(332 days)
No
The summary describes a physical device with sensors for location tracking and electrogram information, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an external reference patch that works with other systems to provide catheter tip location and electrogram information for mapping the heart, which is a diagnostic function, not a therapeutic intervention.
Yes
The device helps to construct "3D electrophysiological maps of the human heart," which is a diagnostic function, even though its primary purpose is movement compensation during mapping.
No
The device description explicitly states it is an "external reference catheter" with a "location sensor" and an "adhesive backing," indicating it is a physical hardware 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 to provide catheter tip location and electrogram information for electrophysiology mapping of the heart. This is a procedure performed on the patient, not on a sample taken from the patient.
- Device Description: The device is an external patch placed on the patient's back. It contains a location sensor and works with other systems to create 3D maps of the heart. This describes a device used for in vivo (within a living organism) procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RefStarTM RMT is indicated for use with the NAVI-STARTM RMT catheter and the CARTOTM RMT system to provide catheter tip location as well as electrogram information.
Product codes
74 DRF,DRF
Device Description
The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's back, human heart
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 RefStar RMT was tested under simulated use conditions, and complies with multiple external electrical and performance standards. Bench testing demonstrates that the devices are functionally equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
SEP 29 2005
K042998
11. 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: | RefStar RMT External Reference Patch |
| COMMON NAME: | Surface Reference Device |
| CLASSIFICATION
NAME: | Electrode Recording Catheter |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR §870.1220 |
| PRODUCT CODE | 74 DRF |
| PREDICATE
DEVICE: | The RefStar RMT is substantially equivalent to the Cordis-Webster
RefStar™ External Surface Reference Device, cleared for
marketing under K980961. |
SUBSTANTIALLY EQUIVALENT TO:
The Biosense Webster, Inc. RefStar RMT External Reference Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, (cleared under K980961).
. . . . . . .
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart.
INDICATION FOR USE:
The RefStarTM RMT is indicated for use with the NAVI-STARTM RMT catheter and the CARTOTM RMT system to provide catheter tip location as well as electrogram information.
1
TECHNICAL CHARACTERISTICS:
The back of the distal end of the RefStar RMT External Reference Patch has an adhesive backing, designed to be placed externally on the patient's back. The catheter contains a location sensor, that, when used together with the CARTO RMT system and the , NAVISTAR RMT Catheter provides catheter tip location information to construct a 3D electrophysiological maps of the human heart in the Stereotaxis Magnetic Navigation System magnetic field (K013484 and K021555) in real-time.
PERFORMANCE DATA:
The RefStar RMT 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. RefStar RMT Exterence Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, cleared for marketing under K980961. The indication for use is the same for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench 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 Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosense Webster, Inc. c/o Mr. Mark O'Donnell Director, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K042998
Trade Name: RefStar RMT External Reference Patch Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: September 1, 2005 Received: September 2, 2005
Dear Mr. O'Donnell:
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.
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 - Mr. Mark O'Donnell
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,
Bhimman per
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RefStar RMT Special 510(k)
- INDICATIONS FOR USE
510(k) Number (if known): K042988
Page 1 of 1
Device Name: REFSTARTM RMT External Reference Patch
Indications for Use:
The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.
Prescription Use x _ x
(Part 21 CFR 801 Subpart D)
OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Zimmerman
(Division Sign-Off) Division of Cardiov
Biosense Webster, Inc. Confidential
Page 19 of 47
fidential