(35 days)
For use in right and left atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli.
The Boston Scientific Constellation® Multiple Electrode Recording and Pacing Catheter (Constellation Catheter) is a sterile, single use advanced heart mapping diagnostic device designed to detect electrical potentials from the endocardial surfaces of the heart and may also be used to deliver externally generated pacing stimuli. The distal expandable 'basket' assembly contains an array of 32 or 64 electrodes mounted along eight resilient support structures called 'splines.' Several configurations are available, including unipolar (electrodes evenly spaced), bipolar (electrodes evenly distributed into pairs), and lower density arrays. The product is available in 31, 38, 48, 60, and 75mm basket sizes.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Constellation® Multiple Electrode Recording and Pacing Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(k) Summary) does not explicitly list quantitative acceptance criteria in a dedicated section. Instead, the justification for substantial equivalence for the expanded indications for use (left atrial electrophysiology procedures) relies on the device being identical in design and materials to its predicate and the cumulative animal and human data supporting its safety and effectiveness.
Therefore, the "acceptance criteria" here are implicitly linked to demonstrating safety and effectiveness for the expanded indication, primarily by showing no new safety concerns and similar performance to existing, cleared devices.
| Acceptance Criteria (Implicit) | Reported Device Performance and Justification |
|---|---|
| Safety in Left Atrial Electrophysiology Procedures (e.g., no increased risk of stroke, TIAs, or other complications) | Demonstrated Safety: The CONFIRM study (Narayan et al., 2012) mapped the left atrium in 92 patients using the Constellation Catheter. The study reported "no strokes or TIAs (transient ischemic attack) reported nor any unanticipated complications related to cardiac catheterization and/or ablation." This, combined with existing animal data, prior IDE study data (G940612), and additional medical literature, supports continued safety. |
| Effectiveness in Left Atrial Electrophysiology Procedures (e.g., ability to diagnose complex arrhythmias) | Demonstrated Effectiveness: The device is indicated "to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone." The study relies on the fact that "The Constellation Catheter with expanded indications for use to include left atrial electrophysiology procedures is substantially equivalent to the predicate Constellation Catheter (K021232) and the Flower/PENTARAY High Density Mapping Catheter (K050217) based on comparison of the devices." The CONFIRM study also indicates its usage in left atrial mapping. |
| Similar Technological Characteristics to Predicate Devices | Identical/Equivalent Design: The Constellation Catheter for left atrial use is "the same device indicated for use in right atrial procedures. Design, principle of operation, and materials are identical to the Constellation Catheter cleared under K983171, K992777, K000277, K003782 and K021232 and equivalent to the Johnson & Johnson/Biosense-Webster Flower High-Density Mapping Catheter/ PENTARAY™ High-Density Mapping Catheter legally marketed under K050217." |
| Non-clinical Performance Data Remains Valid | Non-clinical equivalence: "Device design specifications are identical for both the predicate and subject Constellation Catheter. Therefore the non-clinical testing for the Constellation Catheter that was submitted in previous submissions (K983171, K992777, K000277, K003782, and K021232) remains relevant." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The primary human clinical data referenced is from the CONFIRM study (Narayan et al., 2012), which involved 92 patients.
- Data Provenance: The CONFIRM study is described as a published medical literature study. The location or country of origin for this study is not explicitly stated in the provided text. It is a prospective study, as it involved the active use and observation of the device in patients, evidenced by phrases like "the Constellation Catheter was advanced via an 8.5 F sheath to map the left atrium in 92 patients."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not detail how ground truth was explicitly established for the CONFIRM study in the context of validating a diagnostic device's performance through expert consensus. The study focused on safety outcomes (absence of strokes/TIAs) and the device's application in mapping. It doesn't appear to be a study designed to evaluate the diagnostic accuracy of the catheter against a 'ground truth' diagnosis for complex arrhythmias, but rather its safety and functional application in mapping.
Therefore, information on the number of experts, their qualifications, or their role in establishing ground truth for the test set is not available in the provided text.
4. Adjudication Method for the Test Set
As the study (CONFIRM) primarily focused on safety outcomes and the functional application of the mapping, there is no mention of an adjudication method (like 2+1, 3+1) for interpreting diagnostic results or reviewing discrepancies in a test set. This type of adjudication is typically relevant for studies evaluating the diagnostic accuracy of an AI algorithm or a new diagnostic tool where human readers assess the output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a physical medical device (catheter), not an AI algorithm intended to assist human readers. The clinical performance data focuses on the device's safety and effectiveness in a clinical procedure, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device (catheter) used by a clinician, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth or primary endpoints for the referenced CONFIRM study appear to be:
- Absence of adverse events: Specifically, "no strokes or TIAs reported nor any unanticipated complications related to cardiac catheterization and/or ablation." This is essentially patient outcomes data (safety).
- Successful application in mapping: The use of the catheter "to map the left atrium" implies its successful functional application for its intended purpose.
There isn't a "ground truth" in the sense of a definitive diagnosis (e.g., confirmed pathology) against which the catheter's diagnostic output was explicitly validated as being "correct" for specific arrhythmias in this summary. The primary clinical data focuses on safety during the use of the device for its indicated purpose.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The clinical data cited (CONFIRM study, IDE study, animal data) serves as evidence for the overall safety and effectiveness of the device, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no training set for this device.
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Traditional Premarket Notification Constellation® Multitude Electrode Recording and Pacing Catheter
510(k) Summary per 21 CFR §807.92 (c) Section 5
| Submitter'sName andAddress | Boston Scientific CorporationElectrophysiology150 Baytech DriveSan Jose, CA 95134 |
|---|---|
| Contact Nameand Information | Michelle RoedingPrincipal Regulatory Affairs SpecialistTel: (408) 935-4912Fax: (408) 957-6202E-mail: Michelle.Roeding@bsci.com |
| AlternateContact andInformation | Lisa ScottDirector, Regulatory AffairsTel: (408) 935-6382Fax: (408) 957-6202E-mail: Lisa.Scott@bsci.com |
| Date Prepared | March 21, 2014 |
| Trade Name | Constellation® Multiple Electrode Recording and PacingCatheter |
| Common Name | Catheter, Intracardiac, High Density Array |
| ClassificationName | Catheter, Intracardiac, High Density Array (Product CodeMTD) has been classified as Class II per 21 CFR 870.1220 |
| PredicateDevice | The Constellation Catheter Multiple Electrode Recording andPacing Catheter is substantially equivalent in design andintended use to the same device legally marketed underK983171, K992777, K000277, K003782 and K021232 andJohnson & Johnson/Biosense-Webster Flower High-DensityMapping Catheter/ PENTARAY™ High-Density MappingCatheter legally marketed under K050217. |
| Description ofDevice | The Boston Scientific Constellation® Multiple ElectrodeRecording and Pacing Catheter (Constellation Catheter) is asterile, single use advanced heart mapping diagnostic devicedesigned to detect electrical potentials from the endocardialsurfaces of the heart and may also be used to deliverexternally generated pacing stimuli. The distal expandable'basket' assembly contains an array of 32 or 64 electrodesmounted along eight resilient support structures called'splines.' Several configurations are available, includingunipolar (electrodes evenly spaced), bipolar (electrodesevenly distributed into pairs), and lower density arrays. Theproduct is available in 31, 38, 48, 60, and 75mm basketsizes. |
| IntendedUse/Indicationsfor Use | For use in right and left atrial electrophysiology procedures toassist in the diagnosis of complex arrhythmias that may bedifficult to identify using conventional mapping systems alone(i.e., linear mapping catheters). The Constellation MultipleElectrode Recording and Pacing Catheter System may alsobe used for delivery of externally generated pacing stimuli. |
| DeviceTechnologicalCharacteristicsandComparison toPredicateDevice | The Constellation Catheter indicated for use in left atrialelectrophysiology procedures is the same device indicatedfor use in right atrial procedures. Design, principle ofoperation, and materials are identical to the ConstellationCatheter cleared under K983171, K992777, K000277,K003782 and K021232 and equivalent to the Johnson &Johnson/Biosense-Webster Flower High-Density MappingCatheter/ PENTARAY™ High-Density Mapping Catheterlegally marketed under K050217. |
| Expanding the indication of the Constellation Catheter doesnot involve incorporation of new design features, which areidentical to the predicate Constellation Catheter. In supportof substantial equivalence, Boston Scientific has comparedand evaluated technological characteristics of the Johnson &Johnson/ Biosense-Webster Flower/PENTARAY High-Density Mapping Catheter to the Constellation Catheter. TheConstellation Catheter is unique only in its geometricalconfiguration of splines and electrodes. Otherwise, thedevices are similar in all other technical aspects. | |
| Non-ClinicalPerformanceData | Device design specifications are identical for both thepredicate and subject Constellation Catheter. Therefore thenon-clinical testing for the Constellation Catheter that wassubmitted in previous submissions (K983171, K992777,K000277, K003782, and K021232) remains relevant. |
| ClinicalPerformanceData | Safety and effectiveness of the Constellation Catheter withexpanded indications for use to include the left atrialelectrophysiology procedures is based on cumulative animaland human data. Human clinical data include safety andeffectiveness data from the original Constellation CatheterIDE (G940612) and safety data for use in the left atrium asevidenced from published medical literature, and inparticular, from the CONFIRM [Conventional Ablation With orWithout FIRM (Focal Impulse and Rotor Modulation)] studyreported by Narayan et al (2012). In the CONFIRM study, theConstellation Catheter was advanced via an 8.5 F sheath tomap the left atrium in 92 patients. There were no strokes orTIAs (transient ischemic attack) reported nor anyunanticipated complications related to cardiac catheterizationand/or ablation. |
| Conclusion | The Constellation Catheter with expanded indications for useto include left atrial electrophysiology procedures issubstantially equivalent to the predicate ConstellationCatheter (K021232) and the Flower/PENTARAY HighDensity Mapping Catheter (K050217) based on comparisonof the devices. The summation of the existing animal data,data from the IDE study (G940612) and the CONFIRM study(Narayan et al, 2012), along with the additional medicalliterature, support continued safety and effectiveness of theConstellation Catheter as it relates to expanding the currentindications for use. |
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and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA". Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 28, 2014
Boston Scientific Corporation Michelle Roeding Principal, Regulatory Affairs 150 Baytech Drive San Jose. CA 95134
Re: K140733
Trade/Device Name; Constellation Multiple Electrode Recording and Pacing Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: MTD Dated: March 25, 2014 Received: March 26, 2014
Dear Ms. Michelle Roeding:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Michelle Roeding
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
.........
510(k) Number (if known)
Device Name
Constellation® Multiple Electrode Recording and Pacing Catheter
Indications for Use (Describe)
For use in right and left atrial electrophysiology procedures to assist in the diagnosis of complex arrhytmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli.
Type of Use (Selact one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR HOLD HOW HO HOL
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
§ 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).