MiniMed Mio Advance infusion set

K173879 · Unomedical A/S · FPA · Mar 5, 2018 · General Hospital

Device Facts

• Record ID: K173879
• Device Name: MiniMed Mio Advance infusion set
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Mar 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

Device Story

The MiniMed™ Mio™ Advance infusion set is a sterile, single-use subcutaneous infusion set designed for use with external pumps. It features a 90-degree soft cannula and a pre-loaded insertion device. The device is operated by the patient or caregiver; the user removes a safeguard and presses an activation button to insert the cannula. The insertion needle and soft cannula remain hidden from the user before, during, and after insertion. Following insertion, the needle automatically retracts to prevent needle stick injuries. The device connects to a reservoir via a tubing connector. The infusion set is placed in subcutaneous tissue, typically in the abdomen, upper leg, buttocks, hips, or arms. By automating the insertion and retraction process, the device simplifies the administration of medication and enhances safety for the user.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including functional tests (tensile, serter functionality), packaging/transportation tests (ASTM D4169-16), biocompatibility (ISO 10993 series), and usability testing (IEC 62366-1:2015).

Technological Characteristics

Materials: Polypropylene, polyoxymethylene, copolyester/polycarbonate alloy, Eastalloy DA003-8999K, stainless steel (AISI 304), PTFE, MABS (Terlux 2802 HD), silicone. 90-degree soft cannula (6mm/9mm). Tubing lengths: 46cm, 60cm, 110cm. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10993, ISO 11135, ISO 11607, ISO 14971, IEC 62366-1.

Indications for Use

Indicated for subcutaneous infusion of medication via external 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

• Unomedical Inset™ Subcutaneous Infusion Set (K032854)

Submission Summary (Full Text)

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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.

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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 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 ([e-mail]) or phone [phone] 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

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# 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)

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#### 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: [phone]

Email: [e-mail]

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

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| 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.

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### 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.

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# Table 5A – Comparison of Characteristics

| 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) | |
| 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…