MiniMed Mio Advance infusion set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 5, 2018 Unomedical A/S % Deirdre Barrow Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Bldg 1. Suite 300 Austin, Texas 78746 Re: K173879 Trade/Device Name: MiniMed™ Mio™ Advance infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: December 21, 2017 Received: December 21, 2017 Dear Deirdre Barrow: 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}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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. Tina Kiang S 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173879 #### Device Name MiniMed™ Mio™ Advance infusion set Indications for Use (Describe) The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external 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) #### 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." {3}------------------------------------------------ #### 510(k) Summary #### K 173879 #### 1. Submission Sponsor Unomedical a/s Aaholmvej 1-3, Osted DK-4320 Lejre, Denmark Contact: Heidi Bjerre Lovkvist Title: Regulatory Affairs Specialist #### 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Email: project.management@emergogroup.com Contact: Deirdre Barrow Title: Senior Consultant, RA #### 3. Date Prepared December 21, 2017 #### 4. Device Identification Trade/Proprietary Name: MiniMed™ Mio™ Advance infusion set Common/Usual Name: Set, Administration, Intravascular {4}------------------------------------------------ | Classification Name: | Intravascular administration set | |-----------------------|---------------------------------------| | Regulation Number: | 880.5440 | | Product Code: | FPA, Intravascular administration set | | Device Class: | Class II | | Classification Panel: | General Hospital | ### 5. Legally Marketed Predicate Device(s) ### Table 5A: Legally Marketed Predicate | Device Name | 510(k) No. | Product Code | Classification<br>Regulation | Sponsor | |----------------------------------------------------------------------------------------------------------------|------------|--------------|------------------------------|------------| | Unomedical Inset™<br>Subcutaneous Infusion Set<br>(formerly known as the<br>Unomedical Monica Infusion<br>Set) | K032854 | FPA | 880.5440 | Unomedical | ### 6. Indication for Use Statement The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump. ### 7. Device Description The MiniMed™ Mio™ Advance infusion set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a pre-loaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the MiniMed™ Mio™ Advance infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use. The MiniMed™ Mio™ Advance infusion set will include a 27-gauge introducer needle, and will be available in two different soft cannula lengths of 6 and 9mm and three different tubing lengths of 46, 60 and 110cm. The tube set is available in P-Cap assembly or luer lock. The MiniMed™ Mio™ Advance infusion set has been updated from the predicate K032854 Unomedical Inset ''M Subcutaneous Infusion Set by the same manufacturer. The only modifications were made to the inserter component and include a single molded component rather than two pieces, and the addition of a needle safety shield. The connector and tubing of the tubing set remains unchanged. {5}------------------------------------------------ ### 8. Substantial Equivalence Discussion The following table compares the MiniMed™ Mio™ Advance infusion set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The predicate device has been updated to include a needle safety shield, and to be molded as one piece rather than two, no other changes have been made. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The differences in technological characteristics does not raise different questions of safety or effectiveness. {6}------------------------------------------------ # Table 5A – Comparison of Characteristics | Manufacturer | Unomedical | Unomedical | Device Comparison | 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| Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | | | 510(k) Number | Unknown | K032854 | N/A | | Product Code | FPA | FPA | Same | | Regulation Number | 880.5440 | 880.5440 | Same | | Regulation Name | Intravascular Administration Set | Intravascular Administration Set | Same | | Indications for Use | The MiniMed™ Mio™ Advance infusion<br>set is indicated for subcutaneous<br>infusion of medication administered<br>by an external pump. | The Unomedical Inset™ Subcutaneous<br>Infusion Sets are indicated for the<br>subcutaneous infusion of medication<br>from an external pump. . | Same | | Mechanism of Action | The MiniMed™ Mio™ Advance infusion<br>set is an infusion administration set,<br>connecting to a reservoir/infusion<br>pump and inserted in the<br>subcutaneous tissue of a user. | The Unomedical Inset™ Subcutaneous<br>Infusion Set is an infusion<br>administration set, connecting to a<br>reservoir/infusion pump and inserted<br>in the subcutaneous tissue of a user. | Same | | Technology<br>Overview | Serter:<br>• Subcutaneous insertion of soft<br>cannula by introducer needle<br>situated inside soft cannula at a 90°<br>insertion angle. | Serter:<br>• Subcutaneous insertion of soft<br>cannula by introducer needle<br>situated inside soft cannula at a 90°<br>insertion angle. | Serter:<br>• Same angle of insertion and use<br>of introducer needle and cannula | | Manufacturer | Unomedical | | Device Comparison | | Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | • Both devices use an insertion<br>device to insert the soft cannula,<br>the proposed device has an<br>insertion mechanism preloaded<br>and ready for insertion by simply<br>pressing the activation button<br>after removing the safeguard.<br>This technical difference is not<br>clinically significant as while this<br>additional safety feature does<br>have a minor impact upon the<br>method of operation of the device<br>it does not introduce any different<br>questions of safety or<br>effectiveness. | | • insertion of soft cannula: 2 user<br>steps for insertion: remove<br>protective cap for base and press<br>release button<br><br>• The Base Set in MiniMed™ Mio™<br>Advance infusion set is made of two<br>components, the Fluid Part and the<br>Base Part | • insertion of soft cannula: 3 manual<br>user steps for insertion: loading,<br>inserting and retraction.<br><br>• The Base Set used in Unomedical<br>inset™ is molded as one | • The fluid part of the MiniMed™<br>Mio™ Advance infusion set<br>assembly is inserted into the base<br>assembly (on body). This step is<br>not required for the Unomedical<br>inset™ infusion set. This technical<br>difference is not clinically<br>significant as the additional<br>required step for the proposed<br>device does not significantly<br>impact the method of operation | | | Manufacturer | Unomedical | Unomedical | Device Comparison | | Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | | | | • The MiniMed™ Mio™ Advance<br>infusion set is delivered ready to use<br>in a pre-loaded insertion device<br>with automatic needle retraction.<br>The newly developed mechanism<br>allows the needle to be hidden from<br>the user and/or caregiver before<br>and after insertion. | • The Unomedical Inset™<br>Subcutaneous Infusion Set does not<br>have a mechanism for automatic<br>needle retraction and the needle is<br>visible to the user. | of the device<br>• The insertion needle and soft<br>cannula of the MiniMed™ Mio™<br>Advance infusion set are hidden<br>from the user before, during and<br>after insertion of the soft cannula.<br>This feature helps prevent needle<br>stick injuries. This technical<br>difference does not introduce any<br>new questions regarding safety<br>and efficacy of the device. The<br>additional safety feature does not<br>impact the method of operation<br>of the device. | | | Administration Set:<br>The administration set attaches to the<br>reservoir by means of a "tubing<br>connector", and subcutaneously in to<br>the user through an indwelling<br>catheter made of<br>polytetrafluoroethylene (PTFE). The<br>tubing is made of two layers: the inner<br>layer is polyethylene; the outer is<br>polyurethane. The indwelling catheter | Administration Set:<br>The administration set attaches to the<br>reservoir by means of a "tubing<br>connector", and subcutaneously in to<br>the user through an indwelling<br>catheter made of<br>polytetrafluoroethylene (PTFE). The<br>tubing is made of two layers: the inner<br>layer is polyethylene; the outer is | Same technology used in both<br>devices for the administration set. | | Manufacturer | Unomedical | Unomedical | Device Comparison | | Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | | | | is introduced into the subcutaneous<br>tissue by a removable 27-gauge<br>introducer needle (cannula) made of<br>AISI 304 stainless steel. | is introduced into the subcutaneous<br>tissue by a removable 27-gauge<br>introducer needle (cannula) made of<br>AISI 304 stainless steel. | | | Anatomical Location | Standard recommended sites for<br>subcutaneous infusion of medication<br>i.e. subcutaneous sites are selected<br>based on the presence of adequate<br>adipose tissue. The choice of insertion<br>site depends on treatment and patient<br>specific factors as recommended by<br>HCP. Preference is given to sites that<br>do not affect the patient's mobility,<br>the insertion site has to be free of skin<br>irritation and inflammation such as<br>redness, scar tissue and bleeding.<br>Site selection: the abdomen, in a<br>roughly semicircular area around and<br>below the umbilicus is preferred as an<br>application site. Other insertion sites<br>include the upper leg, upper buttocks,<br>hips, upper arms and lower back and | Standard recommended sites for<br>subcutaneous infusion of medication<br>i.e. subcutaneous sites are selected<br>based on the presence of adequate<br>adipose tissue. The choice of insertion<br>site depends on treatment and patient<br>specific factors as recommended by<br>HCP. Preference is given to sites that<br>do not affect the patient's mobility,<br>the insertion site has to be free of skin<br>irritation and inflammation such as<br>redness, scar tissue and bleeding.<br>Site selection: the abdomen, in a<br>roughly semicircular area around and<br>below the umbilicus umbilicus is<br>preferred as an application site.<br>Other insertion sites include the<br>upper leg, upper buttocks, hips, upper<br>arms and | Same | | Manufacturer | Unomedical | Unomedical | Device Comparison | | Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | | | | occasionally the chest when others<br>sites have edema.<br>The area to place the infusion set is<br>particularly important in patients with<br>many years use, since the overuse of<br>skin sites has an influence on<br>absorption variability. | lower back and occasionally the chest<br>when others sites have edema.<br>The area to place the infusion set is<br>particularly important in patients with<br>many years use, since the overuse of<br>skin sites has an influence on<br>absorption variability. | | | Material | Materials include:<br>Polypropylene, polyoxymethylene,<br>copolyester/polycarbonate alloy,<br>Eastalloy DA003-8999K polymer<br>stainless steel,<br>polytetrafluoroethylene, nonwoven<br>polyester/polyacrylate,<br>polyethylene, silicone, Methyl<br>Methacrylate Acrylonitrile Butadiene<br>Styrene(MABS), Terlux 2802 HD,<br>transp., medical grade paper,<br>polycarbonate | Materials include:<br>Polypropylene, Stainless Steel,<br>Polyethylene, Polyurethane, Silicone,<br>Polycarbonate,<br>Polytetrafluoroethylene, Methyl<br>Methacrylate Acrylonitrile Butadiene<br>Styrene(MABS), Terlux 2802 HD,<br>transp., Medical Grade Paper, UV-<br>cured Glue, Color Pigments | No significant difference as the<br>infusion set which remains on the<br>patient is the same as the predicate<br>device and appropriate<br>biocompatibility testing has been<br>conducted on the insertion device. | | Sterile | Yes – EO – SAL 10-6 | Yes – EO – SAL 10-6 | Same | | Single-Use | Yes | Yes | Same | | Shelf Life | 3 years | 3 years | Same | | Complies with ISO<br>10993-1 | Yes | Yes | Same | | Manufacturer | Unomedical | Unomedical | Device Comparison | | Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | | | Soft Cannula Length | 6 and 9mm | 6 and 9mm | Same | | Tubing:<br>ID<br>OD…