CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 by CORDIS WEBSTER, INC.

The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac structures using stimulation and recording techniques. 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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for a Diagnostic Deflectable Tip Catheter (5 French size) modification. The submission aims to demonstrate substantial equivalence to a predicate device (K892265). The core of the modification is an additional indication for use, allowing the catheter to be used in children 4 years of age and older, and a warning about brachial plexus injury. The device itself has not been altered in its fundamental design or function compared to the predicate device, other than being a smaller diameter version of 6 and 7 French designs. The key change is a modification in the tip electrode connection/termination method, where the puller-wire is soldered directly to the tip electrode, replacing safety wires.

Here's the information broken down as requested:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are not explicitly stated as numerical targets. Instead, the performance evaluation relies on demonstrating substantial equivalence to a predicate device and showing the safety and effectiveness of the modifications.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Pediatric Use: The device must be demonstrated safe and effective for use in children 4 years of age and older.	Published Literature Support: "Further related published literature was cited to show the safety and effectiveness of the smaller french size catheter used in pediatric patients." (No specific studies or data from this literature are detailed).
Mechanical Integrity of Puller-Wire Connection: The modified tip electrode connection, where the puller-wire is soldered directly to the tip electrode, must be robust and reliable.	Process Capability Study: "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." (No specific numerical capability indices or sample sizes are provided).
Similar Technological Characteristics to Predicate Device: The device should not have significant performance differences from the predicate device due to technological changes.	Technological Characteristics: "The technological characteristics of the Modified Device are the same as the Predicate Device." (This implies a direct comparison, but no specific performance data is provided to back this statement beyond the pull test above).
Low Complaint Rate: Maintain a reasonable safety profile in the market.	Complaint Data: "Performance data was provided as the number of complaints versus the number of units sold." (No specific complaint numbers or units sold are provided, nor is an acceptance threshold for complaint rates).
Substantial Equivalence to Predicate Device (K892265): Overall, the device must meet the legal standard of being as safe and effective as the predicate device.	Conclusion Statement: The submission concludes that "the Modified Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For the "process capability study" on puller wires: Not specified. The text only states that "pull tests were conducted."
- For the "published literature" cited for pediatric use: Not specified. It's external literature, not a study performed by the applicant on this specific device.
- For "complaint data": Not specified. "Number of complaints versus the number of units sold" is mentioned, but no actual numbers are provided.
Data Provenance: Not explicitly stated for any of the data points.
- The "process capability study" would likely be an internal study conducted by the manufacturer, but the location is not mentioned.
- "Published literature" could be from various global sources.
- "Complaint data" would be post-market surveillance data, likely collected globally wherever the predicate device was sold.
- General information points to the applicant's address in Baldwin Park, CA, and Diamond Bar, CA, which are in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. The submission does not describe a study involving expert review or ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment relies on mechanical testing (pull tests), existing literature, and market surveillance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no mention of expert adjudication for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a medical device (catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a medical device (catheter), not an algorithm. Standalone performance for an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the pediatric indication, the "ground truth" for safety and effectiveness appears to be derived from published literature on similar smaller French-size catheters, rather than a specific ground truth established for this device's study.
For the mechanical integrity of the puller-wire, the ground truth is established through physical pull tests where the wire's breaking strength or securement is objectively measured against engineering specifications. No expert consensus, pathology, or outcomes data is relevant here.
For overall safety, complaint data (post-market outcomes) indirectly serves as a measure.

8. The sample size for the training set

Not Applicable. As this is a medical device (catheter) and not an AI/algorithmic device, there is no concept of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable. Same as above, no training set is relevant.

Summary

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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.

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Appendix A: 510(k) Summary of Safety and Effectiveness, Continued

Intended use	The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiacstructures using stimulation and recording techniques.
Indicationsstatement	The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated forelectrophysiology mapping of cardiac structures in adults and children 4 yearsof age and older; i.e. stimulation and recording only.
Technologicalcharacteristics	The technological characteristics of the Modified Device are the same as thePredicate Device.
Performancedata	Performance data was provided as the number of complaints versus thenumber of units sold. Further related published literature was cited to showthe safety and effectiveness of the smaller french size catheter used inpediatric patients.A process capability study is referenced which is applicable to all puller wiresthat are attached directly into the stem of the tip electrode for deflectablecatheters. The pull tests that were conducted resulted in high capabilityindices. Based on these results, the process for soldering puller wires to thetip electrode was found to be more than capable.
Conclusion	Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) andthe information provided herein, we conclude that the Modified Device issubstantially equivalent to the Predicate Device under the Federal Food, Drugand Cosmetic Act.
Contact	Mary AdamsRegulatory Affairs ManagerCordis Webster, Inc.4750 Littlejohn StreetBaldwin Park, CA 91706
Date	April 30, 1999

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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.

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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
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Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).