The Reprocessed Webster Duo-Decapolar EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

Device Description

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.

The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) filing for the Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter does not contain the information required to describe acceptance criteria and a study proving a device meets those criteria, as typically seen for AI-enabled medical devices.

This 510(k) pertains to a reprocessed medical device (a catheter), which means it's a device that has been cleaned, disinfected, sterilized, and functionally tested after prior use to be used again. The documentation focuses on demonstrating that the reprocessed device is substantially equivalent to a new, legally marketed predicate device in terms of design, materials, function, intended use, and safety/effectiveness through bench and laboratory testing.

Here's why the requested information about AI model performance, expert ground truth, multi-reader multi-case studies, and training/test set details is not present in this document:

This is not an AI-enabled device. The device is a physical catheter used for electrophysiological mapping of the heart. Its function is based on physical properties, electrical contacts, and mechanical manipulation, not on artificial intelligence algorithms analyzing data.
The "study" refers to bench and laboratory testing. The document lists "Functional and Safety Testing" which includes biocompatibility, cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity and resistance, simulated use, mechanical characteristics, electrical safety testing, and packaging validation. These are standard tests for physical medical devices and do not involve AI performance metrics.
"Acceptance Criteria" here would relate to physical and electrical specifications. For example, "dimensional verification" might have an acceptance criterion for the catheter's length or diameter, or "electrical continuity" might have a resistance range. These are not framed as AI model performance metrics like sensitivity, specificity, or AUC.
Ground truth, experts, and adjudication are irrelevant. They are used to establish the correctness of an AI model's output in interpreting medical data (e.g., images, signals). For a reprocessed catheter, the "ground truth" is its physical and electrical integrity compared to a new device.

Therefore, I cannot populate the requested table or answer the specific questions about AI model validation because the provided text describes a reprocessed physical medical device, not an AI-enabled one.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2019

Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K190980

Trade/Device Name: Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (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: June 25, 2019 Received: June 26, 2019

Dear Amanda Babcock:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

ltem Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)
D728260RT	Webster Duo-DecapolarDiagnostic EPCatheter	110	7F	Large	20	2-8-2-60-2-8-2

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Indications for Use

510(k) Number (if known) K190980

Device Name

Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter

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:

Amanda Babcock Principal Requlatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

April 12, 2019

Device Information:

Trade/Proprietary Name:

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

Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH

Predicate Device:

510(k) Number	510(k) Device	Manufacturer
K101991	Webster Duo-Decapolar Catheter	Biosense Webster

Reference Device:

510(k) Number	510(k) Device	Manufacturer
K171503	Reprocessed CristaCath Diagnostic EPCatheter	Innovative Health, LLC.
K170922	Reprocessed Webster CS Bi-DirectionalDiagnostic EP Catheter	Innovative Health, LLC.

Device Description:

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ltem Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)
D728260RT	Webster Duo-DecapolarDiagnostic EPCatheter	110	7F	Large	20	2-8-2-60-2-8-2

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

Table 5.1: Item Numbers

Indications for Use:

The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Webster Duo-Decapolar 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 Duo-Decapolar Diaqnostic EP Catheters.

This included the following:

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

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

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Conclusion:

Innovative Health concludes that the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters are as safe and effective as 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).