(85 days)
Not Found
Not Found
No
The summary describes a fixed curve catheter for electrophysiology mapping, focusing on physical characteristics and performance studies related to pull strength and clinical experience. There is no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML in medical devices.
No.
The device is indicated for "electrophysiology mapping of cardiac structures" for "stimulation and recording only," which describes a diagnostic rather than therapeutic function.
Yes
The device is indicated for "electrophysiology mapping of cardiac structures," which involves recording and stimulation to assess the electrical activity of the heart, a diagnostic purpose.
No
The device is described as a "Fixed Curve Catheter," which is a physical medical device used for electrophysiology mapping. The summary discusses pull strength testing and complaints related to units sold, indicating a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, the Cordis Webster Fixed Curve Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "electrophysiology mapping of cardiac structures... i.e. stimulation and recording only." This describes a procedure performed in vivo (within the living body) to assess electrical activity.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform such tests on samples.
- Anatomical Site: The device is used on "cardiac structures," which are internal organs. IVDs typically analyze samples derived from the body, not the body itself.
Therefore, the Cordis Webster Fixed Curve Catheter is a medical device used for an in vivo procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis Webster Fixed Curve 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
DRF
Device Description
Not Found
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
Capability testing was performed to ensure adequate pull strength. All samples passed the acceptance criteria. Performance data was provided as the number of complaints versus the number of units sold. Further, three letters from physicians were included as they discuss their clinical experience with the absence of adverse events by using smaller French size catheters in pediatric patients.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Appendix A: 510(k) Summary of Safety and Effectiveness, Continued
| Intended use | The intended use of the Fixed Curve Catheter is to map cardiac structures
using stimulation and recording techniques. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
statement | The Cordis Webster Fixed Curve 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 Subject device have not changed due
to the addition of the pediatric indication. |
| Performance
data | Capability testing was performed to ensure adequate pull strength. All
samples passed the acceptance criteria. Performance data was provided as the
number of complaints versus the number of units sold. Further, three letters
from physicians were included as they discuss their clinical experience with
the absence of adverse events by using smaller French size catheters in
pediatric patients. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the Subject device is
substantially equivalent to the same 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 | September 1, 1999
CORDIS WEBSTER, INC. - STRICTLY CONFIDENTIAL
30 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping figures suggesting a sense of community or support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1999
Ms. Nanette Canepa Requlatory Affairs Associate Cordis Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re : K992965 Cordis Webster Fixed Curve Catheters Requlatory Class: II (two) Product Code: DRF September 1, 1999 Dated: Received: September 2, 1999
Dear Ms. Canepa:
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 leqally 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 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 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 regulation may result in 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 - Ms. Nanette Canepa
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your 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 Also, please note the regulation entitled, (301) 594-4639. "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,
Celia M. Witten, Ph.D.
lia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
510(k) Number: K 992965
Device Name: Fixed Curve Catheter
Indications for Use: The Cordis Webster Fixed Curve 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.
N. Dale Tiller
(Divis Division of Ca and Neurologica 510k) Num
Prescription Use
(Per 21 CFR 801.109)