The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Description

The Reprocessed Webster Coronary Sinus (CS) Diagnostic Electrophysiology (EP) Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115cm. The catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Standard features of this catheter include a braided bi-directional deflectable tip section with an array of platinum electrodes that includes a 2mm tip dome. Additionally, two asymmetric curve types are available providing two 180º opposed, single plane curves. The curve types include DF and FJ. A Rocker Lever is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-driven medical devices.

Instead, this document is an FDA 510(k) clearance letter for a reprocessed medical device: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter. The letter and accompanying 510(k) summary pertain to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a novel device.

Here's why the requested information cannot be fully extracted and what the document does provide:

No AI/ML Component: The device described is a physical catheter used for electrophysiological mapping. There is no mention of any artificial intelligence or machine learning component, therefore, questions regarding effect size of AI assistance, standalone algorithm performance, training sets, or expert adjudication for AI output are not applicable.
Emphasis on Substantial Equivalence: The entire document focuses on proving the reprocessed device is as safe and effective as the original, legally marketed predicate device. This is done through comparisons of technological characteristics, indications for use, and functional/safety testing, rather than setting specific performance metrics for a novel technology.
"Acceptance Criteria" are not performance metrics for a novel device: The "acceptance criteria" for this reprocessed device would be demonstrating that its performance (e.g., electrical continuity, mechanical characteristics, biocompatibility, sterility) is equivalent to the original device after reprocessing, and that the reprocessing itself is safe and effective. The document lists the types of tests conducted, but not specific numeric thresholds they had to meet for the reprocessed device to be considered "accepted."

However, I can provide a summary based on the information available, interpreting "acceptance criteria" in the context of a reprocessed device's substantial equivalence demonstration.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a reprocessed device, the "acceptance criteria" are intrinsically tied to demonstrating equivalence to the predicate device and ensuring the reprocessing does not compromise safety or efficacy. Specific quantitative performance thresholds are not provided in this summary, but the types of tests performed serve as the basis for "acceptance."

Acceptance Criteria Category (Implied by Testing)	Reported Device Performance (Implied by 510(k) Clearance)
Biocompatibility	Demonstrated to meet safety standards after reprocessing.
Cleaning Validation	Demonstrated that the cleaning process effectively removes visible soil and decontaminates the device.
Sterilization Validation	Demonstrated that the sterilization process achieves the required sterility assurance level (SAL).
Functional Testing:
Visual Inspection	Satisfied visual quality standards.
Dimensional Verification	Maintained original device dimensions.
Electrical Continuity and Resistance	Maintained electrical properties equivalent to the original device.
Simulated Use	Performed as expected in simulated use scenarios.
Mechanical Characteristics	Maintained mechanical properties (e.g., steerability, deflection) equivalent to the original device.
Auto ID Verification (for Auto ID models)	Functioned correctly with CARTO EP Navigation Systems.
Electrical Safety Testing:
Dielectric and Current Leakage	Met electrical safety standards.
Packaging Validation	Demonstrated appropriate packaging integrity and protection for the device.
Reprocessing Cycle Limit	Device is reprocessed no more than three (3) times, with the device marked and tracked to prevent further reprocessing after reaching the limit.
Reprocessing Restriction	Reprocessing performed only by Innovative Health; devices previously reprocessed by other reprocessors are excluded.
Substantial Equivalence (Overall)	Concludes that the reprocessed devices are substantially equivalent to the predicate devices in terms of purpose, design, materials, function, and intended use.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., how many catheters were subjected to sterilization validation or mechanical testing). It notes that "Bench and laboratory testing was conducted." The provenance is internal laboratory testing by Innovative Health, LLC. (prospective testing of reprocessed devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For a reprocessed physical device, "ground truth" is established by engineering and laboratory measurements against original device specifications and industry standards, not by expert interpretation of data like in an AI/ML context.

4. Adjudication method for the test set

This question is not applicable for a physical device's engineering and performance testing. Results would be compared directly to established specifications or predicate device performance.

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

Not applicable. This device does not involve AI or human readers.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for evaluating the reprocessed catheter is based on:

Original design specifications of the predicate device.
Industry standards for medical device safety and performance (e.g., biocompatibility, sterility).
Comparative performance data against new, original devices.
The effectiveness of the reprocessing methods themselves (cleaning, sterilization).

8. The sample size for the training set

Not applicable. This device does not involve AI/ML and therefore does not have a training set.

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

Not applicable. As above, no training set.

Summary

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May 4, 2021

Innovative Health, LLC Christina Fleming VP, Compliance and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K203655

Trade/Device Name: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: March 5, 2021 Received: March 8, 2021

Dear Christina Fleming:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh Deoras Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Details of Reprocessed Devices:

The item numbers included in the scope of this submission are as follows:

Item Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Spacing(mm)
BD710DF282RTS	ReprocessedWebster CSBi-DirectionalDiagnostic EPCatheter	115	7F	D-F	2-8-2
BD710FJ282RTS	ReprocessedWebster CSBi-DirectionalDiagnostic EPCatheter	115	7F	F-J	2-8-2
BD710DF282CT	ReprocessedWebster CSBi-DirectionalDiagnostic EPCatheter with Auto ID	115	7F	D-F	2-8-2
BD710FJ282CT	ReprocessedWebster CSBi-DirectionalDiagnostic EPCatheter with Auto ID	115	7F	F-J	2-8-2

Table 10.1: Device Scope

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Indications for Use

510(k) Number (if known)

K203655

Device Name

Reprocessed Webster CS Bi-directional Diagnostic Electrophysiology (EP) Catheters

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5: 510(k) SUMMARY

As required by 21 CFR 807.92(c)

Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

Contact Name and Information:

Christina Fleming VP. Compliance and Requlatory Affairs Innovative Health, LLC. (480) 525-5972 (office) (888) 965-7706 (fax) tfleming@innovative-health.com

Date prepared:

December 14, 2020

Device Information:

Trade/Proprietary Name:

Common Name: Classification Name: Classification Number: Product Code:

Reprocessed Webster CS Bi-directional Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K170922	Reprocessed Webster CS Bi-DirectionalDiagnostic Electrophysiology Catheter	Innovative Health, LLC.
K101345	Webster CS Catheter with EZ SteerTechnology, Webster CS Catheter withEZ Steer Technology and Auto ID	Biosense Webster

Device Description:

Standard features of this catheter include a braided bi-directional deflectable tip section with an array of platinum electrodes that includes a 2mm tip dome. Additionally, two asymmetric curve types are available providing two 180º opposed, single plane curves. The curve types include DF and FJ. A Rocker Lever is used to deflect the tip. The hightorque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

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For Devices with Auto ID Technology:

The catheter is equipped with Electronically Erasable Programmable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize he catheter information.

The catheter interfaces with CARTO EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors.

Note: Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.

Item Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Spacing(mm)
BD710DF282RTS	Reprocessed Webster CSBi-Directional DiagnosticEP Catheter	115	7F	D-F	2-8-2
BD710FJ282RTS	Reprocessed Webster CSBi-Directional DiagnosticEP Catheter	115	7F	F-J	2-8-2
BD710DF282CT	Reprocessed Webster CSBi-Directional DiagnosticEP Catheter with Auto ID	115	7F	D-F	2-8-2
BD710FJ282CT	Reprocessed Webster CSBi-Directional DiagnosticEP Catheter with Auto ID	115	7F	F-J	2-8-2

The item numbers included in the scope of this submission are as follows:

Table 5.1: Item Numbers

This 510(k) adds two (2) reprocessing cycles to the same device cleared under K170922 and minor changes to the reprocessing and sterilization release method.

Indications for Use:

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Webster CS Bidirectional Diagnostic EP Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Webster CS Bi-directional Diagnostic EP Catheters.

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This included the following:

Biocompatibility
Cleaning Validation .
Sterilization Validation .
Functional Testing 0
- o Visual Inspection
- . Dimensional Verification
- Electrical Continuity and Resistance ●
- Simulated Use ●
- Mechanical Characteristics ●
- Auto ID Verification .
Electrical Safety Testing ●
- Dielectric and Current Leakage ●
Packaging Validation ●

The Reprocessed Webster Coronary Sinus (CS) Bi-directional Diagnostic Electrophysiology (EP) Catheters are reprocessed no more than three (3) times. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Predicate Comparison:

A comparison of the device and reprocessing methods with the predicates are provided in the table below:

	This 510(k)	K170922	K101345
Device:	Identical	Identical	Identical
Reprocessing Cycles:	3	1	0
Reprocessing Method:	Change to processingparameters. Packagingconfiguration and labelchange. Shelf lifechange.	Cleared/validatedprocess	N/A
Sterilization:	Change to releasemethod. No change tothe sterilization methodor SAL.	Cleared/validatedprocess	N/A
Routine Monitoring:	Change to frequencyand adjustment of limits.	Cleared process	N/A

Table 5.2: Predicate Comparison

Conclusion:

Innovative Health concludes that the Reprocessed Webster Coronary Sinus (CS) Bidirectional Diagnostic Electrophysiology (EP) Catheters are substantially equivalent to the predicate devices described herein.

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).