The USCI® Pro-Flo, Pro-Flo with Soft Tip, Pro-Flo XT and Pro-Flo XT with Soft Tip are diagnostic intravascular catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.

Device Description

The USCI Pro-Flo and Pro-Flo XT catheters have the same technological characteristics as the USCI Positrol-II catheters. The designs are similar; all three catheters have polyurethane shaft and tip segments with the shaft comprising of an inner jacket of polyurethane, a stainless steel braid and an outer jacket of polyurethane. The soft tip segments are comprised of a softer polyurethane material and are bonded onto the shaft segment for PF ST and PF XT ST catheters.

AI/ML Overview

This document describes a 510(k) summary for the USCI Pro-Flo and Pro-Flo XT angiographic catheters, comparing them to predicate devices (USCI Positrol-II and Cordis Super Torque Plus). It focuses on demonstrating substantial equivalence rather than presenting an AI device study. Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert adjudication, or MRMC studies is not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text, as it relates to the equivalence of the new catheters to existing ones.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table, but it implies that the performance data demonstrate equivalence to the predicate devices. The "performance characteristics" that are assessed are related to mechanical properties.

Acceptance Criterion (Implied)	Reported Device Performance
Shaft stiffness equivalence to predicate devices	Performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
Shaft torque equivalence to predicate devices	Performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
Shaft burst equivalence to predicate devices	Performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
Tensile strength (soft tip, tip joint, hub/shaft) equivalence to predicate devices	Performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
Same indication statements	"Yes." (USCI Pro-Flo, Pro-Flo XT, P-II, and Cordis ST Plus are intravascular diagnostic catheters used to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels.)
Same technological characteristics (design, materials, etc.)	"Yes." (Similar designs, all three catheters have polyurethane shaft and tip segments with inner jacket of polyurethane, stainless steel braid, and outer jacket of polyurethane. Soft tip segments are softer polyurethane.)
Descriptive characteristics precise enough to ensure equivalence	"No." (Differences in durometers lead to minor differences in shaft diameter and stiffness, which is a performance characteristic not precisely describable without performance data.)

Explanation of the Study and its Context:

This document is a 510(k) summary for a medical device (angiographic catheters), not an AI device. The "study" described is a set of performance tests conducted to demonstrate substantial equivalence of the new catheters to existing, legally marketed predicate devices. The goal is to show that the new device is as safe and effective as the predicate devices, not that it meets specific performance metrics for AI algorithms.

Regarding your specific questions for an AI device study, the following are "Not Applicable" (N/A) or "Not Provided" in this document as it is not an AI device study:

Sample size used for the test set and the data provenance: N/A (This is a physical device performance test, not a data-driven AI test)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth in this context would be physical measurements and established engineering standards, not expert clinical interpretation of data/images).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A
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 (No human readers or AI in this context).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests would be the established engineering specifications and performance of the predicate devices based on objective physical measurements (e.g., burst pressure, tensile strength limits, durometer readings).
The sample size for the training set: N/A (No training set for a physical device).
How the ground truth for the training set was established: N/A.

Summary

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OCT 23 1996

USCI Division C.R. Bard, Inc. Clinical and Requlatory Affairs 1200 Technology Park Drive P.O. Box 7025 Billerica, MA 01821 (508) 667-1300 FAX: (508) 670-4326

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Section VI. 510(k) Summary of Safety and Effectiveness Information

This 510(k) summary of safety and effectivenenss information is being submitted in accordance with the requirements of SMDA 1990.

VI. A. General Information

. Name and address of submitter:
USCI Division, C.R. Bard, Inc. 1200 Technology Park Drive P.O. Box 7025 Billerica, MA 01821 Phone #: (508)667-1300 Fax #: (508)670-4301
Contact:
Robert T. Miragliuolo Director of Regulatory Affairs
. Date of Summary: January 2, 1996
. Trade Name of Devices:

USCI® Pro-Flo® Angiographic Catheter USCI® Pro-Flo® XT™ Angiographic Catheter USCI® Pro-Flo® with Soft Tip Angiographic Catheter USCI® Pro-Flo® XT™ with Soft Tip Angiographic Catheter

Common/Usual Name: Cardiovascular Angiographic Catheter

Classification Name: Diagnostic, Intravascular Catheter

Trade Name of Predicate Devices:
USCI® Positrol-II® Angiographic Catheter Cordis® Super Torque Plus® Angiographic Catheter
Description and Intended Use of Device:
The USCI® Pro-Flo, Pro-Flo with Soft Tip, Pro-Flo XT and Pro-Flo XT with Soft Tip are diagnostic intravascular catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.

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VI. B. Summary of Similarities and Differences

The USCI Pro-Flo and Pro-Flo XT catheters are substantially equivalent to the USCI Positrol-II and Cordis ST Plus catheters. The USCI Pro-Flo XT catheters are also commercialized with a soft tip feature. The primary difference between these catheters and the standard Pro-Flo and Pro-Flo XT catheters is that the tip of the catheter is made of a softer polyurethane material called Tecoflex. This soft-tip feature received FDA concurrence in 1988 through the premarket notification submission for the USCI Soft Tip Angiographic Catheter (#K883051, FDA Concurrence date: October 6, 1988). All of the catheters are currently marketed. A table of similarities and differences between these catheters is presented in Exhibit VI.1.

The general design, functionality, and indications for use of the USCI PF and PF XC catheters are equivalent to the USCI P-II and Cordis ST Plus catheters. All four catheters have the same principles of operation. They are used to measure intracardiac pressures, sample blood, and introduce substances into the heart and vessels. They are introduced into femoral or brachial arteries and advanced under fluoroscopic guidance to just past the orifice of the right or left ventricle. Radiopaque contrast medium is injected through the catheter so that the blood vessels and/or cardiac chambers can be visualized with fluoroscopy. The differences between the PF/PF XT catheters and the P-II catheters, as presented in Exhibit VI. 1, are:

VI.B.1. PRO-FLO CATHETER

a. The difference between the PF and P-II catheters is in the durometer of the polyurethane used in the inner sleeve of the PF line.
b. The range of outer diameters are different. The Pro-Flo catheters are available in the 6F and 7F sizes as compared to the 7F and 8F sizes for the Positrol-II catheters.

VI.B.2. PRO-FLO XT CATHETER

a. The Pro-Flo XT catheter differs from the Positrol-II catheter in the durometer of polyurethane used in the outer jacket of the shaft of the catheter.

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b. The Pro-Flo XT catheter is also sold in the 6F and 7F sizes as compared to the 7F and 8F sizes for the P-II catheter.
c. The colorants vary between the PF XT and the PF/P-II catheters for market differentiation. PF XT and PF XT ST are marketed with a blue colorant whereas PF, PF ST and P-II catheters are marketed with a green colorant.

VI.B.3. PF/PF XT CATHETERS WITH SOFT TIP (PF ST AND PF XT ST):

A soft-tip feature was made available in 1989 to the Pro-Flo XT and Pro-Flo line of catheters. The primary difference between these catheters and the standard Pro-Flo and Pro-Flo XT catheters was that the tip of the catheter is made of a softer polyurethane material. The addition of this soft-tip feature on a USCI polyurethane angiographic catheter received FDA concurrence in 1988 through the premarket notification submission for the USCI Soft Tip Angiographic Catheter (#K883051, FDA Concurrence date: October 6, 1988).

VI.B.4. ENHANCED PERFORMANCE PF and PF XT CATHETERS:

The Enhanced Performance Pro-Flo and Pro-Flo XT catheters were introduced in 1992 through a regulatory "No-510(k) file" decision. The reason for introduction of these enhanced performance catheters was to maintain and grow market share. The term "enhanced performance" was a marketing term, referring to this perceived improvement in torque response by some customers. The wire braiding of the 6F PF/PF ST and PF XT/PF XT ST catheters was changed. Also, the JR4 tip segment length (6F/7F PF/PF ST and PF XT ST catheters) and curve style (6F/7F PF/PF ST catheters) were changed to enhance perceived torque response of the PF and PF XT catheters.

VI.B.5. RADIOPAQUE MARKERS:

The presence of radiopaque markers to the PF, PF XT, PF ST and PF XT ST angiographic catheters will be a feature intended for estimation of ventricular volume. Currently, radiopaque markers are offered only on the PF catheters. In the future,

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however, they will be introduced on the PF ST, PF XT and PF XT ST catheters. Multiradiopaque pacing bands previously received FDA concurrence (March 5, 1981) on USCI premarket notification submission, #K810412. The 510(k), #K810412, requested FDA concurrence for the addition of radiopaque markers on USCI's P-II and Nycore angiographic catheters. In addition, radiopaque markers were on older USCI Class III devices such as the Profile Plus PTCA balloon catheter (P790017/S8, FDA approval 10/7/86) and the LPS/LPS II PTCA balloon catheters (P790017/S11, FDA approval 6/15/87).

VI. 3. Substantial Equivalence Decision Tree

The 510(k) "Substantial Equivalence" Decision-Making Process (Detailed in ODE Guidance #K86-3) Guidance on the CDRH Premarket Notification Review Program, was used to determine substantial equivalence. Please refer to Exhibit VI.2 for a diagram of the 510(k) Decision Tree. The answers to the questions lead to a determination of substantial equivalence.

The first question asks, "Does New Device Have Same Indication Statements?" The answer is "Yes".

The USCI Pro-Flo, USCI Pro-Flo XT, USCI P-II and Cordis ST Plus catheters are intravascular diagnostic catheters used to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels. A soft-tip feature was made available in 1989 to the Pro-Flo XT and Pro-Flo line of catheters. The primary difference between these catheters and the standard Pro-Flo and Pro-Flo XT catheters was that the tip of the catheter is made of a softer polyurethane material. The addition of this soft-tip feature on a USCI polyurethane angiographic catheter received FDA concurrence in 1988 through the premarket notification for the USCI Soft Tip Angiographic Catheter (#K883051, FDA Concurrence date: October 6, 1988).

The second question asks, "Does New Device Have Same Technological Characteristics, e.g., Design, Materials, Etc?" The answer is "Yes."

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and an outer jacket of polyurethane. The soft tip segments are comprised of a softer polyurethane material and are bonded onto the shaft segment for PF ST and PF XT ST catheters.

The third question asks, "Are The Descriptive Characteristics Precise Enough to Ensure Equivalence?" The answer is "No."

Descriptive characteristics would not be precise enough to ensure equivalence. The differences in durometers of the polyurethane used in the USCI PF/PF XT and the P-II catheters result in minor differences not only in the dimensions of the diameter of the shaft but also in the stiffness feature of the finished product. While dimensions may be measured and differences in durometer of polyurethane described, the differences in stiffness is a performance characteristic of the device and hence, cannot be described in a precise manner.

The fourth questions asks, "Are Performance Data Available to Assess Equivalence?" The answer is "Yes."

Performance test results are available to assess the equivalence of the PF, PF ST, PF XT and PF XT ST catheters to the predicate devices. The tests that were conducted include the shaft stiffess, shaft torque, shaft burst and tensile (soft tip, tip joint and hub/shaft) tests.

The fifth question asks, "Performance Data Demonstrate Equivalence?" The answer is "Yess".

As indicated by test results, performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.

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).