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.

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.

AI/ML Overview

This 510(k) summary describes a substantial equivalence determination for the Cordis Webster REF-STAR Ex Surface Reference Device, comparing it to a predicate device. The information provided focuses on the nonclinical testing performed to demonstrate this equivalence, rather than a clinical study with detailed acceptance criteria and performance metrics in the way a new, innovative device might be evaluated for efficacy.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in the typical format of a new product performance study (e.g., sensitivity > X%, accuracy > Y%). Instead, the acceptance criterion for this 510(k) submission is "no significant differences in the outcome of the tests...that would affect the safety and effectiveness of the device" compared to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
No significant differences in outcomes compared to the predicate device (Cordis Webster REF-STAR Catheter) across applicable tests, ensuring safety and effectiveness.	"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 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."

Acceptance Criteria (Implicit)

Reported Device Performance

No significant differences in outcomes compared to the predicate device (Cordis Webster REF-STAR Catheter) across applicable tests, ensuring safety and effectiveness.

"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 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."

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

The document describes nonclinical testing. Therefore, there are no human subject sample sizes or data provenance in terms of country of origin or retrospective/prospective clinical data mentioned. The "tests" refer to laboratory or bench tests.

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)

This information is not applicable as the evaluation was based on nonclinical performance testing, not human expert interpretation or ground truth establishment in a clinical context.

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

This information is not applicable as the evaluation was based on nonclinical performance testing, not human expert adjudication.

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

This information is not applicable. The device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

This information is not applicable. The device is a physical surface reference device, not an algorithm. The testing described is nonclinical performance testing comparing the device to a predicate.

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

For the nonclinical performance testing, the "ground truth" would be the expected performance specifications and measurements defined for the device and its predicate. The performance of the REF-STAR Ex Surface Reference Device was compared directly against the performance of the predicate device (Cordis Webster REF-STAR catheter) in a controlled test environment. The implicit ground truth is that the predicate device is considered safe and effective, and thus the new device must perform comparably.

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm requiring a training set. The testing was nonclinical comparative performance testing of a physical device.

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

This information is not applicable for the same reason as above; there is no training set for a physical device undergoing nonclinical performance testing.

Summary

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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

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.

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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:

(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

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).