(28 days)
Not Found
No
The summary describes a physical surgical ablation device and does not mention any software features, data processing, or AI/ML terms.
Yes
The device is intended to ablate cardiac tissue during surgery, which is a therapeutic intervention.
No
Explanation: The device is described as an ablation device used to ablate cardiac tissue during surgery, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "hand-held, single-use, bipolar, radiofrequency ablation device" with a "saline irrigation system," indicating it is a physical hardware device that delivers energy.
Based on the provided information, the Cardioblate® Gemini® Surgical Ablation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "ablate cardiac tissue during cardiac surgery using radiofrequency energy." This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on a sample taken from the patient's body.
- Device Description: The description details a surgical tool for tissue ablation, not a device for analyzing biological samples.
- 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, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
In summary, the Cardioblate® Gemini® Surgical Ablation Device is a surgical device used for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Product codes
OCL
Device Description
The Medtronic Cardioblate® Gemini® Surgical Ablation Device is a hand-held, single-use, bipolar, radiofrequency ablation device intended to ablate cardiac tissue during 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 radiofrequency energy delivery and is intended for intermittent operation. Two unique jaw curvatures are provided: a standard curve (Model 49260) and extra curve (Model 49261). The device is provided sterile, nonpyrogenic, disposable, and for single use only.
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
Not Found
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)
Not Found
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.
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) Summary of Safety and Effectiveness | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------- |
| Date Prepared: | June 14, 2012 |
|---|---|
| Applicant: | Medtronic, Inc. |
| 710 Medtronic Parkway, NE | |
| Minneapolis, MN 55432-5604 | |
| Establishment Registration No. 2135394 | |
| Contact Person: | Mary Donlin |
| Senior Regulatory Affairs Specialist | |
| Phone: (763) 526-9172 | |
| Fax: (763) 367-8147 | |
| E-mail: mary.e.donlin@medtronic.com | |
| Trade Name: | Cardioblate® Gemini® Surgical Ablation Device, Models 49260/49261 |
| (K080509) | |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification: | Class II, 21 CFR 878.4400 |
| Product Code: | OCL |
| Name of Predicate Device: | Cardioblate® Gemini® Surgical Ablation Device, Models 49260/49261 |
| (K080509) |
Device Description:
The Medtronic Cardioblate® Gemini® Surgical Ablation Device is a hand-held, single-use, bipolar, radiofrequency ablation device intended to ablate cardiac tissue during 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 radiofrequency energy delivery and is intended for intermittent operation. Two unique jaw curvatures are provided: a standard curve (Model 49260) and extra curve (Model 49261). The device is provided sterile, nonpyrogenic, disposable, and for single use only.
Intended Use:
The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Page 1 of 2
Section 5-1
Cardioblate® Gemini® Surgical Ablation Device Medtronic Confidential
1
Contraindications:
The Cardioblate® Gemini® Surgical Ablation Device should not be used for patients that have active endocarditis at time of surgery. The device is contraindicated for ablation in a pool of blood (e.g. through a purse string suture on a beating heart). Effects of this type of ablation have not been studied.
Substantial Equivalence:
The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indication process. None required clinical evidence to evaluate impact to safety and effectiveness. The changes were considered to be routine changes to maintain or improve device performance based on internal or external feedback. The information generated as part of design verification and validation activities or technical assessments confirmed these changes did not adversely affect the device's safety or effectiveness.
Conclusion:
The modifications to the Cardioblate® Gemini® Surgical Ablation Device, described in this submission, have not altered the fundamental scientific technology or indications for use of the device. The current device is substantially equivalent to the previously submitted and approved predicate Cardioblate® Gemini® Surgical Ablation Device, Models 49260/49261 (K080509).
Page 2 of 2
Section 5-2
Cardioblate® Gemini® Surgical Ablation Device Medtronic Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUI 1 3 2012
Medtronic, Inc. · c/o Ms. Mary Donlin Senior Regulatory Affairs Specialist 710 Medtronic Parkway, NE Minneapolis, MN 55432
Re: K121767
Trade/Device Name: Cardioblate Gemini Surgical Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II (two) Product Code: OCL Dated: June 14, 2012 Received: June 15, 2012
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 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 - Ms. Mary Donlin
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,
Brad D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K121767
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Cardioblate Gemini Surgical Ablation Device
Indications For Use:
The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
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510(k) Number K121767
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