(85 days)
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.
Not Found
Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate pull strength | All samples passed the acceptance criteria. |
| Absence of adverse events in pediatric patients (implicitly, referring to smaller French size catheters) | Three letters from physicians discussing clinical experience with the absence of adverse events using smaller French size catheters in pediatric patients. |
| Number of complaints | Performance data was provided as the number of complaints versus the number of units sold. (Specific numbers are not provided in the document for direct comparison). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each performance measure.
- For "adequate pull strength," it states "All samples," but the number of samples is not specified.
- For "absence of adverse events in pediatric patients," it refers to "three letters from physicians," which implies a limited sample, but the specific number of pediatric patients observed by these physicians is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective studies. The physician letters suggest clinical experience, which could be retrospective observation. The complaints data would be real-world post-market data. The pull strength testing would be in a controlled lab environment.
- Country of Origin: Not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three (physicians).
- Qualifications: "Physicians" are mentioned. Their specific qualifications (e.g., pediatric cardiologists, electrophysiologists, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- No formal adjudication method is described for the "absence of adverse events" data from the physicians. It appears to be based on individual clinical experience as reported in letters. For pull strength, it's a pass/fail mechanical test, so no expert adjudication is required. For complaint data, it is simply a record of complaints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a physical catheter, not an AI or imaging device where MRMC studies are typically conducted to assess reader performance with or without AI assistance.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Not applicable. This is a physical medical device (catheter), not a software algorithm.
7. Type of Ground Truth Used
- Pull Strength: Mechanical testing against predefined acceptance criteria for physical properties.
- Absence of Adverse Events: Clinical observation and experience as reported by physicians. This is a form of real-world evidence or expert opinion.
- Complaints: Real-world post-market surveillance data.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The "capability testing" for pull strength would be considered part of the verification and validation process, not "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
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Appendix A: 510(k) Summary of Safety and Effectiveness, Continued
| Intended use | The intended use of the Fixed Curve Catheter is to map cardiac structuresusing stimulation and recording techniques. |
|---|---|
| Indicationsstatement | The Cordis Webster Fixed Curve Catheter is indicated for electrophysiologymapping of cardiac structures in adults and children 4 years of age and older;i.e. stimulation and recording only. |
| Technologicalcharacteristics | The technological characteristics of the Subject device have not changed dueto the addition of the pediatric indication. |
| Performancedata | Capability testing was performed to ensure adequate pull strength. Allsamples passed the acceptance criteria. Performance data was provided as thenumber of complaints versus the number of units sold. Further, three lettersfrom physicians were included as they discuss their clinical experience withthe absence of adverse events by using smaller French size catheters inpediatric patients. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) andthe information provided herein, we conclude that the Subject device issubstantially equivalent to the same Predicate Device under the Federal Food,Drug and Cosmetic Act. |
| Contact | Mary AdamsRegulatory Affairs ManagerCordis Webster, Inc.4750 Littlejohn StreetBaldwin Park, CA 91706 |
| Date | September 1, 1999CORDIS WEBSTER, INC. - STRICTLY CONFIDENTIAL30 |
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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)
§ 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).