(232 days)
Not Found
No
The summary describes a mapping catheter with location sensors for use with an EP navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is indicated for electrophysiological mapping (recording or stimulation) and obtaining electrograms, not for treating a disease or condition.
Yes
The device is indicated for "electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only" and is designed "to obtain electrograms in the atrial regions of the heart," which are processes for diagnosing heart conditions. It also mentions being "designed to diagnose veins with different sizes."
No
The device description clearly details a physical catheter with electrodes and location sensors, indicating it is a hardware device, not software-only.
Based on the provided information, the LASSO® NAV Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- LASSO® NAV Catheter Function: The description clearly states the LASSO® NAV Catheter is used for "electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This is an in vivo procedure, meaning it is performed inside the living body.
- Anatomical Site: The device is used within the "atria of the human heart."
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the body. Its function is to record electrical signals directly from the heart tissue.
Therefore, the LASSO® NAV Catheter is an in vivo medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LASSO® NAV Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. This catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® NAV Catheter provides location information when used with compatible CARTO EP Navigation Systems.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The LASSO® NAV Catheter has been designed to facilitate electrophysiological mapping of the atria of the human heart. It is deployed in the right or left atrium through an 8 Fr guiding sheath. This deflectable catheter consists of a 4.5 Fr circular spine on its distal tip with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to add location sensors to provide location/visualization when used with CARTO Electrophysiological (EP) Navigation Systems and a reference device. The LASSO® NAV Catheter will be manufactured in three fixed loop sizes (15, 20, and 25 mm loop diameters) designed to diagnose veins with different sizes. There will be 10 or 20 ring electrodes available on each of the three loop sizes for a total of six new models. The proposed catheter with standard recording equipment via interface cables with appropriate connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria of the human 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® NAV Catheter was subjected to extensive Bench and Animal Testing. This catheter passed all intended criteria in accordance with appropriate standards and test criteria. The nonclinical studies demonstrated that the LASSO® NAV Catheter with location sensors is safe and effective for anatomic mapping of the human heart and established equivalence to the predicate devices, the LASSO® Deflectable Circular Mapping Catheter and the LASSO® 2515 NAV Variable Circular Mapping Catheter.
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
510(k) Notification
Lasso Nav Catheter
.
Pg. 1 of 2
K093376
510(k) Summary 5.
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Road
Diamond Bar, CA 91765 USA
Telephone: 800-729-8597
Fax: 909-839-8804
JUN 1 8 2010 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 27, 2009 |
| Contact Person: | Wayne R. Hohman
Project Manager Regulatory Affairs |
| Trade or Proprietary
Name: | LASSO® NAV Catheter |
| Common or Usual
Name of Device: | Electrophysiological Mapping Catheter |
| Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220; Product Code: DRF) |
| Predicate Devices: | LASSO® Deflectable Circular Mapping Catheter
510(k) K002333 |
| | LASSO® 2515 NAV Variable Circular Mapping Catheter
510(k) K081258 |
| Manufacturer: | Biosense Webster
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 |
Sterilization Site:
Steris Isomedix 7685 St. Andrews Avenue San Diego, CA 92154
Parque Industrial Salvarcar 32599 Juarez, Chihuahua, Mexico
.
Page 22 of 635
1
Pg. 2 of 2
K093376
510(k) Notification Lasso Nav Catheter
Substantially Equivalent To: 5.1
The Biosense Webster LASSO NAV Catheter is substantially equivalent to the Biosense Webster LASSO® Deflectable Circular Mapping Catheter (510(k) K002333 cleared August 31, 2000) and the Biosense Webster LASSO® 2515 NAV Variable Circular Mapping Catheter (510(k) K081258, cleared January 6, 2009).
Description of the Device Subject to Premarket Notification: 5.2
The LASSO® NAV Catheter has been designed to facilitate electrophysiological mapping of the atria of the human heart. It is deployed in the right or left atrium through an 8 Fr guiding sheath. This deflectable catheter consists of a 4.5 Fr circular spine on its distal tip with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to add location sensors to provide location/visualization when used with CARTO Electrophysiological (EP) Navigation Systems and a reference device.
The LASSO® NAV Catheter will be manufactured in three fixed loop sizes (15, 20, and 25 mm loop diameters) designed to diagnose veins with different sizes. There will be10 or 20 ring electrodes available on each of the three loop sizes for a total of six new models.
The proposed catheter with standard recording equipment via interface cables with appropriate connectors.
5.3 Indications for Use:
The LASSO® NAV Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. This catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV Catheter provides location information when used with compatible CARTO EP Navigation Systems.
Performance Data: 5.4
The LASSO® NAV Catheter was subjected to extensive Bench and Animal Testing. This catheter passed all intended criteria in accordance with appropriate standards and test criteria.
5.5 Overall Performance Conclusions:
The nonclinical studies demonstrated that the LASSO® NAV Catheter with location sensors is safe and effective for anatomic mapping of the human heart and established equivalence to the predicate devices, the LASSO® Deflectable Circular Mapping Catheter and the LASSO® 2515 NAV Variable Circular Mapping Catheter.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2010
Biosense Webster, Inc. c/o Mr. Wayne R. Hohman Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765-8597
Re: K093376
Trade/Device Name: Lasso NAV Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: June 17, 2010 Received: June 18, 2010
Dear Mr. 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.
3
Page 2 - Mr. Wayne Hohman
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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification Lasso Nav Catheter
Indications for Use Statement 4.
510(k) No (if known):
Device Name: LASSO® NAV Catheter
Indications for Use:
The LASSO® NAV Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. This catheter is designed to obtain electrograms in the atrial regions of the heart.
093376
The LASSO® NAV Catheter provides location information when used with compatible CARTO EP Navigation Systems.
Prescription Use V (Part 2 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)
Wand
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number. K0643376
Page 21 of 635