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 prompt asks for details about the acceptance criteria and study that proves a device meets those criteria. However, the provided text describes a reprocessed medical device (Webster CS Bi-Directional Diagnostic Electrophysiology (EP) Catheters) and its 510(k) submission to the FDA.

The context of the provided text is a regulatory submission for a reprocessed device, aiming to demonstrate its substantial equivalence to a predicate device. This type of submission focuses on proving that the reprocessed device is as safe and effective as the original, not on proving a novel device's initial performance against specific clinical acceptance criteria in the way an AI algorithm or a de novo device might.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not typically applicable to a 510(k) submission for a reprocessed medical device, as these are more relevant to the validation of diagnostic algorithms or new clinical devices.

Based on the provided text, here’s an analysis aligned with the request, focusing on what is available:

The document describes the regulatory approval process for a reprocessed medical device, not a new AI-powered diagnostic device. As such, the concept of "acceptance criteria" is geared towards demonstrating "substantial equivalence" to a predicate device rather than meeting specific quantifiable performance metrics in a clinical trial setting. Similarly, the "study" proving this largely consists of bench and laboratory testing rather than clinical trials with human subjects for clinical efficacy.

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

The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by the battery of functional, safety, and validation tests performed to ensure the reprocessed device is equivalent to the original. The "reported device performance" is the successful completion of these tests, confirming that the reprocessed device functions as intended and safely.

Acceptance Criteria (Implied by Testing)	Reported Device Performance (Successful Completion)
Device is biocompatible.	Biocompatibility testing was conducted and presumably passed.
Device is adequately cleaned after reprocessing.	Cleaning Validation was conducted and presumably passed, demonstrating effective removal of visible soil and decontamination.
Device is adequately sterilized.	Sterilization Validation was conducted and presumably passed.
Device meets visual inspection standards.	Visual Inspection was conducted and presumably passed.
Device meets dimensional specifications.	Dimensional Verification was conducted and presumably passed.
Device has proper electrical continuity and resistance.	Electrical Continuity and Resistance testing was conducted and presumably passed.
Device performs as expected in simulated clinical use.	Simulated Use testing was conducted and presumably passed.
Device maintains mechanical characteristics.	Mechanical Characteristics testing was conducted and presumably passed.
Auto ID Technology functions correctly (if applicable).	Auto ID Verification testing (for models with Auto ID Technology) was conducted and presumably passed.
Device meets electrical safety standards.	Electrical Safety Testing (Dielectric and Current Leakage) was conducted and presumably passed.
Device packaging maintains integrity and sterility.	Packaging Validation was conducted and presumably passed.
Device is equivalent to the predicate device in all aspects related to safety and effectiveness for its intended use.	Innovative Health concludes "that the Reprocessed Webster Coronary Sinus (CS) Bi-directional Diagnostic Electrophysiology (EP) Catheters are as safe and effective as the predicate devices described herein" based on the comprehensive testing performed. The purpose, design, materials, function, and intended use were found identical, with "no changes to the claims, clinical applications, patient population, performance specifications, or method of operation."

Regarding the other requested information, much of it is not applicable or explicitly stated in this type of regulatory document for a reprocessed device:

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

The document mentions "Bench and laboratory testing was conducted." It does not specify the sample size for each test (e.g., how many reprocessed catheters were tested for electrical continuity).
Data provenance is not specified beyond being "bench and laboratory testing" conducted by or for Innovative Health, LLC. It is likely internal testing data. The country of origin of the data is implied to be within the US, where Innovative Health operates. The data is prospective for the purpose of this submission (i.e., collecting data on the reprocessed devices to support the 510(k)).

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

This is not applicable. The "ground truth" for a reprocessed device is typically conformance to engineering specifications and performance standards of the original device, as evaluated through technical testing. There is no mention of human experts establishing ground truth in a clinical or diagnostic sense for these engineering and safety tests.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of diagnostic outputs, typically in studies involving interpretation of medical images or data by multiple readers. The testing performed here involves objective measurements against predefined engineering and safety criteria.

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:

This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic devices or algorithms (often AI-based) that involve human interpretation. The reprocessed catheter is a physical diagnostic tool for direct physiological measurement, not an interpretative system. The filing states: "The catheter is designed for use in the coronary sinus." and "The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only." There is no AI component.

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

This is not applicable, as there is no algorithm or AI component in this reprocessed catheter.

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

The ground truth for this submission is established through engineering specifications, direct measurements, and established safety/performance standards for the original predicate device and for reprocessed medical devices. This includes demonstrating that the reprocessed device meets physical, electrical, and material requirements, and is appropriately cleaned and sterilized.

8. The sample size for the training set:

This is not applicable, as there is no machine learning/AI model that requires a training set.

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

This is not applicable, as there is no machine learning/AI model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 22, 2017

Innovative Health, LLC. Amy Stoklas-Oakes Sr. Quality and Regulatory Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K170922

Trade/Device Name: Reprocessed Webster CS Bi-Directional Diagnostic Electrophysiology (EP) Catheters (see list of models enclosed)

Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 31, 2017 Received: June 1, 2017

Dear Amy Stoklas-Oakes:

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. 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

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or any Federal 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillemann

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

The following device models are included in this 510(k) submission:

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Indications for Use

510(k) Number (if known)

K170922

Device Name

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

Indications for Use (Describe)

X 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:

Amy Stoklas-Oakes Innovative Health, LLC. Sr. Quality and Requlatory Manager (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com

Date prepared:

March 28, 2017

Device Information:

Trade/Proprietary Name:

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

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

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
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	Webster CSBi-Directional DiagnosticEP Catheter	115	7F	D-F	2-8-2
BD710FJ282RTS	Webster CSBi-Directional DiagnosticEP Catheter	115	7F	F-J	2-8-2
BD710DF282CT	Webster CSBi-Directional DiagnosticEP Catheter with Auto ID	115	7F	D-F	2-8-2
BD710FJ282CT	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

Indications for Use:

Technological 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 ●
- 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 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 is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Innovative Health concludes that the Reprocessed Webster Coronary Sinus (CS) Bidirectional Diagnostic Electrophysiology (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).