The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients,

The reprocessed device is not indicated for use with pediatric patients.

Device Description

The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.

AI/ML Overview

This FDA 510(k) summary describes the reprocessed AcuNav Diagnostic Ultrasound Catheters (K153090) and demonstrates their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance metrics like sensitivity, specificity, or image quality as would be expected for an AI/CADe device. Instead, the focus is on demonstrating that the reprocessed device performs equivalently to the original predicate device and meets safety standards after reprocessing. The "reported device performance" is essentially the successful completion of various validation tests.

Acceptance Criterion Type	Specific Test/Validation	Reported Device Performance
Biocompatibility	Biocompatibility testing	Demonstrated that the reprocessed device is biocompatible.
Cleaning Effectiveness	Cleaning Validation	Demonstrated that the reprocessing method effectively cleans the device.
Sterilization Assurance	Sterilization Validation	Demonstrated that the reprocessing method effectively sterilizes the device.
Visual Integrity	Visual Inspection (part of Functional Testing)	Each device inspected and passed for visual integrity after reprocessing.
Dimensional Accuracy	Dimensional Verification (part of Functional Testing)	Dimensions of the reprocessed device are verified to be within specifications, matching the original device.
Imaging Functionality	Ultrasound Transducer Testing (part of Functional Testing)	Ultrasound transducer performance of the reprocessed device is verified to meet specifications, ensuring 2-D imaging capability.
Clinical Performance	Simulated Use (part of Functional Testing)	The reprocessed device performs as intended in a simulated use environment, demonstrating its ability for intracardiac and intraluminal visualization.
Mechanical Integrity	Mechanical Characteristics (part of Functional Testing)	Mechanical properties of the reprocessed device are verified to meet specifications, including steering mechanism and four-way articulation.
Electrical Safety	Dielectric and Current Leakage (part of Electrical Safety Testing)	Electrical safety parameters (dielectric strength, current leakage) are verified to meet specifications, ensuring electrical safety for patients and users.
Packaging Integrity	Packaging Validation	Demonstrated that the packaging effectively maintains the sterility and integrity of the reprocessed device until use.
Reprocessing Limit	Reprocessing History Tracking	Reprocessed no more than one (1) time; devices reaching the maximum are rejected. Ensures that devices are not over-reprocessed, maintaining performance and safety.
Source Restriction	Restriction on prior reprocessing by other parties	Innovative Health restricts reprocessing to exclude devices previously reprocessed by other reprocessors. This ensures control over the reprocessing quality and history.
Substantial Equivalence	Comparison to predicate device (K071234) and reference device (K063076)	The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices. No changes to claims, clinical applications, performance specifications, or method of operation. Bench and laboratory testing demonstrated performance (safety and effectiveness) equivalent to the predicate.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of patient images). Instead, the "testing" refers to bench and laboratory validation of the reprocessed physical device. The sample sizes for each specific functional and safety test (e.g., how many catheters were subjected to biocompatibility testing, cleaning validation, etc.) are not explicitly stated in this summary.

The provenance of this "data" is from bench and laboratory testing performed by Innovative Health, LLC. It is not clinical data from an in-vivo study on human subjects; rather, it uses reprocessed devices themselves. The country of origin of the data is implicitly the USA, where Innovative Health, LLC is located.

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

This information is not applicable here. There is no "ground truth" derived from expert review of images or clinical outcomes in the traditional sense for an AI/CADe device. The "ground truth" for this reprocessing device is established by engineering specifications, validated test methods (e.g., sterilization effectiveness, dimensional accuracy), and regulatory standards for safety and performance of medical devices.

4. Adjudication Method for the Test Set:

This information is not applicable. There is no adjudication method described as this is not a study involving human reader interpretation or clinical outcomes adjudicated by experts.

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

No, an MRMC comparative effectiveness study was not conducted. This submission is for a reprocessed medical device, not an AI or CADe system that assists human readers in interpretation.

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

This information is not applicable. This is not an AI algorithm; it's a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

Engineering Specifications: Original device design and performance specifications.
Regulatory Standards: Compliance with FDA regulations for device safety, sterilization, biocompatibility, and electrical safety.
Validation Test Results: Data showing that the reprocessed devices meet objective performance criteria through bench and laboratory testing.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. Since there is no training set, there is no ground truth established for one.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2016

Innovative Health, LLC Rafal Chudzik Director of Engineering 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K153090

Trade/Device Name: Reprocessed AcuNav Diagnostic Ultrasound Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: February 5, 2016 Received: February 8. 2016

Dear Rafal Chudzik:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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

Enclosure

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ItemNumber	Description	Length(cm)	French Size
08255790	AcuNav DiagnosticUltrasound Catheter	90	10
10135936	AcuNav DiagnosticUltrasound Catheter	90	8
10135910	AcuNav DiagnosticUltrasound Catheter	90	8
10043342	AcuNav DiagnosticUltrasound Catheter	90	10

Reprocessed Single-Use Device Models Included in Clearance:

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Indications for Use

510(k) Number (if known) K153090

Device Name

Reprocessed AcuNav Diagnostic Ultrasound Catheter

Indications for Use (Describe)

The reprocessed device is not indicated for use with pediatric patients.

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:

Rafal Chudzik Director of Engineering (602) 326-7716 (cell) (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com

Date prepared:

October 23, 2015

Device Information:

Trade/Proprietary Name:	Reprocessed AcuNav™ Diagnostic Ultrasound Catheters
Classification Name:	Reprocessed Intravascular Ultrasound Catheter
Common Name:	Diagnostic Ultrasound Catheter
Classification Number:	Class II, 21 CFR 870.1200
Product Code:	OWQ

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K071234	AcuNav Diagnostic Ultrasound Catheter8F and 10F	Siemens MedicalSolutions

Reference Device:

510(k) Number	510(k) Title	Reprocessor
K063076	Reprocessed Diagnostic UltrasoundCatheter	Ascent HealthcareSolutions

Device Description:

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Indications for Use:

The Reprocessed AcuNav Diagnostic Ultrasound Catheter is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.

The reprocessed device is not indicated for use with pediatric patients.

Technoloqical 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, 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
- · Mechanical Characteristics
· Electrical Safety Testing
- · Dielectric and Current Leakage
· Packaging Validation

The Reprocessed Diagnostic Ultrasound Catheters 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 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).