(136 days)
Not Found
No
The summary describes a radiofrequency ablation system with a generator and hand-held devices, and there is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is intended to ablate cardiac tissue, which is a therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to ablate cardiac tissue," which is a treatment or modification of tissue, not a diagnosis.
No
The device description explicitly states it consists of a reusable radiofrequency generator and hand-held ablation devices, which are hardware components.
Based on the provided information, the Medtronic Cardioblate® System is not an IVD (In Vitro Diagnostic) device.
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 (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details a generator and hand-held devices that deliver energy to tissue. This aligns with a surgical tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
Therefore, the Medtronic Cardioblate® System is a surgical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Medtronic Cardioblate® Surgical Ablation System consists of a reusable radiofrequency generator which can be connected to hand-held monopolar or bipolar radiofrequency devices. The ablation devices are sterile, single-use devices operating in either monopolar or bipolar mode that deliver radiofrequency energy to the selected tissue.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and performance bench test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Biocompatibility Testing
- Accelerated Aging Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Cardioblate® Surgical Ablation System (K080509)
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
K093203 1/2
Special 510(k) BP2 Satine Line Modification
FEB 2 6 2010
510(k) Summary ·
| Date Prepared | October 9, 2009 |
|---|---|
| Submitter | Medtronic |
| 710 Medtronic Parkway NE | |
| Minneapolis, MN 55432-5604 | |
| Establish Registration Number: 2135394 | |
| Contact Person | Mary E. Donlin |
| Senior Regulatory Affairs Specialist | |
| Phone: (763) 526-9172 | |
| Fax: (763) 367-8147 | |
| Email: mary.e.donlin@medtronic.com |
and the control control of the control of the control of
Device Name and Classification
| Trade Name: | Cardioblate® Surgical Ablation System |
|---|---|
| Common/Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Classification: | Class II |
Predicate Device
Cardioblate® Surgical Ablation System (K080509)
Device Description
The Medtronic Cardioblate® Surgical Ablation System consists of a reusable radiofrequency generator which can be connected to hand-held monopolar or bipolar radiofrequency devices. The ablation devices are sterile, single-use devices operating in either monopolar or bipolar mode that deliver radiofrequency energy to the selected tissue.
Indications for Use
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
1
KU93203 2/2
Comparison to Predicate Device
A comparison of the modified product and the currently marketed surgical ablation device has the following similarities to the system which received 510(k) clearance:
- · Same indicated use
- · Same operating principle
- · Same radiofrequency generator and delivery system
- · Similar patient-contacting materials, with the exception of the change in PVC formulation to remove DEHP
- · Same shelf life for disposables
- · Patient-contacting devices are packaged and sterilized using identical materials and processes
Labeling and Intended Use
The labeling and intended use are unchanged as a result of the modification to the saline line cable assembly. The Instructions for Use and Labeling can be provided upon request.
Summary of Performance Data
Biocompatibility and performance bench test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were condusted:
- . Biocompatibility Testing
- . Accelerated Aging Study
Conclusion
The modifications to the saline line cable assembly used with the Cardioblate® Surgical Ablation device described in this submission result in a substantially equivalent device beauxe the fundamental scientific principle, labeling, and the intended use are unchanged as a result of these device modifications.
2
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 2 6 2010
Medtronic Cardiovascular c/o Mary E. Donlin Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K093203
Trade/Device Name: Cardioblate Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 29, 2009 Received: January 29, 2010
Dear Ms. Donlin:
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, 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
3
Paqe 2 ~ Ms. Mary E. Donlin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K093203 1/1
Special 510(k) BP2 Saline Line Modification
INDICATIONS FOR USE STATEMENT
5 10(k) Number:
Cardioblate Surgical Ablation System, consisting of the Cardioblate®68000 Generator (K060400) and the following ablation devices: Cardioblate®BP2 Surgical Ablation Device, Model 60831 and 68031 (K060400 & K080509) Cardioblate®LP Surgical Ablation Device, Model 60841 (K060400)
Indications for use:
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
- These devices are already labeled with the proposed indication statement. .
OR
Prescription Use X (Part 21 CPR 801 Subpart D) Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.R.M.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093203