(93 days)
No
The summary describes a standard RF ablation device with mechanical and electrical components, and mentions software for the energy platform, but there is no indication of AI or ML being used for analysis, decision-making, or control.
Yes
The device is described as a "surgical ablation device" intended to "ablate cardiac tissue" using radiofrequency energy, producing "linear transmural lesions." These actions directly treat or modify the body, which is the definition of a therapeutic device.
No
The device is described as an ablation device intended to ablate cardiac tissue during surgery, not to diagnose conditions.
No
The device is a hand-held, single-use, bipolar, radio-frequency (RF) ablation device with a saline irrigation system. It is a physical hardware device used in surgery. While it is used with a software-controlled energy platform, the device itself is not software-only.
Based on the provided information, the Cardioblate Gemini-s surgical ablation device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to "ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a surgical tool used for applying energy to tissue. It does not mention analyzing samples of human origin (like blood, urine, tissue samples) outside of the body.
- Mechanism of Action: The device works by delivering RF energy to heat and ablate tissue, a physical process applied directly to the patient. IVDs typically involve chemical, biological, or immunological reactions to analyze samples.
- Performance Studies: The performance studies focus on mechanical, electrical, electromagnetic compatibility, benchtop lesion verification, and usability. These are relevant to a surgical device, not an IVD which would focus on analytical performance (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Cardioblate Gemini-s device is a surgical tool used for treatment, not for analyzing samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Product codes
OCL
Device Description
The Cardioblate Gemini-s surgical ablation device (Model 49351) is a hand-held, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.
The proposed Cardioblate Gemini-s device is intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher.
The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue, both atria of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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
Benchtop Lesion Verification: Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems.
Usability: Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June, 3, 2020
Medtronic Rahul Shah Principal Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K200514
Trade/Device Name: Cardioblate Gemini-s Surgical Ablation Device, Model 49351 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: April 8, 2020 Received: April 10, 2020
Dear Rahul Shah:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K200514
Device Name
Cardioblate Gemini-s Surgical Ablation Device, Model 49351
Indications for Use (Describe)
The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared: | February 28, 2020 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Rahul Shah |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9846 | |
| Email: rahul.m.shah@medtronic.com | |
| Alternate Contact: | Mike Green |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9774 |
Device Name and Classification
| Trade Name: | Cardioblate Gemini-s Surgical Ablation Device, Model 49351 |
|---|---|
| Common Name: | Electrosurgical device |
| Classification name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | OCL |
Email: mike.green@medtronic.com
Name of Predicate Device
K121767 Cardioblate Gemini-s Surgical Ablation Device, Model 49260
Name of Reference Device
| K191601 | Valleylab™ FT10 Energy Platform, Model VLFT10GEN |
|---|---|
| --------- | -------------------------------------------------- |
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Device Description
The Cardioblate Gemini-s surgical ablation device (Model 49351) is a hand-held, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.
The proposed Cardioblate Gemini-s device is intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher.
The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
Indications for Use
The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Contraindications
The Cardioblate Gemini-s surgical ablation device should not be used for:
- Patients that have active endocarditis at time of surgery ●
- . Ablation in a pool of blood (for example, through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)
Comparison to Predicate Devices
When compared to predicate devices (K121767), the Cardioblate Gemini-s Surgical Ablation Device presented in this submission have the same:
5
- Intended Use and Contraindications .
- Technological characteristics and operating principle
- . Design features
- Performance specifications
- Patient contacting components and materials ●
- . Shelf life
- Packaging design and configuration .
When compared to predicate devices (K121767), the Cardioblate Gemini-s Surgical Ablation Device presented in this submission have the following key differences:
- New plug connector for VLFT10GEN compatibility
- IFU, Label and shelf carton branding updates .
- Branding - Medtronic logo print on the handle of Gemini-s
Accessories:
The Cardioblate Gemini-s requires two connections: a fluid connection to the saline source, and an electrical connection to the radio frequency generator (reference device, VLFT10GEN).
The saline source connection is a standard luer connection designed for a commercially available standard saline bag pressurized using a pressure cuff. The electrical connection enables ablation that can be activated/deactivated with the use of a hand switch.
Performance Testing
Performance testing was completed to demonstrate substantial equivalence of the system (the proposed Cardioblate Gemini-s surgical ablation devices, when used with the Valleylab FT10 Energy Platform, software version 3.0 or higher) to the identified predicate. Clinical and nonclinical animal testing was not required to establish substantial equivalence. The subject device underwent the following verification and validation testing, as applicable:
Mechanical: Mechanical verification testing was conducted for components of the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements.
Electrical: Electrical verification testing was conducted for the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements.
Electromagnetic compatibility: Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with current IEC 60601-1-2 standard requirements.
Benchtop Lesion Verification: Comparative lesion verification testing was performedusing a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems.
Usability: Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions.
6
Conclusion
Verification and validation test results demonstrate that the subject devices are substantially equivalent to the predicates cleared in K121767. Differences between the subject and predicate devices do not raise different questions of safety and effectiveness. The intended use of the devices has not changed. Moreover, the fundamental scientific technology, operating principle, and design features are unchanged from that of the predicate.