The Commander Series Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The Commander Series guide wires are not intended for use in the cerebral vasculature. Commander steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Device Description

The Commander Series guide wires are steerable guide wires. The Commander guide wire is substantially equivalent to the Phantom guide wire with respect to the design. Both wires contain a hypotube, core wire, spring segment and tip. Although the basic five segments of the Commander guide wire are similar to other currently marketed devices, the Commander guide wire contains radiopaque markers (referred to as Accumarkers).

AI/ML Overview

This 510(k) summary does not contain the detailed performance data or acceptance criteria that would typically be found in a study report. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and results for the Commander Series Guide Wires.

Therefore, many of the requested sections below cannot be fully populated from the provided text. The document refers to "Appendix B in Volume II" for performance data, which is not included here.

Based on the provided text, here's what can be inferred and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text. The document indicates that "Each sub-family of the Commander guide wire has been tested along with a device of similar performance characteristics" and "Performance Data Demonstrate Equivalence." However, specific numerical or qualitative acceptance criteria and the corresponding reported performance values are not present in this summary.	Not explicitly stated in the provided text. The document states "Refer to Appendix B in Volume II for the results of the in vitro testing of the Commander guide wire and the predicate devices." This appendix would contain the actual performance data.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document states "Each sub-family of the Commander guide wire has been tested," implying multiple units were tested, but the exact number is missing.
Data Provenance: The testing was "in vitro testing" (as stated under "7. Performance Data Demonstrate Equivalence?"). The location or country of origin is not specified, but it's likely internal testing by the manufacturer, USCI Division of C.R. Bard, Inc. (Billerica, MA, USA). The study is retrospective in the sense that it evaluates a device against existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the in vitro performance testing described. Ground truth established by experts is typically relevant for studies involving diagnostic image interpretation or clinical outcomes, not for mechanical performance testing of devices like guide wires.

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

This type of information is not applicable to the in vitro performance testing described. Adjudication methods are relevant for expert consensus in clinical studies, not for objective mechanical measurements.

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 type of study is not applicable as the device is a medical instrument (guide wire), not an AI-powered diagnostic tool for human readers.

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

This concept is not applicable as the device is a medical instrument, not an algorithm. The testing described is "standalone" in the sense that it's in vitro testing of the device itself.

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

For the in vitro performance testing, the "ground truth" would be established by objective engineering measurements based on validated test methods (e.g., measurements of forces, flexibility, radiopacity, etc., compared against specifications or predicate device performance). This is not a "ground truth" in the clinical sense with expert consensus or pathology.

8. The sample size for the training set

This concept is not applicable as there is no "training set" for a physical medical device. Training sets are used in machine learning or AI development.

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

This concept is not applicable as there is no "training set" for a physical medical device.

Summary

{0}------------------------------------------------

K961271

JUL 21

Clinical and Regulatory Affairs 1200 Technology Park Drive P.O. Box 7025 Billerica. MA 01821 (508) 667-1300 FAX: (508) 670-4326

: 上一篇:

Image /page/0/Picture/3 description: The image shows the letters "USCI" in bold black font. The letters are inside of a black oval. The letters are all capitalized and evenly spaced. The background is white.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION 6.0

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

General Information 6.1

� Name and Address of Submitter:
USCI Division of C.R. Bard, Inc. 129 Concord Road Billerica, MA 01821
� Contact: Deborah L. Herrington Senior Regulatory Affairs Coordinator
� Date of Summary: April 1, 1996
Name of Device: � USCI® Commander™ Series Guide Wires
� Common/Usual Name of Device: Catheter Guide Wire for PTCA Catheter
� Device Classification: 21 CFR 870.4290

Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, stylized font. The letters are thick and outlined in black, giving them a three-dimensional appearance. The "A" in "BARD" is designed with a unique triangular shape, adding a distinctive element to the overall design.

{1}------------------------------------------------

Predicate Device: �

ﺍﻟﻤﺴﺎﻋﺪﺓ

USCI® Phantom™ Guide Wire (concurrence received June 20, 1989, K890505) USCI® LumiSilk Guide Wire (concurrence received March 1, 1993, K925074/A) USCI® Standard Guide Wire (approval received October 7, 1986, P790017/S8) Interventional Technologies Inc. 0.014" Tec Guide Wire (concurrence received May 23, 1989, K890515)

Description and Intended Use of Device: �

{2}------------------------------------------------

Summary of Similarities and Differences 6.2

】则赚钱

The proposed Commander guide wire family is substantially equivalent to the USCI Phantom Guide Wire (known at the time of filing as the Grey/Black Guide Wire, K890505, concurrence received June 20, 1989). Both wires have the same indications for use in that they are both utilized with USCI Dilatation Catheters. The wording is expanded for the Commander guide wire so that it more clearly identifies the uses of the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion." Since concurrence was received for the Phantom wire in 1989, technology has progressed so that the indications for the Commander guide wire have replaced the phrase "USCI Dilatation Catheters" with "interventional devices" to acknowledge the use of atherectomy devices and balloons that support stents.

The Commander guide wire is substantially equivalent to the Phantom guide wire with respect to the design. Both wires contain a hypotube, core wire, spring segment and tip.

{3}------------------------------------------------

6.3 Substantial Equivalence Decision Tree

The 510(k) "Substantial Equivalence" Decision Making Process (detailed) in ODE Guidance Memo #K86-3 was utilized to make a determination of substantial equivalence. The answers to these questions lead to a determination of substantial equivalence.

Does New Device Have Same Indication Statements? 1.

No. The indications for use for the Commander guide wire have been expanded. Since concurrence was received for the Phantom wire in 1989, technology has progressed so that the indications for the Commander guide wire have replaced the phrase "USCI Dilatation Catheters" with "interventional devices" to acknowledge the use of atherectomy devices and balloons that support stents. This change is consistent with the indication for use included with the 0.014" Tec guide wire from InterVentional Technologies Inc. (K890515). The indication for the Tec wire is as follows: "The InterVentional Technologies Inc. 0.014" Guide Wire is recommended for use to facilitate the navigation and placement of atherectomy and angioplasty interventional catheters through tortuous coronary and peripheral vessels."

Do the Differences Alter the Intended Therapeutic/Diagnostic/etc. Effect (in Deciding, 2. May Consider Impact on Safety and Effectiveness)?
No. The therapeutic/diagnostic effect of the Commander guide wire is "for introduction and placement of diagnostic or interventional devices" which is consistent with the intended therapeutic/diagnostic effect of currently marketed guide wires. The location of the "therapeutic/diagnostic effect" has been expanded to include the peripheral vasculature. There are no new safety or effectiveness concerns raised with the addition of the peripheral vasculature; the same concerns as the coronary vasculature apply here also.
Does New Device Have Same Technological Characteristics, e.g. Design, Materials, etc. ? 3.
No. Although the basic five segments of the Commander guide wire are similar to other currently marketed devices, the Commander guide wire contains radiopaque markers (referred to as Accumarkers).

{4}------------------------------------------------

Could the New Characteristics Affect Safety or Effectiveness? 4.

1 1991

No. All materials utilized during manufacture of the Commander guide wire are identical to a currently marketed device, including the material of the markers. The use of markers is not new to the medical device industry. Radiopaque markers are currently present in balloon dilatation catheters. Exit markers that indicate location are present on PTCA guiding catheters. The markers on the Commander guide wire are contained within the spring; therefore, there is no exposure to the patient and they do not affect the performance characteristics of the device.

Are the Descriptive Characteristics Precise Enough to Ensure Equivalence? ર.

No. Although the Commander guide wire has been described in detail in Section 3.0, it may be difficult to determine how the device in its many different sub-families will perform.

ર. Are Performance Data Available to Assess Equivalence?

Yes. Each sub-family of the Commander guide wire has been tested along with a device of similar performance characteristics. Refer to Appendix B in Volume II. In addition to the Phantom guide wire, the Lumisilk guide wire and the Standard guide wire, the TEC guide wire from IVT was tested due to the stiffness characteristics of the core wire.

7. Performance Data Demonstrate Equivalence?

Yes. Refer to Appendix B in Volume II for the results of the in vitro testing of the Commander guide wire and the predicate devices.

Based on the FDA decision tree, USCI considers the Commander guide wire to be substantially equivalent to the Phantom guide wire.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.