(102 days)
Not Found
No
The document describes a radiofrequency ablation system that delivers controlled energy. There is no mention of AI, ML, image processing, or any data-driven decision-making processes typically associated with AI/ML in medical devices. The performance studies focus on comparing the system to predicate devices through bench and non-bench analyses, not on evaluating the performance of an AI/ML algorithm.
Yes
The "Intended Use / Indications for Use" states the device is "intended to ablate cardiac tissue during cardiac surgery," which describes a therapeutic action.
No
The device is described as an ablation system used to ablate cardiac tissue, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly lists hardware components: a radiofrequency ablation pen and a radiofrequency generator.
Based on the provided information, the Medtronic® Cardioblate™ Radiofrequency Ablation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during cardiac surgery using radiofrequency energy." This describes a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details a system for delivering energy to tissue during surgery. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Cardioblate System's function is to physically alter tissue during surgery, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes
OCL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac surgery
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
The performance characteristics of the Medtronic Cardioblate System were tested and compared to the performance specifications of the listed predicate devices through both bench testing and non-bench analyses.
Key Metrics
Not Found
Predicate Device(s)
K010662, K010956, K011040, K003978, K921884
Reference Device(s)
Not Found
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
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, 2002
Medtronic, Inc. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 710 Medtronic Parkway, NE
Minneapolis, MN 55432-5604 |
| Establishment
Registration No. | 2135394 |
| Contact Person: | Scott Cundy
Sr. 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™ Surgical
Ablation Pen & Cardioblate™ Surgical Ablation Generator |
| Classification Name:
Classification: | Electrosurgical Cutting, and Coagulation Device and Accessories
Class II, 21 CFR 878.4400 |
| Predicate Devices: | TissueLink™ Floating Ball (K010662), Boston Scientific Cobra
RF System (K010956), EndoCare Cryocare Cardiac Surgical
System (K011040), AFx Microwave Flex Ablation Wand System
(K003978), and ValleyLab Force 2 Electrosurgical Generator
(K921884). |
| Device Description: | 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 |
radiofrequency energy that is required for the creation of linear lesions during open-heart surgery. The Cardioblate Generator
1
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.
2
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.
3
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
4
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.
(Please do not Write below this line - continue on another page if needed)
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)