(74 days)
No
The device description and performance metrics focus on the physical characteristics and functionality of a hemostasis valve introducer kit, with no mention of AI or ML.
No
The device is designed to facilitate the introduction of catheters, not provide a therapeutic effect. It's a tool for delivering treatment, not a treatment in itself.
No
The device is described as an introducer kit designed to facilitate percutaneous introduction of catheters and prevent blood backflow, which is a procedural/interventional function, not a diagnostic one. There is no mention of it being used to identify or diagnose a condition.
No
The device description clearly outlines physical components like sheaths, dilators, guidewires, and obturators, which are hardware. There is no mention of software as the primary or sole component.
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 percutaneous introduction of catheters into the vasculature while preventing the backflow of blood." This describes a device used in vivo (within the body) for a procedural purpose, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device (sheath, dilator, guidewire, obturator) designed for insertion into the vasculature. This aligns with an interventional or surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Braun Hemostasis Valve Introducer Kits are a medical device used for vascular access procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.
Product codes
Not Found
Device Description
Braun Hemostasis Introducer Kits consist of a hemostasis valve introducer sheath packaged with a corresponding dilator. One or more of the following accessories may also be packaged with the sheath/dilator; guidewire, and/or obturator. The introducer sheaths are available in both straight and contralateral curve versions. They will be available in 5 - 9 French sizes, in lengths from 30 - 60 cm in the cuved version and 10 - 60 cm in the straight version. Each will be packaged with an appropriately sized dilator. Optional items to be kitted with the sheath and dilator include a guidewire, and/or obturator. The components, their materials and accessories, are similar to those previously cleared under Braun 510(k)s; K894446, K930057, K931743, K945396. and K950882.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K894446, K930057, K931743, K950882
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS ll.
Applicant Name & Address:
B. Braun Medical Inc., Cardiovascular Division, 13000 Hwy 55 Minneapolis, MN 55441-3813 (612) 559-3370
Barbara Atzenhoefer, Regulatory Affairs Manager Contact:
Date Prepared: January 22, 1996
Common or Usual Name: Braun Hemostasis Introducer Kits
Device Classification Name: Catheter Introducer
Substantial Equivilance:
K895044* Balkin Up & Over Braun Fluoro-Tip™ Hemostasis Introducer Kits K945396
Cook B. Braun Cardiovascular
Device Description: Braun Hemostasis Introducer Kits consist of a hemostasis valve introducer sheath packaged with a corresponding dilator. One or more of the following accessories may also be packaged with the sheath/dilator; guidewire, and/or obturator. The introducer sheaths are available in both straight and contralateral curve versions. They will be available in 5 - 9 French sizes, in lengths from 30 - 60 cm in the cuved version and 10 - 60 cm in the straight version. Each will be packaged with an appropriately sized dilator. Optional items to be kitted with the sheath and dilator include a guidewire, and/or obturator. The components, their materials and accessories, are similar to those previously cleared under Braun 510(k)s; K894446, K930057, K931743, K945396. and K950882.
Statement of Intended Use: The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.
Summary/Comparision of Technological Characteristics:
| Characteristic | Braun Hemostasis
Introducer Kits | Cook Up Et Over Balkin
Contralateral- K895044 | Braun Fluoro-Tip
K945396 |
|------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Available French Sizes | 5 - 9 French | Curved versions 5.5, 6 & 7 fr
Straight versions of the
Check-Flo introducer sheaths
are available in 4- 9 french | 7 - 10 fr |
| Available Lengths | curved - 30 - 60 cm
straight - 10 - 60 cm | curved - 40 cm
straight - 7 - 13 cm | 10 - 32 cm |
| Body Stock Design | Braided | non-braided | non-braided, double layer
sheath |
| Sheath Material | peba | Teflon® | FEP (Teflon®) |
| Hub to Body Tensile | 5 fr - 14.5 lbs avg
9 fr - 18.4 lbs avg | 7.2 lbs avg | 7 fr - 14 lbs avg |
| Shape Recovery | 5 fr 85% recovery @ 5 sec
86% recovery @ 60 sec
9fr 85% recovery @ 5 sec
88% recovery @ 60 sec | 72% recovery @ 5 sec
77% recovery @ 60 sec | Not applicable |
| Sheath Leak Test | No leaks at 100 psi | No leaks at 100 psi | Not performed |
| Gasket leak Test | No leaks at 6 psi | No leaks at 6 psi | No leaks at 10 psi |
| Kink Resistance | 5 fr - No kinks at 170°
9 fr - Kinked at avg of 107° | Kinked at an avg of 76° | Not performed |
| Radiopacity | More visible than Cook | Less visible than Braun | Not compared against Cook |