The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Device Description

The Reprocessed Marinr steerable/deflectable tip electrode catheter is a flexible, radiopaque catheter constructed of extruded polymer over stainless steel braid. The catheter is designed for intracardiac recording or stimulation. The Marinr catheter handle controls allow precise tip placement within the heart.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Reprocessed Marinr Diagnostic EP Catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an AI/ML powered device.

Therefore, many of the requested elements (like "reported device performance," "sample size used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set sample size," or "ground truth for training set") are not applicable or not explicitly provided in this type of regulatory submission. This document describes a reprocessing method for an existing medical device, not the development or evaluation of a novel algorithm.

However, I can extract the acceptance criteria related to the reprocessed device's functional and safety testing, and summarize the type of study conducted.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Reported Performance (Summary)
Safety	Biocompatibility	Met established standards for biocompatibility.
	Cleaning Validation	Demonstrated effective removal of visible soil and decontamination.
	Sterilization Validation	Demonstrated sterilization efficacy.
	Electrical Safety Testing (Dielectric and Current Leakage)	Met established electrical safety requirements.
Functional Effectiveness	Functional Testing: Visual Inspection	Passed visual inspection for integrity.
	Functional Testing: Dimensional Verification	Dimensions were verified to be within specifications.
	Functional Testing: Electrical Continuity and Resistance	Met continuity and resistance requirements.
	Functional Testing: Simulated Use	Performed as intended during simulated use.
	Functional Testing: Mechanical Characteristics	Maintained necessary mechanical characteristics.
Packaging	Packaging Validation	Met established packaging integrity and shelf-life requirements.

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

Sample Size: Not explicitly stated. The document refers to "bench and laboratory testing" which implies tests were performed on a representative sample of reprocessed catheters.
Data Provenance: Not applicable in the context of clinical data provenance. The testing was laboratory-based, performed by the manufacturer, Innovative Health, LLC.

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 device is a reprocessed diagnostic catheter; its performance is evaluated against engineering and safety specifications, not by expert interpretation of clinical images or data in a diagnostic context. "Ground truth" here refers to objective measurements and validated protocols, not expert consensus.

4. Adjudication method for the test set

Not applicable. Performance was assessed through objective laboratory and bench tests, not expert adjudication of diagnostic outcomes.

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 not an AI-powered device.

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

Not applicable. This is not an AI-powered device. The device does not operate as an algorithm.

7. The type of ground truth used

The "ground truth" for the reprocessed device's performance relies on objective engineering and safety specifications, validated test methods (e.g., for biocompatibility, sterility, electrical safety, mechanical properties), and comparison against the performance of new (predicate) devices as established through their original clearance. It does not involve expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic clinical study.

8. The sample size for the training set

Not applicable. This is not an AI-powered device and therefore does not have a "training set" in the machine learning context.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of bench and laboratory tests designed to demonstrate the continued safety and functional effectiveness of the Reprocessed Marinr Diagnostic EP Catheter after reprocessing. The manufacturer, Innovative Health, LLC, performed these tests.

The tests covered several critical areas:

Biocompatibility: To confirm the reprocessed device remains safe for contact with human tissue.
Cleaning Validation: To ensure the reprocessing effectively removes contaminants.
Sterilization Validation: To confirm the device is rendered sterile after reprocessing.
Functional Testing: This included visual inspection, dimensional verification, electrical continuity and resistance checks, simulated use, and assessment of mechanical characteristics to ensure the device retains its intended performance.
Electrical Safety Testing: To verify the electrical integrity and safety of the device.
Packaging Validation: To ensure the device remains sterile and protected until use.

The overall conclusion reached by Innovative Health, LLC, is that "The Reprocessed Marinr Catheter is as safe and effective as the predicate devices described herein," based on the successful completion of these functional and safety tests. This approach is typical for the 510(k) pathway for reprocessed devices, where substantial equivalence to a legally marketed predicate device is demonstrated through verified reprocessing protocols and performance testing.

Summary

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November 15, 2018

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

Re: K181897

Trade/Device Name: Reprocessed Marinr 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: October 16, 2018 Received: October 17, 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. 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

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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Description	ItemNumber	ShaftSize(French)	CurveReach(mm) andCurve Type	Number ofElectrodes	ElectrodeSpacing(mm)	UsableLength(cm)
MarinrDiagnosticEP Catheter	072302	7	40-60, MC	4	2-5-2	110
	072402	7	55-75,MCXL	4	2-5-2	110
	043302M	7	55, CS	10	2	90
	043325M	7	55, CS	10	2-5-2	90
	043328M	7	55, CS	10	2-8-2	90
	072322M	7	65, SCXXL	4	2-5-2	90

The item numbers in scope of this submission (K181897) are as follows:

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Indications for Use

510(k) Number (if known)

K181897

Device Name

Reprocessed Marinr Diagnostic Electrophysiology (EP) Catheter

Indications for Use (Describe)

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

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:

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

Date prepared:

July 13, 2018

Device Information:

Trade/Proprietary Name: Reprocessed Marinr Diagnostic EP Catheter Common or Usual Name: Diagnostic Electrophysiology Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Classification: Class II, 21 CFR 870.1220 Product Code: NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K951347	Marinr Series EP Diagnostic Catheters	Medtronic (CardioRhythm)
K931794	Marinr Series EP Diagnostic Catheters	Medtronic (CardioRhythm)

Device Description:

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

Description	ItemNumber	ShaftSize(French)	CurveReach(mm) andCurve Type	Number ofElectrodes	ElectrodeSpacing(mm)	UsableLength(cm)
MarinrDiagnosticEP Catheter	072302	7	40-60, MC	4	2-5-2	110
	072402	7	55-75,MCXL	4	2-5-2	110
	043302M	7	55, CS	10	2	90
	043325M	7	55, CS	10	2-5-2	90
	043328M	7	55, CS	10	2-8-2	90
	072322M	7	65, SCXXL	4	2-5-2	90

Table 5.1: Device Scope

Innovative Health Reprocessed Catheters

Page 1 Traditional 510(k) K181897

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Indications for Use:

The Reprocessed Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Marinr 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 packaqing and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 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 Marinr Catheter is 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 Marinr Catheter is as safe and effective as the predicate devices described herein.

Innovative Health Reprocessed Catheters

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).