(156 days)
Not Found
No
The description focuses on the physical characteristics and mechanical functionality of the catheter for electrophysiological mapping. There is no mention of AI or ML for data analysis, interpretation, or automated functions. The EEPROM mentioned is for storing identification information, not for AI/ML processing.
No.
The intended use explicitly states "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," which indicates a diagnostic function, not a therapeutic one. The device description further supports this by consistently referring to it as a "diagnostic...mapping electrophysiology (EP) catheter" designed to "map electrical activity."
Yes
The "Device Description" section explicitly states that the devices are "diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters."
No
The device description clearly details physical hardware components including catheters, electrodes, handles, shafts, and connectors. While one model mentions EEPROM for storing information, the primary function and description are centered around the physical catheter and its mechanical and electrical properties for mapping.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This describes a procedure performed within the body (in vivo) to measure electrical activity.
- Device Description: The description details a catheter designed to be inserted into the coronary sinus to map electrical activity using electrodes. This is an invasive medical device used for diagnosis in vivo.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a physiological state, disease, or condition. The provided text does not mention any testing of samples or analysis of biological materials outside the body.
Therefore, the Webster CS Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-5-2 mm or 2-8-2 mm electrode spacing, have uni-directional deflection with an MZ curve, and are 115 cm long. The catheters include a handle with a thumb knob, which allows deflection of the distal end of the catheter. The handle also has a 10-pin connector for interfacing to a recording system though a standard catheter cable. The braided, bendable/conformable shaft allows torque and contact force to be transmitted from the handle to the distal end. The distal tip is unbraided and soft. These two predicate models are identical except that the electrode spacing is 2-5-2 mm for D-1263-01-S and 2-8-2 mm for D-1263-02-S. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:
- D-1221-21-S
- D-1221-26-S
- D-1221-25-S
The Webster CS Catheters with EZ Steer Technology (D-1263-04-S & D-1263-05-S) are diagnostic, 7Fr. deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the Webster CS Catheters with EZ Steer Technology include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:
- D-1221-21-S
- D-1221-25-S
- D-1221-26-S
The Webster CS Catheters with EZ Steer Technology (D-1263-06-S & D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the modified Webster CS Catheters include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheters are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.
The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16-S) with the appropriate connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary Sinus
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 Webster CS Catheters have been subjected to performance testing to validate the integrity of the catheters and the performance of the catheters with the ancillary equipment.
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
Ko90898
SEP 04 2009
510(K) SUMMARY
Applicant:
Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765, USA Phone: 800-839-8599 Fax: 909-839-8804
Date:
September 2, 2009
Contact Person:
Natalie Bennington, Regulatory Affairs Manager
Proprietary Device Name / Manufacturing Part Number:
- · Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S)
- · Webster CS Catheter with EZ Steer Technology (D-1263-04-S & D-1263-05-S)
- · Webster CS Catheter with EZ Steer Technology and Auto ID (D-1263-06-S & D-1263-07-S)
Common Device Name:
Electrophysiology Mapping Catheter
Classification Name:
Electrode Recording Catheter (per 21 CFR 870.1220, Product code DRF)
Predicate Device:
Biosense Webster Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S), originally cleared via 510(k) K050877 on June 24, 2005.
1
Manufacturing Facilities:
1
· Biosense Webster, Inc. Circuito Interior Norte #1820 Parque Industrial Salvacar Juarez, Chihuahua Mexico, Mexico 32599
- . Biosense Webster, Inc. 15715 Arrow Highway Irwindale, CA 91706
Device Description
The Webster Coronary Sinus Catheter (D-1263-01-S & D-1263-02-S)
The Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-5-2 mm or 2-8-2 mm electrode spacing, have uni-directional deflection with an MZ curve, and are 115 cm long. The catheters include a handle with a thumb knob, which allows deflection of the distal end of the catheter. The handle also has a 10-pin connector for interfacing to a recording system though a standard catheter cable. The braided, bendable/conformable shaft allows torque and contact force to be transmitted from the handle to the distal end. The distal tip is unbraided and soft. These two predicate models are identical except that the electrode spacing is 2-5-2 mm for D-1263-01-S and 2-8-2 mm for D-1263-02-S. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:
- · D-1221-21-S
- · D-1221-26-S
- . D-1221-25-S
The Webster Coronary Sinus Catheter with EZ Steer Technology (D-1263-04-S & D-1263-05-S)
The Webster CS Catheters with EZ Steer Technology (D-1263-04-S & D-1263-05-S) are diagnostic, 7Fr. deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These
2
catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the Webster CS Catheters with EZ Steer Technology include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The hightorque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:
- · D-1221-21-S
- · D-1221-25-S
- . D-1221-26-S
The Webster Coronary Sinus Catheter with EZ Steer Technology (D-1263-06-S & D-1263-07-S)
The Webster CS Catheters with EZ Steer Technology (D-1263-06-S & D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the modified Webster CS Catheters include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheters are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.
The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16-S) with the appropriate connectors.
Indications for Use
The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
3
Summary of Testing
ﺎ
The Webster CS Catheters have been subjected to performance testing to validate the integrity of the catheters and the performance of the catheters with the ancillary equipment.
Substantial Equivalence
The Webster CS Catheters (D-1263-01-S, D-1263-02-S, D-1263-04-S, D-1263-05-S, D-1263-06-S & D-1263-07-S) are substantially equivalent to the Biosense Webster Coronary Sinus Deflectable Mapping Catheters (D-1263-01 & D-1263-02), originally cleared via 510(k) K050877 on June 24, 2005.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 0 4 2009
Biosense Webster. Inc. c/o Ms. Natalie Bennington Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K090898
Trade/Device Name:
- . Webster CS Catheter (D-1263-01-S and D-1263-02-S);
- Webster CS Catheter with EZ Steer Technology (D-1263-04-S and D-1263-05-S); and
- Webster CS Catheter with EZ Steer Technology and Auto ID (D-1263-06-S and D-1263-07-S).
Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (Two) Product Code: DRF Dated: July 28, 2009 Received: August 5, 2009
Dear Ms. Bennington:
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.
5
Page 2 - Ms. Natalie Bennington
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.J.
or Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) No (if known): K090898
Device Name:
- · Webster CS Catheter D-1263-01-S D-1263-02-S
- · Webster CS Catheter with EZ Steer Technology D-1263-04-S D-1263-05-S
- · Webster CS Catheter with EZ Steer Technology and Auto ID D-1263-06-S D-1263-07-S
Indications for Use:
The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
Prescription Use V (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)
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| (Division Sign-Off) | |
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| Division of Cardiovascular Devices |
F510(k) Number
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