(71 days)
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No
The summary describes a physical medical device (guidewire) and its mechanical and material properties, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is a steerable guidewire, intended to facilitate general intravascular use. It is a tool for navigation within the vasculature and does not provide a therapeutic effect itself.
No
Explanation: The device is described as a steerable guidewire intended for general intravascular use, which is a therapeutic or interventional function, not a diagnostic one. The performance studies focus on mechanical properties relevant to its use as a guidewire, not diagnostic accuracy.
No
The device description explicitly states it is a "Steerable Guidewire with hydrophilic coating and accessories," which are physical hardware components. The performance studies also describe testing of physical properties like tensile strength, flexibility, and coating adherence.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general intravascular use including the peripheral and neurovasculature." This describes a device used within the body for a procedural purpose (guiding other devices), not for testing samples outside the body to diagnose conditions.
- Device Description: The description focuses on the physical characteristics and performance testing related to its function as a guidewire within the vasculature (tip tensile, flexibility, torque, coating, etc.). These are not tests typically associated with IVD devices.
- Lack of IVD Language: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire is a surgical/interventional tool used directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature.
Product codes
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Device Description
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral and neurovasculature
Indicated Patient Age Range
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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
Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
Key Metrics
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Predicate Device(s)
BSC Transend Guidewire, Target Therapeutics Dasher-10 and Seeker-Lite Guidewires, Terumo Corporation's Glidewire Gold Guidewire, Micro Interventional Systems Quicksilver Guidewire
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 28 子
510(k) Premarket Notification BSC Transend Guidewire
November 15, 1996
ATTACHMENT K
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to $513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to $513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Transend Guidewire is as follows:
| Trade Name: | Transend Guidewire |
|---|---|
| Manufacturer : | BSC/SciMed Life Systems, Inc. |
| 6655 Wedgwood Road | |
| Maplegrove, MN 55311-3636 | |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 513 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, | |
| Performance Standards (CFR 870.1330). | |
| Predicate Devices: | BSC Transend Guidewire |
| Target Therapeutics Dasher-10 and Seeker-Lite Guidewires | |
| Terumo Corporation's Glidewire Gold Guidewire | |
| Micro Interventional Systems Quicksilver Guidewire |
Product Desription:
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Transend Guidewire has been shown to be safe and effective for its intended use.