The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)

Device Description

The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the Carto 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 F guiding sheath. This deflectable catheter consists of multiple 3F spines on its distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the Carto 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the Carto 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This device includes an irrigation lumen for connection to a source of continuous anticoagulant fluid.

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

AI/ML Overview

The provided FDA 510(k) summary (K190785) describes the substantial equivalence of a reprocessed medical device (Reprocessed PentaRay Nav eco High-Density Mapping Catheter) to an original predicate device. It addresses device safety and effectiveness through various tests.

However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance. The testing described focuses on the physical and functional integrity, sterility, and biocompatibility of the reprocessed catheter.

Therefore, many of the requested points related to AI/ML device performance (like sample size for test/training sets, expert ground truth, MRMC studies, effect size of AI assistance, standalone performance, etc.) are not applicable to the information provided in this 510(k) summary.

The acceptance criteria and "study" described herein pertain to the reprocessing of a physical medical device, not a diagnostic algorithm.

Here's an interpretation based on the provided document:

Acceptance Criteria and Study for Reprocessed PentaRay Nav eco High-Density Mapping Catheter

The "study" described in the 510(k) summary for the Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785) is not a study of an AI/Machine Learning diagnostic algorithm. Instead, it is a demonstration of the substantial equivalence of a reprocessed medical device to its original predicate device, focusing on its safety and effectiveness after reprocessing.

The acceptance criteria are implied by the battery of functional, safety, and performance tests conducted to ensure the reprocessed device performs as intended and is as safe and effective as the new device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with numerical performance targets for an AI/ML diagnostic system. Instead, the acceptance criteria are implicitly linked to the successful completion and passing of the various tests for the reprocessed catheter, ensuring it meets the original device's specifications and performance.

Test Category	Specific Test	Implied Acceptance Criteria	Reported Device Performance (Implied)
Functional Testing	Visual Inspection	Device must be free from visible damage, defects, or residual soil after reprocessing.	Met: Device is visually inspected.
	Dimensional Verification	Reprocessed device dimensions (e.g., usable length, French size) must conform to specifications (e.g., matching the predicate device dimensions listed).	Met
	Electrical Continuity and Resistance	Electrical components (electrodes) must have proper continuity and resistance within specified ranges to ensure accurate electrophysiological mapping (recording/stimulation).	Met
	Simulated Use	Device must perform as intended in a simulated clinical environment, demonstrating proper deflection, navigation, and signal acquisition capabilities with the compatible Carto 3 EP Navigation Systems.	Met
	Leak/Occlusion	The irrigation lumen and other internal pathways must be free from leaks or occlusions to ensure proper fluid delivery and prevent complications.	Met
	Inner Lumen Occlusion	The inner lumen (presumably for the irrigation) must be clear and unobstructed.	Met
	Mechanical Characteristics	Device must maintain structural integrity, flexibility, and mechanical performance comparable to the new device (e.g., tensile strength, bending properties, durability during deployment) after reprocessing.	Met
Safety Testing	Biocompatibility	Materials of the reprocessed device must remain biocompatible after reprocessing, ensuring no cytotoxicity, sensitization, or irritation when in contact with tissues. (Typically, ISO 10993 standards are followed. The acceptance criterion is biocompatibility as per relevant standards).	Met
	Electrical Safety Testing (Dielectric and Current Leakage)	Electrical insulation must remain intact, and current leakage must be below specified limits to prevent patient or user harm (e.g., electrical shock). (Acceptance criteria are usually specific limits defined by IEC 60601-1 or similar standards).	Met
	Sterilization Validation	The device must achieve a specified sterility assurance level (SAL), typically 10^-6, after sterilization. (Acceptance criterion is successful validation of the sterilization process, demonstrating killing of microorganisms to the target SAL).	Met
	Cleaning Validation	The reprocessing procedure must effectively remove all clinically relevant soil and contaminants from the device to prevent patient infection or foreign body reactions. (Acceptance criterion is residual soil levels below specified thresholds, validated by methods like protein, hemoglobin, or TOC analysis).	Met
Other	Packaging Validation	The packaging must maintain sterility, protect the device from damage, and be suitable for transport and storage until point of use. (Acceptance criterion is successful validation of packaging integrity and barrier properties per relevant ISO standards).	Met
	Maximum Reprocessing Cycles	The device must remain safe and effective only for the validated number of reprocessing cycles (in this case, "no more than one (1) time"). The tracking system must effectively reject devices reaching this limit.	Met: Device marked and tracked.
	Equivalence to Predicate	The overall performance, safety, and effectiveness of the reprocessed device must be demonstrated to be "as safe and effective as the predicate devices," implying that all tested parameters are comparable and within clinically acceptable ranges for its intended use.	Concluded as such by the submitter.

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

Sample Size: The document does not specify the exact number of reprocessed catheters used for each of the functional and safety tests. This information is typically detailed in the study reports submitted to the FDA but is summarized and not fully elaborated in the 510(k) summary. Given these are physical device tests, a statistically representative sample of reprocessed units would have been tested for each protocol.
Data Provenance: The tests are performed "Bench and laboratory testing" by Innovative Health, LLC. This is likely internal testing conducted in a controlled laboratory environment.
- Country of Origin: United States (based on the company and FDA filing location).
- Retrospective or Prospective: These are prospective tests performed on reprocessed devices to validate the reprocessing procedure and the device's performance post-reprocessing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable: This pertains to the validation of a reprocessed physical device, not an AI/ML algorithm requiring expert interpretation for ground truth. Ground truth for these tests would be established by objective measurements against engineering specifications (e.g., electrical resistance values, dimensional tolerances, sterilization test results).

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods like "2+1" or "3+1" are typical for diagnostic imaging studies where multiple readers interpret cases and a consensus or tie-breaking mechanism is needed to establish ground truth. For the physical device testing described, the "ground truth" is determined by objective measurement against established engineering and safety standards.

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

No: An MRMC comparative effectiveness study is not relevant here as the device is not a diagnostic imaging aid or an AI algorithm intended for human-in-the-loop performance evaluation. The study is about the safety and function of a reprocessed catheter.

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

Not Applicable: This is not an algorithm. The "standalone" performance relates to the catheter's ability to perform its intended function (mapping, recording, stimulation) independently when used with compatible equipment. The "Functional testing" and "Electrical Safety Testing" sections would cover aspects of this.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Results: The "ground truth" for the reprocessed catheter's performance and safety is derived from:
- Predicate Device Specifications: The performance and safety parameters of the original, legally marketed predicate device (PentaRay NAV eco High-Density Mapping Catheter, K123837).
- Industry Standards: Compliance with relevant national and international standards (e.g., ISO for biocompatibility, sterilization, packaging; IEC for electrical safety).
- Defined Pass/Fail Criteria: Each test (e.g., electrical continuity, leak test, visual inspection) would have pre-defined quantitative or qualitative acceptance criteria.

8. The Sample Size for the Training Set

Not Applicable: This device is not an AI/ML algorithm that requires a "training set." The reprocessing procedure itself is the "process" being validated, and its parameters are established through rigorous engineering and validation studies, not machine learning.

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

Not Applicable: As there is no AI/ML training set, this question is irrelevant to the provided document. The "ground truth" for developing the reprocessing procedure (if one were to draw a very loose analogy) would be the established performance and safety of the new device, which the reprocessed device must match.

Summary

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June 25, 2019

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

Re: K190785

Trade/Device Name: Reprocessed PentaRay Nav eco High-Density Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLG Dated: March 26, 2019 Received: March 27, 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,

Mark Fellman 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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ItemNumber	UsableLength (cm)	French Size(Fr)	Curve	ElectrodeSpacing	Number ofElectrodes
D128207	115	7	F	4-4-4	20
D128208	115	7	F	2-6-2	20
D128210	115	7	D	4-4-4	20
D128211	115	7	D	2-6-2	20

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) K190785

Device Name

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Indications for Use (Describe)

The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)

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

Date prepared:

March 26, 2019

Device Information:

Trade/Proprietary Name:	Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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	510(k) Title	Manufacturer
K123837	PentaRay NAV eco High-Density MappingCatheter	Biosense Webster, Inc.

Device Description:

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

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For use in mapping procedures, refer to the instructions for the Carto 3 EP Navigation System.

Item Number	Description	UsableLength(cm)	FrenchSize	Curve	Spacing(mm)	Electrodes
D128207	PentaRay Nav eco High-DensityMapping Catheter	115	7F	F	4-4-4	20
D128208	PentaRay Nav eco High-DensityMapping Catheter	115	7F	F	2-6-2	20
D128210	PentaRay Nav eco High-DensityMapping Catheter	115	7F	D	4-4-4	20
D128211	PentaRay Nav eco High-DensityMapping Catheter	115	7F	D	2-6-2	20

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

Table 5.1: Device Scope

Indications for Use:

The Reprocessed PentaRay NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x).

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed PentaRay Nav eco High-Density Mapping 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 PentaRav Nav eco High-Density Mapping Catheter. This included the following:

Biocompatibilitv ●
Cleaning Validation .
Sterilization Validation ●
Functional testing
- . Visual Inspection
- . Dimensional Verification
- . Electrical Continuity and Resistance
- . Simulated Use
- . Leak/Occlusion
- . Inner lumen occlusion
- I Mechanical Characteristics
. Electrical Safety Testing
- Dielectric and Current Leakage .
Packaging Validation

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The Reprocessed Reprocessed PentaRay Nav eco High-Density Mapping 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 PentaRay Nav eco High-Density Mapping 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).