TORQUE DEVICE

• K Number: K964352
• Device Name: TORQUE DEVICE
• Manufacturer: B. BRAUN MEDICAL, INC.
• Date Cleared: 1997-01-28 ( 88 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K903606 , K936032
• Predicate For: K011646

Intended Use

The device is used to facilitate the manipulation of a guidewire into a vein or artery.

Device Description

The guidewire torque device is a cylindrical clamp which slides over the proximal end of a guidewire.

AI/ML Overview

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:

1. 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).
2. Sample Size for Test Set and Data Provenance: No clinical test set is mentioned.
3. Number of Experts and Qualifications: No experts are mentioned as being involved in assessing device performance.
4. Adjudication Method: No adjudication method is mentioned, as there's no clinical data to adjudicate.
5. 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.
6. Standalone Performance Study: No standalone performance study (clinical outcome) is mentioned.
7. Type of Ground Truth: No ground truth (expert consensus, pathology, outcome data) is specified, as no clinical performance data is presented.
8. 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.

Regulation Number and Section

§ 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.