(65 days)
Not Found
No
The summary describes a physical medical device (guide wire) with different configurations and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The guide wires are described as facilitating the placement and exchange of therapeutic devices, rather than performing a therapeutic function themselves.
No
Explanation: The device is described as a guide wire intended to facilitate the placement and exchange of other therapeutic devices. Its purpose is procedural assistance, not the collection or analysis of diagnostic information.
No
The device description clearly outlines a physical guide wire with specific dimensions, materials (polymer sleeve, core wire), and configurations (tip shapes, flexibilities, lengths). There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 within the body for a therapeutic or interventional purpose, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a physical guide wire with specific dimensions, materials, and tip configurations, designed to be inserted into blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the SCIMED ChoICE Guide Wires are classified as an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SCIMED ChoICE 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 Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The available tip flexibilities are Floppy, Intermediate, Extra Support, Standard, Super Support, and Super Support II in a si | Device Description continued | A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the guide wires are • ChoICE-190 cm, • ChoICE Plus-182 cm, and • ChoICE Exchange-300 centimeters.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K943192, K950141, K961015, K964551, K945129, K961015, K964551, K965023, K950113, K961015, K964551, K941895, K950835, K960657, K950216, K960657, K965023, K950266, K960657
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires
Image /page/0/Picture/1 description: The image shows the logo for SCIMED, a division of Boston Scientific Corporation. The word "SCIMED" is written in large, bold, sans-serif letters. Below the logo is the text "Boston Scientific Corporation" in a smaller, sans-serif font. The logo is black and white.
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 string of characters. The characters appear to be "K970244". The handwriting is in black ink and is on a white background. The characters are connected and flow together.
MAR 2 8 1997
Appendix A
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 January 21, 1997
Device Name Proprietary Name SCIMED ChoICE PTCA Guide Wire SCIMED ChoICE Plus PTCA Guide Wire SCIMED ChoICE Exchange PTCA Guide Wire
Common or Usual Name PTCA Guide Wire
Classification Name Catheter Guide Wire
Continued on next page.
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. There is a horizontal line below the text "Boston Scientific Corporation".
SCIMED Life Systems, Inc.
Summary of Safety and Effectiveness, continued Appendix A
Predicate Devices:
The following predicate devices are available from SCIMED.
| Product | 510(k) | Clearance Date |
|---|---|---|
| ChoICE | K943192 | November 22, 1994 |
| K950141 | March 3, 1995 | |
| K961015 | May 15, 1996 | |
| K964551 | Submitted Nov. 14, 1996 | |
| ChoICE Plus | K945129 | March 3, 1995 |
| K961015 | May 15, 1996 | |
| K964551 | Submitted Nov. 14, 1996 | |
| K965023 | Submitted Dec. 17,1996 | |
| ChoICE Exchange | K950113 | March 31, 1995 |
| K961015 | May 15, 1996 | |
| K964551 | Submitted Nov. 14, 1996 | |
| ChoICE PT | K941895 | May 24, 1996 |
| K950835 | May 25, 1995 | |
| K960657 | April 29, 1996 | |
| ChoICE PT Plus | K950216 | June 22, 1995 |
| K960657 | April 29, 1996 | |
| K965023 | Submitted Dec. 17, 1996 | |
| ChoICE PT Exchange | K950266 | April 14, 1996 |
| K960657 | April 29, 1996 |
Device Description
The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The available tip flexibilities are
- · Floppy,
- · Intermediate,
- · Extra Support,
- · Standard,
- · Super Support, and
- · Super Support II
2
Image /page/2/Picture/1 description: The image shows the logo for SCIMED, a division of Boston Scientific Corporation. The logo is in black and white, with the word "SCIMED" in large, bold letters. The words "Boston Scientific Corporation" are in a smaller font below the main logo. The logo also includes the registered trademark symbol.
SCIMED Life Systems, Inc.
Summary of Safety and Effectiveness, continued Appendix A
in a si
| Device Description continued | A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating.
The available lengths for the guide wires are
• ChoICE-190 cm,
• ChoICE Plus-182 cm, and
• ChoICE Exchange-300 centimeters. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SCIMED ChoICE 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 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 ChoICE Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE Family of Guide Wires and the ChoICE PT Family of Guide Wires. The change consists of a modification to the core wire dimensions. |
| Non-Clinical Test Summary | Additional testing of the modified ChoICE Extra Support Guide Wires was not performed since the identical core wire dimension is present on the ChoICE PT Extra Support Guide Wires.
Testing presented in K960657, ChoICE PT Extra Support on the first support diameter is directly applicable to the ChoICE Extra Support because of the identical design in this section of the wire. |