Who is the manufacturer of CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER?

Boston Scientific Corporation filed the 510(k) submission for CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER (K140733).

What is the FDA product code for CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER?

MTD. It is classified under 21 CFR 870.1220 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER

K140733 · Boston Scientific Corporation · MTD · Apr 28, 2014 · Cardiovascular

Device Facts

Record ID	K140733
Device Name	CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
Applicant	Boston Scientific Corporation
Product Code	MTD · Cardiovascular
Decision Date	Apr 28, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

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.

Device Story

Constellation Catheter is a sterile, single-use diagnostic device for cardiac electrophysiology. Distal expandable 'basket' assembly features 32 or 64 electrodes on eight resilient splines; available in 31-75mm sizes. Device is inserted into the heart to detect endocardial electrical potentials and deliver pacing stimuli. Used in clinical electrophysiology labs by physicians. Output consists of electrical signals used for mapping complex arrhythmias; assists clinicians in identifying cardiac electrical activity. Benefits include improved diagnostic capability for complex arrhythmias compared to conventional linear catheters.

Clinical Evidence

Safety and effectiveness for left atrial procedures supported by cumulative animal and human data. Human data includes original IDE study (G940612) and published literature, specifically the CONFIRM study (Narayan et al., 2012). CONFIRM study mapped the left atrium in 92 patients using the device; reported no strokes, TIAs, or unanticipated complications related to catheterization or ablation.

Technological Characteristics

Sterile, single-use intracardiac mapping catheter. Features expandable basket assembly with 32 or 64 electrodes on eight splines. Available in 31, 38, 48, 60, and 75mm sizes. Configurations include unipolar and bipolar arrays. Principle of operation involves endocardial electrical potential detection and pacing stimulus delivery. Identical materials and design to predicate Constellation devices.

Indications for Use

Indicated for patients undergoing right and left atrial electrophysiology procedures to assist in diagnosing complex arrhythmias difficult to identify with conventional linear mapping catheters; also indicated for delivery of externally generated pacing stimuli.

Regulatory Classification

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.

Predicate Devices

Constellation Catheter (K983171, K992777, K000277, K003782, K021232)
Johnson & Johnson/Biosense-Webster Flower High-Density Mapping Catheter/ PENTARAY™ High-Density Mapping Catheter (K050217)

Related Devices

K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) · Cortex, Inc. · Mar 13, 2026
K163709 — FIRMap Catheter · Abbott Electrophysiology · Feb 28, 2017
K223666 — Ablacath Mapping Catheter · Ablacon, Inc. · Mar 17, 2023
K021232 — CONSTELLATION CATHETERS, MODEL 8031M · Boston Scientific Corp · May 16, 2002
K130827 — FIRMAP CATHETER · Topera, Inc. · Oct 31, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ . Traditional Premarket Notification Constellation® Multitude Electrode Recording and Pacing Catheter #### 510(k) Summary per 21 CFR §807.92 (c) Section 5 | Submitter's Name and Address | Boston Scientific Corporation Electrophysiology 150 Baytech Drive San Jose, CA 95134 | |-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and Information | Michelle Roeding Principal Regulatory Affairs Specialist Tel: (408) 935-4912 Fax: (408) 957-6202 E-mail: Michelle.Roeding@bsci.com | | Alternate Contact and Information | Lisa Scott Director, Regulatory Affairs Tel: (408) 935-6382 Fax: (408) 957-6202 E-mail: Lisa.Scott@bsci.com | | Date Prepared | March 21, 2014 | | Trade Name | Constellation® Multiple Electrode Recording and Pacing Catheter | | Common Name | Catheter, Intracardiac, High Density Array | | Classification Name | Catheter, Intracardiac, High Density Array (Product Code MTD) has been classified as Class II per 21 CFR 870.1220 | | Predicate Device | The Constellation Catheter Multiple Electrode Recording and Pacing Catheter is substantially equivalent in design and intended use to the same device legally marketed under K983171, K992777, K000277, K003782 and K021232 and Johnson & Johnson/Biosense-Webster Flower High-Density Mapping Catheter/ PENTARAY™ High-Density Mapping Catheter legally marketed under K050217. | | Description of Device | 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. | | Intended Use/Indications for Use | 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. | | Device Technological Characteristics and Comparison to Predicate Device | The Constellation Catheter indicated for use in left atrial electrophysiology procedures 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. | | | Expanding the indication of the Constellation Catheter does not involve incorporation of new design features, which are identical to the predicate Constellation Catheter. In support of substantial equivalence, Boston Scientific has compared and evaluated technological characteristics of the Johnson & Johnson/ Biosense-Webster Flower/PENTARAY High- Density Mapping Catheter to the Constellation Catheter. The Constellation Catheter is unique only in its geometrical configuration of splines and electrodes. Otherwise, the devices are similar in all other technical aspects. | | Non-Clinical Performance Data | 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. | | Clinical Performance Data | Safety and effectiveness of the Constellation Catheter with expanded indications for use to include the left atrial electrophysiology procedures is based on cumulative animal and human data. Human clinical data include safety and effectiveness data from the original Constellation Catheter IDE (G940612) and safety data for use in the left atrium as evidenced from published medical literature, and in particular, from the CONFIRM [Conventional Ablation With or Without FIRM (Focal Impulse and Rotor Modulation)] study reported by Narayan et al (2012). In the CONFIRM study, the Constellation Catheter was advanced via an 8.5 F sheath to map the left atrium in 92 patients. There were no strokes or TIAs (transient ischemic attack) reported nor any unanticipated complications related to cardiac catheterization and/or ablation. | | Conclusion | 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 summation of the existing animal data, data from the IDE study (G940612) and the CONFIRM study (Narayan et al, 2012), along with the additional medical literature, support continued safety and effectiveness of the Constellation Catheter as it relates to expanding the current indications for use. | {1}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . {2}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 - {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ #### 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) K140733 ### 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) Image /page/5/Picture/15 description: The image shows a logo with the letters FDA. Next to the logo is the word "Date:" followed by the date "2014.04.28". Below the date is the time "20:35:56 -04'00'". 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 lime 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 PRAStaff@fda:hhs.gov "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 (1/14)