The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Device Description

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software is a modification of the NOGA™ Cardiac Navigation System cleared for marketing under K000332. Like the predicate device, the NOGA™ XP System is a computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart in a clear and intuitive manner. Maps are constructed by combining and integrating information from intracardiac electrograms with the respective endocardial locations. Like the CARTO™ Cardiac Navigation systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.

The current NOGA™ Cardiac Navigation System software was upgraded to allow for:

. on-screen visualization of the catheter shaft.
reduction of the steps required to create electromechanical maps .
- · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
- · easier mapping of transient events.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software:

Acceptance Criteria and Device Performance Study

The provided document describes the NOGA™ XP Cardiac Navigation System with QwikMap™ Software as a modification to an existing device, the NOGA™ Cardiac Navigation System. The primary method for demonstrating safety and effectiveness relied on showing substantial equivalence to predicate devices. This means that instead of establishing new performance metrics, the device's performance was compared to that of already cleared devices to ensure it performed in an equivalent manner and did not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance
Safety and Effectiveness Equivalence: The modified device (NOGA™ XP) is as safe and effective as the predicate device (NOGA™ Cardiac Navigation System and CARTO™ XP QWIKMAP™ EP Navigation System).	"The non-clinical bench and animal testing confirms that the NOGATM XP Cardiac Navigation System with QwikMap™ Software is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness."
Similar Indications for Use: The intended use of the NOGA™ XP System is the same as the predicate devices.	"The indications for use for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software are the same as the indications for use for the predicate devices."
Equivalent Functionality: The NOGA™ XP System works in a manner equivalent to the predicates, particularly with the new software upgrades for on-screen visualization, reduced steps for map creation, and easier mapping of transient events.	"Software validation, simulated use, and testing in the porcine model demonstrate that the NOGA™ XP Cardiac Navigation System with QwikMap™ Software works in an equivalent manner to the predicates."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a distinct "test set" in terms of number of cases, patients, or data points for a traditional clinical study. Instead, it mentions "non-clinical bench and animal testing."
- For the animal testing, it explicitly states "testing in the porcine model." The number of animals used is not provided.
Data Provenance:
- Bench Testing: Implied to be laboratory-based.
- Animal Testing: Porcine (pig) model.
- The document does not mention human data for either retrospective or prospective studies. The focus is on demonstrating equivalence through non-clinical means.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the "test set" in the context of a clinical study or even for the bench and animal testing. The evaluation appears to be based on engineering and physiological testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a ground truth adjudication process involving multiple reviewers for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a "cardiac navigation system," which is a tool for clinicians, but the submission focuses on its technical equivalence and functionality rather than changes in human reader performance or diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "cardiac navigation system" and "programmable diagnostic computer." It is inherently a device that provides information and displays data for human clinicians. Therefore, a purely standalone algorithm performance without human-in-the-loop context would not be directly applicable to its intended use. The "performance data" section focuses on the system's ability to acquire, analyze, and display information equivalently to predicate devices.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be based on engineering specifications, known physical properties, electrical signal characteristics, and defined system outputs.
For the animal (porcine) model testing, the ground truth would be based on physiological measurements and observations within the animal model, ensuring the system accurately represented cardiac activity and geometry as expected.

8. The Sample Size for the Training Set

The document does not mention a "training set" or machine learning aspects in a way that implies a distinct dataset for training an AI algorithm. The device is described as a "computerized electromechanical mapping system," suggesting a model-based or rule-based system rather than a machine learning one that requires a dedicated training set. Software validation typically involves testing against requirements and known scenarios, not "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a discrete "training set" for an AI algorithm is not identified in the provided text.

Summary

{0}------------------------------------------------

SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

2006 MAR 9

5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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
TRADE NAME:	NOGATM XP Cardiac Navigation System with QwikMapTMSoftware
COMMON NAME:	Cardiac Mapping System
CLASSIFICATIONNAME:	Programmable diagnostic computer
DEVICECLASSIFICATION:	Class II, 21 CFR §870.1425
PRODUCT CODE	74 DQK - computer, diagnostic, programmable
PREDICATEDEVICE:	NOGATM Cardiac Navigation System and the CARTOTM XPQWIKMAPTM EP Navigation System
MANUFACTURER	Biosense Webster (Israel) Ltd.POB 2009Tirat HaCarmel, 39120Israel

SUBSTANTIALLY EQUIVALENT TO:

The NOGA™ XP Cardiac Navigation System is substantially equivalent to the NOGA™ Cardiac Navigation System cleared for marketing under K000332 and to the CARYOTM XP QWIKMAP™ EP Navigation System cleared for marketing under K020863.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

CONFIDENTIAL

{1}------------------------------------------------

systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.

The current NOGA™ Cardiac Navigation System software was upgraded to allow for:

. on-screen visualization of the catheter shaft.
reduction of the steps required to create electromechanical maps .
- · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
- · easier mapping of transient events.

INDICATION FOR USE:

The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.

PERFORMANCE DATA:

The non-clinical bench and animal testing confirms that the NOGATM XP Cardiac Navigation System with QwikMap™ Software is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software are the same as the indications for use for the predicate devices. Software validation, simulated use, and testing in the porcine model demonstrate that the NOGA™ XP Cardiac Navigation System with QwikMap™ Software works in an equivalent manner to the predicates.

2/2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a symbol resembling three stylized human figures intertwined, positioned to the right. Encircling this symbol is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

Biosense Webster, Inc. c/o Ms. Sigi Caron MedTech Consultants, Inc 2400 Via Carrillo Palos Verdes Estates, CA 90274

Re: K053194

Trade Name: Noga™ XP Cardiac Navigation System with QwikMap™ Softwarc Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: February 16, 2006 Received: February 21, 2006

Dear Ms. Caron:

We bave 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.

{3}------------------------------------------------

Page 2 - Ms. Sigi Caron

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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bfummumor for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K053194

Device Name: NOGA™ XP Cardiac Navigation System with QwikMap™ Software

The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Limmama
(Division Sign-Off)

Page 1 of

Division of Cardiovasc
510(k) Number K

Biosense Webster, Inc.

CONFIDENTIAL

NOGA XP Special 510(k) Page 12 of 341

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).