(113 days)
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.
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.
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.
This document is a 510(k) premarket notification for the Cardioblate CryoFlex Surgical Ablation System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K123733), specifically regarding an updated connector design. As such, it does not describe a clinical study to establish performance against acceptance criteria in the context of disease diagnosis or treatment effectiveness. Instead, the "study" described is a comparison of device characteristics to establish substantial equivalence.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a modification (updated connector design) to a previously cleared device, the "acceptance criteria" are based on demonstrating that the modified device maintains the same fundamental characteristics and performance as the predicate. The performance is reported in terms of substantial equivalence.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (K191526 vs. K123733) |
|---|---|
| Same intended use | Yes |
| Same technological characteristics | Yes |
| Same shelf life | Yes |
| Same operating principle | Yes |
| Substantially equivalent material | Yes (except for connector, which is new but stated as substantially equivalent) |
| Substantially equivalent design features | Yes (internal design unchanged, external design changed for easier handling) |
| Facilitates pneumatic connection to the console | Yes |
| Secures the electrical connection of the probe's thermocouple to the console | Yes |
| Argon gas transferred from console through pneumatic stem into probe for cooling | Yes |
| Same console connection port | Yes |
| Connection to console | Yes |
| Pneumatic stem locks into female quick disconnect fitting on console | Yes |
| Connectors pushed onto console to form connection, pin removed prior to use | Yes |
| External Pull Pin mechanism (predicate only) | Yes (predicate had it, new device does not as mechanism is changed) |
| Connector removed by two hands (predicate only) | Yes (predicate only) |
| Connector removed by one hand via button (new device only) | Yes (new device only) |
| Connector appearance (blue) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
No test set in the traditional sense of patient data is described. The "test" is a comparison of the modified device's technical specifications and functionality to the predicate device. The provenance of this comparison data is from the manufacturer, Medtronic, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There is no "ground truth" related to disease diagnosis or treatment outcome established by experts in this submission. The ground truth for the comparison is the existing design and performance of the predicate device, against which the modified device is assessed.
4. Adjudication Method for the Test Set
Not applicable. There's no clinical trial or expert review of cases described to require an adjudication method. The assessment is a direct comparison of engineering and design characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for a device modification, not an AI-based diagnostic or therapeutic aid requiring MRMC studies to assess human reader improvement.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a surgical ablation system, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" implicitly used for this submission is the established performance and safety profile of the legally marketed predicate device (K123733). The submission aims to demonstrate that the modified device's characteristics are "substantially equivalent" to this existing ground truth.
8. Sample Size for the Training Set
Not applicable. This is a hardware modification submission, not an AI algorithm development. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
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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
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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 (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
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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) |
|---|
| ------------------------------------------------- |
| 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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5.0 510(k) Summary of Safety and Effectiveness
| Date Prepared: | June 7, 2019 |
|---|---|
| Submitter: | Medtronic, Inc.3800 Annapolis LaneMinneapolis, MN 55447Establishment Registration Number: 3008592544 |
| Contact Person(s): | Choua ThaoSenior Regulatory Affairs SpecialistMedtronic Cardiac SurgeryPhone: 763.514.9842Email: choua.thao@medtronic.com |
| Alternate Contact:Mike GreenSenior Regulatory Affairs ManagerMedtronic Cardiac SurgeryPhone: 763.514.9774Email: 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
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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 &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 withClamp, 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.
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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 forminimally invasive cardiac surgical procedures, including thetreatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm,10 cm, and 10-S probes and the Surgical Ablation Console freezetarget tissue and block the electrical conduction pathways bycreating an inflammatory response and cryonecrosis. |
| 60CM1: | The Cardioblate CryoFlex Surgical Ablation System is intended forminimally invasive cardiac surgical procedures, including thetreatment of cardiac arrhythmias. The Cardioblate CryoFlex Clampand Surgical Ablation Probe and the Surgical Ablation Consolefreeze target tissue and block the electrical conduction pathways bycreating 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 andFeatures | Predicate(K123733) | This Submission(K191526) | SubstantialEquivalence |
|---|---|---|---|
| Cardioblate™ CryoFlex™Disposable Probes | Cardioblate™ CryoFlex™Disposable Probes | ||
| Therapy Delivery | |||
| Facilitates pneumatic connectionto the console | ✓ | ✓ | Yes |
| Secures the electrical connectionof the probe's thermocouple to theconsole | ✓ | ✓ | Yes |
| Argon gas is transferred from theconsole through the pneumaticstem in the connector and into theprobe to provide a cooling effect | ✓ | ✓ | Yes |
| User Interface | |||
| Same console connection port | ✓ | ✓ | Yes |
| Connection to console | ✓ | ✓ | Yes |
| Pneumatic stem that locks into afemale quick disconnect fitting onthe console | ✓ | ✓ | Yes |
| Connectors are pushed onto theconsole to form the connection anda pin must be removed prior to use | ✓ | ✓ | Yes |
| External Pull Pin | ✓ | ✓ | Yes |
| Connector is removed byachieving both hands bydepressing the "clips" with onehand and retracting the console'sfemale quick disconnect fittingwith the other hand | ✓ | --- | Yes |
| Connector is removed by using asingle hand by depressing a buttonthat automatically rises duringconnection | --- | ✓ | 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.
§ 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.