(90 days)
Not Found
No
The document describes a radiofrequency ablation system and generator, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is intended to ablate soft tissue during general surgery using radiofrequency energy, which is a direct treatment action.
No
Explanation: The device description and intended use clearly state that this system is for abating soft tissue using radiofrequency energy during general surgery, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components including a bipolar Surgical Ablation Device and a Surgical Ablation Generator, which are physical devices that deliver radiofrequency energy.
Based on the provided information, the Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "ablate soft tissue during general surgery using radiofrequency energy." This describes a surgical procedure performed on a patient's tissue, not a test performed on a sample of tissue or body fluid outside the body to diagnose or monitor a condition.
- Device Description: The description details a system for delivering radiofrequency energy to tissue, consisting of a hand-held device and a generator. This aligns with a surgical tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is a surgical device used for therapeutic purposes (tissue ablation), not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode 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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic® Cardioblate® Radiofrequency Ablation System K013392, AtriCure Bipolar System K020919
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 17 2003
510(k) Summary of Safety and Effectiveness
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:
| 510(k) No.: | K031247 |
|---|---|
| Date Prepared: | |
| Submitter: | April 17, 2003 |
| Medtronic, Inc. | |
| Address: | 710 Medtronic Parkway, NE |
| Minneapolis, MN 55432-5604 | |
| Establishment | |
| Registration No. | 2135394 |
| Contact Person: | Scott Cundy |
| Director Regulatory, Clinical & Quality | |
| Telephone Number: | |
| Fax Number: | (763) 391-9941 |
| (763) 391-9279 |
Device Information:
| Trade Name: | Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System | |||||
|---|---|---|---|---|---|---|
| Common Names: | Medtronic® Cardioblate® Bipolar Surgical Ablation System, which consists of: | |||||
| • Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, model 60890 | ||||||
| • Medtronic® Cardioblate® Bipolar Surgical Ablation Device, models 60821 & 60822 | ||||||
| Classification Name: | Electrosurgical Cutting, and Coagulation Device and Accessories | |||||
| Classification: | Class II, 21 CFR 878.4400 | |||||
| Predicate Devices: | Medtronic® Cardioblate® Radiofrequency Ablation System K013392 | |||||
| AtriCure Bipolar System K020919 |
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- Device Description: The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.
- Intended Uses: The Medtronic Cardioblate System is intended to ablate soft tissue during general surgery using radiofrequency energy.
- Contraindications: The Cardioblate® BP Surgical Ablation Device should not be used for patients that have:
Active endocarditis at time of surgery.
Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.
- Nonclinical The performance characteristics of the Medtronic Cardioblate Performance: System were tested and compared to the performance specifications of the listed predicate devices through both bench testing and non-bench analyses.
Substantial For the intended use listed above, the Medtronic Cardioblate Equivanlence System is considered substantially equivalent to the listed Conclusion: predicate devices. The differences that do exist are believed to be minor and not raise any concern regarding the overall safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Mr. Scott Cundy Director Regulatory, Clinical & Quality Medtronic, Inc. 710 Medtronic Parkway, NE Minneapolis, Minnesota 55432-5604
Re: K031247
Trade/Device Name: Medtronic® Cardioblate® Bipolar Radiofrequency Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 17, 2003 Received: April 23, 2003
Dear Mr. Cundy:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 such 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 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.
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Page 2 - Mr. Scott Cundy
This letter will allow you to begin 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Cardioblate® Bipolar Radiofrequency Ablation System 510(k) Number (if known): KO31247
Indications for Use:
The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general 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) |
(optional format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devi
510(k) Number K031247