(202 days)
No
The summary describes a standard diagnostic electrode catheter for sensing and recording cardiac signals, with no mention of AI or ML capabilities. The performance studies focus on physical and electrical characteristics compared to predicate devices.
No
The device is described as a diagnostic electrode catheter for sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are "intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which are diagnostic activities. Additionally, the device is described as a "fixed curve diagnostic electrode catheter."
No
The device description clearly describes a physical catheter with electrodes, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias." This describes a device used within the body for direct physiological measurement and intervention, not for testing samples outside the body.
- Device Description: The description of a "closed lumen, nonsteerable device" with electrodes for intracardiac use further reinforces its function as an in-vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
This device is an in-vivo diagnostic and therapeutic device used directly within the heart.
N/A
Intended Use / Indications for Use
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.
Product codes
74DRF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Webster Electrophysiology Catheter, Bard Woven Electrode Catheter
Reference Device(s)
K921872, K891908, K904080, K912213
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letter "A" is stylized with a horizontal line through the middle, resembling the Greek letter lambda.
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 Affairs |
| Coordinator | |
| 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
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.
Indications:
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.
Viking Diagnostic Electrode Catheter 510(k) Submission
1
- 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.
2
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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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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
5
D. INDICATIONS FOR USE
Viking Diagnostic Electrode Catheter Device Name:
Indications for Use:
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.
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