(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a guide wire, with no mention of AI or ML technologies.
No
The device is described as a guide wire intended to facilitate the placement and exchange of other therapeutic devices, rather than being a therapeutic device itself.
No.
The device description and intended use clearly state that these are guide wires designed to facilitate the placement and exchange of other therapeutic devices, which is a functional purpose, not a diagnostic one.
No
The device description clearly details physical components like core wires, hypotubes, welds, and adhesive bonds, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wires are used to "facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures." This describes a device used in vivo (within the body) to assist in a medical procedure.
- Device Description: The description details the physical components of a guide wire used for navigating within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is a tool used directly within the body during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Testing and evaluation of the guide wires included Proximal Tensile, Joint Kink, and Fatigue testing. Test results verified that the modified proximal section of the ChoICE Guide Wires met all of the minimum requirements and is adequate for it's intended use. The modified proximal section of the ChoICE Guide Wires is substantially equivalent to the proximal section on the ChoICE Plus, ChoICE PT Plus, EnTre III, EnTre II, and the recently submitted 182 cm ChoICE PT Vision Guide Wire, based on a comparison of intended use, design and the results of in vitro testing and evaluation.
Key Metrics
Not Found
Predicate Device(s)
K945129, K961015, K964551, K950216, K960657, K942333, K946240, K950534, K960563, K931514, K935022, K935577, K962572
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.
0
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
1
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.
2
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 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. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Technological
Characteristics | The modified proximal section on the ChoICE Guide Wires utilize the
same materials and methods of construction as the proximal section on
the ChoICE Plus, ChoICE PT Plus, EnTre III, EnTre II, and the recently
submitted 182 cm ChoICE PT Vision Guide Wires. The modification to
the proximal section consists of an alternative manufacturing method for
attaching the proximal Hiperco*core wire/hypotube assembly. |
| Non-Clinical
Test Summary | Testing and evaluation of the guide wires included
Proximal Tensile, Joint Kink, and Fatigue testing. Results
Test results verified that the modified proximal section of the ChoICE
Guide Wires met all of the minimum requirements and is adequate for
it's intended use.
Summary
The modified proximal section of the ChoICE Guide Wires is
substantially equivalent to the proximal section on the ChoICE Plus,
ChoICE PT Plus, EnTre III, EnTre II, and the recently submitted 182 cm
ChoICE PT Vision Guide Wire, based on a comparison of intended use,
design and the results of in vitro testing and evaluation. |