(79 days)
Not Found
No
The description focuses on the physical characteristics and function of a standard electrophysiology mapping catheter, with no mention of AI or ML capabilities.
No
The device is indicated for electrophysiological mapping, stimulation, and recording only, which are diagnostic functions. It does not treat a disease or condition.
Yes
The device is indicated for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This involves mapping electrical activity to identify issues, which is a diagnostic purpose.
No
The device description clearly details a physical catheter with electrodes, a handle, and a connector, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states the device is a "Coronary Sinus Deflectable Mapping Catheter" used for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This involves directly interacting with the patient's body (in vivo) to measure electrical activity.
- No Specimen Examination: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body.
The device is an invasive medical device used for diagnostic purposes within the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Coronary Sinus Deflectable Mapping Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only.
Product codes
DRF
Device Description
The Coronary Sinus Deflectable Mapping Catheter is a 10 pole deflectable mapping electrophysiology (EP) catheter with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The pre-shaped tip MZ curve facilitates introduction of the catheter into the Coronary Sinus Ostium when approaching the Right Atrium through the inferior Vena Cava. This catheter includes a handle with a thumbknob, which allows deflection of the distal end of the catheter. The handle also has a 10 pin connector for interfacing to a recording system through a standard catheter cable. The catheter has a braided shaft and a distal tip that is unbraided to impart flexibility and softness, which enhances safety to the patient by reducing the chance of perforation. The catheter will be provided in 4, 5, 6 and 7 french sizes with either 2-5-2 or 2-8-2 electrode spacing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures; Coronary Sinus; Right Atrium; inferior Vena Cava
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)
The modified device was assessed with non-clinical bench tests to verify conformance with design and performance specifications. Tests included those conducted to test performance and integrity after the device had been subjected to accelerated aging equivalent to 1 year of real time aging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k): Device Modification
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92. The summary was prepared on 4 April 2005.
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Road
Diamond Bar, CA 91765 USA
Tel: (800) 729-9010
Fax: (909) 839-8804 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael A. Johnson |
| Trade (Proprietary) Name: | Coronary Sinus Deflectable Mapping Catheter |
| Common Name: | Electrophysiology Diagnostic Mapping Catheter |
| Classification Name: | Electrode Recording Catheter (21 CFR 870.1220) |
| Device Class: | II |
| Product code: | DRF |
| Predicate device: | K892265 Biosense Webster Deflectable Mapping
Catheter |
Product Description:
The Coronary Sinus Deflectable Mapping Catheter is a 10 pole deflectable mapping electrophysiology (EP) catheter with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The pre-shaped tip MZ curve facilitates introduction of the catheter into the Coronary Sinus Ostium when approaching the Right Atrium through the inferior Vena Cava. This catheter includes a handle with a thumbknob, which allows deflection of the distal end of the catheter. The handle also has a 10 pin connector for interfacing to a recording system through a standard catheter cable. The catheter has a braided shaft and a distal tip that is unbraided to impart flexibility and softness, which enhances safety to the patient by reducing the chance of perforation. The catheter will be provided in 4, 5, 6 and 7 french sizes with either 2-5-2 or 2-8-2 electrode spacing.
Intended Use:
The Coronary Sinus Deflectable Mapping Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only.
Biosense Webster, Inc.
1
Special 510(k): Device Modification
Summary of substantial equivalence:
The Coronary Sinus Deflectable Mapping Catheter has the same material specifications as the predicate device. The modification is the addition of a "Shepard's Hook" (MZ curve) on the distal end of the catheter. The materials are the same as the predicate; the modified device uses the same fundamental technology, energy source, and has the same intended use as the predicate device.
Testing:
The modified device was assessed with non-clinical bench tests to verify conformance with design and performance specifications. Tests included those conducted to test performance and integrity after the device had been subjected to accelerated aging equivalent to 1 year of real time aging.
Biocompatibility and sterilization validation are the same as the predicate device. Patient-contact materials are identical to the predicate device and the device change does not affect the ability to sterilize the product.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2005
Biosense Webster, Inc. c/o Mr. Michael A. Johnson Regulatory Affairs Specialist 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K050877
K05087 /
Trade Name: Coronary Sinus Deflectable Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrophysiology Diagnostic Mapping Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: June 1, 2005 Received: June 2, 2005
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I (t J picmance is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent i referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predices marketed in interstate for use stated in the enclosure, to teglis nature date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment de of the Medical Device American commerce pror to May 28, 1976, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassined in accounted with are neversed application (PMA).
and Cosmetic Act (Act) that do not require approval of ta provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general vealual registration, listing of
general controls provisions of the Act include requirements mishranding and general controls provisions of the Act mender requirements on and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, be found in the Code of I cuctar Regalations, F.
publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr. Michael A. Johnson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the start of the seemplies with other requirements of the A Please be advised that FDA's issuance of a substantial exitos other requirements of the Act
that FDA has made a determination that your device anders areacies. You must that FDA has made a determination inal your devece by other Federal agencies. You must
or any Federal statutes and regulations administ no registration and listi or any Federal statutes and regulations and united to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration and l comply with all the Act's requirements, including bactice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 801); good manufacturing phation of the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the forth in the quality systems (QS) regulation (2 - OF the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 31 closes in a never bection 510(k)
This letter will allow you to begin marketing your device as described in your device to a This letter will allow you to begin marketury your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo prematication. The FDA finding of subsantal equivalians by .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the supportunities and 1010 (216) 276 (2005 - Also, please note the If you desire specific advice for your device on our lassing regulation entitled,
contact the Office of Compliance at (240) 276-0295. Also, please not the regulation of contact the Office of Compliance at (240) 276 view (21CFR Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Pat 807.97). You may obtai "Misbranding by reference to premarks nonincation " (21 er er t t t trom the Division of Small
other general information on your responsibilities under the Act from the Divis other general information on your responsionines and its toll-free mumber (800) 638-2041 or 1980)
Manufacturers, International and Consumer Assistance as iss toll-free number Manufacturers, International and Consumer Assistance at no on 110 on 110 on 110 and
Sincerely yours,
B. Hummar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT K050877
Device Name: Coronary Sinus Deflectable Mapping Catheter
Indications for Use: The Coronary Sinus Deflectable Mapping Catheter is indicated for Indications for Use: The Coronaly Sinds Denectable Rapping our Stimulation and recording only.
electrophysiological mapping of cardiac structures; i.e., stimulation and reco
Over-the-Counter AND/OR × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummer Jr.
Sign-Off
CIK
Biosense Webster, Inc.
Confidential