(88 days)
Not Found
No
The description focuses on a mechanical device for manipulating a guidewire and does not mention any AI/ML terms or functionalities.
No.
The device facilitates the manipulation of a guidewire, which is a diagnostic or interventional procedure, not a therapeutic treatment itself.
No
The device is used to facilitate the manipulation of a guidewire, which is an interventional/procedural function, not a diagnostic one. There is no mention of it providing information about a patient's health status.
No
The device description explicitly states it is a "cylindrical clamp," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the manipulation of a guidewire into a vein or artery." This describes a device used during a medical procedure on a patient, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description of a "cylindrical clamp which slides over the proximal end of a guidewire" further reinforces its role as a tool for manipulating a guidewire within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The device is used to facilitate the manipulation of a guidewire into a vein or artery.
Product codes
74DQX
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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.
1
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.