The BD FlowSmart™ set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an external infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

AI/ML Overview

This document is a 510(k) summary for the BD FlowSmart™ Set, an infusion set. It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted.

The document primarily focuses on demonstrating "substantial equivalence" of the BD FlowSmart™ Set to existing predicate devices (Medtronic's MiniMed Quickset and Ypsomed's Orbit Infusion Set). This process typically involves comparing the new device's technological characteristics, intended use, and performance data (often non-clinical testing) to those already cleared devices, rather than establishing acceptance criteria for a novel AI algorithm.

Here's what can be extracted, albeit not directly addressing an AI device's acceptance criteria:

Acceptance Criteria and Reported Device Performance (General, not AI-specific): The document states that "Results of these tests were found to be acceptable and demonstrated that the BD FlowSmart™ set met requirements for its intended use and is as safe and as effective as its predicate devices." However, it does not provide a table of specific quantitative acceptance criteria or detailed performance metrics. The testing performed includes broad categories:
- Biocompatibility: ISO 109993: Biological evaluation of medical devices
- Functional Performance: ISO 10555-1: Sterile single use intravascular catheters, ISO ID26: Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps, ISO 1135-1: Sterilization of healthcare products
- Animal Testing: United States Department of Agriculture (USDA) standards, US Animal Welfare Act
- Human Factor Evaluations: IEC 62366:2007
The "reported device performance" is a general statement of meeting requirements and being "as safe and as effective," without specific numerical values.
Sample Size and Data Provenance for Test Set: This information is not provided for individual tests. The document refers to "non-clinical testing," "animal testing," and "human factor evaluations," but does not specify the sample sizes within these tests or the data provenance (e.g., country of origin, retrospective/prospective). It's likely that for a device like an infusion set, "test set" wouldn't mean a clinical data set in the same way it would for an AI algorithm.
Number of Experts and Qualifications for Ground Truth: Not applicable. The "ground truth" for an infusion set would be adherence to scientific and engineering standards (e.g., material properties, flow rates, sterility) rather than expert interpretation of a clinical dataset.
Adjudication Method: Not applicable. This concept is typically relevant to clinical studies involving human interpretation or disagreements, which is not the primary focus here.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses the impact of AI on human reader performance, which is not relevant for an infusion set.
Standalone (Algorithm Only) Performance: Not applicable. The device is a physical infusion set, not an AI algorithm.
Type of Ground Truth Used: The "ground truth" for this device would be established by validated scientific and engineering methods, regulatory standards (like ISO standards), and animal models for biocompatibility and function. It's not based on expert consensus, pathology, or outcomes data in the context of an AI system.
Sample Size for Training Set: Not applicable. The device is not an AI algorithm that requires a training set.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the submission for a medical device (infusion set) under the 510(k) pathway, focusing on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not involve an AI/ML component, and therefore, the requested information pertinent to AI device evaluation criteria is not present.

Summary

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

April 28, 2015

Becton, Dickinson Company Ms. Avital Merl Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, NJ 07666

Re: K150059

Trade/Device Name: BD FlowSmart™ Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: March 24, 2015 Received: March 25, 2015

Dear Ms. Merl:

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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Page 2 - Ms. Avital Merl

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 -S

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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Indications for Use Statement

K150059 510(k) Number (if known):

Device Name: BD FlowSmart™ Set

Indications for Use:

The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

Submitted By:	Avital MerlRegulatory Affairs Manager, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 4739Fax: 201 847 5307
Date Prepared:	April 28, 2015
Device Name:	Trade Name:	BD FlowSmart™ Set
	Common Name:	Subcutaneous Infusion Set
	Classification:	Class II device; 21 CFR 880.5440,Intravascular Administration set)
	Product Code:	FPA (intravascular administration set)FPK (tubing, intravascular administration set)

Legally marketed predicate devices to which substantial equivalence is being claimed: K011071- Medtronic's MiniMed Quickset K130468- Ypsomed's Orbit Infusion Set

Device Description:

The BD FlowSmart™ set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

Intended Use:

The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

Comparison with Predicate Devices:

The BD FlowSmart™ set has a similar intended use as its predicate devices for the subcutaneous delivery of fluids and medication, including insulin, from an external infusion pump. It also shares several similarities in technology compared to its predicate devices. These technological characteristics include an adhesive base, catheter, and tubing connection components. The needle insertion method, 90 degree angle of insertion, and tubing connection types are also similar features to its predicate devices. The technological differences include feature of a single 6mm cannula length, a 30G insertion needle and 28G plastic cannula. Pre-clinical testing and published literature support substantial equivalence of the subject device despite these technological differences. The table below provides a side by side comparison of the subject device compared to its predicates.

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Feature	Subject Device: BDFlowSmart™ Set	Primary Predicate Device:MinMed Quick-Set	Secondary PredicateDevice: Orbit Infusion Set
510(k) Number	NA	K011071	K130468
Manufacturer	BD	Medtronic	Ypsomed
Intended Use	For the subcutaneousinfusion of medication,including insulin, froman external infusionpump.	For the subcutaneous infusionof medication, includinginsulin, from an externalinfusion pump.	For the subcutaneousdelivery of fluids andmedication, such as insulin,from an external infusionpump.
SystemComponents	Infusion set + tubing	Infusion set+ tubing	Infusion set + tubing
Needle insertionmethod	Manual or Automatic	Manual or Automatic	Manual
Insertion NeedleGauge	30G	27G	28G
Angle of Insertion	Straight 90 degrees	Straight 90 degrees	Straight 90 degrees
Plastic CannulaLength	6mm	6mm/9mm	6mm/9mm
Plastic CannulaGauge	28G	25G	26G
TubingConnection Type	Paradigm® and LuerLock	Paradigm®	Luer Lock
Tubing Length(cm)	61 and 107	45, 58, 81, and 109	45, 60, 75, and 105
ConnectionPositions	Multiple	Fixed	Multiple
Replacementfrequency	Disposable, replacedevery 72 hours	Disposable, replaced every 72hours	Disposable, replaced every 72hours
Provided Sterile	YES	YES	YES

Testing:

BD has performed non-clinical testing to demonstrate substantial equivalence. This testing includes device material biocompatibility (ISO 109993: Biological evaluation of medical devices), device functional performance (ISO 10555-1: Sterile single use intravascular catheters, ISO ID26: Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps, ISO 1135-1: Sterilization of healthcare products), animal testing (United States Department of Agriculture (USDA) standards, US Animal Welfare Act), and human factor evaluations (IEC 62366:2007). Results of these tests were found to be acceptable and demonstrated that the BD FlowSmart™ set met requirements for its intended use and is as safe and as effective as its predicate devices.

Conclusion:

The analysis and testing performed demonstrate the BD FlowSmart™ set is substantially equivalent to its predicate devices.

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.