(269 days)
Not Found
No
The device description focuses on the mechanical and electrical aspects of signal acquisition and transmission for physician interpretation. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is indicated for use to diagnose cardiac arrhythmia by acquiring electrical signals from cardiac tissue, not to treat or cure a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are indicated for use to diagnose cardiac arrhythmia."
No
The device description clearly details a physical catheter with a mechanical operating mechanism, electrode wiring, and a handle, 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. They are used outside the body (in vitro).
- Device Function: The description clearly states that this device is a diagnostic catheter used to acquire electrical signals directly from the cardiac tissue within the body. This is an in vivo procedure (within the living organism).
- Method of Use: The device is inserted percutaneously and navigated to the heart to collect electrical signals. This is a direct interaction with the patient's internal anatomy, not a test performed on a sample outside the body.
Therefore, while it is a diagnostic device, it falls under the category of in vivo diagnostics, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EP XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter
Indications for Use (Describe)
EP+XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.
The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic guidance
Anatomical Site
Cardiac tissue, internal jugular vein, subclavian vein, femoral vein, femoral artery, radial artery
Indicated Patient Age Range
The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.
Intended User / Care Setting
Physician
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)
Bioburden Testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, was performed to confirm bioburden levels of the devices were not adversely affected.
Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters to demonstrate that the devices, as manufactured, packaged and 2x EO sterilized, adhere to the requirements set forth in accordance with the applicable product specifications.
Testing was conducted at baseline (T=0) and 37 months (1125 days) accelerated aging to support the labeled shelf life.
The Packaging Design Verification testing provides evidence that the catheter packaging configurations meet the predetermined design input specification and maintain sterility in conformance with ISO 11607-1.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2024
Boston Scientific Corporation Melissa Schneider Senior Regulatory Affairs Specialis 4100 Hamline Ave North St Paul, Minnesota 55112
Re: K240366
Trade/Device Name: EP.XTTM Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XTTM Unidirectional Steerable Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: February 5, 2024 Received: February 6, 2024
Dear Melissa Schneider:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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 S. Deoras -S
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
3
Indications for Use
510(k) Number (if known) K240366
Device Name
EP XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter
Indications for Use (Describe)
EP+XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters
1. Submitter
Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112
Contact:
Melissa Schneider Regulatory Affairs Specialist Phone: 651-582-6935 E-mail: melissa.schneider(@bsci.com
Date Prepared: October 31, 2024
2. Device
Name of Devices: EP.XTTM Unidirectional Steerable Diagnostic Catheter; DYNAMIC TIPTM Unidirectional Steerable Diagnostic Catheter; DYNAMIC XTTM Unidirectional Steerable Diagnostic Catheter
Common Name: Dynamic Unidirectional Steerable Diagnostic Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220
3.Predicate Device
| Subject Device | Predicate Device | Predicate 510(k) |
|---|---|---|
| EP•XT Steerable Diagnostic Catheter | Bard® Steerable Catheter | K921872 |
| Dynamic Tip Steerable Diagnostic | ||
| Catheter | Bard® Dynamic Tip Catheter | K912213 |
| Dynamic XT Steerable Diagnostic | ||
| Catheter | Bard® Steerable Catheter | K921872 |
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Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
300 Boston Scientific Way Marlborough, MA 01752 www.bostonscientific.com
4. Device Description
The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.
The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).
5. Intended Use & Indications for Use
Intended Use
EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.
Indications for Use
EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
6. Comparison of Technological Characteristics with the Predicate Device
The catheters incorporate substantially equivalent design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a blue serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Bioburden Testing
Bioburden testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, was performed to confirm bioburden levels of the devices were not adversely affected.
Design Verification Testing
Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters to demonstrate that the devices, as manufactured, packaged and 2x EO sterilized, adhere to the requirements set forth in accordance with the applicable product specifications.
Testing was conducted at baseline (T=0) and 37 months (1125 days) accelerated aging to support the labeled shelf life.
Packaging Verification Testing
The Packaging Design Verification testing provides evidence that the catheter packaging configurations meet the predetermined design input specification and maintain sterility in conformance with ISO 11607-1.
8. Conclusion
The subject EP.XT, Dynamic Tip, and Dynamic XT Steerable Diagnostic Catheters are substantially equivalent in indications for use, design, product function, materials, and sterility to the predicate Steerable Diagnostic Catheters. The performance data supports that the subject catheters are substantially equivalent to their respective predicate devices.