(40 days)
Not Found
No
The description focuses on the mechanical and electrical components of the catheter and its interface with a navigation system, with no mention of AI or ML for data analysis or decision-making.
No
The device is indicated for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," making it a diagnostic tool rather than a therapeutic one.
Yes
The "Device Description" section explicitly states, "The Webster CS Catheters with EZ Steer Bi-directional Technology... are diagnostic... mapping electrophysiology (EP) catheters."
No
The device description clearly details a physical catheter with electrodes, a handle, and a deflectable tip, indicating it is a hardware device. While it interfaces with a navigation system, the core device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 record electrical signals. This is an invasive medical device used for diagnosis in vivo.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
This device is clearly designed for direct use within the patient's body for diagnostic purposes, which falls outside the definition of an IVD.
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, 74 DQO
Device Description
The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05)
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04) and DF (D-1263-05). 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 .
- D-1221-26 .
- D-1221-25 .
The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology and Auto ID
(D-1263-06 & D-1263-07)
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06 & D-1263-07) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06) and DF (D-1263-07). 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 Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06 & D-1263-07) 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) with the appropriate connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures; 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 passed bench testing to validate the mechanical and electrical 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
:
| 5. | 510(K) SUMMARY | JUN 22 2010
K101345 |
|----|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: 800-729-7272
Fax: 909-839-8804 |
| | Date: | May 11, 2010 |
| | Contact Person: | Balaka Das
Senior Specialist, Regulatory Affairs |
| | Proprietary Device Name: | Webster CS Catheter with EZ Steer Technology
Webster CS Catheter with EZ Steer Technology and
Auto ID |
| | Common Device Name: | Electrophysiology Mapping Catheter |
| | Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220, Product Code DRF) |
| | Predicate Device: | Webster CS Catheter with EZ Steer Technology
Webster CS Catheter with EZ Steer Technology and
Auto ID |
| | Manufacturing Facilities: | Biosense Webster, Inc.
15715 Arrow Highway
Irwindale, CA 91706 USA
Biosense Webster, Inc.
Circuito Interior Norte #1820
Parque Industrial Salvacar
Juarez, Chihuahua, Mexico, 32599 |
Page 1 of 3
:
.
,
.
1
5.1 Substantially Equivalent To:
Webster CS Catheters with EZ Steer Technology and Webster CS Catheters with EZ Steer Technology and Auto ID cleared via 510(k) K090898 cleared on September 4, 2009.
5.2 Description of the Device Subject to Premarket Notification:
The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05)
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04) and DF (D-1263-05). 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 .
- D-1221-26 .
- D-1221-25 .
The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology and Auto ID
(D-1263-06 & D-1263-07)
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06 & D-1263-07) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06) and DF (D-1263-07). 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 Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06 & D-1263-07) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information.
Page 2 of 3
2
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) with the appropriate connectors.
5.3 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.
5.4 Performance Data:
The Webster CS Catheters have passed bench testing to validate the mechanical and electrical integrity of the catheters and the performance of the catheters with the ancillary equipment.
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JUN 2 2 2010
Biosense Webster, Inc. c/o Ms. Balaka Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
K101345 Re:
Trade/Device Name: Webster CS Catheter with EZ Steer Technology; and, Webster CS Catheter with EZ Steer Technology and Auto ID. Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: May 11 2010 Received: May 13, 2010
Dear Ms. Das:
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
Page 2 - Ms. Balaka Das
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/MedicalDevices/Safety/ReportalProblem/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,
M. A. Hellekson
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
510(k) No (if known): K101345
Device Name:
- Webster CS Catheter with EZ Steer Technology . (D-1263-04 & D-1263-05)
- Webster CS Catheter with EZ Steer Technology and Auto ID . (D-1263-06 & D-1263-07)
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)
Page 1 of
U.f. Willelm
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number