BD FlowSmart Set, MiniMed Pro-Set

K160651 · Becton, Dickinson and Company · FPA · Apr 7, 2016 · General Hospital

Device Facts

• Record ID: K160651
• Device Name: BD FlowSmart Set, MiniMed Pro-Set
• Applicant: Becton, Dickinson and Company
• Product Code: FPA · General Hospital
• Decision Date: Apr 7, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Subcutaneous infusion set interfaces with external infusion pumps to deliver medication, including insulin. Device consists of flexible perforated catheter, adhesive patch, and detachable tubing. Operates via manual or automatic needle insertion at 90-degree angle. Single-use, sterile device; replaced every 72 hours. Used by patients to facilitate continuous medication delivery. Adhesive base secures catheter to skin; tubing connects to pump reservoir. Benefits include reliable subcutaneous access for pump-based therapy.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1, -5, -18) and functional performance (ISO 10555-1, ISO ID26, ISO 11135-1).

Technological Characteristics

Adhesive base, 28G plastic cannula (6mm), 30G insertion needle. Tubing connection types: Paradigm® and Luer Lock. Sterile, single-use. Biocompatibility per ISO 10993; functional performance per ISO 10555-1 and ISO 11135-1.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, from an external infusion pump in patients requiring such therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BD FlowSmart™ Set/MiniMedTM Pro-Set™ (K153257)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Submitted By: | Matthew S. Trachtenberg<br>Staff Regulatory Affairs Specialist, BD Medical<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: [phone]<br>Fax: [phone] | |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| 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,<br>Intravascular Administration set |
| | Product Code: | FPA (intravascular administration set)<br>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:

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.

### 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:<br>BD FlowSmart™ Set/<br>MiniMed™ Pro-Set™ | Predicate Device:<br>BD FlowSmart™ Set/<br>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.