(58 days)
Not Found
No
The summary describes a diagnostic catheter used for electrophysiological mapping with a magnetic navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is focused on magnetic steering and location sensing for 3D mapping.
No.
The device is indicated for diagnostic mapping of the heart's electrical activity, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for catheter-based atrial and ventricular electrophysiological mapping." The "Device Description" also mentions it is a "magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping." Mapping is a diagnostic process used to identify the source of electrical signals in the heart.
No
The device description clearly describes a physical catheter with a steerable tip, electrodes, and a location sensor, indicating it is a hardware 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter is a device used inside the body (in vivo) for electrophysiological mapping of the heart. It records electrical signals and provides location information to create a 3D map. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "catheter-based atrial and ventricular electrophysiological mapping," which is an invasive procedure performed directly on the patient.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NAVISTARTM RMT Steerable Tip Diagnostic Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.
When used with the CARTOTM RMT EP Navigation System, the NAVISTARTM RMT Steerable Tip Diagnostic Catheter provides location information.
Product codes (comma separated list FDA assigned to the subject device)
74 DRF/DRA, DRF
Device Description
The NaviStar RMT Steerable Tip Diagnostic Catheter, is a 7 Fr 4mm, magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.
The NAVISTARTM RMT Steerable Tip Diagnostic Catheter is a 7 Fr 4mm, magnetically steerable diagnostic catheter. The catheter contains a location sensor, that, when used together with the CARTO RMT system, provides location information to construct a 3D electroanatomical maps of the human heart in real-time. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum irridium electrodes that can be used for stimulation and recording. The tip can be deflected in multiple planes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human heart
Indicated Patient Age Range
Adults and children four (4) years of age and older.
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 NAVISTARTM RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards,
Bench and animal testing demonstrates that the devices are functionally equivalent.
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.
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
K052083
Page 1 of 2
SUMMARY OF SAFETY AND EFFICACY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
APPLICANT:
Biosense Webster, Inc. 3333 Diamond Canyon Rd Diamond Bar, CA 91765 phone: (800) 729-9010 fax: (909) 839-8804
TRADE NAME: NaviStar RMT Steerable Tip Diagnostic Catheter
COMMON NAME: Steerable Diagnostic EP Catheter
CLASSIFICATION NAME: Electrode Recording Catheter / Steerable Catheter
DEVICE CLASSIFICATION: Class II, 21 CFR §870.1220 and §870.1280
PRODUCT CODE: 74 DRF/DRA
PREDICATE DEVICE:
The NaviStar RMT Diagnostic Steerable Tip Catheter is substantially equivalent to the Biosense Webster STAR Catheter, cleared for marketing under K954390.
SUBSTANTIALLY EQUIVALENT TO:
The Biosense Webster, Inc. NaviStar RMT 7Fr, 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter, (cleared under K954390).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NaviStar RMT Steerable Tip Diagnostic Catheter, is a 7 Fr 4mm, magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.
1
INDICATION FOR USE:
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.
When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.
TECHNICAL CHARACTERISTICS:
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter is a 7 Fr 4mm, magnetically steerable diagnostic catheter. The catheter contains a location sensor, that, when used together with the CARTO RMT system, provides location information to construct a 3D electroanatomical maps of the human heart in real-time. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum irridium electrodes that can be used for stimulation and recording. The tip can be deflected in multiple planes.
PERFORMANCE DATA:
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards,
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The Biosense Webster, Inc. NaviStar™ RMT 7Fr. 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter. (cleared under K954390). The indication for use is identical for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench and animal testing demonstrates that the devices are functionally equivalent.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosense Webster, Inc. c/o Ms. Diana M. Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K052083
Trade Name: NaviStar RMT Steerable Tip Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 29, 2005 Received: August 2, 2005
Dear Ms. Thorson:
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 cnclosure) 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Ms. Diana M. Thorson
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Bzumumor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NaviStar RMT Stecrable Tip Diagnostic Catheter Original 510(k)
KOS2083
Page I of 1
510(k) Number (if known):
Device Name: NAVISTAR™ RMT Diagnostic Steerable Tip Catheter
Indications for Usc:
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS).
When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bammister
Biosense Webster, Inc. Confidential