(312 days)
Not Found
No
The summary describes a mapping catheter that records electrograms and provides location information. There is no mention of AI or ML being used for analysis, interpretation, or any other function. The "TRUEref™ Technology" appears to be related to an internal reference electrode, not AI/ML.
No
The device is indicated for "electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only" and to "obtain electrograms". It does not describe any therapeutic intervention or treatment.
Yes
The device is described as an "electrophysiological mapping catheter" used to "obtain electrograms" and capable of "stimulating and recording," which are diagnostic functions for assessing cardiac electrical activity.
No
The device description clearly details a physical catheter with electrodes, a magnetic location sensor, and an irrigation lumen, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the device is a catheter designed for electrophysiological mapping of cardiac structures in the heart. It is inserted directly into the body to record electrical signals and provide location information.
- The intended use is for recording or stimulation within the heart. This is an in-vivo procedure, not an in-vitro (outside the body) test on a sample.
- The device description focuses on the physical characteristics and function of the catheter within the heart. It describes electrodes for recording and stimulating, a magnetic location sensor, and an irrigation lumen. These are all components for direct interaction with the patient's cardiac tissue.
Therefore, the OPTRELL™ Mapping Catheter with TRUEref™ Technology is an in-vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.
Product codes (comma separated list FDA assigned to the subject device)
MTD
Device Description
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. It is designed for deployment in a heart chamber through an 8.5 Fr guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has eight (8) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 8 (6x8) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures in the heart, atrial and ventricular 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The OPTRELL™ Mapping Catheter with TRUEref™ Technology underwent bench, animal, and biocompatibility testing to demonstrate substantial equivalence.
Testing included Mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, sterilization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety. The catheter passed all intended criteria in accordance 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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March 18, 2022
Biosense Webster, Inc. John Jimenez Senior RA Program Lead 31 Technology Drive Suite 200 Irvine, California 92618
Re: K211438
Trade/Device Name: OPTRELL™ Mapping Catheter with TRUEref™ Technology Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: February 16, 2022 Received: February 18, 2022
Dear John Jimenez:
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
1
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 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 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-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
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Indications for Use
510(k) Number (if known) K211438
Device Name
OPTRELLTM Mapping Catheter with TRUErefTM Technology
Indications for Use (Describe)
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.
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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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 | 4 August 2021 |
|---|---|
| 510(k) Number | K211438 |
| Applicant | Biosense Webster, Inc. |
| 31 Technology Drive, Suite 200 | |
| Irvine, CA 92618 | |
| Establishment Registration Number: 9044811 | |
| Official Correspondent | John Jimenez |
| Senior Program Lead, Regulatory Affairs | |
| Telephone: (949) 923-4774 | |
| Fax: (949) 450-6886 | |
| Trade Name | OPTRELL™ Mapping Catheter with TRUEref™ |
| Technology | |
| Common Name | Electrophysiology Catheter |
| Classification Name | Cardiovascular Catheter |
| Device Classification | Class II, 21 CFR 870.1220 |
| Product Code: DRF | |
| Part Numbers | D-1409-01-S, D-1409-02-S |
| Predicate device | CARTO® OCTARAY™ Mapping Catheter with TRUEref™ |
| Technology (K193237) |
Substantially Equivalent To:
The Biosense Webster Inc. OPTRELL™ Mapping Catheter with TRUEref™ Technology is substantially equivalent to the Biosense Webster Inc. CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology [510(k) K193237 cleared July 31, 2020]. Like the predicate device, the OPTRELL™ Mapping Catheter with TRUEref™ Technology is an 8 French (Fr) diagnostic catheter incorporating the same forty-eight (48) electrode design. They are only formatted in a paddle versus flower shaped array. It also incorporates a
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TRUEref™ electrode at the distal tip of the irrigation lumen for use as an internal close unipolar reference electrode within the heart chamber. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate, with one additional offering. The deflection mechanism is bi-directional versus uni-directional, allowing two curve offerings in the same catheter. The original intended use of the predicate device as a diagnostic catheter designed to facilitate mapping of structures within the heart remains the same in the proposed device.
Description of the Device Subject to Premarket Notification:
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. It is designed for deployment in a heart chamber through an 8.5 Fr guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has eight (8) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 8 (6x8) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.
Indications for Use:
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information only when used with a compatible version of the CARTO™ 3 System.
Technical Characteristics:
The OPTRELL™ Mapping Catheter with TRUEref™ Technology design uses similar technology, has similar intended use, functions, materials and method of operation as the predicate CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology. Instead of an eight (8) flower shaped tip, the OPTRELL™ Mapping Catheter with TRUEref™ Technology has a paddle-shaped tip containing forty-eight (48) electrodes arranged across six (6) spines. Like the predicate, OPTRELL™ also includes a close unipolar reference electrode located at the confluence of the spines. Otherwise, there are no special technical aspects of the ability of this catheter to detect electrical signals from heart endocardium and transmit this information to the CARTO® 3 EP Navigation System and/or recording equipment for display, analysis, and interpretation in detection of various heart arrhythmias. The difference in tip shape between the OPTRELL™ Mapping
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Catheter with TRUEref™ Technology and the CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology have been evaluated through bench, animal, and biocompatibility testing. Results from the bench, and biocompatibility data demonstrated that the proposed device is substantially equivalent to the predicate device and did not result in new questions with regards to safety and effectiveness of the device.
Performance Data:
The OPTRELL™ Mapping Catheter with TRUEref™ Technology underwent bench, animal, and biocompatibility testing to demonstrate substantial equivalence.
Testing included Mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, sterilization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety. The catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Basis for Determination of Substantial Equivalence:
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is substantially equivalent to its currently cleared predicate, CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology, based on the successful completion of nonclinical bench testing and preclinical studies, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.