(154 days)
P950005/S3, K953768
No
The summary describes a physical catheter used for electrophysiology mapping and does not mention any software or algorithms that would incorporate AI/ML. The changes described relate to the physical design, materials, and intended use population.
No.
The device is used for electrophysiology mapping (stimulation and recording) to diagnose cardiac structures, not to treat them.
Yes
The Intended Use/Indications for Use section explicitly states, "The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac structures using stimulation and recording techniques," and further mentions "electrophysiology mapping of cardiac structures." The device is also named "Diagnostic Deflectable Tip Catheter," and its predicate device and one of its reference devices also contain "Diagnostic" in their names.
No
The device description clearly details a physical catheter with electrodes and a deflectable tip, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Diagnostic Deflectable Tip Catheter is used inside the body to map cardiac structures using electrical stimulation and recording. It is a medical device used for a procedure performed directly on the patient.
Therefore, based on its intended use and how it functions, this device is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e., stimulation and recording only.
Product codes (comma separated list FDA assigned to the subject device)
74DRF
Device Description
The Diagnostic Deflectable Tip Catheter (5 French size) modification is applicable only to the Instructions for Use. The function, component materials, and intended use of the Diagnostic Deflectable Tip Catheter as compared to the Predicate Device (of the same name - K892265) are identical. An additional indication for use and warning are added that allows the use of the catheter to not only be used in adults but in children 4 years of age and older. The additional warning is to alert the physician regarding the possibility of brachial plexus injury. These additions to the IFU were requested by FDA on behalf of P950005/S3, the pediatric indication approval for Cordis Webster's Diagnostic/Ablation Deflectable Tip Catheters, 6 and 7 French. They also apply to the 5 French diagnostic catheter. The safety or effectiveness of the subject device was not affected as the device itself has not been altered. The Diagnostic Deflectable Tip Catheter (5 French size) is essentially a smaller diameter version of the Premarket Notified 6. 7 French design. These catheters were designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing platinum electrodes that can be used for stimulation and recording. The 5 French Deflectable Catheter utilized the same design features that are in the present deflectable catheter with the exception of the tip electrode connection/termination method. The electrical connection is made in the same way as is done with the Predicate Device, however, the puller-wire which is normally anchored proximal to the tip is terminated (soldered) directly to the tip electrode. Since the puller-wire is attached to the tip electrode, the puller-wire replaces the safety wires that were in the 6 and 7 French Deflectable Catheters. This tip electrode connection/termination method is also utilized for the Crista Cath™ diagnostic catheter approved under K953768.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures
Indicated Patient Age Range
adults and children 4 years of age and older
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)
Performance data was provided as the number of complaints versus the number of units sold. Further related published literature was cited to show the safety and effectiveness of the smaller french size catheter used in pediatric patients.
A process capability study is referenced which is applicable to all puller wires that are attached directly into the stem of the tip electrode for deflectable catheters. The pull tests that were conducted resulted in high capability indices. Based on these results, the process for soldering puller wires to the tip electrode was found to be more than capable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
P950005/S3, K953768
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Appendix A: 510(k) Summary of Safety and Effectiveness
Statement Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. Device The Diagnostic Deflectable Tip Catheter (5 French size) modification is description applicable only to the Instructions for Use. The function, component materials, and intended use of the Diagnostic Deflectable Tip Catheter as compared to the Predicate Device (of the same name - K892265) are identical. An additional indication for use and warning are added that allows the use of the catheter to not only be used in adults but in children 4 years of age and older. The additional warning is to alert the physician regarding the possibility of brachial plexus injury. These additions to the IFU were requested by FDA on behalf of P950005/S3, the pediatric indication approval for Cordis Webster's Diagnostic/Ablation Deflectable Tip Catheters, 6 and 7 French. They also apply to the 5 French diagnostic catheter. The safety or effectiveness of the subject device was not affected as the device itself has not been altered. The Diagnostic Deflectable Tip Catheter (5 French size) is essentially a smaller diameter version of the Premarket Notified 6. 7 French design. These catheters were designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing platinum electrodes that can be used for stimulation and recording. The 5 French Deflectable Catheter utilized the same design features that are in the present deflectable catheter with the exception of the tip electrode connection/termination method. The electrical connection is made in the same way as is done with the Predicate Device, however, the puller-wire which is normally anchored proximal to the tip is terminated (soldered) directly to the tip electrode. Since the puller-wire is attached to the tip electrode, the puller-wire replaces the safety wires that were in the 6 and 7 French Deflectable Catheters. This tip electrode connection/termination method is also utilized for the Crista Cath™ diagnostic catheter approved under K953768.
00058
1
Appendix A: 510(k) Summary of Safety and Effectiveness, Continued
| Intended use | The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac
structures using stimulation and recording techniques. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
statement | The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for
electrophysiology mapping of cardiac structures in adults and children 4 years
of age and older; i.e. stimulation and recording only. |
| Technological
characteristics | The technological characteristics of the Modified Device are the same as the
Predicate Device. |
| Performance
data | Performance data was provided as the number of complaints versus the
number of units sold. Further related published literature was cited to show
the safety and effectiveness of the smaller french size catheter used in
pediatric patients.
A process capability study is referenced which is applicable to all puller wires
that are attached directly into the stem of the tip electrode for deflectable
catheters. The pull tests that were conducted resulted in high capability
indices. Based on these results, the process for soldering puller wires to the
tip electrode was found to be more than capable. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the Modified Device is
substantially equivalent to the Predicate Device under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Mary Adams
Regulatory Affairs Manager
Cordis Webster, Inc.
4750 Littlejohn Street
Baldwin Park, CA 91706 |
| Date | April 30, 1999 |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT .. 4 1999
Ms. Mary Adams Cordis Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re : K991531/S1 Cordis Webster Diagnostic Deflectable Tip Catheter Regulatory Class: II (two) Product Code: 74DRF August 27, 1999 Dated: Received: August 30, 1999
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 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, Druq, 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 aqainst 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 regulation (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 requlation may result in requlatory 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.
3
Page 2 - Ms. Mary Adams
This letter will allow you to beqin 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of of 1
510(k) Number (if known):
Diagnostic Deflectable Tip Catheter Device Name:
Indications For Use: The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e., stimulation and recording only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | Ka91531 |
|---|---|
| --------------- | --------- |
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)