(73 days)
No
The description focuses on a sensor-based system for tracking catheter location relative to an external reference device, with no mention of AI or ML algorithms for data processing or analysis.
No
The device is described as a "Surface Reference Device" used externally on a patient's back to help locate the tip of a catheter during electrophysiological and electromechanical mapping of the heart. It aids in imaging and mapping, but it does not directly treat or restore health.
No
The Cordis Webster REF-STAR Ex Surface Reference Device is a reference device used with mapping systems (CARTO™ and NOGA™) to compensate for patient movement and provide catheter tip location during electrophysiological and electromechanical mapping of the heart. It does not diagnose a condition but rather aids in the precise localization of a catheter within the body for mapping purposes.
No
The device description explicitly states it consists of a sensor embedded in a polyurethane shaft connected to a handle housing a printed circuit board, indicating it is a hardware device.
Based on the provided information, the Cordis Webster REF-STAR Ex Surface Reference Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide catheter tip location in vivo (within the patient's body) during electrophysiological and electromechanical mapping of the heart. This is a diagnostic procedure performed on the patient, not on a sample taken from the patient.
- Device Description: The device is placed externally on the patient's back and works in conjunction with catheters inserted into the patient. It's part of a system for in vivo mapping.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples. The device's function is related to spatial positioning within the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The REF-STAR Ex Surface Reference Device does not fit this definition.
N/A
Intended Use / Indications for Use
The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR®, NOGA-STAR™, or REF-STAR catheters and the CARTO™ and NOGA ™ systems to provide catheter tip location.
Product codes
DRF
Device Description
The Cordis Webster REF-STAR Ex Surface Reference Device has been designed to be placed externally on the patient's back in order to compensate for movement during electrophysiological and electromechanical mapping of the heart. The Cordis Webster REF-STAR Ex Surface Reference is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology known as CARTO™ and NOGA ™. When used with the CARTO and NOGA system, the location of the mapping catheter tip, the NAVI-STAR, NOGA-STAR or REF-STAR is compared to the location of the reference device. This reference device consists of a sensor embedded in a polyurethane shaft, which is connected to a handle that houses the printed circuit board.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 nonclinical performance testing conducted on REF-STAR Ex Surface Reference Device compared to the predicate device indicated that there was no significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device. The applicable tests were performed according to FDA's "Electrode Recording Catheter Preliminary Guidance".
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).
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1980961
MAY 2 8 1998
510(k) SUMMARY March 13, 1998
Prepared by:
Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706 (626) 939-8604 (626) 813-1477 (fax)
Contact Person:
Mary Adams Regulatory Affairs
- CORDIS WEBSTER, INC. - STRICTLY CONFIDENTIAL *
..
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510(k) Summary
| Classification Name | None |
|---|---|
| Common/Usual Name: | Surface Reference Device |
| Proprietary Name: | Cordis Webster REF-STAR Ex Surface Reference Device |
Name of Predicate Devices
Cordis Webster REF-STAR Catheter
Device Description
The Cordis Webster REF-STAR Ex Surface Reference Device has been designed to be placed externally on the patient's back in order to compensate for movement during electrophysiological and electromechanical mapping of the heart. The Cordis Webster REF-STAR Ex Surface Reference is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology known as CARTO™ and NOGA ™. When used with the CARTO and NOGA system, the location of the mapping catheter tip, the NAVI-STAR, NOGA-STAR or REF-STAR is compared to the location of the reference device. This reference device consists of a sensor embedded in a polyurethane shaft, which is connected to a handle that houses the printed circuit board.
Intended Use
The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR, NOGA-STAR or REF-STAR catheters and the CARTO and NOGA system to provide catheter tip location.
Technological Characteristics
The subject device is technologically equivalent to the predicate device, the Cordis Webster REF-STAR catheter. Both the subject and marketed devices facilitate electrophysiology mapping. There are no known or suspected new or different implications with respect to safety or effectiveness relative to the changes made for this device.
1
2
510(k) Summary (continued)
Performance Data (Nonclinical Testing)
The nonclinical performance testing conducted on REF-STAR Ex Surface Reference Device compared to the predicate device indicated that there was no significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device. The applicable tests were performed according to FDA's "Electrode Recording Catheter Preliminary Guidance".
Conclusions Drawn from the Nonclinical Tests
The results of the nonclinical performance tests indicate that REF-STAR Ex Surface Reference Device performs as well as the currently marketed device and that the differences in testing outcome are not significant; therefore, Cordis Webster concludes that REF-STAR Ex Surface Reference Device is substantially equivalent to the currently marketed device, the Cordis Webster REF-STAR catheter.
* CORDIS WEBSTER, INC. - STRICTLY CONFIDENTIAL *
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1998
Ms. Mary Adams Regulatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706
Re: K980961 Cordis Webster REF-STAR® Ex Surface Reference Device Regulatory Class: II (two) Product Code: DRF Dated: March 13, 1998 March 16, 1998 Received:
Dear Ms. Adams:
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 (for the indications for use stated in the enclosure) to 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. 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 (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 requlation (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.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): TO BE ASSIGNED
Device Name:
CORDIS WEBSTER REF-STAR® EX SURFACE REFERENCE DEVICE
Indications for Use:
The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR®, NOGA-STAR™, or REF-STAR catheters and the CARTO™ and NOGA ™ systems to provide catheter tip location.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices |
(Division Sign-Off) Division of Cardiovascular, Respiratory,
Neurological Devices
510(k) Number K960961