgical Ablation Console
R65CS1 Cardioblate™ CryoFlex™ Surgical Ablation Console, Refurbished
60SF2 Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10 cm
60SF3 Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10-S cm
60SF7 Cardioblate™ CryoFlex™ Surgical Ablation Probe, 7 cm
60CM1 Cardioblate™ CryoFlex™ Surgical Ablation Probe with Clamp, 10 cm
Clearance Date: 01-Apr-2013 - 67RAXNA Tank Regulator
R67RAXNA Tank Regulator, Refurbished
65TC1 Tank Carrier
67H08 Gas Hose
671PCNA Power Cord, North America
67PS6 Pressure Transducer Cable, 6ft
System Overview
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.
Cardioblate™ CryoFlex™ Surgical Ablation Probes
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.
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
Minimally invasive cardiac surgical procedures / operating room
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)
Not Found
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
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2019
Medtronic, Inc. Choua Thao Senior Regulatory Affairs Specialist 3800 Annapolis Lane Plymouth, Minnesota 55447
Re: K191526
Trade/Device Name: Cardioblate CryoFlex Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: July 2, 2019 Received: July 5, 2019
Dear Choua Thao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191526
Device Name
Cardioblate CryoFlex Surgical Ablation System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.2, Subpart B) |
|---|
| On-The-Counter Use (21 CFR 201.2, Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5.0 510(k) Summary of Safety and Effectiveness
| Date Prepared: | June 7, 2019 |
|---|---|
| Submitter: | Medtronic, Inc. |
| 3800 Annapolis Lane | |
| Minneapolis, MN 55447 | |
| Establishment Registration Number: 3008592544 | |
| Contact Person(s): | Choua Thao |
| Senior Regulatory Affairs Specialist | |
| Medtronic Cardiac Surgery | |
| Phone: 763.514.9842 | |
| Email: choua.thao@medtronic.com | |
| Alternate Contact: | |
| Mike Green | |
| Senior Regulatory Affairs Manager | |
| Medtronic Cardiac Surgery | |
| Phone: 763.514.9774 | |
| Email: mike.green@medtronic.com | |
| Device Name and Classification | |
| Trade Name: | Cardioblate™ CryoFlex™ Surgical Ablation System |
| Common Name: | Cryosurgical System |
| Product Code: | OCL |
| Common Name: | Cryosurgical System |
|---|---|
| Product Code: | OCL |
| Regulation Number: | 21 CFR 878.4400 |
| Product Classification: | Class II |
| Classification Name: | Surgical Device, for Ablation of Cardiac Tissue |
Predicate Device
Cardioblate™ CryoFlex™ Surgical Ablation System
4
Device Description
System and Accessories
The Medtronic Cardioblate™ CryoFlex™ Console, Cardioblate™ CryoFlex™ surgical ablation probes, and accessories are used together as a system. The system is comprised of the following components:
| 510(k) Number &
| Clearance Date | Model Number | Device Description |
|---|---|---|
| K123733 | 65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console |
| R65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console, | |
| Refurbished | ||
| 60SF2 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10 cm | |
| 60SF3 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10-S cm | |
| 60SF7 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 7 cm | |
| 60CM1 | Cardioblate™ CryoFlex™ Surgical Ablation Probe with | |
| Clamp, 10 cm | ||
| Clearance Date: | ||
| 01-Apr-2013 | 67RAXNA | Tank Regulator |
| R67RAXNA | Tank Regulator, Refurbished | |
| 65TC1 | Tank Carrier | |
| 67H08 | Gas Hose | |
| 671PCNA | Power Cord, North America | |
| 67PS6 | Pressure Transducer Cable, 6ft |
Table 5-1: Cardioblate™ CryoFlex™ Surgical Ablation Probes, Console, and Accessories
System Overview
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.
Cardioblate™ CryoFlex™ Surgical Ablation Probes
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.
5
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.
| Indications for Use | |
|---|---|
| 60SF2, 60SF3, 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. | |
| 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 |
Contraindications
The Cardioblate™ CryoFlex™ surgical ablation probe is not designed for use inside a beating heart.
Comparison to Predicate Devices
The Medtronic Cardioblate™ CryoFlex™ Surgical Ablation System is substantially equivalent to the predicate surgical ablation system (K123733). A comparison of the proposed modified devices to the currently marketed predicate devices indicates the following similarities:
- Same intended use ●
- Same technological characteristics ●
- Same shelf life ●
- Same operating principle ●
- Substantially equivalent material ●
- The connector of the Cardioblate™ CryoFlex™ Surgical Ablation Probe is changing; therefore, new components are necessary for the updated design
- Substantially equivalent design features ●
- The internal design feature of the probe is not changing (the electrical contacts are still in physical contact with the console); only the external design is changing, the new design allows for easier one-handed attachment and removal of the probe to the console connector
6
| Device Characteristics and
Features | Predicate
(K123733) | This Submission
(K191526) | Substantial
Equivalence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------|
| | Cardioblate™ CryoFlex™
Disposable Probes | Cardioblate™ CryoFlex™
Disposable Probes | |
| Therapy Delivery | | | |
| Facilitates pneumatic connection
to the console | ✓ | ✓ | Yes |
| Secures the electrical connection
of the probe's thermocouple to the
console | ✓ | ✓ | Yes |
| Argon gas is transferred from the
console through the pneumatic
stem in the connector and into the
probe to provide a cooling effect | ✓ | ✓ | Yes |
| User Interface | | | |
| Same console connection port | ✓ | ✓ | Yes |
| Connection to console | ✓ | ✓ | Yes |
| Pneumatic stem that locks into a
female quick disconnect fitting on
the console | ✓ | ✓ | Yes |
| Connectors are pushed onto the
console to form the connection and
a pin must be removed prior to use | ✓ | ✓ | Yes |
| External Pull Pin | ✓ | ✓ | Yes |
| Connector is removed by
achieving both hands by
depressing the "clips" with one
hand and retracting the console's
female quick disconnect fitting
with the other hand | ✓ | --- | Yes |
| Connector is removed by using a
single hand by depressing a button
that automatically rises during
connection | --- | ✓ | Yes |
| Connector | Image: blue connector | Image: blue connector | Yes |
Table 5-2: Device Characteristics and Features Summary
Conclusion
In conclusion, the information included in this submission demonstrates that the Cardioblate™ CryoFlex™ surgical ablation probe, with the updated connector to facilitate gas connection and disconnection to the console is substantially equivalent to the legally marketed predicate devices.