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

Device Description

The BD FlowSmart™MiniMed™ Pro-Set™ infusion 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.

AI/ML Overview

This document, a 510(k) summary for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set, describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria and device performance in the format of AI/ML device studies. Therefore, many of the requested fields cannot be directly answered.

Here's an analysis based on the provided text, highlighting what is available and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table for specific performance metrics like accuracy, sensitivity, or specificity, as would be common for AI/ML device evaluations. Instead, it states that "Results of these tests were found to be acceptable and demonstrated that the subject infusion set met requirements for its intended use and is substantially equivalent to its predicate device."

The testing included:

Device material biocompatibility: ISO 10993 (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 11135-1 (Sterilization of healthcare products)

Since this is a physical medical device (infusion set) and not an AI/ML diagnostic or predictive tool, the "performance" here refers to meeting standards for safety, biocompatibility, and intended mechanical/fluidic function. The document does not provide specific numerical performance results against these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is non-clinical (biocompatibility and functional performance), likely involving laboratory testing of materials and device prototypes, rather than testing on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a physical infusion set, and the "ground truth" concept as typically applied to AI/ML for diagnostic tasks does not apply here. The testing involves adherence to established international standards for medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of non-clinical testing described.

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

This information is not applicable. The device is an infusion set, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. The device is a physical infusion set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of AI/ML device evaluation. For this infusion set, "ground truth" would be defined by the specifications and performance requirements outlined in the referenced ISO standards (e.g., material compatibility as per ISO 10993, fluidic integrity as per ISO 10555-1). Compliance with these standards serves as the benchmark.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" as this is not an AI/ML device.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set. It declares substantial equivalence to a predicate device (K150059 - BD FlowSmart™ Set) based on non-clinical testing. This testing focused on:

Device material biocompatibility: According to ISO 10993
Device functional performance: According to ISO 10555-1, ISO ID26 (related to infusion pumps), and ISO 11135-1 (sterilization).

The conclusion states that the analysis and testing demonstrate the subject device is substantially equivalent to its predicate device. This type of submission relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device, especially when technological changes (like different adhesive material or tubing configuration) are not significant enough to alter fundamental principles or intended use.

Summary

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

December 11, 2015

Becton, Dickinson and Company Matthew Trachtenberg Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07666

Re: K153257

Trade/Device Name: BD FlowSmart™ Set/MiniMed™ Pro-Set™ Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, FPK Dated: November 9, 2015 Received: November 10, 2015

Dear Mr. Matthew Trachtenberg:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Erin |- Keith -S

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

510(k) Number (if known) K153257

Device Name BD FlowSmart™ Set/MiniMedTM Pro-SetTM

Indications for Use (Describe)

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

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)

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510(k) Summary

Submitted By:	Matthew S. TrachtenbergStaff Regulatory Affairs Specialist, BD Medical1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 6337Fax: 201 847 5307
Date Prepared:	December 4, 2015
Device Name:	Trade Name:	BD FlowSmart™ Set/MiniMed™ Pro-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: K150059 - BD FlowSmart™ Set

Device Description:

Intended Use:

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

Comparison with Predicate Devices:

The BD FlowSmart™ Set/MiniMed™ Pro-Set™ infusion set has the same intended use as its predicate device for the subcutaneous delivery of fluids and medication, including insulin, from an external infusion pump. Additionally, the fundamental scientific technology of the proposed device is unchanged from the legally marketed device. The 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 identical features to its predicate device. The modifications made include the incorporation of an alternate adhesive material and a minor modification to the tubing configuration. Nonclinical testing supports 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 predicate.

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Feature	Subject Device:BD FlowSmart™ Set/MiniMed™ Pro-Set™	Predicate Device:BD FlowSmart™ Set
510(k) Number	K153257	K150059
Manufacturer	BD	BD
Intended Use	For the subcutaneous infusion of medication, including insulin, from an external infusion pump.	For the subcutaneous infusion of medication, including insulin, from an external infusion pump.
System Components	Infusion set + tubing	Infusion set + tubing
Needle Insertion Method	Manual or Automatic	Manual or Automatic
Insertion Needle Gauge	30G	30G
Angle of Insertion	Straight 90 degrees	Straight 90 degrees
Plastic Cannula Length	6mm	6mm
Plastic Cannula Gauge	28G	28G
Tubing Connection Type	Paradigm® and Luer Lock	Paradigm® and Luer Lock
Tubing Length (cm)	61 and 107	61 and 107
Connection Positions	Multiple	Multiple
Replacement Frequency	Disposable, replaced every 72 hours	Disposable, replaced every 72 hours
Provided Sterile	YES	YES

Testing:

BD has performed non-clinical testing to demonstrate substantial equivalence. This testing included assessments related to device material biocompatibility (ISO 109993: Biological evaluation of medical devices), and 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 11135-1: Sterilization of healthcare products). Results of these tests were found to be acceptable and demonstrated that the subject infusion set met requirements for its intended use and is substantially equivalent to its predicate device.

Conclusion:

The analysis and testing performed demonstrate the BD FlowSmart™ Set/MiniMed™ Pro-SetTM device is substantially equivalent to its 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.