(28 days)
Not Found
Not Found
No
The description focuses on the physical components and electrical signal processing for providing a reference location, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is used to provide a reference location for mapping/diagnostic catheters and does not directly treat a patient's condition.
No
Explanation: The device provides a reference location and electrogram information in conjunction with other systems but does not perform diagnostic interpretation or diagnosis itself. It facilitates the use of diagnostic catheters.
No
The device description explicitly details hardware components such as a sensor, adhesive patch, handle, printed circuit board, cables, and a Mu Metal Shield.
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 a reference location relative to a mapping/diagnostic catheter within the patient's body when used with specific equipment. This is a device used in vivo (within a living organism) for navigation and location tracking during a medical procedure.
- Device Description: The device is an external patch placed on the patient's back with a sensor that interacts with the CARTO and NOGA systems to determine the location of an intracardiac catheter. It's a component of a system for in vivo navigation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze biological specimens.
The device is clearly designed for use on and in conjunction with a patient during a medical procedure, not for analyzing samples from a patient in a laboratory setting.
N/A
Intended Use / Indications for Use
The REF-STAR External Reference Patch is indicated for use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.
The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's back
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)
Verification testing of the New Device was conducted to verify the structural integrity, electrical integrity and adhesive durability of the External Reference Patch and to compare the applicable results to the Predicate Device.
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.
Not Found
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
1982415
Appendix A: 510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Statement Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device description
The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.
The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.
Intended use
The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
Continued on next page
1
| Indications
statement | The Cordis Webster REF-STAR External Reference Patch is indicated for the
use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and
NOGA systems to provide catheter tip location as well as electrogram
information. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The technological characteristics of the New Device are the same as the
Predicate Device. |
| Performance
data | Verification testing of the New Device was conducted to verify the structural
integrity, electrical integrity and adhesive durability of the External Reference
Patch and to compare the applicable results to the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the New Device is
substantially equivalent to the Predicate Device under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Mary Adams
Regulatory Affairs Manager
Cordis Webster, Inc.
4750 Littlejohn Street
Baldwin Park, CA 91706 |
| Date | July 10, 1998 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Adams Regulatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706
AUG 1 0 1998
Re: K982415 Cordis Webster REF-STARTM External Reference Patch Regulatory Class: II (two) Product Code: DRF Dated: July 10, 1998 Received: July 13, 1998
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 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). 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 Requlations, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
3
This letter will allow you to beqin 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" (21CFR 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,
DA Saylor
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
| 510(k) Number: K | 982415 |
|---|---|
| ------------------ | -------- |
Device Name: REF-STAR External Reference Patch
Indications for Use: The REF-STAR External Reference Patch is indicated for use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.
Prescription Use
(Per 21 CFR 801.109)
Qe th tllh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number