Bard Electrophysiology's fixed curve diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Device Description

The Viking Diagnostic Electrode Catheter is a closed lumen, nonsteerable device. Typical of electrode recording catheters currently sold, the Viking catheter will be offered in 6F diameter with 2-10 electrodes with a variety of inter-electrode spacings and curve styles.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Viking Diagnostic Electrode Catheter, structured according to your request:

Acceptance Criteria and Device Performance for the Viking Diagnostic Electrode Catheter

The 510(k) summary for the Viking Diagnostic Electrode Catheter indicates that its acceptance criteria were established based on the "Electrode Recording Catheter Preliminary Guidance, Data to be Submitted to the Food and Drug Administration in Support of Premarket Notifications" (March, 1995 Draft Version). The study demonstrating the device meets these criteria involved comprehensive bench testing and biocompatibility assessments.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from Text)	Reported Device Performance
Functional Equivalence	Indication Statements	"The uses of these devices are the same...for electrophysiological mapping of cardiac structures."
	Technological Characteristics (Design, Materials)	"The only technological difference is in electrode width," which was "within the range of those of the predicate devices." "Differences in materials are minor, such as the use of different colorants."
Bench Testing	All required characteristics of electrode recording catheters	"The Viking catheter was found to meet all testing acceptance criteria."
	Comparative performance with predicate devices	"Equivalent to, better than, or between the performances of the Cordis Webster and Bard Woven electrode catheters."
Biocompatibility	General biocompatibility requirements	"The Viking catheter passed all tests of biocompatibility."
Clinical Acceptability	Overall safety and performance	"Determined to be clinically acceptable in every case."

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the test set of Viking Diagnostic Electrode Catheters or the predicate devices used for comparative testing. It refers generally to "the Viking catheter" and "the Cordis Webster catheter and/or a Bard Woven electrode catheter."
Data Provenance: The data appears to be from prospective bench testing conducted specifically for this 510(k) submission. There is no mention of retrospective data, clinical trials, or country of origin for patient data. This is a pre-market submission, so it relies on engineering and laboratory testing.

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

Number of Experts: Not applicable. This submission relies on objective engineering and performance testing data, not subjective expert judgment, to establish "ground truth."
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" for the performance testing was objective measurements against predetermined standards and comparisons to predicate devices. There wouldn't be an adjudication process in the sense of reconciling divergent expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This submission is for a medical device (electrode catheter) that performs physical measurements and functions, not for an AI diagnostic tool that requires human interpretation of outputs. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Yes, in a sense. The entirely of the performance testing described is "standalone" in that it evaluates the physical characteristics and functional performance of the catheter itself in a laboratory setting, without human intervention in its diagnostic output interpretation for a patient. The "algorithm" here would be the physical design and manufacturing of the catheter, and its performance was assessed independently.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used for performance evaluation was based on objective engineering specifications, established performance standards for electrode recording catheters (from the 1995 FDA guidance), and comparative performance results against legally marketed predicate devices. For biocompatibility, the ground truth was meeting established biocompatibility standards.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. Training sets are relevant for machine learning or AI models. This submission describes a physical medical device. The "training" in this context would be the design and development iterations of the catheter, which are not quantified as a "training set."

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

How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there isn't a "training set" in the context of an AI algorithm. The device's design and engineering would have been informed by existing knowledge of cardiac electrophysiology, material science, and the performance characteristics of previous catheters, but this isn't "ground truth" derived for a training dataset.

Summary

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K971265

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OCT 2 3 1997

510(k) SUMMARY FOR THE VIKING DIAGNOSTIC ELECTRODE CATHETER

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

Submitter's Information A.

Name:	C.R. Bard, Inc.
Address:	129 Concord Road, Billerica, MA 01821
Phone:	(508) 667-2511 extension 1065
Fax:	(508) 667-8594
Contact Person:	Douglas E. Ferguson, Senior Regulatory AffairsCoordinator
Date of Preparation:	March 31, 1997

B. Device Name:

Trade Name:	Viking Diagnostic Electrode Catheter
Common/Usual Name:	Electrode Recording Catheter
Classification Name:	Electrode Recording Catheter

C. Predicate Device Name(s): Cordis Webster Electrophysiology Catheter

Bard Woven Electrode Catheter

Device Description/Indications for Use: D.

Description

Indications:

Viking Diagnostic Electrode Catheter 510(k) Submission

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Technological Characteristics/Performance Data Summary E.
The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (CDRH 510(k) Manual 92-4158) was utilized in conjunction with the technological characteristics and performance testing results to make a determination of substantial equivalence as follows:

Does New Device Have Same Indication Statements? 1.

Yes. Although the indications for the Viking catheter are more detailed than those of the Cordis Webster catheter, the uses of these devices are the same; they are to be used during the evaluation of cardiac arrhythmias for electrophysiological mapping of cardiac structures. The longer description in the indications for the Viking catheter identifies standard uses of diagnostic electrode catheters which are also contained in the indications for the currently sold preamendment Bard Woven electrode catheters and are referred to in the indications and instructions for use in the Bard® Steerable catheters (K921872; later referred to as the EP+XT™ catheters) and the Bard® Dynamic Tip and Tip Deflecting catheters (K891908, K904080, and K912213).

Does New Device Have Same Technological Characteristics, e.g., 2. Design, Materials, etc.?

No. Although the Viking catheter has similar technological characteristics and component materials, they are not identical.

Could the New Characteristics Affect Safety or Effectiveness? 3.

No. The only technological difference is in electrode width. However, since the distal and proximal electrode widths of the Viking catheter are within the range of those of the predicate devices, this is not an issue. Differences in materials are minor, such as the use of different colorants. Although these minor material differences are unlikely to affect safety, biocompatibility was verified through testing.

4. Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although the materials and technological characteristics are very similar, differences between vendors and manufacturing techniques necessitate bench testing to confirm equivalence.

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Are Performance Data Available to Assess Equivalence? 5.

Yes. The Viking catheter was tested for safety and performance based on the required characteristics of electrode recording catheters. Tests were chosen and developed based on the March, 1995 Draft Version of the "Electrode Recording Catheter Preliminary Guidance, Data to be Submitted to the Food and Drug Administration in Support of Premarket Notifications." Where appropriate, comparative testing was done using the Cordis Webster catheter and/or a Bard Woven electrode catheter. In addition, as previously mentioned, the Viking catheter was subjected to biocompatibility testing.

Do Performance Data Demonstrate Equivalence? 6.

Yes. The performance of the Viking catheter was found to meet all testing acceptance criteria and was therefore clinically acceptable. Where comparative testing was conducted, the Viking catheter performance was equivalent to, better than, or between the performances of the Cordis Webster and Bard Woven electrode catheters or the performance was determined to be clinically acceptable in every case. The Viking catheter passed all tests of biocompatibility.

SUBSTANTIALLY EQUIVALENT DETERMINATION:

The Viking Catheter is substantially equivalent to currently sold electrode recording catheters.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 2 3 1997

Mr. Douglas E. Ferguson C. R. Bard, Inc. 129 Concord Road P.O. Box 566 Billerica, Massachusetts 01821

K971265 Re: Viking Diagnostic Electrode Catheters (38 models) Trade Name: and SureLink Extension Cables (8 models) Regulatory Class: II Product Code: 74DRF Dated: July 24, 1997 Received: July 28, 1997

Dear Mr. Ferguson:

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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. 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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Page 2 - Mr. Douglas E. Ferguson

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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D. INDICATIONS FOR USE

Viking Diagnostic Electrode Catheter Device Name:

Indications for Use:

Contraindications:

The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divisio! Division of . . and Neurological D 510(k) Number .

Rubanfummerer Le Tom Callahan

ision of Cardiovascular, Respiratory, nd Neurological

510(k) Number K97265

Prescription Use (Per 21 CFR 801.109) ()R

Over-the-Counter Use

Viking Diagnostic Electrode Catheter 510(k) Submission

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).