(134 days)
The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.
Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.
This document is a 510(k) premarket notification for a medical device (Braun Percutaneous Introducer Set) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports for AI/ML devices.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus does not contain the specific study design elements you've asked for.
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11. SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant Name & Address:
B. Braun Medical Inc., 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
SEP 17 1996
| Contact: | Mark Alsberge, Regulatory Affairs Manager |
|---|---|
| Date Prepared: | 05/01/96 |
| Common or Usual Name: | Braun Percutaneous Introducer Set |
| Device Classification Name: | Catheter Introducers & vessel dilators |
| Substantial Equivilance: | ||
|---|---|---|
| K810460 | Burron Percutaneous Introducer Set | B. Braun Medical, Inc. |
| K894446 | Angeion Hemostasis Introducer Set | B. Braun Medical, Inc. |
| K894343 and/or K884494 | Venous Introducer | Daig |
| K771982 and/or K770561 | "888" Percutaneous Catheter Introducer | USCI |
| K780126 | PCI Kit | Argon |
| K850820 | Arterial/Venous Percutaneous Catheter Introducer | Universal Medical Instrument(UMI) |
| K932733 | Valveless/Portless Sheath Introducer | Cordis |
| Device Description: |
Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.
Statement of Intended Use:
:
The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.
| Braun PCI | K810460 | K894446 | Daig | USCI | Argon | UMI | Cordis | |
|---|---|---|---|---|---|---|---|---|
| Fr sizes | 3 - 9 | 6-8 | 4-15 | 4 - 9 | 4 - 9 | 4 - 9 | 4 - 8 | 6 - 8 |
| Lengths | 7 - 24 cm | not specifiedin 510(k) | 12 - 24 cm | 8.5 - 12 cm | 8 - 12 cm | unknown | 14 cm | 11 cm |
| Matls | Teflon FEP orHDPE sheathwith HDPEdilator | Teflon® FEPsheath &dilator | Teflon® FEPsheath andHDPE dilator | unknown -"proprietarymaterials" | Teflon | unknown | whiteteflonsheathwithpolyethylenedilator | unknown |
| Sideport | no | yes | yes | no | no | no | no | no |
| Gasket | no | no | yes | no | no | no | no | no |
| Use | percutaneousintroductionof devicesinto thevasculature | percutaneousintroductionof devicesinto thevasculature. | percutaneousintroductionof cathetersinto thevasculaturewhileminimizingthe backflowof blood. | Designed forintroduction ofelectrophysiology and othercatheters intothe venoussystem | percutaneousintroduction ofcatheters intothe vasculature(either venousor arterial) | percutaneousintroduction ofballooncatheters, closedend cathetersand temporarypacing leads intothe vasculature. | percutaneousintroductionof cathetersinto thevasculature(either venousor arterial) | percutaneousintroductionof cathetersinto thevasculature |
Summary/Comparision of Technological Characteristics:
§ 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).