(35 days)
Not Found
No
The description focuses on the physical characteristics and function of a multi-electrode catheter for electrical signal detection and pacing, with no mention of AI or ML for data analysis or interpretation.
No.
The device is described as a diagnostic tool for mapping electrical activity in the heart and assisting in the diagnosis of arrhythmias, not for treating them. While it can deliver pacing stimuli, the primary use is for recording and mapping to assist in diagnosis, which falls under diagnostic rather than therapeutic.
Yes
The "Intended Use / Indications for Use" section states: "to assist in the diagnosis of complex arrhythmias," and the "Device Description" section calls it "a sterile, single use advanced heart mapping diagnostic device designed to detect electrical potentials from the endocardial surfaces of the heart."
No
The device description clearly details a physical catheter with electrodes and a basket assembly, indicating it is a hardware device, not software-only.
No, 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.
- Device Function: The description clearly states that the Constellation Catheter is a device designed to be inserted directly into the heart (endocardial surfaces) to detect electrical potentials and deliver pacing stimuli. This is an in vivo procedure (performed within the living body), not an in vitro procedure (performed outside the living body).
- Intended Use: The intended use is for "electrophysiology procedures to assist in the diagnosis of complex arrhythmias" and "delivery of externally generated pacing stimuli." These are diagnostic and therapeutic procedures performed directly on the patient's heart.
Therefore, based on the provided information, the Constellation Multiple Electrode Recording and Pacing Catheter System is an in vivo diagnostic and therapeutic device, not an IVD.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MTD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right and left atrial electrophysiology
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)
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.
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.
K983171, K992777, K000277, K003782, K021232, K050217
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
.
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)
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.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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