The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

Device Description

The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.

AI/ML Overview

This document describes the validation of a reprocessed medical device, specifically the "Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter" (K191170). The acceptance criteria and the study proving the device meets these criteria are based on comparing the reprocessed device to its predicate devices through a series of functional and safety tests.

It's important to note that this is a 510(k) submission for a reprocessed device, not a novel AI/software medical device. Therefore, the concepts of "AI assistance," "human readers," "ground truth establishment by experts," "multi-reader multi-case (MRMC) studies," and "training/test sets with specific sample sizes for AI models" are not applicable in their conventional sense. The "study" here is a series of bench and laboratory tests demonstrating that the reprocessed device performs comparably and safely to the original, legally marketed predicate devices.

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

The acceptance criteria for this reprocessed device are based on demonstrating that its performance is equivalent to the predicate devices and that it meets safety standards after reprocessing. The reported device performance aims to show this equivalence.

Acceptance Criteria	Reported Device Performance (Summary)
Biocompatibility	Tested to ensure materials remain biocompatible after reprocessing. (Details not explicitly provided in the summary, but implied as satisfactory for clearance).
Cleaning Validation	Demonstrated effective removal of visible soil and decontamination processes. (Implied as satisfactory for clearance).
Sterilization Validation	Validated to ensure sterility after reprocessing. (Implied as satisfactory for clearance).
Functional Testing:
Visual Inspection	Each device inspected for defects after reprocessing. (Implied as passing).
Dimensional Verification	Critical dimensions verified to be within specifications. (Implied as passing, as "functional equivalent" to predicate).
Electrical Continuity and Resistance	Electrical properties maintained after reprocessing. (Implied as passing).
Simulated Use	Performance evaluated under simulated clinical conditions. (Implied as passing, to demonstrate functional equivalence).
Mechanical Characteristics	Mechanical properties (e.g., flexibility, loop adjustment, distal reach) retained. (Implied as passing, to demonstrate functional equivalence).
Electrical Safety Testing:
Dielectric and Current Leakage	Electrical safety parameters tested. (Implied as passing).
Packaging Validation	Ensures packaging maintains device integrity and sterility. (Implied as satisfactory for clearance).
Maximum Reprocessing Cycles	Reprocessed no more than one (1) time, tracked and rejected after max cycles.
Source Restriction	Reprocessing restricted to devices not previously reprocessed by others.

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

The document does not specify exact sample sizes for each specific test (e.g., how many catheters were subjected to each functional test). However, the overall approach of a 510(k) for reprocessed single-use devices involves rigorous testing on a statistically relevant number of reprocessed units to ensure consistency and equivalence.

Sample Size: Not explicitly stated as a number (e.g., 100 devices). Instead, it states "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Reflexion Spiral catheter." This implies a sufficient sample size was tested to establish the required equivalence and safety.
Data Provenance: The testing was conducted by Innovative Health, LLC. The testing is assumed to be prospective as it's part of the premarket notification process for a specific reprocessed device iteration. The testing would have occurred in a controlled laboratory/bench setting in the USA (where Innovative Health is located).

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

This concept is not directly applicable to a reprocessed medical device's performance validation in the way it applies to an AI/software device. The "ground truth" here is the established performance and safety profile of the original, legally marketed predicate device.

"Experts": The "experts" are the engineers, scientists, and quality assurance personnel at Innovative Health who conducted and validated the tests, and implicitly, the FDA reviewers who assessed the submission. Their qualifications would include expertise in medical device testing, reprocessing, materials science, electrical engineering, etc.
Establishment of "Ground Truth": The "ground truth" (i.e., acceptable performance) for the reprocessed device is its ability to meet or exceed the performance and safety characteristics of the predicate device, as demonstrated through the specified functional and safety tests. There isn't a "consensus" of external clinical experts on images or data; rather, it's a technical demonstration of equivalence.

4. Adjudication method for the test set

Not applicable in the context of an AI/software device's test set. The "adjudication" is essentially the detailed review and approval process by the FDA, based on the submitted test data.

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 is an electrophysiology catheter, not an AI software intended to assist human readers (e.g., radiologists interpreting images).

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

Not applicable. This is a physical, reprocessed medical device, not a standalone algorithm. Its performance is inherent to the device itself.

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

The "ground truth" is primarily based on the established performance specifications and safety profiles of the predicate devices. This is demonstrated through:

Bench Testing Data: Direct measurements of physical, electrical, and mechanical properties.
Laboratory Testing Data: Validation of cleaning, sterilization, and biocompatibility processes.
"Simulated Use" Data: Performance under controlled, simulated clinical conditions.

There is no "expert consensus" on clinical interpretations or "pathology/outcomes data" being used as ground truth for this type of device's 510(k) clearance in the way it would be for a diagnostic AI.

8. The sample size for the training set

Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

Not applicable. This is a reprocessed physical device, not an AI model.

Summary

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October 30, 2019

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

Re: K191170

Trade/Device Name: Reprocessed Reflexion Spiral Bi-Directional Variable Radius 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: September 30, 2019 Received: October 1, 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,

Nicole Gillette Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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K191170 - Amanda Babcock

Description	ItemNumber	UsableLength(cm.)	Number ofElectrodes	ElectrodeSpacing(mm)	CatheterFrenchSize	LoopAdjustment(mm)	DistalReach
ReflexionSpiral Bi-DirectionalVariableRadius EPCatheter	D402893	99	20	1-4-1	7	15 to 25	Symmetric
	D402865	99	10	6.3	7	15 to 25	Symmetric
	402804	99	20	1-4-1	7	15 to 25	Asymmetric

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

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Indications for Use

510(k) Number (if known) K191170

Device Name

Reprocessed Reflexion Spiral Bi-Directional Variable Radius 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 Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

April 30, 2019

Device Information:

Trade/Proprietary Name:	Reprocessed Reflexion Spiral Bi-Directional Variable Radius
	EP Catheter
Common or Usual Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
Classification Number:	Class II, 21 CFR 870.1220
Product Code:	NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K072012	Reflexion Spiral Variable Radius Catheter	St. Jude Medical

Device Description:

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

Description	ItemNumber	UsableLength(cm.)	Number ofElectrodes	ElectrodeSpacing(mm)	CatheterFrenchSize	LoopAdjustment(mm)	DistalReach
ReflexionSpiral Bi-DirectionalVariableRadius EPCatheter	D402893	99	20	1-4-1	7	15 to 25	Symmetric
	D402865	99	10	6.3	7	15 to 25	Symmetric
	402804	99	20	1-4-1	7	15 to 25	Asymmetric

Table 5.1: Device Scope

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Indications for Use:

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Reflexion Spiral 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 Reflexion Spiral 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 Reflexion Spiral 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 Reflexion Spiral 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).