B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.

Device Description

B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. In clinical practice, extension sets are connected to primary IV sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter. An extension set attached to a catheter hub allows the clinician to perform syringe aspirations and injections away from the patient's catheter site.

Extension Sets are widely used in the clinical setting, are available in various lengths and dimensions, and may be comprised of various generic components that are broadly used throughout the industry. Various components such as stopcocks, clamps, injection sites, connectors, manifolds, filters and needleless connectors, previously cleared in 510(k)s, may be included on an Extension Set. B. Braun Extension Sets offer a range of lengths and a variety of tubing dimensions (ie: microbore, standard bore) that provide flexibility in a variety of clinical settings. B. Braun Extension Sets are configured to ensure the intended use of the device is met.

B. Braun's optional stabilization component is a non-removable component that slides on the tubing and may be firmly positioned on the patient connector, secured at the discretion of the clinician at time of use. The optional stabilization component provides additional stabilization to intravascular catheters while firmly positioned on the patient connector of the Extension Set. The optional stabilization component supports the patient connector of the extension set, reducing its contact with the skin. The geometrical design of the stabilization component supports the patient connector maintaining the catheter insertion angle, minimizing the catheter movement in the vessel and the potential for catheter kinking at the insertion site.

Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second.

B. Braun Extension Sets may be used for any patient population.

Extension Sets comprised of a female luer adapter, extension tubing, slide clamp, stabilization component and a male luer adapter with cap are included in this premarket notification. The following Extension Set configurations are subject of this submission.

Smallbore Extension Set with stabilization component, Spin-Lock connector, removable slide clamp
Standard Bore Extension Set with stabilization component, Spin-Lock connector, slide clamp
Extension Set with stabilization component, Spin-Lock connector, slide clamp

AI/ML Overview

This is a 510(k) premarket notification for an Extension Set by B. Braun Medical Inc. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing. It is not a study proving device meeting acceptance criteria in the sense of an effectiveness or clinical trial, but rather a submission for regulatory clearance based on performance standards.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, ground truth for test/training set, training set size) are not applicable as this document details a regulatory submission for a medical device rather than a clinical study of AI performance.

However, I can extract information related to acceptance criteria and performance testing for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met their acceptance criteria" for the performance tests conducted. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The summary lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance
Functional Performance
Stabilization Component Angular/Axial Stabilization/Performance	Met acceptance criteria
Visual	Met acceptance criteria
Catheter Angle	Met acceptance criteria
Flow Rate No Catheter	Met acceptance criteria
Flow Rate - With Catheter	Met acceptance criteria
Tape Removal	Met acceptance criteria
Occlusion	Met acceptance criteria
Negative Pressure	Met acceptance criteria
Positive Pressure	Met acceptance criteria
Clamp and Positive Pressure	Met acceptance criteria
Tensile Strength	Met acceptance criteria
Power Injection (up to 400 psi, 15 mL/sec flow rate)	Met acceptance criteria
Mechanical Hemolysis Aspiration and Injection	Met acceptance criteria
Luer Connection	Met acceptance criteria
Gauging	Met acceptance criteria
Liquid and Air Leakage	Met acceptance criteria
Separation Force	Met acceptance criteria
Stress Cracking	Met acceptance criteria
Collar Retention	Met acceptance criteria
Joint Qualification	Met acceptance criteria
Particulate Contamination	Met acceptance criteria
Biocompatibility
ISO 10993-4 (Interactions with blood)	Met acceptance criteria (through component and finished product testing)
ISO 10993-5 (In vitro cytotoxicity)	Met acceptance criteria (through component and finished product testing)
ISO 10993-10 (Irritation & delayed hypersensitivity)	Met acceptance criteria (through component and finished product testing)
ISO 10993-11 (Systemic toxicity)	Met acceptance criteria (through component and finished product testing)
ISO 10993-17 (Leachable substances)	Met acceptance criteria (through component and finished product testing)
ISO 10993-18 (Chemical characterization)	Met acceptance criteria (through component and finished product testing)

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. The data provenance is B. Braun's internal testing facilities (implicit, as they performed the tests for their device). These are retrospective tests performed on manufactured devices for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert assessment of a test set for ground truth. The "ground truth" here is compliance with established performance standards and biocompatibility requirements.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

5. 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

Not applicable. This device is not an AI algorithm, and no MRMC study was performed or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by compliance with recognized international ISO standards for medical devices and performance criteria derived from these standards. For biocompatibility, the ground truth is established by meeting the requirements of the ISO 10993 series.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI or machine learning device requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2016

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

Re: K153293

Trade/Device Name: Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 8, 2016 Received: March 9, 2016

Dear Ms. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) Not yet known K153293

Device Name Extension Sets

Indications for Use (Describe)

B. Braun Extension Sets may be used for direction, intermittent infusion, continuous infusion or aspiration of fluids. medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braum Extension Sets may patient population.

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

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)

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510(k) SUMMARY

DATE:	March 8, 2016
SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500Contact: Kimberly Smith, Regulatory Affairs SpecialistPhone: (610) 596-2326Fax: (610) 266-4962E-mail: kim.smith@bbraun.com
DEVICE NAME:	Extension Sets
COMMON OR USUAL NAME:	IV Administration Set
CLASSIFICATION:	Class II, Product Code FPA, 21 CFR §880.5440,Intravascular administration set
PREDICATE DEVICES:	K083472 Medegen, IncorporatedK140831 CareFusion (formerly Medegen, Incorporated)Class II, Product Code FPA, 21 CFR §880.5440

DESCRIPTION:

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Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second.

B. Braun Extension Sets may be used for any patient population.

Smallbore Extension Set with stabilization component, Spin-Lock connector, ● removable slide clamp
Standard Bore Extension Set with stabilization component, Spin-Lock connector, ● slide clamp
Extension Set with stabilization component, Spin-Lock connector, slide clamp ●

INTENDED USE:

B. Braun Extension Sets are intended for direct injection, intermittent infusion, continuous infusion or aspiration.

INDICATIONS FOR USE:

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Proposed Device: Predicate Device: Predicate Device: Item Extension Sets CareFusion (formerly CareFusion (formerly Medegen Incorporated) Medegen K083472, Publically Incorporated) Available Information K140831, Publically Available Information 510(k) Number K153293 K083472 K140831 FDA Regulation 21 CFR 880.5440 21 CFR 880.5440 21 CFR 880.5440 Intravascular Administration Number, Intravascular Intravascular Administration Set Administration Set Set Regulation Name, Class, Class II Class II Class II and Product FPA FPA FPA Code Intended Use Intended for direct Intended for direct Intended for direct injection, injection, intermittent injection, intermittent intermittent infusion, infusion, continuous infusion, continuous continuous infusion or infusion or aspiration. infusion or aspiration. aspiration. Indications B. Braun Extension Sets The Medegen Pressure Pressure Rated: The may be used for direct Rated Extension Sets are MaxZero multi fuse iniection, intermittent intended for use in today's extension set with needleless infusion, continuous growing professional connector is for single use infusion or aspiration of healthcare environment, only. The extension set may fluids, medications, including healthcare be used for direct injection. blood and blood facilities, home care and intermittent infusion, products. Select sets medical transport that continuous infusion or may be used with power utilize infusion systems for aspiration. This set may be injector procedures to a the delivery of fluids. used with power injector procedures to a maximum maximum pressure of medications, blood and pressure of 325 psi at a flow 400 psi at a maximum blood products. The flow rate of 15 mL per Medegen Pressure Rated rate of 10mL per second. second. B. Braun's Extension Sets allow the Non Pressure Rated: The optional stabilization user to add medication into MaxZero multi fuse extension set with needleless component on an the primary line without extension set is intended the use of a needle. The connector is for single use to provide stability to Medegen Pressure only. The extension set may Extension Sets may also be the patient connector, be used for direct injection, which is attached to an used with low-pressure intermittent infusion, intravascular catheter. power injectors rated up to continuous infusion or B. Braun Extension Sets 325 psi. aspiration. may be used for any patient population. Description B. Braun Extension Sets Extension Sets are intended Extension Sets are intended are single use. for single patient use, for for single patient use, disposable, add-on infusion systems for the including pediatrics and devices used for direct delivery of fluids. immuno-compromised injection, intermittent medications, blood and patients, for direct injection, infusion, continuous blood products. The intermittent infusion infusion or aspiration of Medegen Pressure Rated continuous infusion or fluids, medications, Extension Sets allow the aspiration of drugs, blood blood and blood user to add medication into and fluids. Pressure rated sets products. Select B. the primary line without the may be used with power Braun Extension Sets use of a needle. injector procedures to a may be used with power The Medegen Pressure maximum pressure of 325 psi

SUBSTANTIAL EQUIVALENCE:

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	injector procedures to amaximum pressure of400 psi and at amaximum flow rate of15mL per second. B.Braun Extension Setsmay be comprised ofvarious genericcomponents that arebroadly used in clinicalpractice such asstopcocks, clamps,injection sites,connectors, manifolds,filters and needlelessconnectors. B. BraunExtension Sets alsocontain an optionalstabilization device.	Extension Sets may also beused with low-pressurepower injectors rated up to325 psi. Configurations areavailable with needlelessconnectors, split septumports, filters, stopcocks,manifolds and/or T-connectors.	at a flow rate of 10mL persecond. Configurations areavailable with needlelessconnectors, split septumports, filters, stopcocks,manifolds and/or T-connectors.
DeviceComponents	Tubing, Luer, SlideClamp, StabilizationComponent, Spin-LockConnector (also knownas patient connector,male luer adapter)	Tubing, Luer, CheckValve, Slide Clamp,Needleless Connector,Male Spin lock connector	Tubing, Luer, Check Valve,Slide Clamp, NeedlelessConnector, Male Spin lockconnector

Technological Characteristics

The B. Braun Extension sets have the following similarities to the predicate devices:

· Same Intended Use
· Indications for Use
· Extension Set design
· Principle of operation
· May be used with power injection procedures

The following differences exist between the subject and predicate devices:

· the subject device includes a stabilization component
· the subject device may be used may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second
· the subject device may be used with a needleless connector whereas the predicate device has a needleless connector incorporated on the set

These differences in the indications for use statement for the subject device and predicate devices do not alter the intended use of the subject device. Both the subject and predicate devices have the same intended use for direct injection, intermittent infusion, continuous infusion or aspiration.

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Non-Clinical Data - Performance Testing

B. Braun performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate devices. All test results met their acceptance criteria and support that B. Braun Extension sets are appropriately designed for their intended use.

The following performance standards were utilized in evaluating the functionality of the Extension Sets:

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

ISO 594-2:1998, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"

ISO 1135-4:2012: "Transfusion equipment for medical use - Part 4: Transfusion sets for single use"

ISO 8536-4:2010, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"

ISO 8536-8:2015, "Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus"

ISO 11135-1:2007, "Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"

Successful functional performance testing was completed with the proposed Extension Sets with a stabilization component to demonstrate that the sets perform as intended. The following performance data were provided in support of the substantial equivalence determination:

Stabilization Component Angular/Axial Stabilization/Performance ●
Visual ●
Catheter Angle ●
Flow Rate No Catheter ●
Flow Rate - With Catheter
Tape Removal
Occlusion
Negative Pressure
Positive Pressure ●
Clamp and Positive Pressure
Tensile Strength ●
Power Injection ●
Mechanical Hemolysis Aspiration and Injection ●
Luer Connection

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Gauging ●
Liquid and Air Leakage ●
Separation Force
Stress Cracking ●
Collar Retention ●
Joint Qualification
Particulate Contamination ●

Biocompatibility

The materials of construction of the subject device were evaluated according to the provisions of ISO 10993-1:2009, "Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process". B. Braun applied component material testing as well as finished product testing to demonstrate the biocompatibility of the final device. B. Braun performed testing according to the following parts of the ISO 10993 standard.

ISO 10993-4:2002, "Biological evaluation of medical devices - part 4: Selection of tests for interactions with blood"

ISO 10993-5:2009, "Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity"

ISO 10993-10:2010, "Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity"

ISO 10993-11:2006. "Biological evaluation of medical devices - Part 11: Test for systemic toxicity"

ISO 10993-17:2002, "Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances"

ISO 10993-18:2005,"Biological evaluation of medical devices - Part 18: Chemical characterization of materials"

CONCLUSION:

Results of functional performance and biocompatibility testing conducted with the proposed device along with the same intended use, similarities in indications for use and technological characteristics demonstrate that the B. Braun Extension Sets are substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.