(78 days)
The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The proximal section of the guide wire consists of a differential magnetic (Hiperco®) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco® core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.
The provided document is a "Summary of Safety and Effectiveness" for a medical device (PTCA Guide Wire) seeking 510(k) clearance. It describes the device, its intended use, and a comparison to existing devices to establish substantial equivalence. The document does not describe acceptance criteria for an AI/ML device, nor does it detail a study proving such a device meets acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the input document does not contain this type of information. It specifically focuses on a physical medical device (catheter guide wire) and its mechanical testing, not an AI/ML system.
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Image /page/0/Picture/1 description: The image shows the word "SCIMED" in large, bold, black letters. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font size. The word "SCIMED" appears to be a logo or brand name, and the text below it indicates that it is associated with the Boston Scientific Corporation.
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566 612.494.1700
Image /page/0/Picture/3 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string reads "K965003 MAR-". The text is written in a cursive style, with the letters and numbers connected. The word "MAR" is written in all capital letters and is followed by a hyphen.
Summary of Safety and Effectiveness
Submitter's Information
Name and Address SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311
Contact Person Connie J. Del Toro (612) 494-2656
Date December 13, 1996
Device Name Proprietary Names SCIMED ChoICE Plus PTCA Guide Wires SCIMED ChoICE PT Plus PTCA Guide Wires SCIMED 182 cm ChoICE PT Vision PTCA Guide Wires
Common or Usual Name PTCA Guide Wire
Classification Name Catheter Guide Wire (per 21CFR 870.1330)
Continued on next page.
Section 6
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Image /page/1/Picture/1 description: The image shows the logo for SCIMED, a Boston Scientific Corporation. The logo is in black and white, with the word "SCIMED" in large, bold letters. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
SCIMED Life Systems, Inc.
Summary of Safety and Effectiveness, Continued Section 6
Substantial Equivalence Comparison The modified proximal section on the ChoICE Guide Wires is substantially equivalent to the proximal section on the following SCIMED products.
| Product | 510(k) | Clearance Date |
|---|---|---|
| ChoICE Plus | K945129 | March 3, 1995 |
| K961015 | May 15, 1996 | |
| K964551 | Submitted November 14, 1996 | |
| ChoICE PT Plus | K950216 | June 22, 1995 |
| K960657 | April 29, 1996 | |
| EnTre III | K942333 | August 31, 1994 |
| (marketed as the Sceptor Guide | K946240 | March 31,1995 |
| Wire) | K950534 | April 28, 1996 |
| K960563 | April 29, 1996 | |
| EnTre II | K931514 | June 25, 1993 |
| K935022 | January 18, 1993 | |
| K935577 | November 17, 1993 | |
| 182 cm ChoICE PT Vision | K962572 | Submitted July 1, 1996. |
Proximal Section Description
The proximal section of the guide wire consists of a differential magnetic (Hiperco®) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco® core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.
Continued on next page.
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Image /page/2/Picture/1 description: The image shows the logo for SCIMED, which is a division of Boston Scientific Corporation. The word "SCIMED" is in large, bold, black letters at the top of the logo. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font. There is a horizontal line below the text "Boston Scientific Corporation".
SCIMED Life Systems, Inc.
Summary of Safety and Effectiveness, Continued Section 6
| Intended Use | The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICEPT Vision Guide Wires are intended to facilitate the placement andexchange of balloon dilatation catheters or other therapeutic devicesduring PTCA or other intravascular interventional procedures. TheChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT VisionGuide Wires are not intended for use in the cerebral vasculature. Thedevices are provided sterile and intended for one procedure only. |
|---|---|
| Summary ofTechnologicalCharacteristics | The modified proximal section on the ChoICE Guide Wires utilize thesame materials and methods of construction as the proximal section onthe ChoICE Plus, ChoICE PT Plus, EnTre III, EnTre II, and the recentlysubmitted 182 cm ChoICE PT Vision Guide Wires. The modification tothe proximal section consists of an alternative manufacturing method forattaching the proximal Hiperco*core wire/hypotube assembly. |
| Non-ClinicalTest Summary | Testing and evaluation of the guide wires includedProximal Tensile, Joint Kink, and Fatigue testing. ResultsTest results verified that the modified proximal section of the ChoICEGuide Wires met all of the minimum requirements and is adequate forit's intended use.SummaryThe modified proximal section of the ChoICE Guide Wires issubstantially equivalent to the proximal section on the ChoICE Plus,ChoICE PT Plus, EnTre III, EnTre II, and the recently submitted 182 cmChoICE PT Vision Guide Wire, based on a comparison of intended use,design and the results of in vitro testing and evaluation. |
§ 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.