The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Device Description

The Reprocessed ViewFlex Xtra ICE is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction.

AI/ML Overview

The provided text is a 510(k) Summary for a Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter. It focuses on the substantial equivalence of the reprocessed device to its predicate devices, rather than a clinical study evaluating diagnostic performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies cannot be found in this document.

However, I can extract information related to the device's functional and safety testing, which serves as a form of "acceptance criteria" for demonstrating the reprocessed device's safety and effectiveness compared to the original and previously reprocessed versions.

Here's a breakdown of what can be inferred and what is explicitly stated:

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

The document does not present specific quantitative acceptance criteria or numerical performance results for diagnostic accuracy (e.g., sensitivity, specificity, AUC) because it's a submission for reprocessing an existing diagnostic device and demonstrating its functional equivalence, not evaluating its diagnostic capability from scratch. The "performance" here refers to the functional and safety aspects of the reprocessed device.

Category	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility	Must meet established biocompatibility standards for medical devices.	Demonstrated. (Specific details not provided in this summary)
Cleaning Validation	Must effectively remove visible soil and decontaminate the device to prevent patient harm.	Demonstrated. Includes removal of visible soil and decontamination. (Specific metrics not provided)
Sterilization Validation	Must achieve a specified sterility assurance level (SAL).	Demonstrated. Change to release method, but no change to sterilization method or SAL.
Functional Testing	Must operate as intended, match original dimensions, and ultrasound transducer must function correctly during simulated use.	Demonstrated. Includes Visual Inspection, Dimensional Verification, Ultrasound Transducer Testing, Simulated Use, and Mechanical Characteristics.
Packaging Performance Validation	Packaging must maintain sterility and product integrity until point of use.	Demonstrated. (Specific details not provided)
Electrical Safety Testing	Must meet electrical safety standards (dielectric and current leakage).	Demonstrated. Includes Dielectric and Current Leakage.
Reprocessing Cycles	Maintained functionality and safety for two reprocessing cycles.	Demonstrated. Device now cleared for two reprocessing cycles (previously one).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the functional or safety tests. The summary indicates "bench and laboratory testing" was conducted.
Data Provenance: Not specified. Given it's laboratory and bench testing, it's likely internal data from Innovative Health, LLC.
Retrospective or Prospective: These terms are generally applied to clinical studies involving patient data. For bench/lab testing, it's typically prospective testing of reprocessed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This information pertains to studies evaluating diagnostic accuracy, which is not the focus of this submission. The "ground truth" here would be objective measurements and standards from engineering and microbiology for functional and safety testing.

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

Not applicable/Not specified. No expert adjudication process for diagnostic interpretations is discussed.

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

No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-assisted diagnostic devices, which this reprocessed ultrasound catheter is not.

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

Not applicable. This is not an AI algorithm.

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

For the functional and safety testing, the "ground truth" would be established by:

Industry standards for biocompatibility (e.g., ISO 10993).
Microbiological testing standards for cleaning and sterilization effectiveness.
Engineering specifications and performance metrics of the original device for functional and mechanical characteristics.
Electrical safety standards.

8. The sample size for the training set

Not applicable. This document does not describe an AI/machine learning model that would require a training set.

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

Not applicable, as no training set for an AI model is described.

In summary: This document is a 510(k) submission for a reprocessed medical device, focusing on demonstrating the functional and safety equivalence of the reprocessed device to its original predicate. It does not contain information about studies evaluating the diagnostic performance (e.g., sensitivity, specificity) of the ultrasound catheter, which is what the provided questions are primarily geared towards. The "acceptance criteria" here are related to ensuring the device remains safe and performs as intended after reprocessing, rather than its diagnostic accuracy.

Summary

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November 20, 2020

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 435 North Hayden Road Suite 100 Scottsdale, Arizona 85257

Re: K202042

Trade/Device Name: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: October 19, 2020 Received: October 20, 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 probibitions 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

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801); 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 (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-devices/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 (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 Ouality Center for Devices and Radiological Health

Enclosure

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REF ItemNumber	Catalog/ReorderItem Number	Description	SheathUsableLength(cm)	FrenchSize	System Compatibility
D087031	100046963	ViewFlex Xtra ICEDiagnostic UltrasoundCatheter	90	9F	St. Jude MedicalViewMate, ViewMateII, ViewMate ZConsole/PhillipsCX50

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

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Indications for Use

510(k) Number (if known)

K202042

Device Name

Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter

Indications for Use (Describe)

The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

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:

November 19, 2020

Device Information:

Trade/Proprietary Name:

Common Name: Classification Name: Classification Number: Product Code:

Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter ICE Catheter Reprocessed Intravascular Ultrasound Catheter Class II, 21 CFR 870.1200 owq

Predicate Device:

510(k) Number	Device	Manufacturer
K173262	Reprocessed ViewFlex Xtra ICE DiagnosticUltrasound Catheter	Innovative Health, LLC.
K133853	ViewFlex Xtra ICE Catheter	Irvine Biomedical, Inc. aSt. Jude Medical Company

Device Description:

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

REF ItemNumber	Catalog/ReorderItem Number	Description	SheathUsableLength(cm)	FrenchSize	System Compatibility
D087031	100046963	ViewFlex Xtra ICEDiagnostic UltrasoundCatheter	90	9F	St. Jude MedicalViewMate, ViewMateII. ViewMate ZConsole/PhillipsCX50

Table 5.1: Device Scope

This 510(k) adds a second reprocessing cycle to the same device cleared under K173262 and minor changes to the reprocessing and sterilization release method.

Indications for Use:

The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters 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 Diagnostic Ultrasound 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 Diagnostic Ultrasound Catheters. This included the following:

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

The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than two (2) times. 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.

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Predicate Comparison:

A comparison of the device and reprocessing methods with the predicates are provided in the table below:

	K202042	K173262	K133853
Device:	Identical	Identical	Identical
Reprocessing Cycles:	2	1	0
Reprocessing Method:	Change to processingparameters toaccommodate increasein batch size.Packaging configurationchange.	Cleared/validatedprocess	N/A
Sterilization:	Change to releasemethod. No change tothe sterilization methodor SAL.	Cleared/validatedprocess	N/A
Routine Monitoring:	Change to frequencyand adjustment of limits.	Cleared process	N/A

Conclusion:

Innovative Health concludes that the Reprocessed Diagnostic Ultrasound Catheter is as safe and effective as the predicate devices described herein.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).