The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

Device Description

The Reprocessed Visions PV .035 catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.

The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm from the imaging plane, with the 25th RO marker overlapping the distal most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.

The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.

A hydrophilic coating is applied externally to a distal portion of the catheter.

AI/ML Overview

This document is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification by Innovative Health, LLC for a reprocessed medical device, the Reprocessed Visions PV .035 Digital IVUS Catheter.

In the context of reprocessed devices, the primary goal of the 510(k) submission is to demonstrate substantial equivalence to a predicate (new) device, not to showcase novel performance or "AI" capabilities. The "acceptance criteria" here are largely related to demonstrating that the reprocessed device performs as safely and effectively as the original, new device, and that the reprocessing process itself is robust.

Therefore, many of the requested points regarding AI, MRMC studies, specific performance metrics, and training data are not applicable to this type of submission.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with numerical performance results in the way a new device with novel functionality might. Instead, it demonstrates substantial equivalence by confirming that the reprocessed device maintains the same functional and safety characteristics as the predicate device after reprocessing.

The "acceptance criteria" for this device would broadly be:

Biocompatibility identical to the new device.
Cleaning effectiveness to remove contaminants.
Sterilization effectiveness.
Functional performance (visual, dimensional, simulated use) equivalent to the new device.
Mechanical characteristics equivalent to the new device.
Hydrophilic coating integrity maintained.
System compatibility with existing Volcano systems.
Packaging integrity maintained.

The "reported device performance" is the successful completion of these tests, leading to the conclusion of substantial equivalence.

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

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Visions PV .035 Catheter."

Sample Size: The specific number of reprocessed catheters used for each type of testing (biocompatibility, cleaning, sterilization, functional, mechanical, packaging) is not specified in the provided text.
Data Provenance: The testing was conducted in a "bench and laboratory" setting, indicating controlled laboratory conditions rather than patient data. The country of origin is not specified but implicitly within the US, given the FDA submission. This is 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)

This question is not applicable to this submission. The "ground truth" for a reprocessed device like this is the performance and safety profile of the original, new device, and the successful validation of the reprocessing steps to ensure equivalence. This doesn't involve expert readers or diagnostic accuracy assessments in the traditional sense. The evaluations are primarily engineering and scientific tests.

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

This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic decisions, and not in the bench/laboratory testing described for this reprocessed device.

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

This question is not applicable. This device is an Intravascular Ultrasound (IVUS) catheter, a imaging tool, and the submission is for a reprocessed version of it. It does not involve Artificial Intelligence (AI) or human-in-the-loop performance improvement.

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

This question is not applicable. The device does not contain an algorithm or AI for standalone performance assessment. It's a hardware medical device.

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

The "ground truth" for this reprocessed device is established by demonstrating that its performance and safety characteristics after reprocessing are equivalent to those of the predicate (new) device. This is assessed through:

Physical and chemical testing: Biocompatibility, material integrity, cleaning efficacy.
Functional testing: Visual inspection, dimensional verification, simulated use (e.g., tracking over guide wires), mechanical characteristics (e.g., tensile strength, kink resistance), hydrophilic coating performance.
Sterilization validation: Ensuring sterility assurance level.

There is no "expert consensus" on diagnostic findings, pathology, or outcomes data involved in this specific submission for substantial equivalence of a reprocessed device.

8. The sample size for the training set

This question is not applicable. This device is a reprocessed physical medical device, not an AI/machine learning algorithm. Therefore, there is no training set in the computational sense.

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

This question is not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2019

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

Re: K181126

Trade/Device Name: Reprocessed Visions PV .035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: December 17, 2018 Received: December 19, 2018

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica E. Paulsen -S

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

Description	ItemNumber	FrenchSize	Guide Wire	MinimumSheath	Length(cm)
Visions PV .035Digital IVUS Catheter	88901	7	0.035" - 0.038"	8.5 F	90

Table 1: Device Scope

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Indications for Use

510(k) Number (if known)

K181126

Device Name

Reprocessed Visions PV .035 Digital IVUS Catheter

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)

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

Date prepared:

April 26, 2018

Device Information:

Trade/Proprietary Name: Common or Usual Name: Classification Name: Classification Number: Product Code:

Reprocessed Visions PV .035 Digital IVUS Catheter Ultrasonic Imaging Catheter Diagnostic Intravascular Catheter Class II, 21 CFR 870.1200 OWQ

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K153094	Visions PV .035 Digital IVUS Catheter	Volcano Corporation

Device Description:

The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.

The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm from the imaging plane, with the 25th RO marker overlapping the distal most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-tomiddle, with wider marks indicating 5 cm intervals.

The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.

A hydrophilic coating is applied externally to a distal portion of the catheter.

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

Description	ItemNumber	FrenchSize	Guide Wire	MinimumSheath	Length(cm)
Visions PV .035Digital IVUS Catheter	88901	7	0.035" – 0.038"	8.5 F	90

Table 5.1: Device Scope

Indications for Use:

The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed 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 Visions PV .035 Catheter. This included the following:

Biocompatibility
Cleaning Validation
Sterilization Validation ●
Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- . Simulated Use
- Mechanical Characteristics .
- . Hydrophilic Coating
- . System Compatibility
Packaging Validation ●

The catheter is reprocessed no more than one (1) time. Each device is marked 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 Visions PV .035 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).