(88 days)
The device is used to facilitate the manipulation of a guidewire into a vein or artery.
The guidewire torque device is a cylindrical clamp which slides over the proximal end of a guidewire.
This document, K964352, is a 510(k) summary for a "TORQUE DEVICE" manufactured by B. Braun Medical, Inc. It describes a medical device, its intended use, materials, and substantial equivalence to previously cleared devices.
Critical Analysis of the Provided Document for the Requested Information:
The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data in the way the request specifies. This document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, primarily through manufacturing and material specifications, rather than clinical efficacy or diagnostic accuracy.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving device performance because that information is not present in the provided text.
Specific Reasons for Lacking Information:
- Table of Acceptance Criteria and Reported Device Performance: This document describes manufacturing release specifications (physical testing, visual examination) but not clinical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, or other clinically relevant outcomes).
- Sample Size for Test Set and Data Provenance: No clinical test set is mentioned.
- Number of Experts and Qualifications: No experts are mentioned as being involved in assessing device performance.
- Adjudication Method: No adjudication method is mentioned, as there's no clinical data to adjudicate.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned. The device is a physical tool, not an AI or imaging diagnostic aid.
- Standalone Performance Study: No standalone performance study (clinical outcome) is mentioned.
- Type of Ground Truth: No ground truth (expert consensus, pathology, outcome data) is specified, as no clinical performance data is presented.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are not applicable to the information provided, as the document is not about a machine learning or AI-driven device.
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II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
JAN 28 9997
October 28, 1996
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Mark S. Alsberge, Regulatory Affairs Manager Contact:
Product Name: TORQUE DEVICE
Trade Name: LTD Torque Device
Classification name: Catheter Guide Wire
Cardiovasular Class II, 74DQX 21 CFR 870.1330
SUBSTANTIAL EQUIVALENCE1 TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K903606 | Torque Device | Namic |
| K936032 | Scout Torque Device | Merit Medical |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Torque Device. The guidewire torque device is a cylindrical clamp which slides over the proximal end of a guidewire. The device is used to facilitate the manipulation of a guidewire into a vein or artery.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
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Material:
The Torque Device is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
Substantial equivalence: .
The Torque Device is similar in materials, form, and intended use to the Torque Device cleared by Namic and the Scout Torque Device cleared by Merit Medical. There are no new issues of safety or effectiveness raised by the Torque Device.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.
§ 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.