BD FlowSmart Set

K150059 · Becton, Dickinson Company · FPA · Apr 28, 2015 · General Hospital

Device Facts

• Record ID: K150059
• Device Name: BD FlowSmart Set
• Applicant: Becton, Dickinson Company
• Product Code: FPA · General Hospital
• Decision Date: Apr 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

BD FlowSmart™ is a single-use, sterile subcutaneous infusion set; interfaces with external infusion pumps to deliver medication (e.g., insulin). Device consists of an adhesive patch, a flexible 28G perforated plastic cannula, and detachable tubing. Operates via 90-degree manual or automatic insertion into subcutaneous tissue. Used in home or clinical settings by patients or caregivers. Tubing connects to pump reservoir; adhesive base secures cannula to skin. Perforated cannula design facilitates medication delivery. Healthcare providers/patients use the device to manage chronic conditions requiring continuous subcutaneous infusion; benefits include reliable medication delivery and pump compatibility via Paradigm® or Luer Lock connections.

Clinical Evidence

No clinical trials were conducted. Evidence consists of non-clinical bench testing, including biocompatibility (ISO 10993), functional performance (ISO 10555-1, ISO 1135-1, ISO ID26), animal testing per USDA standards/Animal Welfare Act, and human factor evaluations (IEC 62366:2007). Results demonstrated the device meets requirements for its intended use.

Technological Characteristics

Single-use sterile subcutaneous infusion set. Features: 30G insertion needle, 28G plastic cannula (6mm length), adhesive base, and detachable tubing. Connectivity: Paradigm® and Luer Lock compatible. Materials evaluated per ISO 10993. Sterilization: Sterile. Form factor: Perpendicular (90-degree) insertion. No software or electronic components.

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

• Medtronic's MiniMed Quickset (K011071)
• Ypsomed's Orbit Infusion Set (K130468)

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 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 [phone] or [phone] 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 [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 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 Merl<br>Regulatory Affairs Manager, BD Medical<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: [phone]<br>Fax: [phone] | | |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--|
| 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,<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: 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: BD<br>FlowSmart™ Set | Primary Predicate Device:<br>MinMed Quick-Set | Secondary Predicate<br>Device: Orbit Infusion Set |
|----------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | NA | K011071 | K130468 |
| Manufacturer | BD | Medtronic | Ypsomed |
| Intended Use | For the subcutaneous<br>infusion of medication,<br>including insulin, from<br>an external infusion<br>pump. | For the subcutaneous infusion<br>of medication, including<br>insulin, from an external<br>infusion pump. | For the subcutaneous<br>delivery of fluids and<br>medication, such as insulin,<br>from an external infusion<br>pump. |
| System<br>Components | Infusion set + tubing | Infusion set+ tubing | Infusion set + tubing |
| Needle insertion<br>method | Manual or Automatic | Manual or Automatic | Manual |
| Insertion Needle<br>Gauge | 30G | 27G | 28G |
| Angle of Insertion | Straight 90 degrees | Straight 90 degrees | Straight 90 degrees |
| Plastic Cannula<br>Length | 6mm | 6mm/9mm | 6mm/9mm |
| Plastic Cannula<br>Gauge | 28G | 25G | 26G |
| Tubing<br>Connection Type | Paradigm® and Luer<br>Lock | Paradigm® | Luer Lock |
| Tubing Length<br>(cm) | 61 and 107 | 45, 58, 81, and 109 | 45, 60, 75, and 105 |
| Connection<br>Positions | Multiple | Fixed | Multiple |
| Replacement<br>frequency | Disposable, replaced<br>every 72 hours | Disposable, replaced every 72<br>hours | Disposable, replaced every 72<br>hours |
| 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.