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

Here's a breakdown of the acceptance criteria and study information for the BD FlowSmart™ Set/MiniMed™ Pro-Set™ based on the provided document.

It's important to note that this document is a 510(k) summary for a medical device seeking substantial equivalence, not a standalone clinical study report for an AI algorithm. Therefore, the information will be geared towards demonstrating this equivalence for a physical medical device, not AI performance. Many of the requested AI-specific details (like MRMC studies, training set ground truth, number of experts for ground truth establishment) are not applicable or provided in this type of submission.

Acceptance Criteria and Reported Device Performance

The document doesn't present explicit quantitative acceptance criteria for specific device performance metrics in a table. Instead, it relies on demonstrating that the "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." This implies the acceptance criteria are implicitly defined by the standards and predicate device performance.

The "reported device performance" is a general statement of meeting the requirements and demonstrating substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Parameter / Aspect	Acceptance Criteria (Inferred from standards/predicate)	Reported Device Performance
Biocompatibility	Complies with ISO 10993 Parts 1, 5, and 18 for biological evaluation of medical devices. (Non-toxic, non-irritating, etc.)	Met requirements (tested according to ISO 10993 standards).
Functional Performance	Complies with ISO 10555-1 (Sterile single-use intravascular catheters) and ISO ID26 (Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps). (e.g., flow rate, integrity, connection security)	Met requirements (tested according to ISO 10555-1 and ISO ID26).
Sterilization Efficacy	Complies with ISO 11135-1 (Sterilization of healthcare products). (Ensures sterility)	Met requirements (tested according to ISO 11135-1).
Substantial Equivalence	Performance and safety are equivalent to the legally marketed predicate device (K153257).	Demonstrated substantial equivalence through testing and comparison.

Study Details

Given this is a 510(k) for a physical medical device, the concept of "test set" and "training set" as typically used for AI algorithms does not directly apply in the same way. The "testing" refers to non-clinical bench testing and adherence to standards.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the context of a dataset. The testing was performed on representative samples of the device components and finished product to demonstrate compliance with the referenced ISO standards.
- Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (BD) or contracted testing facilities. There is no mention of country of origin for data in the sense of patient data, as this is bench testing. The studies are prospective in the sense that the testing was performed on new device designs to evaluate their performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device's non-clinical testing, "ground truth" is not established by human experts in the way it is for diagnostic image interpretation. The "ground truth" or reference standard for biocompatibility, functional performance, and sterilization is the established parameters and thresholds defined by the international ISO standards (e.g., specific chemical leaching limits, flow rate tolerances, sterility assurance levels). These standards are developed by expert committees, but not in the context of individual case "ground truth" adjudication.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, often involving multiple human readers interpreting medical images or clinical data. This document describes non-clinical laboratory testing of a physical device where results are measured against defined engineering specifications and international standards, not against human interpretations requiring adjudication.
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. This is a physical medical device (an infusion set), not an AI algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standards-Based Specifications and Prior Validated Methods. The "ground truth" for non-clinical testing is based on:
  - Defined specifications: Engineering and design requirements for the device.
  - Compliance with international standards: ISO 10993 (biocompatibility), ISO 10555-1 and ISO ID26 (functional performance), ISO 11135-1 (sterilization).
  - Comparison to predicate device: The predicate device is considered safe and effective, and the new device must perform equivalently.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set in the AI sense, this question is not relevant.

Summary of Device and Approval Context:

This 510(k) submission is for an intravascular administration set (BD FlowSmart™ Set/MiniMed™ Pro-Set™). The device is substantially equivalent to a previously cleared predicate device (K153257). The "acceptance criteria" and "studies" are focused on demonstrating that the new device, despite a minor change in adhesive material, meets all relevant safety and performance standards (biocompatibility, functional performance, sterilization) and performs identically to its predicate. The detailed AI-specific questions are not relevant for this type of medical device submission.

Summary

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

April 7, 2016

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

Re: K160651

Trade/Device Name: BD FlowSmart™ Set/MiniMedTM Pro-Set™ Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: March 7, 2016 Received: March 9, 2016

Dear Mr. 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.

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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 devicerelated 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 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,

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

510(k) Number (if known)

K160651

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:	April 7, 2016
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: K153257 - BD FlowSmart™ Set/MiniMedTM Pro-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. Non-clinical 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/MiniMed™ Pro-Set™
510(k) Number	TBD	K153257
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:

A risk assessment was performed and, based on the risks, BD has performed non-clinical testing to demonstrate substantial equivalence. This testing included assessments related to device material biocompatibility (ISO 10993 Parts 1, 5, and 18: 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-Set™ 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.