(82 days)
Not Found
No
The document describes a mapping catheter and its modifications, focusing on hardware components and their interaction with a navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is indicated for "electrophysiological mapping of cardiac structures" and to "obtain electrograms," which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states the device is "indicated for multiple electrode electrophysiological mapping of cardiac structures" and "intended to obtain electrograms in the atrial and ventricular regions of the heart." Additionally, the "Device Description" explicitly mentions it is "designed for diagnostic electrogram mapping and pacing."
No
The device description clearly details a physical catheter with electrodes, a handle, and a magnetic location sensor. While it interacts with a software system (CARTO® 3 EP Navigation System), the device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only." This involves interacting directly with the patient's heart to record electrical signals and potentially stimulate the tissue.
- Device Description: The device is a catheter designed to be inserted into the heart. It has electrodes that record electrical activity.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device operates within the body.
The device is clearly an in vivo medical device used for diagnostic and potentially therapeutic (stimulation) purposes within the patient's body.
N/A
Intended Use / Indications for Use
The Biosense Webster PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 3.x.)
Product codes (comma separated list FDA assigned to the subject device)
MTD
Device Description
The PENTARAY® High-Density Mapping Catheter family is a 7 Fr, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram mapping and pacing in all chambers (atria and ventricles) of the heart. Six proposed PENTARAY® NAV eco High-Density Mapping Catheters (D-1282-07-S to D-1282-12-S) will be similar to six predicate PENTARAY® NAV High-Density Mapping Catheters (D-1282-01-S to D-1282-06-S), modified only to implement an "eco" Handle. The modification to implement this "eco" Handle involves removing the Printed Circuit Board (PCB) that is associated with the Magnetic Location Sensor from the Handle Extension and connecting this catheter to an existing "eco" Interface Cable and a short, reusable cable component that now contains this PCB. This cable containing the PCB (known as the Dongle) is associated with the CARTO® 3 Electrophysiology (EP) Navigation System. This "eco" Handle is the only modification of the predicate catheters to create the six proposed Biosense Webster PENTARAY NAV eco Catheter models.
The working tip of the six proposed PENTARAY NAV eco Catheters is identical to the predicate catheters. The proposed catheters will continue to have five flexible spines, each with four ring electrodes for a total of 20 electrodes. There will continue to be three different electrode spacing configurations (4-4-4, 2-6-2, or 1-8-1 mm) and two different curves (F or D) in order to accommodate different clinical situations. The tip of the shaft of both the predicate and proposed catheters house a Magnetic Location Sensor that provides magnetic location information when used with the CARTO® 3 EP Navigation System. In addition to the 20 spine electrodes, two additional Ring Electrodes are located near the tip of the shaft for a total of 22 ring electrodes that provide location information via ACL technology when used with the CARTO 3 EP Navigation System. The shafts of the proposed and predicate catheters are the same as are the distal ends of the Handle. All the modifications are in the proximal portion of the Handle where the changes described in the previous paragraph were effected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures in the heart, atrial and ventricular regions of the heart
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 PENTARAY® NAV eco High-Density Mapping Catheter underwent Bench Testing and passed all intended criteria in accordance with appropriate standards and test criteria. The only animal test that was conducted was one to confirm that the proposed device had not change in the quality of the ECG signals. No clinical testing was deemed necessary.
The nonclinical studies demonstrate that the PENTARAY® NAV eco High-Density Mapping Catheter is safe and effective for anatomic mapping of the heart and establish equivalence of the PENTARAY® NAV eco High-Density Mapping Catheters to their predicate devices, the PENTARAY® NAV High-Density Mapping Catheters.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
MAR 0 5 2013
18. 510(K) SUMMARY
Applicant:
Contact Person:
Date:
Trade or Proprietary Name:
Common or Usual Name of Device:
Classification Name:
Predicate Devices:
Manufacturer:
Manufacturing Sites:
Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 Phone: 800-729-9010 x8597 Fax: 909-839-8804
Wayne R. Hohman Project Manager Regulatory Affairs
December 11, 2012
PENTARAY® NAV eco High-Density Mapping Catheter
Deflectable Tip Electrophysiology Catheter-Diagnostic
Electrode recording catheter or electrode recording probe (21 CFR 870.1220, Product Code MTD)
PENTARAY® NA V High-Density Mapping Catheter 510(k): K120425
Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Biosense Webster, Inc 15715 Arrow Highway Irwindale, CA 91706
Cordis de Mexico, S.A., de C.V. Circuito Interior Norte 1820 Parque Industrial Salvarcar Cuidad Juarez, Chihuahua CP 32599 Mexico
Sterilization Sites:
Steris Isomedix 7685 St. Andrews Avenue San Diego, CA 92154
Sterigenics, Inc. 2400 Airport Road
1
Santa Teresa, NM 88008
18.1 Substantially Equivalent To
The Biosense Webster PENTARAY® NAV eco High-Density Mapping Catheter is substantially equivalent to the Biosense Webster PENTARAY® NAV High-Density Mapping Catheter (510(k) K120425, cleared May 24, 2013).
Description of the Device Subject to Premarket Notification 18.2
The PENTARAY® High-Density Mapping Catheter family is a 7 Fr, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram mapping and pacing in all chambers (atria and ventricles) of the heart. Six proposed PENTARAY® NAV eco High-Density Mapping Catheters (D-1282-07-S to D-1282-12-S) will be similar to six predicate PENTARAY® NAV High-Density Mapping Catheters (D-1282-01-S to D-1282-06-S), modified only to implement an "eco" Handle. The modification to implement this "eco" Handle involves removing the Printed Circuit Board (PCB) that is associated with the Magnetic Location Sensor from the Handle Extension and connecting this catheter to an existing "eco" Interface Cable and a short, reusable cable component that now contains this PCB. This cable containing the PCB (known as the Dongle) is associated with the CARTO® 3 Electrophysiology (EP) Navigation System. This "eco" Handle is the only modification of the predicate catheters to create the six proposed Biosense Webster PENTARAY NAV eco Catheter models.
The working tip of the six proposed PENTARAY NAV eco Catheters is identical to the predicate catheters. The proposed catheters will continue to have five flexible spines, each with four ring electrodes for a total of 20 electrodes. There will continue to be three different electrode spacing configurations (4-4-4, 2-6-2, or 1-8-1 mm) and two different curves (F or D) in order to accommodate different clinical situations. The tip of the shaft of both the predicate and proposed catheters house a Magnetic Location Sensor that provides magnetic location information when used with the CARTO® 3 EP Navigation System. In addition to the 20 spine electrodes, two additional Ring Electrodes are located near the tip of the shaft for a total of 22 ring electrodes that provide location information via ACL technology when used with the CARTO 3 EP Navigation System. The shafts of the proposed and predicate catheters are the same as are the distal ends of the Handle. All the modifications are in the proximal portion of the Handle where the changes described in the previous paragraph were effected.
18.3 Indications for Use
The Biosense Webster PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO® 3 EP
2
Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 3.x.)
Performance Data 18.4
The PENTARAY® NAV eco High-Density Mapping Catheter underwent Bench Testing and passed all intended criteria in accordance with appropriate standards and test criteria. The only animal test that was conducted was one to confirm that the proposed device had not change in the quality of the ECG signals. No clinical testing was deemed necessary.
18.5 Overall Performance Conclusions
The nonclinical studies demonstrate that the PENTARAY® NAV eco High-Density Mapping Catheter is safe and effective for anatomic mapping of the heart and establish equivalence of the PENTARAY® NAV eco High-Density Mapping Catheters to their predicate devices, the PENTARAY® NAV High-Density Mapping Catheters.
3
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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Biosense Webster, Inc Wayne Hohman, Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K123837
Trade/Device Name: PENTARAY® NAV eco High-Density Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: MTD Dated: December 11, 2012 Received: February 4, 2013
· Dear Mr. Wayne Hohman:
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.
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
4
Page 2 – Mr. Wayne Hohman
forth in the quality systems (OS) 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/CDRHQffices/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.
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
7. INDICATIONS FOR USE STATEMENT
510(k) No (if known):
Device Name: PENTARAY® NAV eco High-Density Mapping Catheter
Indication for Use:
The Biosense Webster PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 3.x.)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)