(34 days)
Not Found
No
The summary describes a physical catheter device used for electrophysiological mapping and navigation within the heart, interfacing with a separate navigation system. There is no mention of AI or ML in the device description, intended use, or performance studies. The modification described is related to the catheter connector and PCB placement.
No
The device is indicated for "electrophysiological mapping," "recording," and "stimulation only" of cardiac structures. It does not perform any therapeutic intervention or treatment.
Yes.
The device's intended use is for "electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only" and to "obtain electrograms in the atrial regions of the heart," which are diagnostic activities.
No
The device description clearly details physical components like a catheter, electrodes, and a circular spine, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This involves directly interacting with the patient's heart to measure electrical activity.
- Device Description: The device is a catheter designed to be inserted into the heart to obtain electrograms. This is an invasive procedure performed in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens in vitro.
The device is clearly designed for in vivo use for diagnostic purposes (mapping electrical activity in the heart), but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
LASSO® 2515 NAV eco Variable Catheter
The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® 2515 NAV eco Variable 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 2.3.)
LASSO® NAV eco Catheter
The LASSO® NAV eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV eco 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 2.3.)
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F guiding sheath. Both deflectable catheters consists of a circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to modify the catheter connector, so that the Printed Circuit Board (PCB) can be removed from the single-use only catheter and placed in a reusable interface cable as part of the CARTO 3 EP Navigation System.
The LASSO 2515 NAV eco Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).
The LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, and 25 mm loop sizes to accommodate different vein sizes. Each loop size will be available with either 10 or 20 electrodes.
The proposed catheters will continue to interface with standard recording equipment via interface cables and appropriate connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria of the heart, cardiac structures of the heart, atrial 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 LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter underwent Bench and Animal Testing. Both catheters passed all intended criteria in accordance with appropriate standards and test criteria.
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
DEC - 5 2011
18. 510(K) SUMMARY
. .
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Road
Diamond Bar, CA 91765
Phone: 800-729-9010 x8534
Fax: 909-839-8804 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Jimenez
Senior Specialist, Regulatory Affairs |
| Date: | October 31, 2011 |
| Trade or Proprietary Name: | LASSO® 2515 NAV eco Variable Catheter
LASSO® NAV eco Catheter |
| Common or Usual
Name of Device: | Electrophysiological Mapping Catheter |
| Classification Name: | Electrode Recording Catheter
(21 CFR 870.1220, Product Code DRF) |
| Predicate Devices: | LASSO® 2515 NAV Variable Catheter
510(k): K081258
LASSO® NAV Catheter
510(k): K093376 |
| Manufacturer: | Biosense Webster, Inc.
3333 Diamond Canyon Road
Diamond Bar, CA 91765 |
| Manufacturing Sites: | Biosense Webster, Inc.
15715 Arrow Highway
Irwindale, CA 91706
Biosense Webster, Inc.
Cordis de Mexico
Circuito Interior Norte #1820
Parque Industrial Salvarcar 32599
Juarez, Chihuahua, Mexico |
CONFIDENTIAL
1
18.1 Substantially Equivalent To
The Biosense Webster LASSO®2515 NAV eco Variable Catheter is substantially equivalent to the Biosense Webster LASSO®2515 NAV Variable Catheter [510(k) K081258, cleared January 6, 2009] and the Biosense Webster LASSO® NAV Catheter (510(k) K093376. cleared June 18, 2010).
18.2 Description of the Device Subject to Premarket Notification
The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F guiding sheath. Both deflectable catheters consists of a circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to modify the catheter connector, so that the Printed Circuit Board (PCB) can be removed from the single-use only catheter and placed in a reusable interface cable as part of the CARTO 3 EP Navigation System.
The LASSO 2515 NAV eco Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).
The LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, and 25 mm loop sizes to accommodate different vein sizes. Each loop size will be available with either 10 or 20 electrodes.
The proposed catheters will continue to interface with standard recording equipment via interface cables and appropriate connectors.
18.3 Indications for Use
LASSO® 2515 NAV eco Variable Catheter
The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. .
The LASSO® 2515 NAV eco Variable 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 2.3.)
LASSO® NAV eco Catheter
2
The LASSO® NAV eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV eco 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 2.3.)
18.4 Performance Data
The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter underwent Bench and Animal Testing. Both catheters passed all intended criteria in accordance with appropriate standards and test criteria.
18.5 Overall Performance Conclusions
The nonclinical studies demonstrate that the LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter are safe and effective for anatomic mapping of the heart and establish equivalence of the LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter to their respective predicate devices, the LASSO 2515 NAV Variable Catheter and the LASSO NAV Catheter.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
DEC - 5 2011
Biosense Webster, Inc. c/o Mr. John Jimenez Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K113213
Trade/Device Name: LASSO® 2515 V eco Variable Catheter and LASSO® NAV Catheter Regulatory Number: 21 CFR 870.1220 Regulation Name: Catheter, Electrode Recording Regulatory Class: II (two) Product Code: 74 DRF Dated: October 31, 2011 Received: November 1, 2011
Dear Mr. Jimenez:
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 - Mr. John Jimenez
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/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,
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: LASSO® 2515 NAV eco Variable Catheter and LASSO®NAV eco Catheter
Indication for Use:
LASSO® 2515 NAV eco Variable Catheter
The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® 2515 NAV eco Variable 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 2.3.)
LASSO® NAV eco Catheter
The LASSO® NAV eco Catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV eco 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 2.3.)
- AND/OR
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter (21 CFR 801 Subpart C)
Use
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
510(k) Number_ KIB213
Division of Cardiovascular Devices
(Division Sign-Off)
Biosense Webster, Inc.
CONFIDENTIAL
Page 24 of 165