(169 days)
Not Found
No
The description focuses on the physical characteristics and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guide wire intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices, indicating it is not a therapeutic device itself but rather an accessory to them.
No
The device is a guide wire intended to facilitate the placement and exchange of other therapeutic devices, not to diagnose a condition.
No
The device description clearly details a physical guide wire made of stainless steel, polyurethane, and PTFE, indicating it is a hardware device, not software only.
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 device is 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) for a medical procedure.
- Device Description: The description details a physical guide wire designed to be inserted into 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 compatibility testing.
IVD devices are used to perform tests outside of the body on biological samples. This device is used inside the body to assist with a medical procedure.
N/A
Intended Use / Indications for Use
The SCIMED ChoICE PT Vision PTCA 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 PT Vision PTCA 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 ChoICE PT Vision PTCA Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy, Intermediate, Extra Support, Standard, Super Support, and Super Support II. The distal two centimeters of all models are straight shapeable or available in a pre-formed J-Tip.
The tapered, distal stainless steel core wire is surrounded by a polyurethane sleeve and is coated with ICE™ Hydrophilic Coating. The Floppy, Intermediate, Extra Support, and Standard guide wires will have the distal 38 centimeters surrounded by the polyurethane sleeve and are available in radiopaque lengths of 2 and 38 cm. The Super Support and Super Support II guide wires will have the distal 10 centimeters surrounded by the polyurethane sleeve, and are available in radiopaque lengths of 2 and 10 cm. The proximal wire is coated with polytetrafluoroethylene (PTFE)
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 tip tensile, tip torsion, combined load, and tip flexibility. Additionally, J-Tip curve retention, polyurethane shear strength, torque response, and PTCA catheter compatibility were performed. Test results verified that the ChoICE PT Vision PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use.
Key Metrics
Not Found
Predicate Device(s)
K943192 & K961015, K945129 & K961015, K950113 & K961015, K941895 & K960657, K950216 & K960657, K950266 & K960657, K960563
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
510(k) Notification SCIMED ChoICE PT Vision PTCA Guide Wires
Image /page/0/Picture/2 description: The image shows the logo for SCIMED, which is a medical device company. The logo consists of the word "SCIMED" in bold, black letters, with a partial circle to the left of the "S". Below the logo is the text "Boston Scientific Corporation" in a smaller font size. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566 612.494.1700
DEC 1 7 1996
SECTION THREE-- SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) Prepared June 28, 1996
I. General Provisions:
Submitter's Name and Address:
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311
Contact Person:
Connie J. Del Toro (612) 494-2656
Classification Name:
Catheter Guide Wire
PTCA Guide Wire
Common or Usual Name:
Proprietary Name:
SCIMED ChoICE PT Vision PTCA Guide Wires
Name of Predicate Devices: II.
| 510(k) Reference No. | Predicate Device |
|---|---|
| K943192 & K961015 | SCIMED ChoICE PTCA Guide Wire |
| K945129 & K961015 | SCIMED ChoICE Plus PTCA Guide Wire |
| K950113 & K961015 | SCIMED ChoICE Exchange PTCA Guide Wire |
| K941895 & K960657 | SCIMED ChoICE PT PTCA Guide Wire |
| K950216 & K960657 | SCIMED ChoICE PT Plus PTCA Guide Wire |
| K950266 & K960657 | SCIMED CholCE PT Exchange PTCA Guide Wire |
| K960563 | SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire |
| (Alternative Black PTFE Coating) |
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 One SCIMED Place Maple Grove, MN 55311-1566 612.494.1700
III. Device Description:
The ChoICE PT Vision PTCA Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy, Intermediate, Extra Support, Standard, Super Support, and Super Support II. The distal two centimeters of all models are straight shapeable or available in a pre-formed J-Tip.
The tapered, distal stainless steel core wire is surrounded by a polyurethane sleeve and is coated with ICE™ Hydrophilic Coating. The Floppy, Intermediate, Extra Support, and Standard guide wires will have the distal 38 centimeters surrounded by the polyurethane sleeve and are available in radiopaque lengths of 2 and 38 cm. The Super Support and Super Support II guide wires will have the distal 10 centimeters surrounded by the polyurethane sleeve, and are available in radiopaque lengths of 2 and 10 cm. The proximal wire is coated with polytetrafluoroethylene (PTFE)
IV. Intended Use:
The SCIMED ChoICE PT Vision PTCA 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 PT Vision PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
V. Summary of Technological Characteristics:
The ChoICE PT Vision PTCA Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE and ChoICE PT family of Guide Wires.
2
Image /page/2/Picture/1 description: The image shows the logo for SCIMED, which is a company that is part of Boston Scientific Corporation. The logo is in black and white and features the word "SCIMED" in a bold, sans-serif font. The words "Boston Scientific Corporation" are written in a smaller font below the logo. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566 612·494·1700
Non-Clinical Test Summary: VI.
Testing and evaluation of the guide wires included tip tensile, tip torsion, combined load, and tip flexibility. Additionally, J-Tip curve retention, polyurethane shear strength, torque response, and PTCA catheter compatibility were performed. Test results verified that the ChoICE PT Vision PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use. The ChoICE PT Vision PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (ChoICE, and ChoICE PT Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.