(99 days)
Not Found
No
The description focuses on the mechanical design and function of the catheter for recording and stimulating electrical activity, with interpretation performed by trained physicians. There is no mention of automated analysis or algorithms that would suggest AI/ML.
No.
The device is used for recording and stimulation for diagnostic purposes (mapping electrical activity) to diagnose arrhythmias, not to treat them.
Yes
The device's intended use is for "mapping of the cardiac structures of the heart, i.e. recording and stimulation only," and it is designed to "acquire, analyze and display electrical activity in the human heart." The description further states that "Trained physicians interpret the electrograms in diagnosing cardiac arrhythmias," directly linking its function to diagnosis.
No
The device description clearly details a physical catheter with mechanical components (tip, handle, deflecting mechanisms, puller wire, cam assembly) designed to be inserted into the heart. While it interacts with electrophysiological equipment for data acquisition and display, the core device itself is a hardware component.
Based on the provided text, 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 description clearly states that this catheter is used for "electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only." It acquires and transmits electrical signals within the body.
- No Sample Analysis: There is no mention of analyzing samples taken from the patient. The device interacts directly with the heart's electrical activity.
Therefore, the LASSO 2515 Variable Circular Mapping 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 and stimulation only. The LASSO 2515 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Variable LASSOTM 2515 electrophysiologic mapping catheter now incorporates a tip with a variable radius mechanism that allows selection of radii in a range from 15-25 mm. The LASSO predicate device cleared in K002333 is marketed with fixed radii of 10, 15, 20 and 25 mm. The subject device will allow the user to select a continuum of radii from 10- 25 mm. To facilitate user selection of this range of radii, design changes were required in the handle of the catheter. The Variable Lasso handle mechanism now has two independently operating deflecting mechanisms that control tip deflection and circular spine expansion and contraction. Tip deflection is controlled with a thumbknob attached to the distal end of a piston mechanism enclosed in the handle barrel. The spine contraction and expansion mechanism is also controlled by the movement of a puller wire attached to a cam assembly mechanism in the catheter handle that when rotated either contracts or expands the distal loop in a diameter range from 15 to 25 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures of the heart, atrial chambers of the heart, pulmonary veins in the left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians
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)
Various non - clinical bench tests were conducted to verify conformance of Variable Lasso catheter to design and performance specifications. Mechanical, dimensional, and reliability tests were performed and all requirements were met prior to submission of the 510k. No new questions of safety and effectiveness were raised as a result of these tests.
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
Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name. The graphic is an abstract design that resembles a heart or a stylized letter. The text "Biosense Webster" is written in a bold, sans-serif font, with the words stacked on top of each other. Below the company name, in a smaller font, is the text "a Johnson & Johnson company."
JUL 2 2 2003
| 510(k) Summary for the LASSO™ 2515 Variable Circular Mapping | |
|---|---|
| Catheter | |
| 510(k) Notification submitted by: | Biosense Webster, Inc. |
| 3333 Diamond Canyon Rd. | |
| Diamond Bar, CA 91765 | |
| USA | |
| Phone: +1-800-729-9010 | |
| Fax: +1-909-839-8804 | |
| Contact person: | William Welch |
| Regulatory Affairs Project Manager | |
| Proprietary device name: | LASSO 2515 Mapping Catheter |
| Classification name: | Electrode Recording Catheter |
| (per 21 CFR 870.1220) | |
| Common device name: | Deflectable Electrophysiologic Mapping |
| Catheter | |
| Predicate device: | LASSO Deflectable Circular Mapping Catheter |
| 510(k) No. K002333 | |
| Manufacturer: | Biosense Webster Inc. |
| 3333 Diamond Canyon Road | |
| Diamond Bar, CA 91765 |
Overview
The LASSO 2515 Variable mapping catheter when used in conjunction with electrophysiological pacing and recording equipment is designed to acquire, analyze and display electrical activity in the human heart. In particular the device is targeted for use in the atrial chambers of the heart and is particularly well-suited for placement in or near the pulmonary veins in the left atrium. The catheter transmits electrical pulses from the pacing equipment and intracardiac electrical signals to the recording equipment for display as electrograms (ECG traces). Trained physicians interpret the electrograms in diagnosing cardiac arrhythmias.
Design
The Variable LASSO™ 2515 electrophysiologic mapping catheter now incorporates a tip with a variable radius mechanism that allows selection of radii in a range from 15-25 mm. The LASSO predicate device cleared in K002333 is marketed with fixed radii of 10, 15, 20 and 25 mm. The subject device will allow the user to select a continuum of radii from 10- 25 mm. To facilitate user selection of this range of radii, design changes were
1
Image /page/1/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name, "Biosense Webster," which is printed in a serif font. Below the company name, in a smaller font, is the text "a Johnson & Johnson company."
required in the handle of the catheter. The Variable Lasso handle mechanism now has two independently operating deflecting mechanisms that control tip deflection and circular spine expansion and contraction. Tip deflection is controlled with a thumbknob attached to the distal end of a piston mechanism enclosed in the handle barrel. The spine contraction and expansion mechanism is also controlled by the movement of a puller wire attached to a cam assembly mechanism in the catheter handle that when rotated either contracts or expands the distal loop in a diameter range from 15 to 25 mm.
Testing
Various non - clinical bench tests were conducted to verify conformance of Variable Lasso catheter to design and performance specifications. Mechanical, dimensional, and reliability tests were performed and all requirements were met prior to submission of the 510k. No new questions of safety and effectiveness were raised as a result of these tests.
Biocompatibility and sterilization validation testing were not repeated since patient contact materials identical to the predicate device are used and since the described design changes do not affect the ability to sterilize the product.
Indications and Contraindications for Use
The intended use of this device is identical to the predicate Lasso device, namely:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO 2515 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Contraindications - No new contraindications have been introduced as a result of implementing the design changes necessary to operate a Variable Lasso catheter.
Packaging and Shelf Life
The catheter is packaged in a thermoformed tray and sealed in a nylon/Tyvek breather pouch. The pouch is placed in a preprinted unit box, labeled, and with other units, is placed in an outer shipping box prior to sterilization. Testing has been conducted to establish the expiration date of the product which is printed on the pouch and unit box labels as a "Use By" date.
Risks
An additional risk to patient safety involves failure of the handle rotation mechanism and associated components which may require the catheter to be replaced with another catheter. This is a standard practice for any catheter when one or more performance features of the catheter are compromised and thus this is not viewed as a new risk but
2
Image /page/2/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K031161'. The characters are written in a simple, sans-serif font, and the image appears to be a close-up shot of the sequence. The characters are uniformly sized and spaced, creating a clear and legible sequence.
Image /page/2/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the company name "Biosense Webster" in a bold, sans-serif font. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, cursive font. The logo is black and white.
instead an additional cause for the risk. All risks have been mitigated by appropriate means.
Summary of Substantial Equivalence
The design differences between the Variable Lasso 2515 and Lasso predicate device do not raise new questions of safety and effectiveness. The devices use the same fundamental technology, energy source, patient contact materials, and have the same the intended use as the predicate device. Finally, verification testing has raised no new questions of safety or effectiveness.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2003
Biosense Webster, Inc. c/o Mr. William Welch Regulatory Affairs Project Manager 3333 Diamond Canyon Road Diamond Bar, CA 92128
Re: K031161
Trade Name: Lasso 2515 Variable Circular Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: DRF Dated: July 17, 2003 Received: July 18, 2003
Dear Mr. Welch:
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.
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
4
Page 2 – Mr. William Welch
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Kortu
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) No:
Device Name: Variable LASSO™ 2515 Circular Mapping Catheter
Indications For Use:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO 2515 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Prescription Use Only
Ve Vettl
on Sian-Off Division of Cardiova 510(k) Numbe
Biosense Webster CONFIDENTIAL April 10, 2003
000023