(28 days)
Not Found
No
The description focuses on the physical characteristics of the catheter and its function in recording electrical potentials and delivering pacing stimuli. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used to assist in the diagnosis of complex arrhythmias and for delivery of pacing stimuli, which are diagnostic and therapeutic functions respectively. However, the question asks if the device itself is a therapeutic device. While pacing is a therapeutic function, this device is used for delivery of externally generated pacing stimuli, meaning it acts as a conduit for therapy rather than providing the therapy itself. Its primary intended use is diagnostic (recording and detecting electrical potentials to assist in diagnosis).
Yes
The intended use explicitly states, "to assist in the diagnosis of complex arrhythmias." The device detects and records electrical potentials, which are then used for diagnostic purposes.
No
The device description explicitly details a physical catheter with electrodes and accessories, indicating it is a hardware-based medical 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 is for "right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias" and "delivery of externally generated pacing stimuli." This describes a device used within the body to interact with and measure electrical activity of the heart.
- Device Description: The description details a catheter with electrodes designed to be inserted into the heart to "detect and record electrical potentials from the endocardial surfaces." This is an invasive procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
This device is clearly used in vivo (within the living body) for diagnostic and therapeutic purposes related to cardiac electrophysiology, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
For use in right 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.
For use in right atrial electrophysiology procedures to assist in the diagnosis of complex r or aso in right anal blockeply words on the conventional mapping systems alone (i.e., linear mapping catheters). The Constellation® Multiple Electrode Recording and Pacing Catheters 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/EP Technologies (EPT) Constellation® Multiple Electrode Recording and Pacing Catheter is a sterile, single use device used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli. The distal, expandable "basket" assembly is, in essence, eight miniature octapolar "catheters". The basket assembly contains an array of between 32 to 64 electrodes mounted along eight resilient support structures called "splines". Several configurations are available, including unipolar (electrodes evenly spaced), bipolar (electrodes evenly EPT furnishes the distributed into pairs), and lower density arrays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocardial surfaces of the heart (right atrial)
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)
Performance testing with the new configuration demonstrated substantial equivalence with the predicate device. Specifically, non-clinical tests included electrical integrity testing. Bench testing was sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence of the new configuration. Clinical data was therefore determined to be unnecessary.
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.
Not Found
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.
K983171, K992777, K000277, K003782
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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MAY 1 6 2002
Attachment 4
510(k) Summary
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Correspondent: | Christina L. Rowe |
| Associate II, Regulatory Affairs | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Information: | E-mail: rowec@bsci.com |
| Phone: 408.895.3526 | |
| Fax: 408.895.2202 | |
| Device Common Name | Catheter, Intracardiac, High Density Array |
| Device Proprietary Name | Constellation® Multiple Electrode |
| Recording and Pacing Catheter | |
| Device Classification | Class II, MTD |
| Predicate Device | Catheter, Intracardiac, High Density Array |
| Predicate Device Manufacturer(s) | Boston Scientific/EP Technologies Inc. |
| Predicate Device Proprietary Name(s) | Constellation® Multiple Electrode |
| Recording and Pacing Catheter | |
| Predicate Device Classification Number | MTD |
| Predicate Device Classification(s) | 21 CFR § 870.1220 |
Date Summary Was Prepared:
April 17, 2002
Description of the Device:
The Boston Scientific/EP Technologies (EPT) Constellation® Multiple Electrode Recording and Pacing Catheter is a sterile, single use device used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli. The distal, expandable "basket" assembly is, in essence, eight miniature octapolar "catheters". The basket assembly contains an array of between 32 to 64 electrodes mounted along eight resilient support structures called "splines". Several configurations are available, including unipolar (electrodes evenly spaced), bipolar (electrodes evenly EPT furnishes the distributed into pairs), and lower density arrays.
1
Constellation® Catheter either with or without the Duraflo® coating. EPT also furnishes accessories that include EPT Constellation Accessory Cables (sterile, reuseable), an EPT Constellation Pacing Switchbox (non-sterile, re-useable), and EPT Constellation extension cables (non-sterile, re-useable).
Intended Use:
For use in right 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.
Additionally, all Constellation® Catheter Directions for Use (DFU) contain a boxed warning with text which is 2 points larger than the surrounding text.
The use of this device in conjunction with radiofrequency ablation, as part of the diagnosis and therapeutic treatment of atrial arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.
Technological Characteristics:
Constellation® identical technological catheter features The modified characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduced from a range between 2 -- 13mm to a range between 1 -- 13mm.
2
Comparison to Predicate Device:
| | Constellation® Catheter
38, 48, 60 & 75 mm | Modified Device |
|--------------------------|------------------------------------------------------------|--------------------|
| 510(k) Reference | K983171; K992777; K000277;
K003782 | Current Submission |
| Intended Use | Intracardiac electrophysiological
mapping and or pacing | Same |
| Device
Description | Multiple Electrode Mapping and
Pacing Catheter | Same |
| Electrode Spacing | 2 - 13 mm | 1 - 13 mm |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/EPT | Same |
| Device
Classification | Class II / MTD
21 CFR 870.1220 | Same |
Summary of the Non-clinical Data:
Performance testing with the new configuration demonstrated substantial equivalence with the predicate device. Specifically, non-clinical tests included electrical integrity testing.
Abstract of the Clinical Data:
Bench testing was sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence of the new configuration. Clinical data was therefore determined to be unnecessary.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles, possibly representing the department's focus on people and well-being.
MAY 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christina L. Rowe Associate II, Regulatory Affairs Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re: K021232
Trade Name: Constellation® Multiple Electrode Recording and Pacing Catheters System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: MTD Dated: April 17, 2002 Received: April 18, 2002
Dear Ms. Rowe:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
WARNING: The use of this device in conjunction with radiofrequency ablation, as part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.
The Warning must be presented in within a black box, and the font size of the text should be at least 2 points larger than any surrounding text. The Warning must be present on the first page of your Operator's Manual, and on the packaging for each individual device.
4
Page 2 - Ms. Christina L. Rowe
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); good manufacturing practice requirements as set 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K021232
Device Name: Constellation® Multiple Electrode Recording and Pacing Catheters System
Indications For Use for device:
For use in right atrial electrophysiology procedures to assist in the diagnosis of complex r or aso in right anal blockeply words on the conventional mapping systems alone (i.e., linear mapping catheters). The Constellation® Multiple Electrode Recording and Pacing Catheters System may also be used for delivery of externally generated pacing stimuli.
Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use_
Nela Ten
Division of Cardiovascular & Reani
510(k) Number K021232
OR