The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS).

When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

Device Description

The NaviStar RMT Steerable Tip Diagnostic Catheter, is a 7 Fr 4mm, magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter is a 7 Fr 4mm, magnetically steerable diagnostic catheter. The catheter contains a location sensor, that, when used together with the CARTO RMT system, provides location information to construct a 3D electroanatomical maps of the human heart in real-time. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum irridium electrodes that can be used for stimulation and recording. The tip can be deflected in multiple planes.

AI/ML Overview

The provided text describes a medical device, the NaviStar RMT Steerable Tip Diagnostic Catheter, and its clearance process (K052083) based on substantial equivalence to a predicate device (K954390). However, it does not contain detailed acceptance criteria, specific reported device performance metrics beyond general compliance, or information about a study designed to prove the device meets acceptance criteria in the manner typically seen for new, innovative devices requiring extensive clinical trials. Instead, the clearance is based on similarity to an existing device.

Therefore, the requested information cannot be fully extracted as structured in your request. I will articulate what is available from the text and note what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (K954390)	"The Biosense Webster, Inc. NaviStar™ RMT 7Fr. 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter. (cleared under K954390). The indication for use is identical for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench and animal testing demonstrates that the devices are functionally equivalent."
Compliance with External Electrical and Performance Standards	"The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards."
Indication for Use: Catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.	Device is stated to be for this indication, implying it meets this functional requirement.
When used with CARTO™ RMT EP Navigation System, provides location information.	Device is stated to provide location information when used with this system, implying it meets this functional requirement.

Missing Information/Why it's not applicable based on the text:
The document does not specify quantitative acceptance criteria (e.g., minimum accuracy rates, precision metrics, sensitivity, specificity, or specific error tolerances) for the device's performance, nor does it provide detailed quantitative results from a specific study designed to measure these against acceptance thresholds. The primary "acceptance" was substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "Bench and animal testing" but does not give sample sizes for either.
Data Provenance: "Bench and animal testing" are mentioned. No information regarding country of origin, retrospective, or prospective nature is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Given that the clearance is based on substantial equivalence and "bench and animal testing" rather than a clinical study requiring expert ground truth establishment for diagnostic accuracy, such details would likely not be included.

4. Adjudication method for the test set

This information is not provided.

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 or AI-assisted study is mentioned. The device described here is a diagnostic catheter, not an AI-powered diagnostic tool.

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

Not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the "Bench and animal testing," the ground truth would typically be established by direct measurement during the tests or by physiological responses in the animal models, consistent with engineering and preclinical testing standards. No specific "type of ground truth" (like pathology or outcomes data) for a diagnostic accuracy study is mentioned because such a study is not described.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dataset.

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

Not applicable for the same reason as point 8.

Summary of Study (as described in the document):

The document describes preclinical testing consisting of "Bench and animal testing" performed to demonstrate that the NaviStar RMT Steerable Tip Diagnostic Catheter is "functionally equivalent" to its predicate device, the Biosense Webster NaviStar Diagnostic Catheter (K954390). It also states that the device "was tested under simulated use conditions, and complies with multiple external electrical and performance standards."

The primary study presented for regulatory clearance is a substantial equivalence comparison to a legally marketed predicate device (K954390). The "study" (rather, the basis for clearance) hinges on demonstrating that the new device has identical indications for use, meets the same design requirements, and has similar technological characteristics to the predicate device, supported by the aforementioned bench and animal testing. No detailed quantitative clinical performance study is provided as the basis for clearance in this 510(k) summary.

Summary

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K052083

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SUMMARY OF SAFETY AND EFFICACY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:

Biosense Webster, Inc. 3333 Diamond Canyon Rd Diamond Bar, CA 91765 phone: (800) 729-9010 fax: (909) 839-8804

TRADE NAME: NaviStar RMT Steerable Tip Diagnostic Catheter

COMMON NAME: Steerable Diagnostic EP Catheter

CLASSIFICATION NAME: Electrode Recording Catheter / Steerable Catheter

DEVICE CLASSIFICATION: Class II, 21 CFR §870.1220 and §870.1280

PRODUCT CODE: 74 DRF/DRA

PREDICATE DEVICE:

The NaviStar RMT Diagnostic Steerable Tip Catheter is substantially equivalent to the Biosense Webster STAR Catheter, cleared for marketing under K954390.

SUBSTANTIALLY EQUIVALENT TO:

The Biosense Webster, Inc. NaviStar RMT 7Fr, 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter, (cleared under K954390).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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INDICATION FOR USE:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.

When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

TECHNICAL CHARACTERISTICS:

PERFORMANCE DATA:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards,

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The Biosense Webster, Inc. NaviStar™ RMT 7Fr. 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter. (cleared under K954390). The indication for use is identical for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench and animal testing demonstrates that the devices are functionally equivalent.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird.

SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosense Webster, Inc. c/o Ms. Diana M. Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K052083

Trade Name: NaviStar RMT Steerable Tip Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 29, 2005 Received: August 2, 2005

Dear Ms. Thorson:

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 cnclosure) 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 adultcration.

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.

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Page 2 – Ms. Diana M. Thorson

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 (QS) 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) 276-0295. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bzumumor 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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NaviStar RMT Stecrable Tip Diagnostic Catheter Original 510(k)

KOS2083

Page I of 1

510(k) Number (if known):

Device Name: NAVISTAR™ RMT Diagnostic Steerable Tip Catheter

Indications for Usc:

When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bammister

Biosense Webster, Inc. Confidential

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).