(278 days)
Not Found
No
The summary describes a mapping catheter and its compatibility with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The provided text mentions that the device is used for "electrophysiology recording and stimulation" and to "create three-dimensional electroanatomic maps" of the heart. It does not indicate that the device is used for directly treating a medical condition.
Yes
The device is indicated for "multiple electrode electrophysiology recording and stimulation of the atrial region of the heart," and it is used to "create three-dimensional electroanatomic maps." These functions are diagnostic as they gather information about the heart's electrical activity and structure to identify abnormalities.
No
The device description clearly states it is a physical catheter with electrodes and an embedded sensor, designed for insertion into the body. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The LASSOSTAR™ NAV Circular Mapping Catheter is an invasive device inserted into the body (specifically the atrial region of the heart). Its function is to record and stimulate electrical activity within the heart and to provide location information for creating 3D maps. This is a diagnostic procedure performed inside the body (in vivo).
The device's intended use and description clearly indicate it's used for electrophysiology recording and mapping within the heart, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The LASSOSTAR™ NAV Circular Mapping Catheter is indicated for multiple electrode electrophysiology recording and stimulation of the atrial region of the heart. The catheter can be used with a compatible CARTO™ 3 System to provide location information and to create three-dimensional electroanatomic maps. (The catheter is not compatible with CARTO™ 3 Systems prior to Version 7.)
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Biosense Webster LASSOSTAR™ NAV Circular Mapping Catheter is a 3.5 Fr, multielectrode electrophysiological circular mapping catheter designed to provide location information and to create three-dimensional electroanatomic maps of the heart. On its distal tip, the catheter has a loop with platinum electrodes that can be used for recording and stimulation. The tip has an embedded sensor that allows the catheter to provide location information and create threedimensional electroanatomic maps when used with a compatible Biosense Webster Inc. CARTO™ 3 System. The catheter is available in three loop diameters: 15 mm, 20 mm and 25 mm to allow for use in pulmonary veins of differing size. The catheter can be visualized using conventional systems (such as fluoroscopy or ultrasound imaging), or with a compatible CARTO™ 3 System via interface cables with the appropriate connectors. The LASSOSTAR™ NAV Circular Mapping catheter has three product configurations (D-1404-01-S, D-1404-02-S, D-1404-03-S).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy or ultrasound imaging
Anatomical Site
atrial region 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 LASSOSTAR™ NAV circular catheter underwent bench and animal testing using similar pre-determined acceptance criteria as the predicate device. Testing was completed to support the subject modifications. The GLP animal study evaluated various sizes of deflectable sheaths and a catheter with a guide wire lumen to determine mapping capabilities of the subject device. The decreased outer diameter and change in shaft material were analyzed using functional and biocompatibility testing. The results of the testing demonstrate the device in scope of this premarket notification meet the product requirements with appropriate test criteria and standards.
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
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January 26, 2022
Biosense Webster, Inc. Michelle Wheeler Senior Regulatory Affairs Specialist 31 Technology Drive Suite 200 Irvine, California 92618
Re: K211219
Trade/Device Name: LASSOSTAR™ NAV Circular Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: April 22, 2021 Received: April 23, 2021
Dear Michelle Wheeler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211219
Device Name
LASSOSTARTM NAV Circular Mapping Catheter
Indications for Use (Describe)
The LASSOSTAR™ NAV Circular Mapping Catheter is indicated for multiple electrode electrophysiology recording and stimulation of the atrial region of the heart. The catheter can be used with a compatible CARTO™ 3 System to provide location information and to create three-dimensional electroanatomic maps. (The catheter is not compatible with CARTOTM 3 Systems prior to Version 7.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Date Summary Prepared | September 22, 2021 |
|---|---|
| Applicant | Biosense Webster, Inc. |
| 31 Technology Drive Suite 200 | |
| Irvine, CA 92618 | |
| Establishment Registration Number: 9044811 | |
| Official Correspondent | Michelle Wheeler |
| Senior Regulatory Affairs Specialist | |
| Telephone: (949) 923-4793 | |
| Fax: (949) 450- 6886 | |
| Trade Name | LASSOSTAR™ NAV Circular Mapping Catheter |
| Common Name | Electrophysiology Catheter |
| Classification Name | Catheter, Electrode Recording, Or Probe, Electrode |
| Recording | |
| Device Classification | Class II, 21 CFR 870.1220 |
| Product Code: DRF | |
| Device Configuration | D-1404-01-S, D-1404-02-S, D-1404-03-S |
| Predicate device | LassoStar™ (K193632) |
Substantially Equivalent
The Biosense Webster Inc. LASSOSTAR™ NAV Circular Mapping Catheter is substantially equivalent to the Biosense Webster Inc. LassoStar™ Non Nav Circular Mapping Catheter [510(k) K193632 cleared June 30, 2020].
Description of the Device Subject to Premarket Notification
The Biosense Webster LASSOSTAR™ NAV Circular Mapping Catheter is a 3.5 Fr, multielectrode electrophysiological circular mapping catheter designed to provide location information and to create three-dimensional electroanatomic maps of the heart. On its distal tip, the catheter has a loop with platinum electrodes that can be used for recording and stimulation. The tip has an embedded sensor that allows the catheter to provide location information and create threedimensional electroanatomic maps when used with a compatible Biosense Webster Inc. CARTO™ 3 System. The catheter is available in three loop diameters: 15 mm, 20 mm and 25 mm to allow for use in pulmonary veins of differing size. The catheter can be visualized using
4
conventional systems (such as fluoroscopy or ultrasound imaging), or with a compatible CARTO™ 3 System via interface cables with the appropriate connectors. The LASSOSTAR™ NAV Circular Mapping catheter has three product configurations (D-1404-01-S, D-1404-02-S, D-1404-03-S).
Indications for Use
The LASSOSTAR™ NAV Circular Mapping Catheter is indicated for multiple electrode electrophysiology recording and stimulation of the atrial region of the heart. The catheter can be used with a compatible CARTO™ 3 System to provide location information and to create three-dimensional electroanatomic maps. (The catheter is not compatible with CARTO™ 3 Systems prior to Version 7.)
Technological Characteristics
The LASSOSTAR™ NAV Circular Mapping Catheter uses similar technology and method of operation as the predicate device. The subject device includes the same number of electrodes, loop diameters, distal end shape and spine cover material as the predicate. The main differences of the subject device are the usable length. Carto™ compatibility, french size, shaft material and navigation sensor feature. Table 2-1 provides a summary comparison of the Technological features of the subject and predicate device.
| Subject Area | Subject Device
(LASSOSTARTM NAV) | Predicate Device
(LASSOSTARTM Non Nav, K193632) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DRF | DRF |
| Indications for Use | The LASSOSTARTM NAV Circular
Mapping Catheter is indicated for
multiple electrode electrophysiology
recording and stimulation of the atrial
region of the heart. The catheter can be
used with a compatible CARTOTM 3
System to provide location information
and to create three-dimensional
electroanatomic maps. (The catheter is
not compatible with CARTOTM 3
Systems prior to Version 7.) | The LassoStarTM Circular Mapping
Catheter is indicated for multiple
electrode electrophysiological
recording and stimulation of the atrial
region of the heart. The catheter is
designed to obtain electrograms in the
atrial region of the heart. |
| Outer Diameter | 3.5 French | 3 French |
| Usable catheter
Length | 179 cm $\pm$ 1.0cm | 193 cm $\pm$ 3.0cm |
| Number of Electrodes | 10 | 10 |
| Distal End Shape | Circular loop | Circular loop |
| Loop Diameter | 3 sizes: 15mm, 20mm, 25mm | 3 sizes: 15mm, 20mm, 25mm |
| Spine Cover Material | Pellethane | Pellethane |
| Shaft Material | Stainless Steel with Polyimide jacket | Stainless Steel |
Table 2-1: Characteristic Comparison
5
| Method of Tip
| Deflection | No deflection | No deflection |
|---|---|---|
| CARTO | ||
| compatibility | Carto 3, Version 7 and higher | Carto 3 visualization following |
| mapping with navigational catheter | ||
| Navigation Sensor | Yes | No |
Performance Data
The LASSOSTAR™ NAV circular catheter underwent bench and animal testing using similar pre-determined acceptance criteria as the predicate device. Testing was completed to support the subject modifications. The GLP animal study evaluated various sizes of deflectable sheaths and a catheter with a guide wire lumen to determine mapping capabilities of the subject device. The decreased outer diameter and change in shaft material were analyzed using functional and biocompatibility testing. The results of the testing demonstrate the device in scope of this premarket notification meet the product requirements with appropriate test criteria and standards. The following tests were performed in support of the substantial equivalence determination:
- . Visual Inspections
- Electrical ●
- EEPROM Burn Checks ●
- Buckle Force
- Insertion
- Torque
- Tensile Strength
- Impedance and resistance ●
- Visualization ●
- Packaging Sterile Barrier Gross Leak ●
- Transportation
- Sterilization
- Simulated Use ●
- Electrical Compatibility ●
Conclusion
The LASSOSTAR™ NAV Circular Mapping Catheter is substantially equivalent to the currently cleared predicate device and is considered as safe and as effective as the predicate device.