Cardioblate CryoFlex Surgical Ablation System

K191526 · Medtronic, Inc. · OCL · Oct 1, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191526
• Device Name: Cardioblate CryoFlex Surgical Ablation System
• Applicant: Medtronic, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Oct 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. 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.

Device Story

Argon-based cryosurgical system; includes console, disposable probes, and clamp. Probes feature malleable stainless steel shafts and bellows-configured ablation segments with integrated thermocouples. Surgeon shapes probe shaft for stability in operating field; insulative sleeve adjusts ablation zone size. System uses argon gas for rapid, controlled freezing of target cardiac tissue; creates inflammatory response and cryonecrosis to block electrical conduction pathways. Used in minimally invasive cardiac surgery; operated by surgeons in OR. Probe connects to console via pneumatic hose; updated connector design allows one-handed attachment/removal. Output is localized tissue freezing; enables treatment of arrhythmias. Benefits include controlled, effective ablation of cardiac tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing of the updated connector design and comparison of technological characteristics to the predicate.

Technological Characteristics

Argon-based cryosurgical system. Probes constructed from heat-treated stainless steel. Features include integrated thermocouples for temperature monitoring, malleable shafts, and bellows-configured ablation segments. Connectivity via pneumatic hose and electrical connection to console. Single-use, sterile, non-reusable. Updated connector design for one-handed operation.

Indications for Use

Indicated for patients undergoing minimally invasive cardiac surgical procedures requiring treatment of cardiac arrhythmias. Contraindicated for use inside a beating heart.

Regulatory Classification

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.

Predicate Devices

• Cardioblate™ CryoFlex™ Surgical Ablation System (K123733)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> Registration Use (Part 21 CFR 201.2, Subpart B) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> 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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# 5.0 510(k) Summary of Safety and Effectiveness

| Date Prepared: | June 7, 2019 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>3800 Annapolis Lane<br>Minneapolis, MN 55447<br>Establishment Registration Number: 3008592544 |
| Contact Person(s): | Choua Thao<br>Senior Regulatory Affairs Specialist<br>Medtronic Cardiac Surgery<br>Phone: [phone]<br>Email: [e-mail] |
| | Alternate Contact:<br>Mike Green<br>Senior Regulatory Affairs Manager<br>Medtronic Cardiac Surgery<br>Phone: [phone]<br>Email: [e-mail] |
| 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

K123733

Cardioblate™ CryoFlex™ Surgical Ablation System

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# 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 &<br>Clearance Date | Model Number | Device Description |
|-----------------------------------|--------------|---------------------------------------------------------------------|
| K123733 | 65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console |
| | R65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console,<br>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<br>Clamp, 10 cm |
| Clearance Date:<br>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.

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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<br>minimally invasive cardiac surgical procedures, including the<br>treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm,<br>10 cm, and 10-S probes and the Surgical Ablation Console freeze<br>target tissue and block the electrical conduction pathways by<br>creating an inflammatory response and cryonecrosis. |
| 60CM1: | The Cardioblate CryoFlex Surgical Ablation System is intended for<br>minimally invasive cardiac surgical procedures, including the<br>treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp<br>and Surgical Ablation Probe and the Surgical Ablation Console<br>freeze target tissue and block the electrical conduction pathways by<br>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

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| Device Characteristics and<br>Features | Predicate<br>(K123733) | This Submission<br>(K191526) | Substantial<br>Equivalence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------|
| | Cardioblate™ CryoFlex™<br>Disposable Probes | Cardioblate™ CryoFlex™<br>Disposable Probes | |
| Therapy Delivery | | | |
| Facilitates pneumatic connection<br>to the console | ✓ | ✓ | Yes |
| Secures the electrical connection<br>of the probe's thermocouple to the<br>console | ✓ | ✓ | Yes |
| Argon gas is transferred from the<br>console through the pneumatic<br>stem in the connector and into the<br>probe to provide a cooling effect | ✓ | ✓ | Yes |
| User Interface | | | |
| Same console connection port | ✓ | ✓ | Yes |
| Connection to console | ✓ | ✓ | Yes |
| Pneumatic stem that locks into a<br>female quick disconnect fitting on<br>the console | ✓ | ✓ | Yes |
| Connectors are pushed onto the<br>console to form the connection and<br>a pin must be removed prior to use | ✓ | ✓ | Yes |
| External Pull Pin | ✓ | ✓ | Yes |
| Connector is removed by<br>achieving both hands by<br>depressing the "clips" with one<br>hand and retracting the console's<br>female quick disconnect fitting<br>with the other hand | ✓ | --- | Yes |
| Connector is removed by using a<br>single hand by depressing a button<br>that automatically rises during<br>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.