The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Device Description

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated, 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 catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It is important to note that this document is for a reprocessed medical device, meaning it is a device that has been previously used, cleaned, sterilized, and prepared for re-use. The testing conducted primarily focuses on ensuring the reprocessed device performs comparably to the original new device and meets safety standards, rather than testing new clinical efficacy.

Based on the provided information, I can extract the following details regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various functional and safety tests performed but does not explicitly state quantitative acceptance criteria or detailed numerical performance results for most of them. It generally states that testing was conducted "to demonstrate performance (safety and effectiveness)".

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Device materials are biocompatible (e.g., non-toxic, non-allergenic)	Passed (implied, as the device is deemed safe and effective)
Cleaning Validation	Device is adequately cleaned to remove contaminants	Passed (implied; reprocessing includes removal of visible soil and decontamination)
Sterilization Validation	Device is effectively sterilized to eliminate pathogens	Passed (implied; reprocessing includes sterilization)
Visual Inspection	Device meets visual quality standards	Passed (implied; each device is inspected)
Dimensional Verification	Device dimensions conform to original specifications	Passed (implied)
Electrical Continuity	Electrical components function as intended	Passed (implied)
Simulated Use	Device performs as expected under simulated operational conditions	Passed (implied)
Mechanical Characteristics	Device mechanical properties (e.g., steerability, flexibility) are maintained	Passed (implied)
Electrical Safety Testing	Device meets electrical safety standards (e.g., dielectric, current leakage)	Passed (implied)
Packaging Validation	Packaging maintains sterility and protects the device	Passed (implied)
Function/Intended Use	The reprocessed device performs identically to the predicate device for its indicated use (recording or stimulation, obtaining electrograms)	No changes to claims, clinical applications, patient populations, performance specifications, or method of operation compared to the predicate device. Stated to be "as safe and effective as the predicate devices."

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

The document does not specify the sample sizes used for any of the functional and safety tests.

Regarding data provenance:

The tests are described as "Bench and laboratory testing".
The data is retrospective in the sense that it relies on demonstrating equivalence to an already marketed device (the predicate device). It's not a prospective clinical trial generating new outcome data directly on patients.
The location of the testing is not explicitly stated, but it would have been conducted by Innovative Health, LLC, which is based in Scottsdale, Arizona, USA.

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

This information is not provided in the document. For a reprocessed device and the types of engineering and safety tests described, ground truth would typically be established by internal engineering specifications, regulatory standards, and comparison to the original device's performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes bench and laboratory testing to ensure the safety and effectiveness of the reprocessed device itself, not a study assessing human reader performance with or without AI assistance.

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

No, this is not an AI/algorithm-based device. The device is a physical electrophysiology catheter. Therefore, "standalone algorithm performance" is not applicable. The core of the submission is about the reprocessing process and ensuring the physical device's performance after reprocessing.

7. The type of ground truth used:

For the functional and safety testing, the ground truth is primarily based on:

Engineering specifications and standards: For dimensional, electrical, and mechanical tests.
Regulatory standards: For biocompatibility, cleaning, sterilization, and electrical safety.
Performance of the original predicate device: The reprocessed device is demonstrated to have "identical" purpose, design, materials, function, and intended use to the predicate device, implying its performance should match the original.

8. The Sample Size for the Training Set:

This is not applicable. This is a reprocessed physical medical device, not an AI or machine learning 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 training set for an AI model.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 3, 2020

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

Re: K200212

Trade/Device Name: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLG Dated: July 31, 2020 Received: August 3, 2020

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

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

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 mediation-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.

Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

The item number included in the scope of this submission is as follows:

Item Number	Description	UsableLength(cm)	FrenchSize	Curve	Spacing(mm)	Electrodes	SystemCompatibility
D-AVHD-DF16	ReprocessedAdvisor HD GridMapping Catheter,Sensor Enabled	110	8F	DF	3	16	EnSiteVelocity andEnSitePrecisionCardiacMappingSystems

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

Indications for Use

510(k) Number (if known)

K200212

Device Name

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Indications for Use (Describe)

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)

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}------------------------------------------------

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:

August 21, 2020

Device Information:

Trade/Proprietary Name:	Reprocessed Advisor High Density (HD) Grid Mapping
	Catheter, Sensor Enabled
Common or Usual Name:	Diagnostic Electrophysiology Mapping Catheter
Classification Name:	Electrode Recording Catheter or Electrode Recording
	Probe
Classification Number:	Class II, 21 CFR 870.1220
Product Code:	NLG

Predicate Device:

510(k) Number	Device	Manufacturer
K172393	Advisor HD Grid Mapping Catheter, SensorEnabled	St. Jude Medical

Reference Device:

510(k) Number	Device	Manufacturer
K181458	Reprocessed Advisor FL, Sensor Enabled,Circular Mapping Catheter	Innovative Health, LLC.
K190785	Reprocessed PentaRay Nav eco High-Density Mapping Catheter	Innovative Health, LLC.

Device Description:

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

The item number in scope of this submission is as follows:

ltem Number	Description	UsableLength(cm)	FrenchSize	Curve	Spacing(mm)	Electrodes	System Compatibility
D-AVHD-DF16	ReprocessedAdvisor HD GridMapping Catheter,Sensor Enabled	110	8F	DF	3	16	EnSite Velocity andEnSite PrecisionCardiac MappingSystems

Table 1: Device Scope

Indications for Use:

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Advisor HD Grid Mapping Catheter (Sensor Enabled) are identical to the predicate device. 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 the Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. This included the following:

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

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cvcles, the device is reiected 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 HD Grid Mapping Catheter, Sensor Enabled, 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).