BRAUN HEMOSTASIS INTRODUCERS

K960406 · B.Braun Medical, Inc. · DYB · Apr 12, 1996 · Cardiovascular

Device Facts

• Record ID: K960406
• Device Name: BRAUN HEMOSTASIS INTRODUCERS
• Applicant: B.Braun Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

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.

Device Story

Braun Hemostasis Introducer Kits consist of hemostasis valve introducer sheath, dilator, and optional guidewire/obturator. Used by physicians in clinical settings to facilitate percutaneous catheter insertion into vasculature. Sheath design prevents blood backflow during procedure. Available in straight and contralateral curve configurations, 5-9 French sizes, 10-60 cm lengths. Device provides access path for diagnostic or interventional catheters; enables clinician to maintain vascular access while minimizing blood loss.

Clinical Evidence

Bench testing only. Performance metrics include: hub-to-body tensile strength (14.5-18.4 lbs), shape recovery (85-88%), kink resistance (no kinks at 170° for 5F), and leak testing (no leaks at 100 psi for sheath, 6 psi for gasket).

Technological Characteristics

Materials: PEBA sheath. Construction: Braided body. Sizes: 5-9 French. Lengths: 10-60 cm. Configurations: Straight and contralateral curve. Features: Hemostasis valve, dilator, optional guidewire/obturator. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring percutaneous catheterization of the vasculature, facilitating device introduction while maintaining hemostasis.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Balkin Up & Over Cook (K895044)
• Braun Fluoro-Tip™ Hemostasis Introducer Kits (K945396)

Reference Devices

• Braun 510(k) K894446
• Braun 510(k) K930057
• Braun 510(k) K931743
• Braun 510(k) K950882

Submission Summary (Full Text)

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K960406

# II. SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address: B. Braun Medical Inc., Cardiovascular Division, 13000 Hwy 55 Minneapolis, MN 55441-3813 [phone]

Contact: Barbara Atzenhoefer, Regulatory Affairs Manager

Date Prepared: January 22, 1996

Common or Usual Name: Braun Hemostasis Introducer Kits

Device Classification Name: Catheter Introducer

## Substantial Equivalence:

K895044* Balkin Up & Over Cook
K945396 Braun Fluoro-Tip™ Hemostasis Introducer Kits 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 curved 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/Comparison of Technological Characteristics:

| Characteristic | Braun Hemostasis Introducer Kits | Cook Up & 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 |

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