(139 days)
Not Found
No
The device description and performance studies focus on electrosurgery and temporary cardiac pacing/sensing, with no mention of AI or ML capabilities.
Yes.
The device is intended to ablate cardiac tissue and for temporary cardiac pacing, sensing, recording, and stimulation, which are therapeutic actions.
No
The device is primarily intended for ablation of cardiac tissue and temporary cardiac pacing, stimulation, sensing, and recording, which are therapeutic and monitoring functions, not solely diagnostic. While it can "sense depolarization's," this sensing is part of its function for pacing and arrhythmia evaluation during surgery, not primarily for initial diagnosis.
No
The device description clearly states it is a "hand-held, electrosurgical instrument" and mentions physical components like a "return electrode" and "footswitch," indicating it is a hardware device.
Based on the provided text, the Cardioblate® Monopolar Pen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to ablate cardiac tissue using radiofrequency energy and for temporary cardiac pacing, sensing, recording, and stimulation during surgery. This involves direct interaction with the patient's body.
- Device Description: The description reinforces its use as a hand-held electrosurgical instrument for ablating tissue and for pacing/sensing when connected to external devices. Again, this is a direct interaction with the patient.
- Anatomical Site: The anatomical site is "cardiac tissue," which is within the living patient.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue samples) to provide information for diagnostic purposes. The Cardioblate Monopolar Pen does not examine specimens in vitro.
The device is clearly intended for use in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OCL
Device Description
The Medtronic Cardioblate® Monopolar Pen is a hand-held, electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to the Cardioblate 68000 generator along with a return electrode when the operator presses the footswitch. In addition, the Cardioblate Pen can be used with the Medtronic Model 2090/2290 Programmer/Analyzer, and the Medtronic Model 5348/5388 External Temporary Pacemaker. When connected to a ground source, the monopolar pen can sense depolarization's of the ventricle and stimulate (pace) either the atrium or ventricle. The Cardioblate Pen is intended for intermittent operation, is sterile, non-pyrogenic, disposable, and 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)
The Cardioblate Monopolar Pen Model 60813 and XL Pen Model 60814 are equivalent to the predicate products in their indications for use, basic overall function and materials. The performance characteristics of the Cardioblate Monopolar Pen and XL Pen were tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool. There have been no changes to the Cardioblate Monopolar Pen that is currently marketed today in order to expand the indication for use. The Cardioblate® Monopolar Pens, Model 60813 and XL Pen Model 60814 have been tested and are considered safe and effective per the following standards for Medical Electrical Equipment: Part 1:General Requirements, IEC 60601-1 and, IEC 60601-2-27
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.
K040812, K061593, K013392, K031247
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
JUN 1 8 2007
510(k) SUMMARY of Safety and Effectiveness K070288
(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)
I. Applicant Information:
| Date Prepared:
Submitter: | January 29, 2007
Medtronic, Inc. |
|-----------------------------------|---------------------------------------------------------|
| Address: | 710 Medtronic Parkway, NE
Minneapolis, MN 55432-5604 |
| Establishment
Registration No. | 2135394 |
| Contact Person: | Debbie Kidder.
Senior Regulatory Affairs Specialist |
| Telephone Number:
Fax Number: | (763) 391-9251
(763) 391-9279 |
II. Device Information:
| Trade Name: | Cardioblate® Monopolar Pen, Model 60813 and
XL Pen Model 60814 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardioblate® Surgical Ablation System, which consists of the
Cardioblate® Surgical Ablation Generator (K060400) and
Monopolar Pen (K013392 and K031247) |
Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification: Class II, 21 CFR 878.4400 Product Code: GEI
- The Medtronic Cardioblate® Monopolar Pen is a hand-held, Device Description: electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to the Cardioblate 68000 generator along with a return electrode when the operator presses the footswitch. In addition, the Cardioblate Pen can be used with the Medtronic Model 2090/2290 Programmer/Analyzer, and the Medtronic Model 5348/5388 External Temporary Pacemaker. When connected to a ground
1
source, the monopolar pen can sense depolarization's of the ventricle and stimulate (pace) either the atrium or ventricle. The Cardioblate Pen is intended for intermittent operation, is sterile, non-pvrogenic, disposable, and single use only.
The Cardioblate® Monopolar Pen is a sterile, single use Intended Use: electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.
.
The Medtronic Cardioblate® System is contraindicated for patients Contraindications: that have active endocarditis at the time of surgery.
Medtronic Detect™ Surgical Pacing and Mapping Tool Predicate Device 1: 510(k) No. K040812, Reg. No. 870.3680; Product Code: LDF
Predicate Device Intended Use: The Medtronic Detect™ Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.
Atricure Isolator™ Transpolar Pen System Predicate Device 2: 510(k) No. K061593, Reg. No. 878.4400; Product Code: GEI
Predicate Device Intended Use: The Isolator™ Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Medtronic Cardioblate® Monopolar Pen Predicate Device 3: 510(k) No. K013392 and K031247, Reg. No. 878.4400; Product Code: GEI
The Cardioblate® device is Predicate Device Intended Use: currently indicated to ablate cardiac tissue during general surgery using radiofrequency energy.
2
III.SUBSTANTIAL EQUIVALENCE SUMMARY
The Cardioblate Monopolar Pen Model 60813 and XL Pen Model 60814 are equivalent to the predicate products in their indications for use, basic overall function and materials. The performance characteristics of the Cardioblate Monopolar Pen and XL Pen were tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool. There have been no changes to the Cardioblate Monopolar Pen that is currently marketed today in order to expand the indication for use. The Cardioblate® Monopolar Pens, Model 60813 and XL Pen Model 60814 have been tested and are considered safe and effective per the following standards for Medical Electrical Equipment: Part 1:General Requirements, IEC 60601-1 and, IEC 60601-2-27
Medtronic Cardioblate® Monopolar Pen and XL Pen 510(k) Premarket Notification
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three human profiles incorporated into its design. The profiles appear to be facing towards the right.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Mr. Scott Cundy Senior Director Regulatory and Clinical Medtronic Cardiac Surgery 7601 Northland Drive Minneapolis, MN 55428
Re: K070288
Trade/Device Name: Cardioblate Monopolar Pen model 60813 and Cardioblate XL Monopolar Pen model 60814 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: May 30, 2007
Dear Mr. Cundy:
This letter corrects our substantially equivalent letter of June 18, 2007.
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.
4
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number: Ko"70288
Device Name: Medtronic Cardioblate Surgical Ablation Pen and XL Pen (Models 60813 and 60814)
Indications for use:
The Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.
Prescription Use (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)
Bhumlamon
Medtronic Cardioblate® Monopola 510(k) Premarket Notification
Section 4 - Page 1