(70 days)
Not Found
No
The summary describes a radiofrequency ablation system with a generator and hand-held devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on safety and effectiveness in creating electrical conduction blocks, not on AI/ML performance metrics.
Yes
The device is intended to "ablate cardiac tissue," which is a direct treatment of a medical condition.
No
The device is used to ablate cardiac tissue, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states that the system 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 In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during general surgery using radiofrequency energy." This describes a therapeutic procedure performed directly on a patient's internal tissue, not a test performed on samples taken from the body (which is the hallmark of IVDs).
- Device Description: The device consists of a generator and hand-held ablation devices that deliver energy to tissue. This aligns with surgical tools used for treatment, not diagnostic testing.
- Anatomical Site: The device is used on "cardiac tissue," which is part of the living patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue biopsies, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cardioblate System is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Cardioblate® Surgical Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during general surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OCL
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 ablation devices. The ablation devices are sterile, single-use devices, operating in either monopolar or bipolar mode, that deliver the 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
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)
Verification and validation testing has demonstrated that all components of the Cardioblate Surgical Ablation System are safe and effective. Clinical data demonstrating the acute safety and ability of the device to create lines of electrical conduction block in the heart as assessed intraoperatively are provided to support the indication.
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
(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92) MAY - 5 2008
Applicant Information: I.
| Date Prepared: | February 22, 2008 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Address: | Medtronic Cardiac Surgical Technologies |
| 7601 Northland Drive N. | |
| Brooklyn Park, MN 55428-1088 | |
| Establishment | |
| Registration No. | 2135394 |
| Contact Person: | Julia Nelson |
| Principal Regulatory Affairs Specialist | |
| Telephone Number: | (763) 391-9183 |
| Fax Number: | (763) 391-9259 |
II. Device Information:
| Trade Name: | Cardioblate® Surgical Ablation System |
|---|---|
| Common Name: | Cardioblate® Surgical Ablation System, which consists of the Cardioblate® 68000 Generator (K060400) and the following ablation devices: |
| Cardioblate® Monopolar Pens, Models 60813 and 60814 (K013392) Cardioblate® BP2 Surgical Ablation Device, Model 60831 (K060400) Cardioblate® LP Surgical Ablation Device, Model 60841 (K060400) Cardioblate® Gemini™ Surgical Ablation Device, Models 49260/049261 (K070311) | |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification: | Class II, 21 CFR 878.4400 |
Product Code: GEI
K080509 Cardioblate® Surgical Ablation System
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| o | Predicate Devices: Cardioblate® Monopolar Pen, Model 60813 and Model 60814 |
|---|---|
| (K013392), and AtriCure® Bipolar System (K043579). | |
| Predicate Device Intended Uses: |
"The Medtronic Cardioblate" System is intended to ablate cardiac tissue during general surgery using radiofrequency energy. " (K013392)
"The Atricure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery. " (K043579)
The Medtronic Cardioblate® Surgical Ablation System consists of a reusable Device Description: radiofrequency gencrator which can be connected to hand-held monopolar or binolar radiofrequency ablation devices. The ablation devices are sterile, singleuse devices, operating in either monopolar or bipolar mode, that deliver the radiofrequency energy to the selected tissue.
The Cardioblate® Surgical Ablation System is intended to ablate cardiac tissue Intended Use: during cardiac surgery using radiofrequency energy.
The Cardioblate® Surgical Ablation System is contraindicated for patients that Contraindications: have active endocarditis at the 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 have not been studied.
Comparison to
The Cardioblate® Surgical Ablation System, including the generator and all Predicate Device: ablation devices, has already been cleared by the FDA with the appropriate premarket notifications referenced above. No changes to the design or technology of the devices are contemplated in this submission. The sole change to the Cardioblate® devices is to clarify the intended tissue as "cardiac tissue" in accordance with the predicate devices (K013392 & K043579). The AtriCure Bipolar System (K0403579) was also device was identified as a predicate device with a similar indication.
Verification and validation testing has demonstrated that all components of the Test Data: Cardioblate Surgical Ablation System are safe and effective. Clinical data demonstrating the acute safety and ability of the device to create lines of electrical conduction block in the heart as assessed intraoperatively are provided to support the indication.
Based on the accumulated technical information, intended use, laboratory Summary: verification tests and clinical performance data provided, the Cardioblate System is substantially cquivalent to the currently marketed predicate devices.
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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 stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the staff and a single snake winding around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. Medtronic Cardiac Surgical Technologies c/o Ms. Preeti Jain Director of Regulatory Affairs 7601 Northland Drive Minneapolis, MN 55428
MAY - 5 2008
Re: K080509
Cardioblate Surgical Ablation System, Models 60813 and 60814 Monopolar Pens, Model 60831 BP2, Model 60841 LP, and Models 49260/049261 Gemini Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: February 22, 2008 Received: February 25, 2008
Dear Ms. Jain:
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, Or vo 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.
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.
3
Page 2 - Ms. Preeti Jain
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrl/industry/support/index.html.
Sincerely yours,
D. lohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Cardioblate® Surgical Ablation System, consisting of the Cardioblate® 68000 Generator (K060400) and the following ablation devices:
- Cardioblate® Monopolar Pens*, Models 60813 and 60814 (K013392) .
- Cardioblate® BP2 Surgical Ablation Device, Model 60831 (K060400) .
- Cardioblate® LP Surgical Ablation Device, Model 60841 (K060400) .
- Cardioblate® Gemini™ Surgical Ablation Device, Models 49260/049261 (K070311) .
Indications for use:
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during general surgery using radiofrequency energy.
- These devices are already labeled with the proposed indication statement.
Prescription Use X (Part 21 CFR 801 Subpart D) OR 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)
er R. Archer
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number_上り80509
Medtronic Cardioblate® Surgical Ablation System 510(k) Premarket Notification
Section 4 -- Page 1