The True® Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the True® Flow Valvuloplasty Perfusion Catheter, which claims substantial equivalence to a previously cleared predicate device (K152613). The core of the information regarding device performance and acceptance criteria comes from a post-market clinical study conducted on the predicate device, the TRUE-FLOW study.

Here's an analysis of the acceptance criteria and study data based on the provided text:

Acceptance Criteria and Reported Device Performance

The text describes two primary endpoints for the TRUE-FLOW study, which effectively serve as performance and safety acceptance criteria for the device's functionality during balloon aortic valvuloplasty.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Endpoint)	Reported Device Performance
Primary Performance Endpoint: Successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter.	In 21 (87.5%) cases, the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. (Note: Data for one subject was not recorded, implying the 87.5% is out of 24 subjects, with 3 unsuccessful or unrecorded cases). The study indicated that the design allowed adequate blood flow to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.
Primary Safety Endpoint: Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure.	No device-related serious adverse events were reported during the study.

Acceptance Criteria (Endpoint)

Reported Device Performance

Primary Performance Endpoint: Successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter.

In 21 (87.5%) cases, the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. (Note: Data for one subject was not recorded, implying the 87.5% is out of 24 subjects, with 3 unsuccessful or unrecorded cases). The study indicated that the design allowed adequate blood flow to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.

Primary Safety Endpoint: Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure.

No device-related serious adverse events were reported during the study.

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: 24 subjects were included in the analysis population. 25 subjects were initially enrolled, but one withdrew consent post-discharge.
- Data Provenance: The study (TRUE-FLOW) was a post-market clinical study conducted on the predicate device. The text does not specify the country of origin, but given the FDA submission, it implicitly aligns with US regulatory requirements and likely US-based data, though this is not explicitly stated. It was a prospective, observational study.
Number of Experts and Qualifications for Ground Truth:
- The text does not provide information on the number or qualifications of experts used to establish ground truth for the test set. It describes clinical outcomes observed by the study, presumably by the treating physicians and study investigators, but there's no mention of independent expert review for ground truth establishment per se.
Adjudication Method for the Test Set:
- The text does not specify any explicit adjudication method (e.g., 2+1, 3+1). Decisions regarding "successful dilatation" and "freedom from adverse events" would have been part of the study's pre-defined endpoints and data collection protocols, likely adjudicated by the study investigators or a clinical events committee, but the method is not detailed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study was a clinical performance and safety study of the device itself, not an evaluation of human readers' performance with or without AI assistance. The device is a physical catheter, not an AI diagnostic tool.
Standalone (Algorithm Only) Performance:
- Not applicable. The device is a physical medical device (catheter) used in a medical procedure, not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
Type of Ground Truth Used:
- The ground truth for the performance and safety endpoints was based on clinical outcomes data from the patients undergoing the procedure. This includes observed success of aortic valve dilatation and the absence of pre-defined device-related or procedure-related adverse events.
Training Set Sample Size:
- Not applicable. This study is not a machine learning model, so there is no concept of a "training set" in the context of this device. The data mentioned is for clinical validation of the device's performance and safety.
How Ground Truth for Training Set Was Established:
- Not applicable, as there is no training set for a physical medical device.

In summary, the provided document focuses on the clinical performance and safety evaluation of a physical medical device. It outlines the specific performance and safety criteria (endpoints) that the device needed to meet and presents the observed outcomes from a prospective clinical study of the predicate device. The concepts of AI-related ground truth establishment, expert adjudication, MRMC studies, or training sets are not relevant to this type of device submission.

Summary

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December 13, 2017

C. R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281

Re: K172932

Trade/Device Name: True Flow Valvuloplasty Perfusion Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: September 25, 2017 Received: September 26, 2017

Dear Mr. Conovaloff:

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

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

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.

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,

Nicole G. Ibrahim -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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Indications for Use

510(k) Number (if known) K172932

Device Name

True® Flow Valvuloplasty Perfusion Catheter

Indications for Use (Describe)

The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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True® Flow Valvuloplasty Perfusion Catheter

Submitter Information:

Bard Peripheral Vascular, Inc. 1625 West Third St. Tempe, AZ 85281

Phone: (480) 350-6012 Fax: (480) 449-2546

Contact Person: Aaron Conovaloff, Regulatory Affairs Specialist Date of Submission: September 25, 2017

Subject Device Name:

Name of Device:	True® Flow Valvuloplasty Perfusion Catheter
Common or Usual Name:	Balloon Aortic Valvuloplasty
Classification Name:	Balloon Aortic Valvuloplasty
Regulatory Class:	II
Regulation Number:	21 CFR 870.1255

Predicate Device:

Name of Device:	True® Flow Valvuloplasty Perfusion Catheter (K152613
Common or Usual Name:	Balloon Aortic Valvuloplasty
Classification Name:	Balloon Aortic Valvuloplasty
Regulatory Class:	II
Regulation Number:	21 CFR 870.1255

Device Description:

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on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

Attribute	True® Flow Valvuloplasty Perfusion CatheterProduct Offering
Balloon Diameter(mm)	18, 20, 22, 24, 26
Balloon Length(cm)	3.5
Catheter ShaftLength (cm)	110
Introducer SheathCompatibility byBalloon Diameter(mm)	11F: 18 mm, 20 mm12F: 22 mm14F: 24 mm16F: 26 mm

Indications for Use of Device:

The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

Technological Comparison to Predicate Devices:

The True® Flow Valvuloplasty Perfusion Catheter has the following similarities to the predicate device, the True® Flow Valvuloplasty Perfusion Catheter (clearance to market via K152613 on January 19, 2016):

. Same intended use
. Same indications for use
. Same target population
Same operating principle .
. Same fundamental scientific technology
Same sterility assurance level and method of sterilization .

It should be noted that the subject True® Flow Valvuloplasty Perfusion Catheter is identical to the predicate device with respect to manufacturing and design. The only difference between the subject and predicate devices is an update to the Instructions for Use to provide results from clinical experience with the device.

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Performance Data:

Subsequent to clearance of K152613, a post-market clinical study (the TRUE-FLOW study) was conducted on the predicate True® Flow Valvuloplasty Perfusion Catheter. Twenty- five subjects were enrolled, of which all were successfully treated with the study device. One subject withdrew consent following all study procedures and hospital discharge, and is thus not included in the Analysis Population (n =24). Subjects eligible to be enrolled in this study were adult male and non-pregnant females scheduled to undergo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis who had an annulus diameter that could be treated with the available sizes of the study device, in accordance with the IFU. The primary performance endpoint was successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter. The primary safety endpoint was freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure. In 21 (87.5%) cases the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. For one subject these data were not recorded. No device related serious adverse events were reported during the study. The results of the TRUE-FLOW prospective, observational study indicated that the design of the True® Flow Valvuloplasty Perfusion Catheter allowed adequate blood flow through the device's central orifice to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.

Conclusions:

As the only difference between the subject and predicate devices is the addition of the above clinical experience to the IFU, there is no change to the intended use or indications for use, or any design specifications or manufacturing. Therefore the subject True® Flow Valvuloplasty Perfusion Catheter is substantially equivalent to the legally marketed predicate device, the True® Flow Valvuloplasty Perfusion Catheter.

Regulation Number and Section

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.