(90 days)
No
The 510(k) summary describes a traditional electrosurgery device for ablation, pacing, and sensing. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's functionality. The performance studies focus on equivalence to predicate devices through bench and animal testing, not on the performance of an AI/ML algorithm.
Yes
The device is used to ablate cardiac tissue and for temporary cardiac pacing, sensing, recording, and stimulation, which are therapeutic interventions.
Yes.
The device is intended for "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery," which involves gathering information about the heart's electrical activity to diagnose or assess arrhythmias.
No
The device description clearly states it is a "hand held, monopolar, radiofrequency ablation device" and mentions physical components like a saline irrigation system and electrode tip. It also undergoes bench testing and animal studies, which are typical for hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is used directly on cardiac tissue during surgery. It performs actions like ablation (destroying tissue), pacing (stimulating the heart), sensing (detecting electrical activity), and recording. These are all procedures performed within the body (in vivo).
- Intended Use: The intended use clearly states it's for "ablating cardiac tissue using radiofrequency energy" and "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery." This is a surgical tool, not a diagnostic test performed on a sample.
Therefore, based on its function and intended use, the Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.
Product codes (comma separated list FDA assigned to the subject device)
OCL, LDF
Device Description
The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a hand held, monopolar, radiofrequency ablation device powered by the Cardioblate® 68000 Generator (cleared via K060400, K080509). It has a saline irrigation system that delivers fluid at the contact point between tissue and electrode tip to cool tissue during radiofrequency energy delivery. The device can also be used with the Medtronic Model 2090/2290 Programmer/Analyzer and the Medtronic Model 5388/5348 External Temporary Pacemaker for two pole sensing of the ventricle or the atrium and two pole stimulation (pacing) of the atrium. The device is intended for intermittent operation. The device is provided sterile (via ethylene oxide sterilization), 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)
Verification and validation testing, including bench testing and animal studies, were performed on the MAPS device, demonstrating equivalence to predicate devices.
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
JUN 1 6 2009
Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Ko90721 9, 1/3 Device 510(k) Summary
I. Applicant Information
| Date Prepared | March 17, 2009 |
|---|---|
| Submitter | Medtronic, Inc. |
| Address | 710 Medtronic Parkway, NE |
| Minneapolis, MN 55432 | |
| Establishment | |
| Registration Number | 2135394 |
| Contact Person | Peter Liu |
| Sr. Regulatory Affairs Specialist |
II. Device Information
Trade Name Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device (Model 49205) Classification Name Electrosurgical cutting and coagulation device and accessories. Class 2, 21 CFR 878.4400 Classification Class 2, 21 CFR 870.3680 Product Code OCL LDF Device Description The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a hand held, monopolar, radiofrequency ablation device powered by the Cardioblate® 68000 Generator (cleared via K060400, K080509). It has a saline irrigation system that delivers fluid at the contact point between tissue and electrode tip to cool tissue during radiofrequency energy delivery. The device can also be used with the Medtronic Model 2090/2290 Programmer/Analyzer and the Medtronic Model 5388/5348 External Temporary Pacemaker for two pole sensing of the ventricle or the atrium and two pole stimulation (pacing) of the atrium. The device is intended for intermittent operation. The device is provided sterile (via ethylene oxide sterilization), nonpyrogenic, disposable and for single use only.
1
K090721 P.2/3
.
the submit and the submit of the submit of the subscription of the subject of
| Intended Use | The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker. |
|---|---|
| Contraindications | The Medtronic Cardioblate® System is contraindicated for patients that have active endocarditis at the time of surgery. |
| The Medtronic Cardioblate® System 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. | |
| Predicate Device 1 | Medtronic Cardioblate® Monopolar Pen K070288 (cleared June 18, 2007), K080509 (cleared May 5, 2008); Reg 878.4400, Product Code: OCL |
| Predicate Indications: 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. | |
| Predicate Device 2 | Medtronic Detect Surgical Pacing and Mapping Tool K040812, cleared September 2, 2004, Reg 870.3680, Product Code: LDF |
| Predicate Indications: The Detect™ Surgical Pacing and Mapping tool is a hand held, single use device designed to provide temporary cardiac pacing or monitoring |
:
2
K09072i p.3/3
- III. Summary of Technological Characteristics Compared to Predicate Devices The MAPS device has the same indications for use as the Monopolar Pens. The MAPS device is also capable of producing irrigated, monopolar radiofrequency ablations on cardiac tissue in a manner functionally equivalent to the existing Cardioblate Monopolar Pens and bipolar sensing, and mapping in a manner functionally equivalent to the existing Detect device. The change to bipolar mapping, pacing, and sensing results in greater clarity and reduced noise, and does not raise new types of safety and effectiveness questions.
IV. Brief Discussion of Non-Clinical Performance Data
Verification and validation testing, including bench testing and animal studies, were performed on the MAPS device, demonstrating equivalence to predicate devices.
V. Conclusions from Non-Clinical Data
Based upon the technical information, intended use, in vitro, in vivo, and clinical performance information provided in previous pre-market notifications, the Medtronic Cardioblate MAPS device described in this submission has been shown to be substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2009
Medtronic, Inc. c/o Mr. Peter Liu Sr. Regulatory Affairs Specialist 710 Medtronic Parkway Minneapolis, MN 55432-5604
Re: K090721
Trade/Device Name: Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device (Model 49205)
Regulation Number: 21 CFR 878.4400.
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II
Product Code: OCL, LDF
Dated: March 17, 2009
Received: March 18, 2009
Dear Mr. Liu:
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.
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
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram 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
5
Indications for Use
510(k) Number (if known): K 09072 1
Device Name: Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device (Model 49205)
Indications for Use:
The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page _ of _/
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) /
6/16/09
Division of Cardiovascular Devices
510(k) Number