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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s Surgical Ablation Device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/ML-enabled diagnostic device.

Therefore, the information required to answer your specific questions about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies is not present in this document. This submission is for an electrosurgical device, not an AI software.

However, I can extract and structure the information that is available regarding performance testing to show what kind of "acceptance criteria" and "study" were relevant for this type of device based on its nature.

Based on the provided Medtronic 510(k) Summary for the Cardioblate Gemini-s Surgical Ablation Device (K200514), here's what can be inferred about its "acceptance criteria" and "study" for regulatory approval:

Core Principle for Approval: The primary "acceptance criterion" for this Class II device, as outlined in the 510(k) process, is demonstrating substantial equivalence to a legally marketed predicate device (K121767 Cardioblate Gemini-s Surgical Ablation Device, Model 49260). This means the device must perform as safely and effectively as the predicate, and any differences must not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Since this is a substantial equivalence submission for an electrosurgical device, the "acceptance criteria" are not reported as quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they are related to compliance with relevant standards and demonstrating comparable performance to the predicate.

Acceptance Criterion (Inferred from Performance Testing)	Reported Device Performance (Summary)
Mechanical Compliance: Adherence to IEC 60601-1 and IEC 60601-2-2 standards.	"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." (Implies successful compliance)
Electrical Compliance: Adherence to IEC 60601-1 and IEC 60601-2-2 electrical requirements.	"Electrical verification testing was conducted for the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements." (Implies successful compliance)
Electromagnetic Compatibility (EMC): Adherence to IEC 60601-1-2 standard.	"Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with current IEC 60601-1-2 standard requirements." (Implies successful compliance)
Benchtop Lesion Verification: Ablation performance comparable to predicate.	"Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems." (Implies successful demonstration of equivalence)
Usability: Verification and validation of usability requirements.	"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." (Implies successful verification and validation)
Overall Substantial Equivalence: No new questions of safety or effectiveness.	"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." (This is the overarching conclusion of the submission, affirming all "acceptance criteria" for substantial equivalence were met.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an AI test set. For the benchtop lesion verification, the "sample size" would likely refer to the number of ablation attempts or tissue samples tested. This number is not provided.
Data Provenance: The studies were non-clinical performance tests (mechanical, electrical, EMC, benchtop lesion verification, usability). They were not based on patient data in the sense of retrospective or prospective clinical studies. The "data" comes from engineering and benchtop laboratory testing.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable: This type of submission relies on engineering and laboratory testing against established standards and predicate device performance, not expert human image interpretation to establish ground truth for an AI algorithm. Therefore, there's no mention of experts or their qualifications for ground truth establishment in this context.

4. Adjudication Method for the Test Set:

Not Applicable: There is no "test set" in the sense of a dataset requiring human adjudication for ground truth for an AI algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No: An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This device is an electrosurgical tool, not an AI diagnostic, so an MRMC study was not performed or necessary.

6. If a Standalone (Algorithm Only) Performance Study was Done:

Not Applicable: This is an electrosurgical device, not an AI algorithm. The performance studies evaluate the physical device's specifications and capabilities.

7. The Type of Ground Truth Used:

Engineering Standards and Predicate Performance: The "ground truth" for this device's performance is compliance with established international standards (IEC 60601 series) for medical electrical equipment, and demonstrably equivalent performance to the predicate device in terms of mechanical function, electrical safety, EMC, and the ability to create lesions in a soft tissue model.

8. The Sample Size for the Training Set:

Not Applicable: This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable: As there is no training set for an AI/ML model, this question does not apply.

In summary: The provided document is a 510(k) submission for a physical medical device (an electrosurgical ablation device) seeking clearance based on substantial equivalence to a predicate. The "acceptance criteria" and "studies" described primarily involve engineering and benchtop testing to demonstrate compliance with standards and comparable performance to the existing predicate device, rather than the rigorous clinical validation methodology (including AI-specific elements like ground truth establishment, expert adjudication, and MRMC studies) that would be required for an AI/ML software as a medical device (SaMD).

Summary

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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

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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)

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 Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Rahul ShahPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.514.9846Email: rahul.m.shah@medtronic.com
Alternate Contact:	Mike GreenSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 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 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.

Indications for Use

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:

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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.

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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.

Regulation Number and Section

§ 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.