(182 days)
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 is intended to acquire and display multiple electrograms simultaneously and to deliver physician generated pacing stimuli.
Constellation Catheters (Uncoated)
48mm Constellation, unipolar, uncoated: 8048 U
60mm Constellation, unipolar, uncoated: 8060 U
75mm Constellation, unipolar, uncoated: 8075 U
48mm Constellation, bipolar, uncoated: 8048 BU
60mm Constellation, bipolar, uncoated: 8060 BU
75mm Constellation, bipolar, uncoated: 8075 BU
Constellation Catheters (Coated)
48mm Constellation, unipolar, coated: 8048 C
60mm Constellation, unipolar, coated: 8060 C
75mm Constellation, unipolar, coated: 8075 C
48mm Constellation, bipolar, coated: 8048 BC
60mm Constellation, bipolar, coated: 8060 BC
75mm Constellation, bipolar, coated: 8075 BC
Sheaths
Straight: 961
Curved: 960 962
Pacing Switchbox
Standard Switchbox: 951
Cables
Universal, primary: 900
Universal, secondary: 901A 901B
Single spline, primary: 657
Single spline, secondary: 626
The provided document is a 510(k) clearance letter for a medical device (Constellation Multiple Electrode Pacing and Recording Catheter System and Accessories). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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)."
This means the device was cleared based on substantial equivalence to a predicate device, not on a study demonstrating it met specific acceptance criteria for performance, safety, or effectiveness. 510(k) clearance does not typically involve the submission of extensive clinical trial data or performance studies against predefined acceptance criteria in the same way a Premarket Approval (PMA) would.
Therefore, I cannot extract the requested information (performance table, sample sizes, ground truth details, MRMC study, etc.) from this document. The document's purpose is to grant market clearance based on substantial equivalence, not to describe the results of a performance study.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1999
Boston Scientific/EP Technologies Steve Jwanouskos Senior Director Benior or Affairs and Quality Compliance 2710 Orchard Parkway San Jose, CA 95134
Re: K983171 K963171
Trade Name: Constellation Multiple Electrode Pacing and conscellations (see attached list of model numbers) Regulatory Class: II Regulatory Crass: II
Product Code: MTD – High density array intracardiac mapping catheter Dated: September 9, 1998 Received: September 10, 1998
Dear Mr. Jwanouskos:
We have reviewed your Section 510(k) notification of intent to we have levrewed your become bove and we have determined the market the device ferenced above afort afor the indications for use device is substanciary oqually marketed predicate devices Stated in the barstate commerce prior to May 28, 1976, the marketed in theorouse of the Medical Device Amendments, or to devices enatement date of che neaders
that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, the reachar rood, bray, subject to the general controls chercrore, marked and the limitations described below. The provisions of the rovisions of the Act include requirements for general concrolo provision of devices, good manufacturing annual regiberaing, 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 incended abound rate form. Therefore, in accordance with Section
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Page 2 - Mr. Steve Jwanouskos
513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The use of this device in conjunction with WARNING: 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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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.
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Page 3 - Mr. Steve Jwanouskos
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Susan Alpert Ph.D. M.D.
Susan Alpert, Ph.D., Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Description
Model Number
:
| Constellation Catheters (Uncoated) | |
|---|---|
| 48mm Constellation, unipolar, uncoated | 8048 U |
| 60mm Constellation, unipolar, uncoated | 8060 U |
| 75mm Constellation, unipolar, uncoated | 8075 U |
| 48mm Constellation, bipolar, uncoated | 8048 BU |
| 60mm Constellation, bipolar, uncoated | 8060 BU |
| 75mm Constellation, bipolar, uncoated | 8075 BU |
| Constellation Catheters (Coated) | |
| 48mm Constellation, unipolar, coated | 8048 C |
| 60mm Constellation, unipolar, coated | 8060 C |
| 75mm Constellation, unipolar, coated | 8075 C |
| 48mm Constellation, bipolar, coated | 8048 BC |
| 60mm Constellation, bipolar, coated | 8060 BC |
| 75mm Constellation, bipolar, coated | 8075 BC |
| Sheaths | |
| Straight | 961 |
| Curved | 960 962 |
| Pacing Switchbox | |
| Standard Switchbox | 951 |
| Cables | |
| Universal, primary | 900 |
| Universal, secondary | 901A901B |
| Single spline, primary | 657 |
| Single spline, secondary | 626 |
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:
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Attachment 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Constellation ® Multiple Electrode Recording and Device Name: __ Pacing Catheter System, and Accessories
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 systems alone (1.6., incal napping cannotes, and maily generated pacing stimuli.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Beth Telle
Prescription Use
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Pcr 21 CFR 801.109)
§ 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).