(73 days)
SCIMED ChoICE™ PT Exchange PTCA Guide Wire, SCIMED ChoICE™ PT Plus PTCA Guide Wire, SCIMED ChoICE™ PT PTCA Guide Wire
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No
The device description and performance studies focus on the physical properties and mechanical performance of the guide wires, with no mention of AI or ML technologies.
No
The device is a guide wire intended to facilitate the placement and exchange of therapeutic devices, rather than being a therapeutic device itself.
No
The device is a guide wire intended to facilitate the placement and exchange of therapeutic devices, not to diagnose a condition.
No
The device description clearly details physical components like wires, coatings, and tips, indicating it is a hardware medical 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) for a therapeutic or interventional procedure.
- Device Description: The description details the physical characteristics of a 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 medical procedures.
N/A
Intended Use / Indications for Use
The SCIMED ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper 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, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper 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
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Device Description
The ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are steerable guide wires available in nominal diameters of 0.014 inches and nominal lengths of 190, 182 and 300 centimeters. The magnetic proximal section of the 182 cm length is designed to facilitate exchange of devices when used with SCIMED's Magnet Exchange Device. The 300 cm length allows exchange of therapeutic devices without the use of other exchange devices, e.g., docking systems or extension wires. The distal 35 centimeters on the entire ChoICE PT family of guide wires contains a stainless steel core wire that is jacketed with a radiopaque polymer and coated with ICE™ Hydrophilic Coating. The distal two centimeters of the guide wire are straight shapeable or available in a pre-formed J-Tip. The proximal wire is coated with either polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP). The distal core wire tapers have increased in thickness or length to differentiate the Extra Support and Extra Support Long Taper models from the ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Guide Wires. The Extra Support designates a taper of 2.25 inches proximal to the distal tip, whereas the Extra Support Long Taper designates a taper of 3.5 inches proximal to the distal tip. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper Guide Wires will be provided sterile and are intended for one procedure use only (disposable).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary: Testing and evaluation of the guide wires included tip tensile, torsion, combined load, and flexibility. Additionally, torque response and J-Tip curve retention were determined. Test results verified that the ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use. No additional testing was performed on the ChoICE PT and ChoICE PT Plus Extra Support and Extra Support Long Taper models as a result of their identical distal design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
SCIMED ChoICE™ PT Exchange PTCA Guide Wire, SCIMED ChoICE™ PT Plus PTCA Guide Wire, SCIMED ChoICE™ PT PTCA Guide Wire
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.
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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/0 description: The image shows the logo for SCIMED Life Systems, Inc. The word "SCIMED" is in large, bold, black letters, with a registered trademark symbol to the right of the word. Below the word "SCIMED" is the text "LIFE SYSTEMS, INC." in a smaller, non-bold font.
¥960657
APR 2 9 1996
SECTION TWO 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) Prepared April 3, 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 | |
| Common or Usual Name: | PTCA Guide Wire | |
| Proprietary Name: | ||
| SCIMED ChoICE™ PT Exchange | ||
| Extra Support PTCA Guide Wire | ||
| SCIMED ChoICE™ PT Exchange | ||
| Extra Support Long Taper PTCA Guide Wire | ||
| SCIMED ChoICE™ PT Plus | ||
| Extra Support PTCA Guide Wire | ||
| SCIMED ChoICE™ PT Plus | ||
| Extra Support Long Taper PTCA Guide Wire | ||
| SCIMED ChoICE™ PT | ||
| Extra Support PTCA Guide Wire | ||
| SCIMED ChoICE™ PT | ||
| Extra Support Long Taper PTCA Guide Wire | ||
| II. | Name of Predicate Devices: |
SCIMED ChoICE™ PT Exchange PTCA Guide Wire SCIMED ChoICE™ PT Plus PTCA Guide Wire SCIMED ChoICE™ PT PTCA Guide Wire
1
SYSTEMS, INC
III. Device Description:
The ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are steerable guide wires available in nominal diameters of 0.014 inches and nominal lengths of 190, 182 and 300 centimeters. The magnetic proximal section of the 182 cm length is designed to facilitate exchange of devices when used with SCIMED's Magnet Exchange Device. The 300 cm length allows exchange of therapeutic devices without the use of other exchange devices, e.g., docking systems or extension wires. The distal 35 centimeters on the entire ChoICE PT family of guide wires contains a stainless steel core wire that is jacketed with a radiopaque polymer and coated with ICE™ Hydrophilic Coating. The distal two centimeters of the guide wire are straight shapeable or available in a pre-formed J-Tip. The proximal wire is coated with either polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP). The distal core wire tapers have increased in thickness or length to differentiate the Extra Support and Extra Support Long Taper models from the ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Guide Wires. The Extra Support designates a taper of 2.25 inches proximal to the distal tip, whereas the Extra Support Long Taper designates a taper of 3.5 inches proximal to the distal tip. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper Guide Wires will be provided sterile and are intended for one procedure use only (disposable).
IV. Intended Use:
The SCIMED ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper 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, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
2
Image /page/2/Picture/0 description: The image shows the logo for SCIMED Life Systems, Inc. The word "SCIMED" is in large, bold, black letters, with a registered trademark symbol next to the "D". Below the company name is the text "LIFE SYSTEMS, INC." in a smaller font.
V. Summary of Technological Characteristics:
The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange PTCA Guide Wires. The only difference is the increase in thickness or length of the core wire tapers proximal to the tip.
VI. Non-Clinical Test Summary:
Testing and evaluation of the guide wires included tip tensile, torsion, combined load, and flexibility. Additionally, torque response and J-Tip curve retention were determined. Test results verified that the ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use.
No additional testing was performed on the ChoICE PT and ChoICE PT Plus Extra Support and Extra Support Long Taper models as a result of their identical distal design.
The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.