BRAUN HEMOSTASIS INTRODUCERS

• K Number: K955820
• Device Name: BRAUN HEMOSTASIS INTRODUCERS
• Manufacturer: B. BRAUN MEDICAL, INC.
• Date Cleared: 1996-03-25 ( 90 days)
• Product Code: DYB
• Regulation Number: 870.1340

Intended Use

For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

Device Description

16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm.

Predicate Devices

K894446, K931743, K871153, K930057, K945396

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard introducer device with a silicone gasket and does not mention any AI/ML-related terms, image processing, or performance studies indicative of AI/ML functionality.

Therapeutic

No

The device is an introducer for catheters, not a device that provides therapy itself. Its function is to facilitate the introduction of other devices into the vasculature.

Diagnostic

No
Explanation: The device is described as an introducer for catheters, preventing blood backflow during percutaneous introduction into the vasculature. Its function is to facilitate the delivery of other devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Braun Hemostasis Introducer with silicone gasket," which are physical hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
• Device Description and Intended Use: The description and intended use clearly state that this device is for the percutaneous introduction of catheters into the vasculature. This is a procedure performed on the patient's body, not a test performed on a sample from the patient's body.
• Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.

This device is a surgical/interventional device used for accessing the vascular system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

Product codes

DYB, DRE

Device Description

16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K894446, K931743, K871153, K930057, K945396

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

SUMMARY OF SAFETY AND EFFECTIVENESS 11.

Applicant Name & Address:

B. Braun Medical Inc., Cardiovascular Division, 13000 Hwy 55 Minneapolis, MN 55441-3813 [phone]

Barbara Atzenhoefer, Regulatory Affairs Manager Contact:

December 19, 1995 Date Prepared:

Common or Usual Name: Catheter introducer and Vessel dilator for percutaneous catheterization

Device Classification Name:

Introducer: 21 CFR Reference- 870.1340, Class II Panel- 74 DYB

11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

Dilator: 21 CFR Reference- 870.1310, Class II, Panel- 74 DRE

Substantial Equivilance:

510(k) #	Product	Manufacturer
K894446	Angeion Hemostasis Valve Introducer Kit	B. Braun Cardiovascular - MN
K931743	Burron Cardiovascular Angestat	B. Braun Cardiovascular - MN
K871153	ANGETEAR Tear-away Introducer Kits	B. Braun Cardiovascular - MN
K930057	Fluoro-tip Hemostasis Introducer Set	B. Braun Cardiovascular - MN
K945396	Fluoro-tip Hemostasis Introducer Set	B. Braun Cardiovascular - MN

Device Description:

16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm. Statement of Intended Use:

For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. Summary/Comparision of Technological Characteristics:

Characteristic	Braun Hemostasis Introducers	K894446 Hemostasis Introducer	K931743 Angestat	K871153 ANGETEAR
A) Labeling/Pkg
Labels & IFUs	See Attachment B	All Braun Hemostasis Introducer
Label formats are identical	All Braun Hemostasis
Introducer Label formats are
identical	same information
provided on pouch and
box labels as on
hemostasis labels
Expiration Dating	2 years	2 years	2 years	4 years
Pyrogen Free	Yes	Yes	Yes	Yes
Packaging	Tyvek/Polymylar pouch	Tyvek/Polymylar pouch	Tyvek/Polymylar pouch	Tray w/ tyvek lid w/in a
tyvek/polymylar pouch
B) Intended Use	percutaneous introduction of
catheters into the vasculature
while minimizing the backflow
of blood	percutaneous introduction of
catheters into the vasculature
while minimizing the backflow of
blood	percutaneous introduction of
catheters into the vasculature
while minimizing the backflow
of blood	percutaneous
introduction of catheters
into the vasculature
C) Physical Char.
Available french sizes	4-18 french	5-14 french	4-15 french	4-16 french
Lengths	10-40 cm	12-24 cm	15-32 cm	16-30 cm
gasket material	silicone	Natural rubber	silicone	none
sheath material	FEP with BaSO₄	FEP teflon with BaSO₄	FEP with BaSO₄	polyethylene with
bismuth subcarbonate
dilator material	high density polyethylene with
bismuth subcarbonate	polyethylene with bismuth
subcarbonate	polyethylene with bismuth
subcarbonate	FEP with BaSO₄ or
polyethylene with
bismuth subcarbonate
D) Anatomical Sites	vasculature	vasculature	vasculature	vasculature