Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical infusion set with no mention of AI or ML capabilities. The modifications are purely mechanical and related to the inserter component and needle safety.

Therapeutic

No
The device is an infusion set, which is used to deliver medication, but it does not treat or cure a disease itself. It is a delivery mechanism for a therapeutic agent.

Diagnostic

No

The device is an infusion set used to deliver medication administered by an external pump, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical medical device (infusion set with cannula, needle, tubing, and inserter) and details hardware modifications and performance testing related to these physical components. There is no mention of software as a component of this device.

IVD (In Vitro Diagnostic)

Based on the provided text, the MiniMed™ Mio™ Advance infusion set is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is "for subcutaneous infusion of medication administered by an external pump." This describes a device used to deliver medication directly into the body, not to perform tests on samples taken from the body.
Device Description: The description details a sterile, single-use subcutaneous infusion set with a cannula and insertion device. This aligns with a device for drug delivery, not diagnostic testing.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases

The device is clearly intended for the delivery of medication, which falls under the category of therapeutic devices, not diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Standard recommended sites for subcutaneous infusion of medication i.e. subcutaneous sites are selected based on the presence of adequate adipose tissue. The choice of insertion site depends on treatment and patient specific factors as recommended by HCP. Preference is given to sites that do not affect the patient's mobility, the insertion site has to be free of skin irritation and inflammation such as redness, scar tissue and bleeding. Site selection: the abdomen, in a roughly semicircular area around and below the umbilicus is preferred as an application site. Other insertion sites include the upper leg, upper buttocks, hips, upper arms and lower back and occasionally the chest when others sites have edema. The area to place the infusion set is particularly important in patients with many years use, since the overuse of skin sites has an influence on absorption variability.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

As part of demonstrating substantial equivalence of Min™ Advance infusion set, Unomedical completed a number of non-clinical performance tests. The MiniMed™ Mio™ Advance infusion set meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design output meets the design inputs and specifications for the device. The tube set is identical to that used in the predicate, additional testing was not performed to validate these components.

The MiniMed™ Mio™ Advance infusion set has met the requirements for testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Testing:

Functional tests:
- Tensile tests of introducer needle from needle hub, soft cannula from Fluid Part assembly, Fluid Part assembly from base assembly, connector needle from cannula housing,
- Serter functionality tests
Packaging tests
- Dynamic and Visual Peel Test
- Print on Packaging and labelling
Transportation Tests in accordance with ASTM D4169-16
Dimensional Tests
- Distance soft cannula to set
- Distance of introducer needle bevel to soft cannula
- Length of tubes
Cytotoxicity Testing in accordance with ISO 10993-5
Sensitization Testing in accordance with ISO 10993-10
Irritation Sensitivity Testing in accordance with ISO 10993-10
Acute Systemic Toxicity testing in accordance with ISO 10993-11
Pyrogen/Endotoxin Testing in accordance with ISO 11737-1
Shelf life Testing in accordance with ISO 11607
Sterilization Testing in accordance with ISO 11135:2014
Usability Testing In accordance with IEC 62366-1:2015

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K032854

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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.

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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 (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

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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: (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

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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
Regulation | Sponsor |
|----------------------------------------------------------------------------------------------------------------|------------|--------------|------------------------------|------------|
| Unomedical Inset™
Subcutaneous Infusion Set
(formerly known as the
Unomedical Monica Infusion
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
Infusion Sets (formerly known as The
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
set is indicated for subcutaneous
infusion of medication administered
by an external pump.	The Unomedical Inset™ Subcutaneous
Infusion Sets are indicated for the
subcutaneous infusion of medication
from an external pump. .	Same
Mechanism of Action	The MiniMed™ Mio™ Advance infusion
set is an infusion administration set,
connecting to a reservoir/infusion
pump and inserted in the
subcutaneous tissue of a user.	The Unomedical Inset™ Subcutaneous
Infusion Set is an infusion
administration set, connecting to a
reservoir/infusion pump and inserted
in the subcutaneous tissue of a user.	Same
Technology
Overview	Serter:
• Subcutaneous insertion of soft
cannula by introducer needle
situated inside soft cannula at a 90°
insertion angle.	Serter:
• Subcutaneous insertion of soft
cannula by introducer needle
situated inside soft cannula at a 90°
insertion angle.	Serter:
• Same angle of insertion and use
of introducer needle and cannula
Manufacturer	Unomedical		Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)	• Both devices use an insertion
device to insert the soft cannula,
the proposed device has an
insertion mechanism preloaded
and ready for insertion by simply
pressing the activation button
after removing the safeguard.
This technical difference is not
clinically significant as while this
additional safety feature does
have a minor impact upon the
method of operation of the device
it does not introduce any different
questions of safety or
effectiveness.
• insertion of soft cannula: 2 user
steps for insertion: remove
protective cap for base and press
release button

• The Base Set in MiniMed™ Mio™
Advance infusion set is made of two
components, the Fluid Part and the
Base Part | • insertion of soft cannula: 3 manual
user steps for insertion: loading,
inserting and retraction.

• The Base Set used in Unomedical
inset™ is molded as one | • The fluid part of the MiniMed™
Mio™ Advance infusion set
assembly is inserted into the base
assembly (on body). This step is
not required for the Unomedical
inset™ infusion set. This technical
difference is not clinically
significant as the additional
required step for the proposed
device does not significantly
impact the method of operation | |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set) | |
| | • The MiniMed™ Mio™ Advance
infusion set is delivered ready to use
in a pre-loaded insertion device
with automatic needle retraction.
The newly developed mechanism
allows the needle to be hidden from
the user and/or caregiver before
and after insertion. | • The Unomedical Inset™
Subcutaneous Infusion Set does not
have a mechanism for automatic
needle retraction and the needle is
visible to the user. | of the device
• 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 prevent needle
stick injuries. This technical
difference does not introduce any
new questions regarding safety
and efficacy of the device. The
additional safety feature does not
impact the method of operation
of the device. |
| | Administration Set:
The administration set attaches to the
reservoir by means of a "tubing
connector", and subcutaneously in to
the user through an indwelling
catheter made of
polytetrafluoroethylene (PTFE). The
tubing is made of two layers: the inner
layer is polyethylene; the outer is
polyurethane. The indwelling catheter | Administration Set:
The administration set attaches to the
reservoir by means of a "tubing
connector", and subcutaneously in to
the user through an indwelling
catheter made of
polytetrafluoroethylene (PTFE). The
tubing is made of two layers: the inner
layer is polyethylene; the outer is | Same technology used in both
devices for the administration set. |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set) | |
| | is introduced into the subcutaneous
tissue by a removable 27-gauge
introducer needle (cannula) made of
AISI 304 stainless steel. | is introduced into the subcutaneous
tissue by a removable 27-gauge
introducer needle (cannula) made of
AISI 304 stainless steel. | |
| Anatomical Location | Standard recommended sites for
subcutaneous infusion of medication
i.e. subcutaneous sites are selected
based on the presence of adequate
adipose tissue. The choice of insertion
site depends on treatment and patient
specific factors as recommended by
HCP. Preference is given to sites that
do not affect the patient's mobility,
the insertion site has to be free of skin
irritation and inflammation such as
redness, scar tissue and bleeding.
Site selection: the abdomen, in a
roughly semicircular area around and
below the umbilicus is preferred as an
application site. Other insertion sites
include the upper leg, upper buttocks,
hips, upper arms and lower back and | Standard recommended sites for
subcutaneous infusion of medication
i.e. subcutaneous sites are selected
based on the presence of adequate
adipose tissue. The choice of insertion
site depends on treatment and patient
specific factors as recommended by
HCP. Preference is given to sites that
do not affect the patient's mobility,
the insertion site has to be free of skin
irritation and inflammation such as
redness, scar tissue and bleeding.
Site selection: the abdomen, in a
roughly semicircular area around and
below the umbilicus umbilicus is
preferred as an application site.
Other insertion sites include the
upper leg, upper buttocks, hips, upper
arms and | Same |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set) | |
| | occasionally the chest when others
sites have edema.
The area to place the infusion set is
particularly important in patients with
many years use, since the overuse of
skin sites has an influence on
absorption variability. | lower back and occasionally the chest
when others sites have edema.
The area to place the infusion set is
particularly important in patients with
many years use, since the overuse of
skin sites has an influence on
absorption variability. | |
| Material | Materials include:
Polypropylene, polyoxymethylene,
copolyester/polycarbonate alloy,
Eastalloy DA003-8999K polymer
stainless steel,
polytetrafluoroethylene, nonwoven
polyester/polyacrylate,
polyethylene, silicone, Methyl
Methacrylate Acrylonitrile Butadiene
Styrene(MABS), Terlux 2802 HD,
transp., medical grade paper,
polycarbonate | Materials include:
Polypropylene, Stainless Steel,
Polyethylene, Polyurethane, Silicone,
Polycarbonate,
Polytetrafluoroethylene, Methyl
Methacrylate Acrylonitrile Butadiene
Styrene(MABS), Terlux 2802 HD,
transp., Medical Grade Paper, UV-
cured Glue, Color Pigments | No significant difference as the
infusion set which remains on the
patient is the same as the predicate
device and appropriate
biocompatibility testing has been
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
10993-1 | Yes | Yes | Same |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance infusion set | Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set) | |
| Soft Cannula Length | 6 and 9mm | 6 and 9mm | Same |
| Tubing:
ID
OD | 0.385 mm,
1.50 mm | 0.385 mm,
1.50 mm | Same |
| Soft Cannula OD | 0.68mm | 0.68mm | Same |
| Needle Gauge | 27 gauge | 27 gauge | Same |
| Tubing Length | 46 cm, 60 cm and 110 cm | 60 and 110 cm | An additional tubing length of 46 cm
has been made available for the
proposed device |
| Angle of Insertion | 90 degrees, perpendicular | 90 degrees, perpendicular | Same |
| Insertion Method | Pre-loaded insertion device with
automatic needle retraction. The
insertion needle and soft cannula are
hidden from the user before, during
and after insertion of the soft cannula. | Insertion device, which enables the
user not to place the soft cannula in
the tissue manually | Similar in that both devices allow for
the patient to not have to insert the
device in the tissue manually - the
proposed device includes an
additional mechanism so that the
patient does not need to see the
needle or cannula at any stage of the
process and has an automatic needle
retraction to help ensure needle
safety |
| Time of Use | Up to 72 hours | Up to 72 hours | Same |

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The indications for use statement and the intended use of the subject device are identical to the predicate device. The differences between the subject device and the predicate device are:

1. The predicate inserter was comprised of 2 pieces, the subject inserter is now molded as 1 piece
1. A needle safety shield has been added to the inserter.

9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence of Min™ Advance infusion set, Unomedical completed a number of non-clinical performance tests. The MiniMed™ Mio™ Advance infusion set meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design output meets the design inputs and specifications for the device. The tube set is identical to that used in the predicate, additional testing was not performed to validate these components.

The MiniMed™ Mio™ Advance infusion set has met the requirements for testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Testing:

· Functional tests:
- o Tensile tests of introducer needle from needle hub, soft cannula from Fluid Part assembly, Fluid Part assembly from base assembly, connector needle from cannula housing,
- Serter functionality tests o
· Packaging tests
- o Dynamic and Visual Peel Test
- O Print on Packaging and labelling
Transportation Tests in accordance with ASTM D4169-16
· Dimensional Tests
- o Distance soft cannula to set
- Distance of introducer needle bevel to soft cannula O
- o Length of tubes
Cytotoxicity Testing in accordance with ISO 10993-5
· Sensitization Testing in accordance with ISO 10993-10
· Irritation Sensitivity Testing in accordance with ISO 10993-10
Acute Systemic Toxicity testing in accordance with ISO 10993-11
. Pyrogen/Endotoxin Testing in accordance with ISO 11737-1
Shelf life Testing in accordance with ISO 11607
· Sterilization Testing in accordance with ISO 11135:2014
Usability Testing In accordance with IEC 62366-1:2015

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Standards:

ASTM F1980:2011; Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM D4169-16; Standard Practice for Performance Testing of Shipping Containers and Systems

ISO 10993-1:2009; Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residual.

ISO 10993-11:2006; Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

ISO 10993-18:2009; Biological evaluation of medical devices. Chemical characterization of materials

ISO 11135:2014; Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 11607-1:2009; Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2:2006; Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

ISO 11737-1:2006; Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products

ISO 11737-2:2009; Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 14971:2012; Medical devices. Application of risk management to medical devices

ISO 15223-1:2016; Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

EN 556-1:2001 & EN556-1/AC:2006; Sterilization of medical devices - Requirements for medical devices to be designated "sterile" - Part: 1 Requirements for terminally sterilized medical devices (Swedish Standard)

EN ISO 11138-1: 2006; Sterilization of health care products -- Biological indicators -- Part 1: General requirements

EN ISO 11138-2: 2006; Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes

EN 62366-1:2015/AC; Medical devices -- Part 1: Application of usability engineering to medical devices

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10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

The MiniMed™ Mio™ Advance infusion set is substantially equivalent to the predicate device.