(105 days)
No
The summary describes a mechanical infusion set and does not mention any AI/ML components or functionalities.
No.
The device is an accessory (an infusion set) for the infusion of medication and not the medication itself or a device that directly treats a disease.
No
The device is described as an "infusion set" intended for "subcutaneous infusion of medication." Its function is to administer medication from an external pump to the patient. It does not mention any capabilities for diagnosis, detection, or monitoring of a medical condition.
No
The device description clearly states it is a subcutaneous administration set with physical components like a catheter, tubing, and adhesive patch, intended to interface with infusion pumps. It is described as a single-use sterile device, indicating a physical product, not software.
Based on the provided information, the BD FlowSmart™ set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medication... from an external infusion pump." This describes a device used to deliver substances into the body, not to test samples from the body.
- Device Description: The description details a set of tubing and a catheter for connecting an infusion pump to the patient's skin. This aligns with a delivery system, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The BD FlowSmart™ set's function is purely for the delivery of medication.
N/A
Intended Use / Indications for Use
The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.
Product codes
FPA, FPK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
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.
1
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
2
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)
Page __ of ___
3
510(k) Summary
| Submitted By: | Avital Merl
Regulatory Affairs Manager, BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 4739
Fax: 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.
4
| Feature | Subject Device: BD
FlowSmart™ Set | Primary Predicate Device:
MinMed Quick-Set | Secondary Predicate
Device: Orbit Infusion Set |
|----------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | NA | K011071 | K130468 |
| Manufacturer | BD | Medtronic | Ypsomed |
| 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. | For the subcutaneous
delivery of fluids and
medication, such as insulin,
from an external infusion
pump. |
| System
Components | Infusion set + tubing | Infusion set+ tubing | Infusion set + tubing |
| Needle insertion
method | Manual or Automatic | Manual or Automatic | Manual |
| Insertion Needle
Gauge | 30G | 27G | 28G |
| Angle of Insertion | Straight 90 degrees | Straight 90 degrees | Straight 90 degrees |
| Plastic Cannula
Length | 6mm | 6mm/9mm | 6mm/9mm |
| Plastic Cannula
Gauge | 28G | 25G | 26G |
| Tubing
Connection Type | Paradigm® and Luer
Lock | Paradigm® | Luer Lock |
| Tubing Length
(cm) | 61 and 107 | 45, 58, 81, and 109 | 45, 60, 75, and 105 |
| Connection
Positions | Multiple | Fixed | Multiple |
| Replacement
frequency | Disposable, replaced
every 72 hours | Disposable, replaced every 72
hours | Disposable, replaced every 72
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.