(71 days)
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature.
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.
This document is a 510(k) Premarket Notification for a medical device (BSC Transend Guidewire) and not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, the requested information based on AI/ML study characteristics (like sample size for test/training sets, expert ground truth, MRMC studies, etc.) cannot be extracted from the provided text.
The document discusses the safety and effectiveness of a traditional medical device (a guidewire) based on various mechanical, material, and in vivo tests. It does not involve any AI or algorithmic performance evaluation.
If you have a document describing an AI/ML device study, please provide that, and I will be able to answer your questions.
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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 RoadMaplegrove, MN 55311-3636 | |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 513 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards (CFR 870.1330). |
| Predicate Devices: | BSC Transend GuidewireTarget Therapeutics Dasher-10 and Seeker-Lite GuidewiresTerumo Corporation's Glidewire Gold GuidewireMicro 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.
§ 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.