(249 days)
Not Found
No
The summary describes a physical mapping catheter and its performance in clinical studies, with no mention of AI or ML algorithms for data processing or analysis.
No
The device is described as a diagnostic catheter for mapping cardiac structures and obtaining electrograms, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for multiple electrode electrophysiological mapping of cardiac structures" and is "intended to obtain electrograms." The "Device Description" section also explicitly calls it a "multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping." These functions are diagnostic in nature as they involve gathering information to identify a medical condition.
No
The device description clearly describes a physical catheter with electrodes and a flower-shaped probe, 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:
- Intended Use: The intended use clearly states that the device is for "multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only." This involves interacting directly with the patient's body to measure electrical signals.
- Device Description: The description details a catheter designed to be inserted into the heart to record and stimulate cardiac tissue.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device operates within the body.
- Anatomical Site: The anatomical site is the "cardiac structures in the heart," which is an in-vivo application.
Therefore, the CARTO® OCTARAY™ Mapping Catheter with TRUErcf™ Technology is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode clectrophysiological 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 compatible versions of the CARTO® 3 EP Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
MTD
Device Description
The Biosense Webster CARTO® OCTARA Y™ Mapping Catheter with TRUEref™ Technology is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 8 spines that radiate from the center. Each spine has 6 ring electrodes that are used for stimulation and recording within the heart. The catheter also includes an electrode located at the confluence of the spines that can be used as a close internal unipolar reference. The flower is available in a 30mm or a 40 mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology underwent bench testing, animal testing, and Clinical testing to demonstrate substantial equivalence. Testing included Mechanical integrity, electrical leakage, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization and navigation, sterilization, packaging, shelf life, Animal testing to assess device safety, device maneuverability and signal quality, and clinical testing to assess device effectiveness and safety. The catheter passed all predetermined acceptance criteria.
The Clinical study was a prospective, single arm, non-randomized, multi-center study. The study intended to enroll 30 subjects with a target of equal numbers of subjects (n=10) among three study arrhythmia subgroups: ischemic ventricular tachycardia, scar related AT (including PAF re-do/repeat procedures), and PsAF. The Study was performed outside of the United States.
The Primary objectives include meeting an effectiveness endpoint of completing preablation mapping and clinically indicated mapping without the need for another device and a safety endpoint of having no serious adverse events within 7 days of the study procedure.
The study population included subjects scheduled to have a clinically-indicated catheter mapping and ablation procedure for management of an arrhythmia in the following 3 subgroups: Ischemic ventricular tachycardia (VT) n=31, Scar-related atrial tachycardia (AT; includes atypical atrial flutter) resulting from previous paroxysmal atrial fibrillation (PAF) ablation procedures, mitral valve repair procedures, or PAF "re-do" procedures n=30, and Persistent Atrial Fibrillation (PsAF) n=30.
The study met Primary endpoints for both safety and effectiveness.
No Serious Adverse events were reported resulting from the use of the study catheter and all physicians were able to perform pre-ablation mapping with the subject device.
In the Per-Protocol Population, 82.1% (23/28) had pre-ablation mapping requirements successfully performed without the need of another catheter.
Clinically indicated mapping was started and finished in 100.0% (15/15) without the need for another device.
The study had 17 adverse events occur across 12 subjects and all were classified as unrelated to the study device.
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.
PENTARAY® Nav eco Mapping Catheter (K123837)
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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
July 31, 2020
Biosense Webster, Inc. Richard Lauhead Sr. Program Lead, RA 33 Technology Dr Irvine. California 92618
Re: K193237
Trade/Device Name: Carto Octaray 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: June 29, 2020 Received: July 1, 2020
Dear Richard Lauhead:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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 1
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--|
| 510(k) Number (if known) | K193237 | |
| Device Name | CARTO® OCTARAY™ MAPPING CATHETER WITH TRUEREF™ TECHNOLOGY | |
Indications for Use (Describe)
The CARTO® OCTARAY™ Mapping Catheter with TRUErcf™ Technology is indicated for multiple electrode clectrophysiological 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 compatible versions of the CARTO® 3 EP Navigation System.
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
1. 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 | 25 June 2020 |
|---|---|
| Applicant | Biosense Webster, Inc. |
| 33 Technology Drive | |
| Irvine, CA 92618 | |
| Establishment Registration Number: 9044811 | |
| Official | |
| Correspondent | Richard Lauhead |
| Senior Program Lead, Regulatory Affairs | |
| Telephone: (949) 789-8583 | |
| Fax: (949) 450-6886 | |
| Trade Name | CARTO® OCTARAY™ MAPPING CATHETER WITH |
| TRUEREF™ TECHNOLOGY | |
| Common Name | Electrophysiology Catheter |
| Classification Name | Electrode recording Catheter |
| Device | |
| Classification | Class II, 21 CFR 870.1220 |
| Product Code: MTD | |
| Model Numbers | D-1609-01-S, D-1609-02-S, D-1609-03-S, D-1609-04-S, |
| D-1609-05-S, D-1609-06-S | |
| Predicate device | PENTARAY® Nav eco Mapping Catheter (K123837) |
Substantially Equivalent To:
The Biosense Webster Inc. CARTO® OCTARA Y™ Mapping Catheter with TRUEref™ Technology is substantially equivalent to the Biosense Webster Inc. PENTARAY® Nav eco Mapping Catheter [510(k) K123837 cleared March 05, 2013]. Like the predicate device, the CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology features a piston like deflection mechanism, allowing for uni-directional deflection of the shaft. The proposed catheter also has similar deflectable curve offerings and a similar flower shaped distal tip. 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 Biosense Webster CARTO® OCTARA Y™ Mapping Catheter with TRUEref™ Technology is a multi-electrode diagnostic catheter designed to facilitate
4
electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 8 spines that radiate from the center. Each spine has 6 ring electrodes that are used for stimulation and recording within the heart. The catheter also includes an electrode located at the confluence of the spines that can be used as a close internal unipolar reference. The flower is available in a 30mm or a 40 mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.
Indications for Use:
The CARTO® OCTARAY™ 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 compatible versions of the CARTO® 3 EP Navigation System.
Technical Characteristics:
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ design uses similar technology, has similar intended use, functions, materials and method of operation as the predicate PENTARAY® Nav eco Mapping Catheter. The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology has a flower shaped tip containing 48 electrodes arranged across 8 spines and includes a close uni-polar reference electrode 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 differences in the number of spines and electrodes between the CARTO® OCTARA Y™ Mapping Catheter with TRUEref™ Technology and the PENTARAY® Nav eco Mapping Catheter have been evaluated through bench, animal and biocompatibility testing. Bench, clinical and animal testing demonstrated that the subject device is substantially equivalent to the predicate device. Results from the bench, animal, biocompatibility, and clinical data did not result in new questions with regards to safety and effectiveness of the device.
Performance Data:
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology underwent bench testing, animal testing, and Clinical testing to demonstrate substantial equivalence.
Testing included Mechanical integrity, electrical leakage, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization and navigation, sterilization, packaging, shelf life, Animal testing to assess device safety, device maneuverability and signal quality, and clinical testing to assess device effectiveness and safety.
The catheter passed all predetermined acceptance criteria.
5
The Clinical study was a prospective, single arm, non-randomized, multi-center study. The study intended to enroll 30 subjects with a target of equal numbers of subjects (n=10) among three study arrhythmia subgroups: ischemic ventricular tachycardia, scar related AT (including PAF re-do/repeat procedures), and PsAF. The Study was performed outside of the United States.
The Primary objectives include meeting an effectiveness endpoint of completing preablation mapping and clinically indicated mapping without the need for another device and a safety endpoint of having no serious adverse events within 7 days of the study procedure.
The study population included subjects scheduled to have a clinically-indicated catheter mapping and ablation procedure for management of an arrhythmia in the following 3 subgroups: Ischemic ventricular tachycardia (VT) n=31, Scar-related atrial tachycardia (AT; includes atypical atrial flutter) resulting from previous paroxysmal atrial fibrillation (PAF) ablation procedures, mitral valve repair procedures, or PAF "re-do" procedures n=30, and Persistent Atrial Fibrillation (PsAF) n=30.
Table A summarizes the Subject enrollment.
Table B summarizes subject demographic information
| | All
Enrolled
(N=31)
n (%) | VT
(n=11)
n (%) | AT/PAF
(n=10)
n (%) | PSAF
(n=10)
n (%) |
|---------------------------------------------------------|------------------------------------|-----------------------|---------------------------|-------------------------|
| Disposition | | | | |
| Enrolled Subjects | 31
(100.0%) | 11
(100.0%) | 10
(100.0%) | 10
(100.0%) |
| No study catheter
inserted | 1
(3.2%)* | 0 (0.0%) | 0 (0.0%) | 1
(10.0%)* |
| Safety Population | 30
(96.8%) | 11
(100.0%) | 10
(100.0%) | 9
(90.0%) |
| Catheter inserted
but no mapping | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Mapping
performed but not
for study
arrhythmia | 2
(6.5%) † | 1
(9.1%) † | 0 (0.0%) | 1
(10.0%) † |
| Per Protocol
Population | 28
(90.3%) | 10
(90.9%) | 10
(100.0%) | 8
(80.0%) |
Table A - Subject Enrollment and Accountability (Enrolled Subjects, N=31)
- Subject 632-003 did not meet eligibility criteria and was withdrawn prior to a study procedure
† Subjects 847-001 (PsAF) & 847-003 (VT) had mapping performed despite not having study arrhythmia
6
| Disposition | All
Arrhythmias
(n=31) | OCTARAY
FIM
AT/PAF
(n=10) | OCTARAY
FIM
PsAF
(n=10) | OCTARAY
FIM
VT
(n=11) |
|---------------------------|------------------------------|------------------------------------|----------------------------------|--------------------------------|
| Age at Consent | | | | |
| Mean ± SD (n) | 67.8 ± 8.52
(31) | 64.5 ± 9.23
(10) | 68.1 ± 7.75
(10) | 70.5 ± 8.25
(11) |
| Median (Q1/Q3) | 66.0
(63.0,74.0) | 65.5
(57.0,73.0) | 68.0
(63.0,72.0) | 69.0
(64.0,79.0) |
| Min / Max | 51.0 / 83.0 | 51.0 / 76.0 | 54.0 / 79.0 | 57.0 / 83.0 |
| Sex, n/N (%) | | | | |
| Male | 27 (87.1%) | 9 (90.0%) | 7 (70.0%) | 11
(100.0%) |
| Female* | 4 (12.9%) | 1 (10.0%) | 3 (30.0%) | 0 (0.0%) |
| Race, n/N (%) | | | | |
| Black/African
American | 1 (3.2%) | 0 (0.0%) | 1 (10.0%) | 0 (0.0%) |
| White | 25 (80.6%) | 8 (80.0%) | 9 (90.0%) | 8 (72.7%) |
| Race not reported | 5(16.1%) | 2(20.0%) | 0(0.0%) | 3(27.3%) |
| Ethnicity, n/N (%) | | | | |
| Not Hispanic or
Latino | 9 (90.0%) | 9 (90.0%) | 10 (100.0%) | 7 (63.6%) |
| Not Reported | 5(16.1%) | 1(10.0%) | 0(0.0%) | 4(36.4%) |
Table B - Study Demographic information (Enrolled Subjects, N=31)
Study Results:
The study met Primary endpoints for both safety and effectiveness.
No Serious Adverse events were reported resulting from the use of the study catheter and all physicians were able to perform pre-ablation mapping with the subject device.
In the Per-Protocol Population, 82.1% (23/28) had pre-ablation mapping requirements successfully performed without the need of another catheter.
- . Three (3) VT subjects did not have LAT mapping performed for reasons of patient safety. It is the position of the Sponsor that these were acceptable minor protocol deviations for patient safety and that the associated endpoint failures do not reflect a
7
deficiency of the catheter's ability to map but rather a unique unforeseen scenario. Pre-ablation voltage mapping was successfully performed for these subjects.
- . One (1) VT subject did not have LAT mapping completed due to the operator's inability to maintain stable contact with the area of interest; the Sponsor has made note of this operator's feedback.
- . One (1) PsAF subject that had CARTOFINDER mapping performed out of sequence was due to human error and was not affected by the catheter design or protocol prescribed workflow.
Clinically indicated mapping was started and finished in 100.0% (15/15) without the need for another device.
The study had 17 adverse events occur across 12 subjects and all were classified as unrelated to the study device. The Adverse Events reported include: Heart Failure, thoracic pain, perifissural nodule, Flu, constipation (two separate subjects), bladder infection, fever, hematuria, AV block 2:1, Dizziness, shoulder bruises, sore throat, non cardiac chest aches, shortness of breath, headaches, and allergic reaction.
Basis for Determination of Substantial Equivalence:
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology is substantially equivalent to its currently cleared predicate. PENTARA Y Nav eco Mapping Catheter, based on the successful completion of nonclinical bench testing, pre-clinical animal studies, a clinical study, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.