(62 days)
Not Found
No
The description focuses on a physical reference patch and cable for a navigation system, with no mention of AI or ML algorithms for data processing or analysis.
No
The device is described as providing a reference point for catheter tip location, which is a diagnostic or navigational function, not a therapeutic one. It facilitates the use of other systems (CARTO® and NOGA®) but does not directly treat a medical condition.
No
The device provides a reference point for catheter tip location, which is a supportive function for navigation systems rather than a diagnostic one that identifies or determines the nature of a disease or condition.
No
The device description explicitly details hardware components including a sensor, adhesive patch, shaft, connector, cable, printed circuit board, and EEPROM. It is an integral part of a larger hardware system (CARTO® and NOGA® Systems).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used with navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location. This is a function related to in vivo procedures (inside the body), specifically electrophysiology navigation.
- Device Description: The description reinforces its role in a non-fluoroscopic catheter tip location system. It describes a sensor embedded in an adhesive patch that is applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to assist with procedures within the body. This device's function is to provide a spatial reference during a medical procedure performed on a patient.
N/A
Intended Use / Indications for Use
REFSTAR® PLUS with QWIKPATCH® External Reference Patch:
The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable:
The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.
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 REFSTAR® PLUS with QWIKPATCH® External reference Patch and REFSTAR® PLUS Cable have passed bench testing to validate the mechanical and electrical integrity of the devices and the performance of the devices with the CARTO® and NOGA® Systems.
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.
REFSTAR® External Reference Patch (K061468), Interface Cable (K982415)
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
14. 510(K) SUMMARY
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765,
USA
Phone: 800-839-8599
Fax: 909-839-8804 |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 19, 2009 |
| Contact Person: | Balaka Das
Senior Specialist, Regulatory Affairs |
| Proprietary Device Name,
Manufacturing Part Number: | REFSTAR® PLUS with QWIKPATCH® External Reference
Patch, D-1210-03
REFSTAR® PLUS Cable, M-4700-106 |
| Common Device Name: | Surface Reference Device |
| Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220, Product code DRF |
| Predicate Device: | REFSTAR® External Reference Patch (K061468)
Interface Cable (K982415) |
| Manufacturing Facilities: | REFSTAR® PLUS with QWIKPATCH® External Reference
Patch
Biosense Webster, Inc.
Circuito Interior Norte #1820
Parque Industrial Salvacar
Juarez Chihuahua |
Biosense Webster, Inc. 15715 Arrow Highway Irwindale, CA 91706
Mexico 32599
CONFIDENTIAL
MAR 2 4 2009
1
Special 510(k) RefStar Plus with QwikPatch External Reference Patch RefStar Plus Cable
REFSTAR® PLUS Cable Biosense Webster (Israel) Ltd. POB 2009 4 Etgar Street, Einstein Bldg. Tirat HaCarmel, 39120 Israel
14.1 Description of Device
The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.
14.2 Indications for Use
REFSTAR® PLUS with QWIKPATCH External Reference Patch:
The Biosense Webster REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable:
The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
14.3 Summary of Testing
The REFSTAR® PLUS with QWIKPATCH® External reference Patch and REFSTAR® PLUS Cable have passed bench testing to validate the mechanical and electrical integrity of the devices and the performance of the devices with the CARTO® and NOGA® Systems.
14.4 Substantial Equivalence
The REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable are substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended
2
.
use, operating principles, fundamental scientific technology, design and performance.
·
.
・、
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. MAR 2 4 2009
Biosense Webster, Inc. c/o Mr. Balaka Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K090120
Trade Name: REFSTAR(6) PLUS with OWIKPATCH(8) External Reference Patch REFSTAR(6) PLUS Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 4, 2009 Received: March 5, 2009
Dear Mr. Das:
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.
4
Page 2 - Mr. Balaka Das
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 (OS) 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5. INDICATIONS FOR USE
510(k) No (if known): _ K 096120
Device Name: REFSTAR® PLUS with QWIKPATCH® External Reference Patch REFSTAR® PLUS Cable
Indications for Use:
REFSTAR® PLUS with QWIKPATCH® External Reference Patch:
The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable:
The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
Prescription Use ﻠﻴ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular Devices | ||
| 510(k) Number K090120 | ||
| Biosense Webster, Inc. | CONFIDENTIAL | Page 13 of 188 |