(80 days)
Not Found
No
The document describes a passive reference patch used for navigation, with no mention of AI or ML in its function or description.
No
The device is described as an "External Reference Patch" that provides a "reference point for catheter tip location" when used with navigation systems. Its function is to assist in locating a catheter tip, not to treat a medical condition or restore health.
No
The device is described as providing a reference point for catheter tip location, meaning it helps to localize instrumentation within the body rather than diagnosing a condition or disease.
No
The device description explicitly states it consists of a sensor embedded in an adhesive patch connected to a handle housing a printed circuit board, indicating it is a hardware device.
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 point for catheter tip location within the body during a medical procedure. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is an external patch with a sensor used in conjunction with navigation systems to track the location of a catheter inside a patient. This aligns with an in vivo tracking or navigation system, not an in vitro diagnostic test that analyzes samples like blood or tissue.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory analysis.
Therefore, the Biosense Webster RefStar External Reference Patch is a medical device used for navigation and tracking during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the RefStar External Reference Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
The Biosense Webster RefStar External Reference Patch is indicated for use with Biosense Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.
Product codes
DRF
Device Description
The Biosense Webster RefStar 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 systems, 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, 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)
All testing previously submitted for the RefStar External Reference Patch still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device. Therefore, no additional testing is submitted in this Premarket Notification.
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).
0
KOSI468
13 510(k) Summary
SPONSOR'S NAME & ADDRESS 13.1 AUG I 4 2006 Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 OFFICIAL CORRESPONDENT 13.2 Natalie Bennington Project Manager, Regulatory Affairs Phone: 909-839-7272 Fax: 909-839-8804 Email: nbenning@bwius.jnj.com 13.3 SUBMISSION DATE May 26, 2006 TRADE NAME 13.4 RefStar External Reference Patch 13.5 COMMON NAME Surface Reference Device CLASSIFICATION NAME 13.6 Electrode Recording Catheter 13.7 CLASSIFICATION Class II 13.8 PREDICATE DEVICE
RefStar External Reference Device, K982415, August 10, 1998
1
13.9 DESCRIPTION OF DEVICE
The Biosense Webster RefStar 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 systems, 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, which is connected to a handle that houses the printed circuit board.
13.10 INTENDED USE
The intended use of the RefStar External Reference Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
13.11 INDICATIONS FOR USE
The Biosense Webster RefStar External Reference Patch is indicated for use with Biosense Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.
13.12 DESCRIPTION OF MODIFICATION
The modified RefStar External Reference Device is physically identical to the predicate device in terms of design, manufacturing methods, materials and performance. There are absolutely no changes to the device what so ever. The only modification is to the labeling for the device to indicate that the device is indicated for use with Biosense Webster navigation catheters, specifically adding the use of the EsophaStar Esophageal Mapping Catheter.
SUMMARY OF NONCLINICAL TESTS 13.13
All testing previously submitted for the RefStar External Reference Patch still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device. Therefore, no additional testing is submitted in this Premarket Notification.
2
13.14 SUBSTANTIAL EQUIVALENCE
The modified RefStar External Reference Device is identical to the previously cleared RefStar External Reference Device in that the devices:
- have the same intended use, .
- use the same operating principle, .
- use the same fundamental scientific technology, .
- incorporate the same design, .
- incorporate the same materials and construction, .
- have the same shelf life, and .
- are packaged using the same materials and processes. .
In summary, the RetStar External Reference Device described in this submission is substantially equivalent to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2006
Biosense Webster, Inc. c/o Ms. Natalie Bennington Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K061468
Trade/Device Name: Refstar External Reference Patch Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: May 26, 2006 Received: May 26, 2006
Dear Ms. Bennington:
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 ear or louin further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Natalie Bennington
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumes or a on device complies with other requirements of the Act that I DA has made a decemmandir that Jour seee a agencies. You must of any Federal Statures and regulations and mitsees of of not limited to: registration and listing (21 comply with an the 7ter 31equirements, 01); good manufacturing practice requirements as set CFK Fart 607), labeling (21 OFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k) This letter whit anow you to oogin manteaning of substantial equivalence of your device to a legally premarked notification. "The PDT Imazing sification 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 If you desire specific at not 10. 90. 70. (240) 276-0120. Also, please note the regulation entitled, Conact the Office of Comphalled at (21 t ) = 1 = 1 = 1 = 1 807.97). You may obtain Misoraning Uy reference to premientonibilities under the Act from the Division of Small other general information on your responser 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,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 6
510(k) No (if known): _ K061468
Device Name: RefStar™ External Reference Patch
Indications for Use:
The Biosense Webster RefStar External Reference Patch is indicated for use with The Drooms Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.
Prescription Use __ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1
| 510(k) Number | N061468 |
|---|---|
| Division of Cardiovascular Devices | |
| (Division Sign-Off) |