(293 days)
No
The 510(k) summary describes a diagnostic intravascular catheter and its physical characteristics and performance testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic intravascular catheter" used to "record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels," indicating diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are diagnostic intravascular catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels."
No
The device description clearly outlines physical components like polyurethane shafts, tips, and stainless steel braid, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the catheters are used to "record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels." These are procedures performed within the body (in vivo), not on samples of bodily fluids or tissues outside the body (in vitro).
- Device Description: The description details the physical construction of a catheter designed for insertion into the cardiovascular system.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic tests.
The device is a diagnostic intravascular catheter, but the diagnostic function is related to measuring pressures and sampling blood directly from within the body, not performing tests on those samples in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The USCI® Pro-Flo, Pro-Flo with Soft Tip, Pro-Flo XT and Pro-Flo XT with Soft Tip are diagnostic intravascular catheters. The Pro-Flo XT catheters are also commercialized with a soft tip feature, where the tip of the catheter is made of a softer polyurethane material called Tecoflex. The catheters are typically introduced into femoral or brachial arteries and advanced under fluoroscopic guidance. They have a polyurethane shaft with 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. The Pro-Flo catheters are available in 6F and 7F sizes. The Pro-Flo XT catheters are also sold in 6F and 7F sizes, and are marketed with a blue colorant, while PF, PF ST and P-II catheters are marketed with a green colorant. Some models include radiopaque markers for estimation of ventricular volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
heart and vessels (intracardiac), femoral or brachial arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance test results were 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. Performance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
USCI® Positrol-II® Angiographic Catheter, Cordis® Super Torque Plus® Angiographic Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
#K883051, #K810412, P790017/S8, P790017/S11
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows a sequence of characters and numbers written in a bold, handwritten style. The sequence begins with the letter 'K', followed by the numbers '9600056'. The characters and numbers are all connected, giving the impression of a single, continuous stroke.
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
Image /page/0/Picture/3 description: The image shows the letters "USCI" in bold, sans-serif font, enclosed in a black oval. The letters are arranged horizontally, with "U" on the left, "S" in the middle, "C" to the right of "S", and "I" on the far right. The oval border is thin and consistent in width, providing a clear outline for the letters.
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.
Image /page/0/Picture/20 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and prominent appearance. The font style is geometric and modern, with sharp angles and clean lines.
1
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.
2
-
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,
058
3
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."
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
4
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.