The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.

The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.

Device Description

The Reprocessed DecaNav Catheter has been designed to be used with the Carto 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The catheter has a single proximal electrode that can be used for unipolar recording signals. The catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.

This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the Reprocessed DecaNav Diagnostic Electrophysiology Catheter. Instead, it describes various tests performed to demonstrate its safety and effectiveness, and then concludes that the device is "as safe and effective as the predicate devices."

Therefore, the table will reflect the types of tests conducted, which imply the areas of performance that were evaluated.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Passed (demonstrated)
Cleaning Validation	Passed (demonstrated)
Sterilization Validation	Passed (demonstrated)
Functional Testing:
- Visual Inspection	Passed (inspected)
- Dimensional Verification	Passed (verified)
- Electrical Continuity & Resistance	Passed (tested)
- Simulated Use	Passed (tested)
Mechanical Characteristics	Passed (tested)
Electrical Safety Testing:
- Dielectric & Current Leakage	Passed (tested)
Packaging Validation	Passed (validated)
Overall Safety and Effectiveness	Concluded to be as safe and effective as predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual test (e.g., how many catheters were tested for electrical continuity). It generally states that "Bench and laboratory testing was conducted."

Sample Size: Not specified in the provided text.
Data Provenance: The tests listed are "Bench and laboratory testing." This suggests prospective, controlled laboratory studies conducted by the manufacturer, Innovative Health, LLC. The country of origin is not explicitly stated, but Innovative Health, LLC. is located in Scottsdale, Arizona, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "ground truth" and expert review as typically understood in AI/imaging studies (e.g., for diagnostic accuracy) is not directly applicable here. This document describes a medical device undergoing reprocessing for which safety and functional performance are being evaluated. The "ground truth" is established by adherence to engineering specifications, validated cleaning/sterilization processes, and comparison to the original device's performance.

Therefore:

Number of Experts: Not applicable in the context of expert consensus for ground truth as per typical AI studies. The "experts" would be the engineers and quality control personnel performing the tests and validating the processes according to established standards.
Qualifications of Experts: Not specified. It can be inferred that these would be qualified professionals in biomedical engineering, quality assurance, microbiology (for sterilization/cleaning), etc.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements or validated processes rather than subjective interpretations requiring adjudication.

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 is a submission for a reprocessed medical device (a catheter), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Engineering specifications and design parameters of the original (new) device.
Validated laboratory methods and industry standards for testing biocompatibility, cleaning, sterilization, electrical safety, and mechanical performance.
Comparison to the predicate device's known performance characteristics.

Essentially, the reprocessed device's performance is compared against the performance of a new device and established medical device standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not a machine learning model.

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 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.

June 19, 2018

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

Re: K180710

Trade/Device Name: Reprocessed DecaNav Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 18, 2018 Received: May 21, 2018

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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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Description	REFNumber	ItemNumber	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)	InsertionLength(cm)
DecaNavDiagnostic EPCatheter	R7D282CT	D-1285-01-S	7	D	10	2-8-2	115
DecaNavDiagnostic EPCatheter	R7F282CT	D-1285-02-S	7	F	10	2-8-2	115

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

Table 1: Device Scope

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Indications for Use

510(k) Number (if known)

K180710

Device Name

Reprocessed DecaNav Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.

The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.

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:

March 16, 2018

Device Information:

Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:

Reprocessed DecaNav Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Electrode Recording Catheter or Electrode Recording Probe Class II, 21 CFR 870.1220 NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K080425	CS RefStar Catheter	Biosense Webster

Device Description:

This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.

Description	REFNumber	ItemNumber	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)	InsertionLength(cm)
DecaNavDiagnostic EPCatheter	R7D282CT	D-1285-01-S	7	D	10	2-8-2	115
DecaNavDiagnostic EPCatheter	R7F282CT	D-1285-02-S	7	F	10	2-8-2	115

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

Table 5.1: Device Scope

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Indications for Use:

The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus,

The catheter provides tip location information when used with the compatible Carto 3 EP Navigation Systems.

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed DecaNav Diagnostic EP Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Catheter 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 Reprocessed Diagnostic EP Catheter. 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 DecaNav Diagnostic EP Catheter 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.

Conclusion:

Innovative Health concludes that the Reprocessed DecaNav Diagnostic EP Catheter is 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).