(102 days)
The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Medtronic Cardioblate System is comprised of a radiofrequency ablation pen, radiofrequency generator, and accessories for the application of radiofrequency energy to tissue. The Cardioblate Pen is a hand-held, unipolar, radiofrequency surgical ablation pen for use during open-heart surgery. The Cardioblate Generator is capable of delivering the controlled radiofrequency energy that is required for the creation of linear lesions during open-heart surgery. The Cardioblate Generator delivers up to 50 Watts to the delivery device with a 20 - 500 Ohm range.
The Medtronic Cardioblate Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The device met acceptance criteria by demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Substantial equivalence to predicate devices regarding performance characteristics for intended use. | Performance characteristics tested and compared to predicate device specifications. Differences deemed minor and not raising concerns for safety and effectiveness. | Bench testing and non-bench analyses |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify a "test set" in the context of patient data. The device's performance was evaluated through "bench testing and non-bench analyses" against specifications of predicate devices. This suggests engineering or laboratory testing rather than a clinical study with a patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study involved non-clinical performance testing against predicate device specifications, not expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. The study involved non-clinical performance testing, not a clinical trial requiring adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on non-clinical performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance evaluation was of the device itself (radiofrequency ablation system) in a non-clinical setting, without a human operator performing interpretations or making decisions that would be part of a "human-in-the-loop" clinical scenario for an AI device. However, this is not an AI device, so the concept of "standalone" algorithm performance as typically applied to AI is not directly relevant. The "standalone" performance here refers to the device's ability to meet its technical specifications.
7. The Type of Ground Truth Used
The "ground truth" for the performance study was the performance specifications of the legally marketed predicate devices. The Cardioblate System's performance was compared to these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a "training set." Its performance was evaluated through engineering and laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no "training set" for this device.
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510(k) Premarket Submission - Medtronic, Inc. - Cardioblate™ System
KO13392
510(k) Summary of Safety and Effectiveness
JAN 2 5 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Application Information:
...
| Date Prepared:Submitter: | January 8, 2002Medtronic, Inc. |
|---|---|
| Address: | 710 Medtronic Parkway, NEMinneapolis, MN 55432-5604 |
| EstablishmentRegistration No. | 2135394 |
| Contact Person: | Scott CundySr. Regulatory and Quality Manager |
| Telephone Number:Fax Number: | (763) 391-9941(763) 391-9279 |
| Device Information: | |
| Trade Name: | Medtronic® Cardioblate™ Radiofrequency Ablation System |
| Common Names: | Cardioblate™ System, which is made up of Cardioblate™ SurgicalAblation Pen & Cardioblate™ Surgical Ablation Generator |
| Classification Name:Classification: | Electrosurgical Cutting, and Coagulation Device and AccessoriesClass II, 21 CFR 878.4400 |
| Predicate Devices: | TissueLink™ Floating Ball (K010662), Boston Scientific CobraRF System (K010956), EndoCare Cryocare Cardiac SurgicalSystem (K011040), AFx Microwave Flex Ablation Wand System(K003978), and ValleyLab Force 2 Electrosurgical Generator(K921884). |
| Device Description: | The Medtronic Cardioblate System is comprised of aradiofrequency ablation pen, radiofrequency generator, andaccessories for the application of radiofrequency energy to tissue.The Cardioblate Pen is a hand-held, unipolar, radiofrequencysurgical ablation pen for use during open-heart surgery.The Cardioblate Generator is capable of delivering the controlledradiofrequency energy that is required for the creation of linear |
radiofrequency energy that is required for the creation of linear lesions during open-heart surgery. The Cardioblate Generator
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14.1 1
delivers up to 50 Watts to the delivery device with a 20 - 500 Ohm range.
The Medtronic Cardioblate System is intended to ablate cardiac Intended Uses: tissue during cardiac surgery using radiofrequency energy.
The Medtronic Cardioblate System is contraindicated for patients Contraindications: with active systemic infection or patients that have active endocarditis at time of surgery.
- The performance characteristics of the Medtronic Cardioblate Nonclinical System were tested and compared to the performance Performance: specifications of the listed predicate devices through both bench testing and non-bench analyses.
For the intended use listed above, the Medtronic Cardioblate Substantial System is considered substantially equivalent to the listed Equivanlence predicate devices. The differences that do exist are believed to be Conclusion: minor and not raise any concern regarding the overall safety and effectiveness.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Mr. Scott Cundy Senior Product Regulation Manager Medtronic Cardiac Surgery Technologies 7601 Northland Drive Minneapolis, MN 55428
Re: K013392
Trade/Device Name: Medtronic ® Cardioblate™ Radiofrequency Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: January 8, 2002 Received: January 10, 2002
Dear Mr. Cundy:
This letter corrects our substantially equivalent letter of January 25, 2002.
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 (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. 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.
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.
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Page 2 - Mr. Scott Cundy
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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Q.mall.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Cardioblate Radiofrequency Ablation System 510(k) Number (if known): K013392
Indications for Use:
The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: or Prescription Use: ✔ (Per 21 CFR 801.109)
Mark n-Millersen
eral, Rest Lative Division ological Device
510(k) Number
(optional format 1-2-96)
§ 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.