The Reprocessed Advisor FL Circular Mapping Catheter is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide Technology system to enable real-time positioning and navigation. The MediGuide Technology system is indicated for use as an adjunct to fluoroscopy.

Device Description

The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled, is a steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a reprocessed medical device, specifically a Reprocessed Advisor FL, Sensor Enabled, Circular Mapping Catheter. As such, it details the safety and functionality testing to establish substantial equivalence to a predicate device, rather than providing the kind of detailed clinical study results (like MRMC studies for AI/software devices or specific performance metrics with acceptance criteria) that would be common for novel, performance-driven devices.

Therefore, many of the requested criteria for a study proving a device meets acceptance criteria (especially those related to AI model evaluation like test sets, ground truth establishment by experts, MRMC studies, effect size of human improvement with AI, standalone AI performance) are not applicable to this type of regulatory submission and device.

However, I can extract the information relevant to the safety and functional performance tests conducted for this reprocessed catheter.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

Information Extracted/Inferred:

1. A table of acceptance criteria and the reported device performance:
The document lists various functional and safety tests, implying that the reprocessed device met established acceptance criteria for each to demonstrate substantial equivalence. However, the specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this summary. The summary states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Catheter." and "Innovative Health concludes that the Reprocessed Catheter is as safe and effective as the predicate devices described herein." This implies the acceptance criteria were met.

The types of tests conducted (which would have associated acceptance criteria) include:

Test Type	General Performance Goal (Inferred)	Specific Reported Performance (Not detailed in document)
Biocompatibility	Must be safe for biological contact; no adverse tissue reactions.	Met standards for safety.
Cleaning Validation	Must effectively remove contaminants to safe levels.	Cleaning process validated as effective.
Sterilization Validation	Must achieve sterility assurance level (SAL).	Sterilization process validated as effective.
Functional Testing (Overall)	Must perform its intended function as designed, identical to predicate.	Demonstrated performance equivalent to predicate.
- Visual Inspection	Must meet visual quality standards; no visible defects.	Passed visual inspection.
- Dimensional Verification	Must meet specified dimensions.	Dimensions verified as correct.
- Electrical Continuity & Resistance	Must have proper electrical properties for signal recording.	Electrical properties within acceptable range.
- Simulated Use	Must function correctly in simulated clinical conditions.	Performed as expected in simulated use.
- Mechanical Characteristics	Must have appropriate flexibility, durability, and steerability.	Mechanical properties maintained.
Electrical Safety Testing	Must be electrically safe (no excessive current leakage or breakdown).	Passed dielectric and current leakage tests.
- Dielectric and Current Leakage	Specified limits for electrical safety.	Within acceptable limits.
Packaging Validation	Packaging must maintain sterility and protect integrity until use.	Packaging validated for integrity and sterility.

2. Sample size used for the test set and the data provenance:
The document mentions "Bench and laboratory testing" but does not specify the sample size for these tests. Data provenance is implied to be from Innovative Health's internal testing. It's a retrospective evaluation of their reprocessing procedures and the resulting devices. Country of origin for data is not explicitly stated but would be 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 applicable here. Ground truth in this context refers to the physical and functional properties of the catheter, established by engineering specifications and direct measurement/testing, not expert interpretation of diagnostic data.

4. Adjudication method for the test set:
Not applicable. Testing involves direct measurement and objective assessment against specifications, not subjective interpretation 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 not an AI/software device that assists human readers. It's a reprocessed physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its "standalone" performance means its functional and safety characteristics as a physical device.

7. The type of ground truth used:
For the various tests (e.g., dimensional, electrical, mechanical, biological safety), the "ground truth" would be engineering specifications, industry standards (e.g., ISO for biocompatibility, sterility), and established performance characteristics of the original predicate device.

8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
Not applicable.

Summary of what is possible to provide based on the document:

This submission focuses on demonstrating that the reprocessed physical device maintains the same safety and effectiveness as the original, legally marketed predicate device. The "acceptance criteria" are implied by the successful completion of a battery of rigorous functional and safety tests (biocompatibility, cleaning, sterilization, electrical, mechanical, visual, packaging, simulated use). The "study" involves these various bench and laboratory tests. The "ground truth" for these tests are the established engineering specifications and performance parameters of the original device and relevant industry standards. There is no mention of clinical studies involving human patients or complex data interpretation by experts, as would be common for AI/software devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2018

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

Re: K181458

Trade/Device Name: Reprocessed Advisor FL, Sensor Enabled, Circular Mapping 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 17, 2018 Received: September 18, 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 mav, 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 avare 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

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.

Muda Jellman
for

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

Enclosure

{2}------------------------------------------------

K181458 - Amanda Babcock

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

Description	Item Number	Curve	Length(cm)	Number ofElectrodes	Spacing(mm)	LoopDiameter(mm)	FrenchSize
Advisor FLSensor EnabledCircularMappingCatheter	DAVSEDF10F15	DF	115	10	3-3-3	15	8
	DAVSEDF10F20	DF	115	10	5-5-5	20	8

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K181458

Device Name

Reprocessed Advisor FL, Sensor Enabled, Circular Mapping 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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:

May 31, 2018

Device Information:

Trade/Proprietary Name:	Reprocessed Advisor FL, Sensor Enabled, Circular MappingCatheter
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
K160335	Advisor FL Circular Mapping Catheter	St. Jude Medical

Device Description:

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

Description	Item Number	Curve	Length(cm)	Number ofElectrodes	Spacing(mm)	LoopDiameter(mm)	FrenchSize
Advisor FLSensor EnabledCircularMappingCatheter	DAVSEDF10F15	DF	115	10	3-3-3	15	8
	DAVSEDF10F20	DF	115	10	5-5-5	20	8

Table 5.1: Device Scope

Innovative Health Reprocessed Catheters

{5}------------------------------------------------

Indications for Use:

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Advisor 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 Catheter. This included the following:

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

The Reprocessed Advisor 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 Advisor 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).