The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

Device Description

The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise ≤ 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath (K212165). This is a reprocessed medical device, and the submission focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device.

The provided text does not contain information related to a study involving AI, machine learning, or complex algorithms. The device is a physical medical instrument (a guiding sheath used in cardiac procedures). Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth for the test set," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," "Stand-alone (algorithm only) performance," "Type of ground truth," "Sample size for the training set," and "How ground truth for the training set was established" are not applicable to this type of device and submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a reprocessed device like this primarily revolve around demonstrating that the reprocessed device is as safe and effective as the original, single-use device. This is typically shown through functional, material, and safety testing (e.g., sterilization, biocompatibility, mechanical integrity).

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table with numerical acceptance criteria and direct performance metrics in the way one might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, substantial equivalence for a reprocessed device is shown by demonstrating that the reprocessed device meets the same performance characteristics as the predicate device.

Acceptance Criterion (Type of Test)	Reported Device Performance (Conclusion)
Biocompatibility	Tested to ensure safety for patient contact.
Cleaning Validation	Tested to ensure effective removal of contaminants.
Sterilization Validation	Tested to ensure the device is sterile after reprocessing.
Functional testing:
* Visual Inspection	Passed (Inspected prior to packaging and labeling).
* Dimensional Verification	Passed (No changes in claims, clinical applications, patient populations, performance specifications).
* Dynamic Continuity	Passed (No changes in claims, clinical applications, patient populations, performance specifications).
* Simulated Use	Passed (Purpose, design, materials, function, and intended use are identical to the predicate).
* Leak	Passed (No changes in claims, clinical applications, patient populations, performance specifications).
Mechanical Characteristics	Passed (No changes in claims, clinical applications, patient populations, performance specifications).
Electrical Safety Testing:
* Dielectric and Current Leakage	Tested to ensure electrical safety.
Packaging Validation	Tested to ensure package integrity and sterility maintenance.

Overall Conclusion: Innovative Health concludes that the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein, implying all functional and safety tests were met.

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

Not Applicable for this type of device. The testing performed is physical/bench testing on representative reprocessed devices, not a test set of data like in AI/ML studies. The "provenance" would be the manufactured/reprocessed devices themselves, subject to the testing protocols.

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

Not Applicable. Ground truth in this context is established through validated physical, chemical, and electrical testing methods and standards, performed by qualified laboratory personnel, not by medical experts making diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a physical device re-processing submission, not an AI/ML diagnostic system requiring expert adjudication of results.

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-assisted device.

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

Not Applicable. This is not an algorithmic device.

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

For this device, "ground truth" is fundamentally defined by meeting established engineering specifications, safety standards (e.g., ISO, ASTM), and clinical performance criteria for physical devices. This is verified through:

Biocompatibility testing: Conformance to standards like ISO 10993.
Cleaning validation: Demonstrated removal of biological soil to predefined levels.
Sterilization validation: Demonstrated sterility assurance level (SAL).
Functional and Mechanical testing: Meeting pre-defined specifications for dimensions, leak integrity, steerability, electrical safety, etc., often benchmarked against the original predicate device's performance.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set. The "training" in manufacturing comes from established and validated reprocessing procedures.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. For a reprocessed device, established procedures and performance specifications for the predicate device guide the reprocessing "training" and validation.

Summary

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March 10, 2022

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

Re: K212165

Trade/Device Name: Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: PNE Dated: March 7, 2022 Received: March 8, 2022

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (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 (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 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,

Aneesh Deoras 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

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K212165 - Amanda Babcock

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

Product Description	Item Number	Curve size	Outer Diameter	Usable length	Inner Diameter	Number of Electrode
ReprocessedCarto VizigoBi-DirectionalGuidingSheath	D138501	Small (17 mm)	11.5F	71 cm	8.5F	4
D138502	Medium (22 mm)	11.5F	71 cm	8.5F	4
D138503	Large (50 mm)	11.5F	71 cm	8.5F	4

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Indications for Use

510(k) Number (if known) K212165

Device Name

Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath

Indications for Use (Describe)

The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

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

Date prepared:

July 09, 2021

Device Information:

Trade/Proprietary Name: Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath Common or Usual Name: Guiding Sheath Classification Name: Reprocessed Catheter Introducer Classification Number: Class II, 21 CFR 870.1340 Product Code: PNE

Predicate Device:

510(k) Number	Device	Manufacturer
K170997	Carto Vizigo Bi-Directional Guiding Sheath	Biosense Webster

Reference Device:

510(k) Number	Device	Manufacturer
K170311	Reprocessed Agilis NxT Steerable Introducer	Innovative Health, LLC.

Device Description:

Note: Only the steerable sheath and dilator are subject of this submission. The quidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.

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

ProductDescription	ItemNumber	Curvesize	OuterDiameter	Usablelength	InnerDiameter	Number ofElectrode
ReprocessedCarto VizigoBi-DirectionalGuidingSheath	D138501	Small(17 mm)	11.5F	71 cm	8.5F	4
	D138502	Medium(22 mm)	11.5F	71 cm	8.5F	4
	D138503	Large(50 mm)	11.5F	71 cm	8.5F	4

Table 5.1: Device Scope

Indications for Use:

The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed device is 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 reprocessed device 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 Carto Vizigo Bi-Directional Guiding Sheath. This included the following:

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

The device 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 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 Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).