K Number

K961745

Device Name

BRAUN PERCUTANEOUS INTRODUCER SET

Manufacturer

B. BRAUN MEDICAL, INC.

Date Cleared

1996-09-17

(134 days)

Product Code

DYB

Regulation Number

870.1340

Intended Use

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K810460, K894446, K894343 and/or K884494, K771982 and/or K770561, K780126, K850820, K932733

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple mechanical device (introducer sheath, dilator, guidewire, needle) and makes no mention of AI, ML, image processing, or any computational analysis.

Therapeutic

No
The device is described as an introducer kit designed to facilitate percutaneous introduction of other devices into the vasculature, rather than providing a direct therapeutic effect itself.

Diagnostic

No
The device is described as an introducer kit designed to facilitate the percutaneous introduction of other devices into the vasculature, which is a procedural function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it consists of physical components like an introducer sheath, dilator, guidewire, and introducer needle, which are hardware.

IVD (In Vitro Diagnostic)

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 devices into the vasculature." This describes a surgical or interventional procedure performed directly on a patient's body.
Device Description: The components (introducer sheath, dilator, guidewire, introducer needle) are all tools used for accessing and navigating within the body's vascular system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose diseases or conditions.

Therefore, the Braun Percutaneous Introducer Kits are medical devices used for interventional procedures, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

Product codes

Not Found

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.

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K810460, K894446, K894343 and/or K884494, K771982 and/or K770561, K780126, K850820, K932733

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

11. SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address:

B. Braun Medical Inc., 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400

K961745

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 specified
in 510(k)	12 - 24 cm	8.5 - 12 cm	8 - 12 cm	unknown	14 cm	11 cm
Matls	Teflon FEP or
HDPE sheath
with HDPE
dilator	Teflon® FEP
sheath &
dilator	Teflon® FEP
sheath and
HDPE dilator	unknown -
"proprietary
materials"	Teflon	unknown	white
teflonsheath
with
polyethylene
dilator	unknown
Sideport	no	yes	yes	no	no	no	no	no
Gasket	no	no	yes	no	no	no	no	no
Use	percutaneous
introduction
of devices
into the
vasculature	percutaneous
introduction
of devices
into the
vasculature.	percutaneous
introduction
of catheters
into the
vasculature
while
minimizing
the backflow
of blood.	Designed for
introduction of
electrophysiolo
gy and other
catheters into
the venous
system	percutaneous
introduction of
catheters into
the vasculature
(either venous
or arterial)	percutaneous
introduction of
balloon
catheters, closed
end catheters
and temporary
pacing leads into
the vasculature.	percutaneous
introduction
of catheters
into the
vasculature
(either venous
or arterial)	percutaneous
introduction
of catheters
into the
vasculature

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 870.1340 Catheter introducer.

11. SUMMARY OF SAFETY AND EFFECTIVENESS

Statement of Intended Use:

Summary/Comparision of Technological Characteristics: