(292 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the catheter for electrophysiological mapping, with no mention of AI or ML capabilities.
No
The catheter is indicated for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," which describes a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheter is indicated for "electrophysiological mapping of cardiac structures" and "facilitate electrogram mapping in the atrial region of the heart and the coronary sinus," which are diagnostic activities. Additionally, the "Predicate Device(s)" include "The Cordis Webster A20 Diagnostic Deflectable Tip Catheter," reinforcing its diagnostic nature.
No
The device description clearly details a physical catheter with electrodes, a handpiece for tip deflection, and a connector subassembly, indicating it is a hardware device.
Based on the provided information, 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 to examine these samples outside of the body.
- Device Function: The description clearly states the catheter is used for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This involves inserting the device directly into the body to interact with and measure electrical activity within the heart.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is entirely focused on in-vivo measurement and stimulation.
Therefore, the Webster Duo-Decapolar Catheter is an invasive medical device used for diagnostic and potentially therapeutic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheter is indicated for electrophysiological mapping of cardiac structures: i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Biosense Webster. Duo-Decapolar Catheter, manufacturing part number D-1171-35. is designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque 7 Fr shaft with a tip section containing 10 pairs of platinum-iridium electrodes that can easily be seen under fluoroscopy. The 10 pairs of electrodes are arranged in two sets of five with a spacing of 60 mm between the sets. The electrode spacing within each set is 2-8-2 mm. The D-1171-35 catheter facilitates simultaneous local electrograms due to the greater number of electrodes and its deflection capabilities. All of the electrodes may be used for recording and stimulation purposes.
Tip deflection is controlled at the proximal end by a tubular hand piece in which a piston slides. The piston in the handpiece is attached to an internal puller wire which changes the radius of the curvature. When the piston is pushed forward with the thumbknob, the radius of the curvature is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section straightens. 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 catheter has a bifurcated Pigtail Connector Subassembly at the proximal end of the hand piece that houses a pair of 10-pin circular connectors. This connector provides a means for the catheter to connect to an interface cable and allow interface of the catheter with standard recording equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures, atrial region of the heart, 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 design of the Webster Duo-Decapolar Catheter underwent extensive bench (mechanical, electrical and simulated use) testing. The catheter passed all testing in accordance with appropriate test criteria and standards. The catheter was assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology.
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
MAY - 2 20i1
510(K) SUMMARY 6.
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: 800-729-9010
Fax: 909-839-8804 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 13, 2010 |
| Contact Person: | Balaka Das
Senior Specialist, Regulatory Affairs |
| Proprietary Device Name: | Webster Duo-Decapolar Catheter |
| Common Device Name: | Electrophysiology Mapping Catheter |
| Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220, Product Code DRF) |
| Predicate Device: | 1. The Cordis Webster A20 Diagnostic
Deflectable Tip Catheter (510(k) K953768)
2. The Webster CS Catheter with EZ Steer
Technology (510(k) K090898 and K101345) |
| Manufacturing Facilities: | Biosense Webster, Inc.
15715 Arrow Highway
Irwindale, CA 91706 USA
Biosense Webster, Inc.
Circuito Interior Norte, #1820
Parque Industrial Salvacar
Juarez, Chihuahua MX 32599 |
1
6.1 Substantially Equivalent To:
The Webster Duo-Decapolar Catheter is substantially equivalent to:
-
- The Cordis Webster A20 Diagnostic Deflectable Tip Catheter D-1097-442 (510(k) K953768)
6.2 Description of the Device Subject to Premarket Notification:
The Biosense Webster. Duo-Decapolar Catheter, manufacturing part number D-1171-35. is designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque 7 Fr shaft with a tip section containing 10 pairs of platinum-iridium electrodes that can easily be seen under fluoroscopy. The 10 pairs of electrodes are arranged in two sets of five with a spacing of 60 mm between the sets. The electrode spacing within each set is 2-8-2 mm. The D-1171-35 catheter facilitates simultaneous local electrograms due to the greater number of electrodes and its deflection capabilities. All of the electrodes may be used for recording and stimulation purposes.
Tip deflection is controlled at the proximal end by a tubular hand piece in which a piston slides. The piston in the handpiece is attached to an internal puller wire which changes the radius of the curvature. When the piston is pushed forward with the thumbknob, the radius of the curvature is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section straightens. 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 catheter has a bifurcated Pigtail Connector Subassembly at the proximal end of the hand piece that houses a pair of 10-pin circular connectors. This connector provides a means for the catheter to connect to an interface cable and allow interface of the catheter with standard recording equipment.
6.3 Indications for Use:
The catheter is indicated for electrophysiological mapping of cardiac structures: i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
2
6.4 Performance Data:
The design of the Webster Duo-Decapolar Catheter underwent extensive bench (mechanical, electrical and simulated use) testing. The catheter passed all testing in accordance with appropriate test criteria and standards. The catheter was assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology.
ર્ભ.ર Overall Performance Conclusions:
Based on the results of bench, and animal and studies performed it is concluded that the Webster Duo-Decapolar Catheter, part number D-1171-35, described in this submission is as safe and effective as the predicate devices for its indicated use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with outstretched wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biosense Webster, Inc. c/o James Petrie Regulatory Affairs Manager 3333 Diamond Canyon Road Diamond Bar, CA 91765
MAY - 2 2011
Re: K101991
Trade/Device Name: Webster Duo-Decapolar Catheter D-1171-35 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: April 27, 2011 Received: April 28, 2011
Dear Mr. Petrie:
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.
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
4
Page 2 - Mr. James Petrie
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (feporting of medical CFR Part 807); labeling (21 CFR Parl 601); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); pood manufacturing practice absettonic device-related adverse events) (21 CFR 803); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path Ag); 11 CFR 1000-1050 forth in the quality systems (QS) regulation (21-51-142 of the Act); 21 CFR 1000-1050.
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
lycm (1580) http://www.comment.com/accr.com/offices/ucm115809.htm for If you desire specific advice for your device of top november of the more of the form for the go to http://www.tda.gov/AboutfDA/CentersOffices CDHs) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDH) assessesses notification" (2 the Center for Devices and Radiological Health 3 (2007 and the motification" (21 CFR Part
note the regulation entitled, "Misbranding by reference overs under the MDR regulati note the regulation entitled, "Misoralding by relection to promations of the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to http://www.ida.gov/Micaletrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information' on your l Copysioner Assistance at its toll-free number
Division of Small Manufacturers, International and Copyrigh (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 038-2041 of (301) 770 - 100 of ar in tw ressfor You/Industry/default.htm.
Sincerely yours,
Bram D. Juckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT న్.
510(k) No (if known): K 10199/
Device Name: Webster Duo-Decapolar Catheter
Indications for Use:
The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and 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_1_
(Division Sidn-Off) ardiovascular Devices 510(k) Number