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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MiniMed™ Mio™ Advance infusion set. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or provided in this document as it pertains to a clinical trial.

Instead, the document details non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for a clinical study. Instead, it refers to a set of non-clinical performance tests and adherence to various national and international standards. The "Performance" in this context refers to meeting these engineering and safety standards, rather than clinical efficacy metrics.

Test Category	Standards / Requirements Met
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.
Biocompatibility Tests	- 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.- Biocompatibility testing for the insertion device. (The infusion set which remains on the patient is the same as the predicate device, thus existing biocompatibility data is relied upon).
Sterilization & Shelf Life	- Shelf life Testing in accordance with ISO 11607.- Sterilization Testing in accordance with ISO 11135:2014.- ISO 10993-7:2008 (Ethylene Oxide Sterilization Residual).- ISO 11607-1:2009 (Packaging for terminally sterilized medical devices).- ISO 11607-2:2006 (Validation requirements for forming, sealing and assembly processes).- ISO 11737-1:2006 (Determination of a population of microorganisms on products).- ISO 11737-2:2009 (Tests of sterility performed in the definition, validation and maintenance of a sterilization process).- EN 556-1:2001 & EN556-1/AC:2006 (Requirements for medical devices to be designated "sterile").- EN ISO 11138-1: 2006 (Biological indicators - General requirements).- EN ISO 11138-2: 2006 (Biological indicators for ethylene oxide sterilization processes).
Usability Testing	- In accordance with IEC 62366-1:2015.
Other Standards	- ASTM F1980:2011 (Accelerated Aging of Sterile Barrier Systems).- ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1).- ISO 10993-18:2009 (Chemical characterization of materials).- ISO 14971:2012 (Application of risk management to medical devices).- ISO 15223-1:2016 (Symbols for medical device labels).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The submission relies on non-clinical performance data and comparison to a predicate device, not a human clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There was no clinical ground truth established for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set was used requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is an infusion set, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the clinical sense. The "ground truth" for this submission is established through adherence to recognized national and international engineering and safety standards, and documented performance in non-clinical laboratory tests.

8. The sample size for the training set:

Not applicable. There is no AI component or training set described.

9. How the ground truth for the training set was established:

Not applicable. There is no AI component or training set described.

Summary

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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	ClassificationRegulation	Sponsor
Unomedical Inset™Subcutaneous Infusion Set(formerly known as theUnomedical Monica InfusionSet)	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

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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™ SubcutaneousInfusion Sets (formerly known as TheUnomedical 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 infusionset is indicated for subcutaneousinfusion of medication administeredby an external pump.	The Unomedical Inset™ SubcutaneousInfusion Sets are indicated for thesubcutaneous infusion of medicationfrom an external pump. .	Same
Mechanism of Action	The MiniMed™ Mio™ Advance infusionset is an infusion administration set,connecting to a reservoir/infusionpump and inserted in thesubcutaneous tissue of a user.	The Unomedical Inset™ SubcutaneousInfusion Set is an infusionadministration set, connecting to areservoir/infusion pump and insertedin the subcutaneous tissue of a user.	Same
TechnologyOverview	Serter:• Subcutaneous insertion of softcannula by introducer needlesituated inside soft cannula at a 90°insertion angle.	Serter:• Subcutaneous insertion of softcannula by introducer needlesituated inside soft cannula at a 90°insertion angle.	Serter:• Same angle of insertion and useof introducer needle and cannula
Manufacturer	Unomedical		Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set)	• Both devices use an insertiondevice to insert the soft cannula,the proposed device has aninsertion mechanism preloadedand ready for insertion by simplypressing the activation buttonafter removing the safeguard.This technical difference is notclinically significant as while thisadditional safety feature doeshave a minor impact upon themethod of operation of the deviceit does not introduce any differentquestions of safety oreffectiveness.
• insertion of soft cannula: 2 usersteps for insertion: removeprotective cap for base and pressrelease button• The Base Set in MiniMed™ Mio™Advance infusion set is made of twocomponents, the Fluid Part and theBase Part	• insertion of soft cannula: 3 manualuser steps for insertion: loading,inserting and retraction.• The Base Set used in Unomedicalinset™ is molded as one	• The fluid part of the MiniMed™Mio™ Advance infusion setassembly is inserted into the baseassembly (on body). This step isnot required for the Unomedicalinset™ infusion set. This technicaldifference is not clinicallysignificant as the additionalrequired step for the proposeddevice does not significantlyimpact the method of operation
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set)
	• The MiniMed™ Mio™ Advanceinfusion set is delivered ready to usein a pre-loaded insertion devicewith automatic needle retraction.The newly developed mechanismallows the needle to be hidden fromthe user and/or caregiver beforeand after insertion.	• The Unomedical Inset™Subcutaneous Infusion Set does nothave a mechanism for automaticneedle retraction and the needle isvisible to the user.	of the device• The insertion needle and softcannula of the MiniMed™ Mio™Advance infusion set are hiddenfrom the user before, during andafter insertion of the soft cannula.This feature helps prevent needlestick injuries. This technicaldifference does not introduce anynew questions regarding safetyand efficacy of the device. Theadditional safety feature does notimpact the method of operationof the device.
	Administration Set:The administration set attaches to thereservoir by means of a "tubingconnector", and subcutaneously in tothe user through an indwellingcatheter made ofpolytetrafluoroethylene (PTFE). Thetubing is made of two layers: the innerlayer is polyethylene; the outer ispolyurethane. The indwelling catheter	Administration Set:The administration set attaches to thereservoir by means of a "tubingconnector", and subcutaneously in tothe user through an indwellingcatheter made ofpolytetrafluoroethylene (PTFE). Thetubing is made of two layers: the innerlayer is polyethylene; the outer is	Same technology used in bothdevices for the administration set.
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set)
	is introduced into the subcutaneoustissue by a removable 27-gaugeintroducer needle (cannula) made ofAISI 304 stainless steel.	is introduced into the subcutaneoustissue by a removable 27-gaugeintroducer needle (cannula) made ofAISI 304 stainless steel.
Anatomical Location	Standard recommended sites forsubcutaneous infusion of medicationi.e. subcutaneous sites are selectedbased on the presence of adequateadipose tissue. The choice of insertionsite depends on treatment and patientspecific factors as recommended byHCP. Preference is given to sites thatdo not affect the patient's mobility,the insertion site has to be free of skinirritation and inflammation such asredness, scar tissue and bleeding.Site selection: the abdomen, in aroughly semicircular area around andbelow the umbilicus is preferred as anapplication site. Other insertion sitesinclude the upper leg, upper buttocks,hips, upper arms and lower back and	Standard recommended sites forsubcutaneous infusion of medicationi.e. subcutaneous sites are selectedbased on the presence of adequateadipose tissue. The choice of insertionsite depends on treatment and patientspecific factors as recommended byHCP. Preference is given to sites thatdo not affect the patient's mobility,the insertion site has to be free of skinirritation and inflammation such asredness, scar tissue and bleeding.Site selection: the abdomen, in aroughly semicircular area around andbelow the umbilicus umbilicus ispreferred as an application site.Other insertion sites include theupper leg, upper buttocks, hips, upperarms and	Same
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set)
	occasionally the chest when otherssites have edema.The area to place the infusion set isparticularly important in patients withmany years use, since the overuse ofskin sites has an influence onabsorption variability.	lower back and occasionally the chestwhen others sites have edema.The area to place the infusion set isparticularly important in patients withmany years use, since the overuse ofskin sites has an influence onabsorption variability.
Material	Materials include:Polypropylene, polyoxymethylene,copolyester/polycarbonate alloy,Eastalloy DA003-8999K polymerstainless steel,polytetrafluoroethylene, nonwovenpolyester/polyacrylate,polyethylene, silicone, MethylMethacrylate Acrylonitrile ButadieneStyrene(MABS), Terlux 2802 HD,transp., medical grade paper,polycarbonate	Materials include:Polypropylene, Stainless Steel,Polyethylene, Polyurethane, Silicone,Polycarbonate,Polytetrafluoroethylene, MethylMethacrylate Acrylonitrile ButadieneStyrene(MABS), Terlux 2802 HD,transp., Medical Grade Paper, UV-cured Glue, Color Pigments	No significant difference as theinfusion set which remains on thepatient is the same as the predicatedevice and appropriatebiocompatibility testing has beenconducted 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 ISO10993-1	Yes	Yes	Same
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	MiniMed™ Mio™ Advance infusion set	Unomedical Inset™ SubcutaneousInfusion Sets (formerly known as TheUnomedical Monica Infusion Set)
Soft Cannula Length	6 and 9mm	6 and 9mm	Same
Tubing:IDOD	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 cmhas been made available for theproposed device
Angle of Insertion	90 degrees, perpendicular	90 degrees, perpendicular	Same
Insertion Method	Pre-loaded insertion device withautomatic needle retraction. Theinsertion needle and soft cannula arehidden from the user before, duringand after insertion of the soft cannula.	Insertion device, which enables theuser not to place the soft cannula inthe tissue manually	Similar in that both devices allow forthe patient to not have to insert thedevice in the tissue manually - theproposed device includes anadditional mechanism so that thepatient does not need to see theneedle or cannula at any stage of theprocess and has an automatic needleretraction to help ensure needlesafety
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.

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.