(249 days)
Not Found
No
The summary describes a physical catheter used for electrophysiological mapping and navigation, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device is used for electrophysiological mapping (recording and stimulation for diagnostic purposes) of the heart, not for treating a condition.
Yes
The device is described as facilitating "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 diagnostic functions.
No
The device description clearly details a physical catheter with electrodes, a Nitinol loop, and interface cables, indicating it is a hardware device, not software-only.
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.
- Device function: The LASSO 2515 NAV Variable Catheter is a medical device used inside the body (in vivo) to perform electrophysiological mapping of the heart. It records electrical signals and can be used for stimulation.
- Intended Use: The intended use clearly states "electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This is an in-vivo procedure.
- Device Description: The description details a catheter inserted into the heart, not a test performed on a sample outside the body.
Therefore, the LASSO 2515 NAV Variable Catheter is an in-vivo diagnostic and therapeutic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.
The LASSO 2515 NAV 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 catheter interfaces with standard recording equipment via interface cables with the 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 Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
The nonclinical studies demonstrate that the Lasso 2515 NAV Variable Catheter is safe and effective for anatomic mapping of the heart and establish equivalence of the Lasso 2515 NAV Variable Catheter to the predicate devices, the Variable Lasso 2515 Circular Mapping Catheter and the NaviStar Diagnostic 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) SUMMARY 5.
Image /page/0/Picture/1 description: The image shows a handwritten document with the text "K081258 Pg 1 of 2". The text appears to be a document identifier or page number. The handwriting is clear and legible, with the characters well-formed. The document seems to be part of a larger set, as indicated by the page number "1 of 2".
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: +1-800-729-7272
Fax: +1-909-839-8804 | JAN - 6 2009 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | May 1, 2008 | |
| Contact Person: | Natalie Bennington
Manager, Regulatory Affairs | |
| Proprietary Device Name: | Lasso 2515 NAV Variable Catheter, D-1290-01 &
D-1290-02 | |
| Common Device Name: | Electrophysiologic Mapping Catheter | |
| Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220, Product Code DRF) | |
| Predicate Devices: | 1. Variable Lasso 2515 Circular Mapping Catheter
[510(k) K031161]
2. Star Diagnostic Catheter ([510(k) K954390] (later
renamed NaviStar Diagnostic Catheter) | |
Manufacturer:
Manufacturing Sites:
Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
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
1
5.1 Substantially Equivalent To:
The Biosense Webster, Inc. Lasso 2515 NAV Variable Catheter is substantially equivalent to the Biosense Webster Variable Lasso 2515 Circular Mapping Catheter [510(k) K031161, cleared July 22, 2003] and the Biosense Webster NaviStar Diagnostic Catheter [510(k) K954390, cleared Dec. 21, 1995].
5.2 Description of the Device Subject to Premarket Notification:
The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.
The LASSO 2515 NAV 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 catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
5.3 Indications for Use:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
5.4 Performance Data:
The Lasso 2515 NAV Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Overall Performance Conclusions: ર્સ્ડ
The nonclinical studies demonstrate that the Lasso 2515 NAV Variable Catheter is safe and effective for anatomic mapping of the heart and establish equivalence of the Lasso 2515 NAV Variable Catheter to the predicate devices, the Variable Lasso 2515 Circular Mapping Catheter and the NaviStar Diagnostic Catheter.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2009
Biosense Webster, Inc. c/o Ms. Natalie Bennington Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
K081258 Re:
Trade/Device Name: Lasso 2515 NAV Variable Catheter, D-1290-01 and D-1290-02 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: November 25, 2008 Received: November 26, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 – Ms. Natalie Bennington
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qame
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081258
Device Name: Lasso 2515 NAV Variable Catheter, D-1290-01 & D-1290-02
Indications For Use:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Page 1 of 1 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices |
KOBI258 510(k) Number