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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the RefStar External Reference Patch. This submission describes a modification to the labeling of an already cleared device, specifically adding the use of the EsophaStar Esophageal Mapping Catheter. The key takeaway is that no new performance studies were conducted because the device itself and its performance characteristics remain unchanged from its predicate.

Therefore, many of the requested details about acceptance criteria, study findings, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as they pertain to new device testing.

Here's a breakdown of what can be gleaned from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in this 510(k) summary. Given that this is a labeling modification, performance acceptance criteria would have been established and met during the original clearance of the predicate device (RefStar External Reference Device, K982415, August 10, 1998).
Reported Device Performance: The document states, "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." This implies that the device performance met the criteria of its original clearance, but no specific performance metrics are reported in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this 510(k) submission. No new testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable for this 510(k) submission. No new testing was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this 510(k) submission. No new testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is an external reference patch used in conjunction with a catheter tip location system, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" does not apply here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware device (an external reference patch), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for this 510(k) submission. No new testing was performed. For the original clearance of the predicate device, ground truth would likely have been established through methods verifying the accuracy of catheter tip location relative to the reference patch, potentially using phantoms or in vivo models with known reference points.

8. The sample size for the training set

Not applicable. This device is a hardware component and does not involve AI or machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant for this device.

Summary

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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

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13.9 DESCRIPTION OF DEVICE

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

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.

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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.

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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.

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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

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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)

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510(k) Number	N061468
Division of Cardiovascular Devices
(Division Sign-Off)

Regulation Number and Section

§ 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).