(186 days)
No
The document describes a physical medical device (catheter) for electrophysiological mapping and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for electrophysiological recording and stimulation to obtain electrograms, which are diagnostic activities, not therapeutic treatments.
Yes
The device description explicitly states, "The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation)."
No
The device description explicitly states it is a multi-electrode circular diagnostic catheter with a physical distal end, electrodes, and a circular spine, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- LassoStar™ Catheter Function: The LassoStar™ Circular Mapping Catheter is used inside the body (in vivo) to directly record and stimulate electrical activity in the heart's atrial region. It's a diagnostic tool, but it operates by interacting directly with the patient's anatomy, not by analyzing samples taken from the patient.
The description clearly states its purpose is for "electrophysiological recording and stimulation of the atrial region of the heart" and to "obtain electrograms in the heart." This is an invasive procedure performed within the body.
N/A
Intended Use / Indications for Use
The LassoStar™ Circular Mapping Catheter is indicated for multiple electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the heart.
Product codes
DRF
Device Description
The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation). The catheter's distal end is a circular spine with ten ring electrodes located circularly that are used for stimulation and recording within the atria. The loop is available in multiple diameters (15 mm, 20 mm and 25 mm) to achieve optimal contact in variably sized pulmonary veins. The device is provided sterile (EtO) and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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™ catheter underwent bench and animal testing using similar pre-determined acceptance criteria as the predicate device. Testing was completed to support the proposed modifications. The GLP animal study evaluated various sizes of deflectable sheaths to determine mapping capabilities of the proposed device with no deflection. 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. 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
- Biocompatibility
- Sterilization ●
- Simulated Use .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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June 30, 2020
Biosense Webster, Inc. Michelle Wheeler Senior Specialist, Regulatory Affairs 33 Technology Drive Irvine, California 92618
Re: K193632
Trade/Device Name: LassoStar 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: May 19, 2020 Received: May 21, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K193632
Device Name LassoStar™ Circular Mapping Catheter
Indications for Use (Describe)
The LassoStar™ Circular Mapping Catheter is indicated for multiple electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the heart.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Biosense Webster, a part of the Johnson & Johnson family of companies. The logo features a stylized graphic element to the left of the text "Biosense Webster." Below the company name, in smaller font, is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92
| Date Summary Prepared | 23 December 2019 |
|---|---|
| Applicant | Biosense Webster, Inc. |
| 33 Technology Drive | |
| 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™ Circular Mapping Catheter |
| Common Name | Electrophysiology Catheter |
| Classification Name | Electrode Recording Catheter or Electrode Recording Probe |
| Device Classification | Class II, 21 CFR 870.1220 |
| Product Code: DRF | |
| Model Numbers | D-1390-01-S, D-1390-02-S, D-1390-03-S |
| Predicate device | Lasso™ Deflectable Circular Mapping Catheter (K002333) |
Substantially Equivalent
The Biosense Webster Inc. LassoStar™ Catheter is substantially equivalent to the Biosense Webster LASSO™ Deflectable Circular Mapping Catheter [510(k) K002333 cleared August 31, 2000].
Description of the Device Subject to Premarket Notification
The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation). The catheter's distal end is a circular spine with ten ring electrodes located circularly that are used for stimulation and recording within the atria. The loop is available in multiple diameters (15 mm, 20 mm and 25 mm) to achieve optimal contact in variably sized pulmonary veins. The device is provided sterile (EtO) and intended for single use.
4
Image /page/4/Picture/0 description: The image shows the logo for Biosense Webster, a company that is part of the Johnson & Johnson family of companies. The logo consists of a stylized heart shape on the left, followed by the company name in a sans-serif font. Below the company name, in smaller font, is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
Indications for Use
The LassoStar™ 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.
Technological Characteristics
The LassoStar™ Circular Mapping Catheter uses similar technology, intended use and method of operation as the predicate device. The proposed device includes the same number of electrodes, loop diameters, distal end shape and spine cover material as the predicate device. The main differences of the proposed device are the outer diameter size, shaft material and method of tip deflection mechanism. Table 2-1 provides a direct comparison of the Technological features of the proposed and predicate device.
| | Proposed Device
(LASSOSTAR) | Predicate Device
(Lasso, K002333) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Area | | |
| Product Code | DRF | DRF |
| Indications for Use | The Biosense Webster
LASSOSTAR™ 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 | The catheter is indicated for
multiple electrode
electrophysiological mapping
of cardiac structures, i.e.
recording or stimulation only.
The Lasso Catheter is
designed to obtain
electrograms in the atrial
region of the heart. |
| Outer Diameter | 3 French | 7 French |
| Usable catheter Length | $193 cm \pm 3.0cm$ | $115 cm \pm 5.0cm$ |
| Number of Electrodes | 10 | 10 or 20 |
| Distal End Shape | Circular loop | Circular loop |
| Loop Diameter | 3 sizes:
15mm
20mm
25mm | 6 sizes:
12mm 25mm
15mm 30mm
20mm 35mm |
| Spine Cover Material | Pellethane | Pellethane |
| Shaft Material | Stainless Steel | Pebax |
| Method of Tip
Deflection | No deflection | deflection |
| Table 2-1: Characteristic Comparison | ||
|---|---|---|
| -- | -------------------------------------- | -- |
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Image /page/5/Picture/0 description: The image shows the logo for Biosense Webster, a part of the Johnson & Johnson family of companies. The logo features a stylized graphic to the left of the company name. The text "Biosense Webster" is displayed prominently, with the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" appearing in smaller font beneath it.
Performance Data
The LassoStar™ catheter underwent bench and animal testing using similar pre-determined acceptance criteria as the predicate device. Testing was completed to support the proposed modifications. The GLP animal study evaluated various sizes of deflectable sheaths to determine mapping capabilities of the proposed device with no deflection. 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. 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
- Biocompatibility
- Sterilization ●
- Simulated Use .
Basis for Determination of Substantial Equivalence
The LassoStar™ Circular Mapping Catheter is substantially equivalent to the currently cleared predicate device. The performance data supports the safety and effectiveness of the proposed device and demonstrates the device should perform as intended in the specified use conditions.