(86 days)
Not Found
No
The description focuses on the mechanical design and materials of a guide wire, with no mention of AI, ML, or image processing.
No
The device is described as a steerable guide wire used for the introduction and placement of other diagnostic or interventional devices, rather than providing therapy itself.
No
The device is described as a steerable guide wire used for the introduction and placement of diagnostic or interventional devices, facilitating the substitution of one device for another. It does not perform diagnostic functions itself.
No
The device description clearly states it is a physical guide wire with components like a hypotube, core wire, spring segment, and tip, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature." This describes a device used within the body for medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details the physical components of a guide wire used in vascular procedures.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or any other activities typically associated with in vitro diagnostics.
Therefore, the Commander Series Guide Wires are medical devices used for interventional and diagnostic procedures within the body, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
The Commander Series Guide Wires are steerable guide wires. Both wires contain a hypotube, core wire, spring segment and tip. the Commander guide wire contains radiopaque markers (referred to as Accumarkers).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
in vitro testing of the Commander guide wire and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K890505, K925074/A, P790017/S8, K890515
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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� 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
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� Date of Summary: April 1, 1996
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Name of Device: � USCI® Commander™ Series Guide Wires
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� Common/Usual Name of Device: Catheter Guide Wire for PTCA Catheter
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� 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.
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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: �
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.
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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.
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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."
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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).
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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.