BD FlowSmart Set/MiniMed Pro-Set

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October 18, 2018 Becton, Dickinson and Company Meriam Youssef Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K181718 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: September 9, 2018 Received: September 18, 2018 Dear Meriam Youssef: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarket safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/6 description: The image shows the name "Geeta K. Pamidimukkala -S" in a clear, sans-serif font. The text is stacked vertically, with "Geeta K." on the top line and "Pamidimukkala -S" on the second line. The text is black, and the background is white. for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | | <b>Indications for Use</b> | | Form Approved: OMB No. 0910-0120 | |----------------------------------| | Expiration Date: 06/30/2020 | | See PRA Statement below. | | 510(k) Number (if known) | | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | BD FlowSmart ™ Set/MiniMed™ Pro-Set™ | | Indications for Use (Describe) | The BD FlowSmart™ Set/MiniMed™ Pro-Set™ 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 style="display:inline-block; margin-right: 5px;"> <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> <span><b>X</b></span> </div> </span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="display:inline-block; margin-right: 5px;"> <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> </div> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| ။-9 ခုနှစ်များ {3}------------------------------------------------ # 510(k) Summary | Submitted By: | Meriam Youssef<br>Staff Regulatory Affairs Specialist, BD Medical<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: 201 847 6557<br>Fax: 201 847 5307 | | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Date Prepared: | October 18, 2018 | | | Device Name: | | | | | Trade Name: | BD FlowSmart™ Set/MiniMed™ Pro-Set™ | | | Common Name: | Intravascular adminstration set | | | Classification: | Class II device; 21 CFR 880.5440,<br>(intravascular administration set) | | | Product Code: | FPA, FPK | ## Legally marketed predicate devices to which substantial equivalence is being claimed: K160651: BD FlowSmart™ Set/MiniMedTM Pro-Set™ #### Device Description: The subject infusion set is a single use infusion administration set intended to be used for 48-72 hours. The product is 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 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. The plastic catheter of the device contains a proprietary side-port. It is a single-use sterile device. #### Indications for Use: BD FlowSmart™ Set/MiniMed™ Pro-Set™ is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump. There are no changes to the Indications for Use as a result of the device modifications. ### Comparison with Predicate Devices: The subject device has the same fundamental scientific technology as the predicated device. The purpose of this submission is to introduce design modifications to the catheter length and introducer needle gauge sizes, labeling and material modifications. BD has conducted bench studies confirming that the product performance is substantially equivalent to the predicate device. The table below provides a side by side comparison of the subject device compared to its predicate. {4}------------------------------------------------ | Feature | Subject: BD Infusion Set | Predicate Device: BD<br>Infusion Set | |-------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Pending | K160651 | | Manufacturer | BD | BD | | Intended Use | Unchanged | The BD<br>FlowSmart™/MiniMed™<br>Pro-Set™ infusion set is<br>intended for the<br>subcutaneous infusion of<br>medication,<br>including insulin, from an<br>external infusion pump. | | System components | Unchanged | Infusion set + tubing | | Needle insertion method | Unchanged | Manual or Automatic via<br>Quickserter (K160860) | | Angle of Insertion | Unchanged | Straight 90 degrees | | Insertion Needle Gauge | 29G | 30G | | Catheter Length (mm) | 6.6 | 6.0 | | Cannula Gauge | Unchanged | 28G | | Tubing Connection Type | Unchanged | Paradigm® and Luer Lock | | Tubing Length (in) | Unchanged | 24, 42 | | Connection Positions | Unchanged | Multiple | | Replacement Frequency | Unchanged | Disposable, replaced<br>every 72 hours | | Provided Sterile | Unchanged | YES | ### Testing: The subject device has the same technological characteristics as the predicate devices cleared in K160651. BD has verified the modifications of the subject device through bench performance and biocompatibility studies. Bench performance studies included the following test methods: | Test Method | Acceptance Criteria | Results<br>(Pass/Fail) | |--------------------------------------------------------|------------------------------------------------|------------------------| | Introducer Needle Integrity during<br>Manual Insertion | Equivalent to predicate device | Pass | | Skin Penetration and Drag Force | Equivalent to predicate device | Pass | | Introducer Needle to Needle Hub<br>Strength | Equivalent to predicate device | Pass | | Catheter to Base Attachment Strength | Testing in accordance with ISO<br>10555-1:1995 | Pass | | Tip Radial Strength | Equivalent to predicate device | Pass | The results of the bench studies successfully demonstrated the subject device has met the requirements. Biocompatibility studies were conducted per ISO 10993-1 and included: - Comparative chemical characterization - Cytotoxicity evaluation ● {5}------------------------------------------------ The results of the comparative chemical characterization demonstrated that there are no new compounds or compounds at higher levels in the subject device compared to the predicate device. An insulin compatibility study was performed to demonstrate insulin compatibility. The testing demonstrates the BD FlowSmart™ Set/MiniMed™ Pro-Set™ device meet requirements for its intended use and is substantially equivalent to its predicate device. #### Conclusion: The testing performed demonstrates the BD FlowSmart™ Set/MiniMed™ Pro-Set™ device is substantially equivalent to its predicate device.