The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

Device Description

The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.

The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.

The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.

The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.

AI/ML Overview

The provided text describes the B. Braun Tear-Away Introducer Needle and its substantial equivalence to a predicate device (Summit Medical Products, ambIT® Introducer) for FDA 510(k) clearance.

Based on the document, this is not an AI/ML device. It is a physical medical device (an introducer needle). Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

However, I can extract and present the information provided regarding the device's acceptance criteria and the (non-clinical) study that proves it meets them.

Device: B. Braun Tear-Away Introducer Needle

Type of Device: Physical Medical Device (Catheter Introducer/Introducer Needle) - NOT AI/ML

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO standards.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance (Summary)
Physical and Dimensional Characteristics	Visual Inspection	Visual inspection was performed.
	Dimensional Inspection	Dimensional inspection was performed.
Luer Compatibility	Luer Compatibility - Gauging (ISO 594-1:1986, ISO 80369-7:2016)	Testing performed.
Needle/Sheath Functionality & Integrity	Needle Removal Force	Testing performed.
	Occlusion	Testing performed.
	Pressure	Testing performed.
	Cannula Deflection (ISO 9626:2016)	Testing performed.
	Cannula Breakage (ISO 9626:2016)	Testing performed.
	Tensile Strength	Testing performed.
	Associated Device (likely compatibility/function with other devices)	Testing performed.
	Stress Cracking	Testing performed.
	Fluid Leakage by Pressure Decay	Testing performed.
	Subatmospheric Pressure Air Leakage	Testing performed.
	Resistance to Separation from Unscrewing	Testing performed.
	Resistance to Separation from Axial Load	Testing performed.
	Resistance to Overriding	Testing performed.
	Strength of Union (implied by separation/tensile tests)	Testing performed.
Sterility	Sterilization Method (Ethylene Oxide, SAL 10^-6)	The device undergoes Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10^-6.
Biocompatibility	Biocompatibility requirements per ISO 10993-1:2009 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Rabbit Pyrogen)	Materials meet biocompatibility requirements. The device is a "Limited (<24 hrs) Contact Duration device" (patient exposure <1 hr), classified as an "External Communicating Device – Tissue/Bone/Dentin."
Overall Performance for Intended Use	Performance standards for intravascular catheter introducers (ISO 11070:2014)	Results of testing demonstrate that the proposed device performs similarly to the predicate device and can be used according to its intended use. Overall, the device is found substantially equivalent to the predicate device based on the testing performed. No clinical testing was performed.

Study Details (Non-Clinical Bench Testing)

As this is a physical medical device and the clearance is based on substantial equivalence through non-clinical testing, the following points are not applicable (N/A) in the context of an AI/ML device approval. However, I can state what is available in the document.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of a test set for an AI/ML model. The document indicates that various non-clinical bench tests were performed to evaluate the device's characteristics and performance. The number of units tested for each specific test is not detailed.
- Data Provenance: N/A for AI/ML data provenance. The "data" here refers to physical test results obtained from the manufactured devices. The manufacturer is B. Braun Medical Inc., located in Allentown, Pennsylvania, USA. The testing would have been conducted by or for B. Braun.
- Retrospective or Prospective: N/A. This is bench testing of physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth for an AI/ML model does not apply here. The "ground truth" for a physical device is its adherence to specified physical and functional performance metrics, typically measured by engineering and quality control professionals using calibrated equipment and standard test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This is not an image classification or diagnostic device. Adjudication methods are relevant for human interpretation of data, typically in AI/ML performance evaluation studies.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The document explicitly states: "No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." MRMC studies are for AI/ML devices involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A for AI/ML "ground truth". The ground truth for this device is based on engineering specifications, compliance with international standards (ISO), and direct physical measurements/tests to ensure the device performs as intended and is safe and effective when compared to a legally marketed predicate device.
The sample size for the training set:
- N/A. There is no AI/ML training set. The "training" for such a device involves manufacturing processes and quality control to meet design specifications.
How the ground truth for the training set was established:
- N/A. No AI/ML training set exists for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 22, 2017

B. Braun Medical Inc. Kimberly Smith Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K171584

Trade/Device Name: B. Braun Tear-Away Introducer Needle Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: November 21, 2017 Received: November 21, 2017

Dear Kimberly Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang
S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171584

Device Name

B. Braun Tear-Away Introducer Needle

Indications for Use (Describe)

The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500Contact: Kimberly Smith, Sr. Regulatory Affairs Specialist
	Phone: (610) 596-2326Fax: (610) 266-4962E-mail: Kim.smith@bbraun.com
DATE:	December 22, 2017
DEVICE NAME:	B. Braun Tear-Away Introducer Needle
COMMON NAME:	Catheter Introducer
CLASSIFICATION:	Class II per 21 CFR 868.5120, Anesthesia conduction catheterProduct Code: BSOPanel: Anesthesiology
PREDICATE DEVICE:	Summit Medical Products, ambIT® IntroducerK102460, Class II, BSO, 868.5120

Description

The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.

{5}------------------------------------------------

Intended Use

The B. Braun Tear-Away Introducer Needle is intended for the percutaneous placement of a catheter.

Indications for Use

The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

Substantial Equivalence

Predicate Device - Summit Medical Products, ambIT Introducer (K102460)

The B. Braun Tear-Away Introducer Needle presented in this submission has the identical intended use, similar indications for use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of the same components and similar materials and meet performance specifications similar to the predicate device.

Characteristic	Proposed	Predicate Device – K102460
	B. Braun Tear-Away Introducer Needle	ambIT Introducer
Intended Use	Percutaneous placement of a catheter.	Percutaneous placement of a catheter.
Indications for Use	The B. Braun Tear-Away Introducer Needleis intended to allow for the percutaneousplacement of catheters in close proximity tonerves and around or into surgical wound ornon-surgical wound sites.	The amibIT Introducer products line isintended to allow for the percutaneousplacement of catheters in close proximity tonerves and around or into surgical wound ornon-surgical wound sites. It may be used toinject or aspirate the introduction area via theluer hub of the needle.
Materials ofconstruction	Needle - Stainless steel (304)Needle hub - polystyrene (clear)Tear-away sheath hub – HDPE withMasterbatch light blueTear-away sheath tube - HDPE with 10%BaSO4, 1% TiO2Protective Needle Guard – LDPE	Needle - Stainless steel (304), 18 GaNeedle hub - polystyrene (clear)Tear-away sheath hub – HDPESheath shaft (tube) - HDPE with 10% BaSO4
Summary ofnonclinical tests fordetermination ofsubstantial	Visual• Dimensional Inspection• Luer Compatibility-Gauging• Needle Removal Force• Occlusion• Pressure• Cannula Deflection• Cannula Breakage• Tensile Strength• Associated Device• Stress Cracking• Fluid Leakage by Pressure Decay• Subatmospheric Pressure Air Leakage• Resistance to Separation from Unscrewing• Resistance to Separation from Axial Load• Resistance to Overriding	• Liquid Leakage test• Air Leakage test• Separation Force test• Unscrewing Torque• Ease of assembly• Resistance to Overriding• Stress Cracking• Force to Break• Strength of Union

{6}------------------------------------------------

Characteristic	Proposed	Predicate Device – K102460
	B. Braun Tear-Away Introducer Needle	ambIT Introducer
Principle ofoperation	Manual	Manual
Environment of use	For use by a surgeon in hospital environments	Unknown
Sterilization Method	Ethylene Oxide, SAL 10-6	Unknown
Biocompatibilityand ContactDuration	External Communicating Device –Tissue/Bone/Dentin, Limited (<24 hrs)Contact Duration device that has a patientexposure of <1hr. Materials meetbiocompatibility requirements per ISO 10993-1:2009.• Cytotoxicity• Sensitization• Intracutaneous reactivity• Systemic toxicity• Rabbit Pyrogen	Meets the requirements as set forth in ISO10993-1.

Testing

The following performance standards were considered when evaluating the functionality of the B. Braun Tear-Away Introducer Needle.

ISO 594-1:1986 - "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements"

ISO 9626:2016 - "Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods"

ISO 11070:2014 - "Sterile single-use intravascular catheter introducers, dilators and guidewires"

ISO 10993-1:2009 - "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 80369-7:2016 - "Smallbore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications"

Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used according to its intended use. No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

Conclusion:

The testing performed demonstrates that the B. Braun Tear-Away Introducer Needles are substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).