Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical infusion set and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is an infusion set used to deliver medication, but it does not inherently provide therapy or treat a condition itself.

Diagnostic

No

This device is an infusion set designed for delivering medication, not for diagnosing conditions. Its primary function is to administer a substance, not to analyze or identify a medical state.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula and is delivered in a preloaded insertion device. This describes a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

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 into the body, not to perform tests on samples taken from the body.
Device Description: The description details a sterile, non-pyrogenic, single-use subcutaneous infusion set with a cannula and insertion device. This aligns with a drug delivery device, not a diagnostic device.
Anatomical Site: The anatomical sites mentioned are areas for subcutaneous injection, which is consistent with drug delivery.
Lack of Diagnostic Language: The text does not mention any terms related to testing, analyzing samples (blood, urine, tissue, etc.), or diagnosing conditions.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication, which falls outside the scope of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

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

FPA

Device Description

The Medtronic Extended infusion set manufactured by Unomedical a/s 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 preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.

The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent 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 Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

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 other sites have edema. The area to place the infusion set is particularly important in patients with many years of 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)

Clinical Evaluation: A clinical study has been conducted in the US. A total of 291 subjects were enrolled at 15 investigational centers. The results of the clinical study demonstrated that the use of the Medtronic Extended infusion set was safe and effective for the full 7 days. There were no device-related serious adverse events.

Non-Clinical Performance Data: Non-clinical performance tests were completed to demonstrate safety and effectiveness, and substantial equivalence. The Medtronic Extended infusion set met all requirements for overall design, sterilization, biocompatibility, and usability, confirming that the design output meets the design inputs and specifications. Testing was conducted in accordance with internal, national, and international standards.

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.

K173879

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

July 16, 2021

Unomedical A/S Lone Vestergaard Jepsen Regulatory Affairs Specialist Aaholmvei 1-3 Osted, Lejre 4320 Denmark

Re: K210544

Trade/Device Name: Medtronic Extended infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 5, 2021 Received: May 10, 2021

Dear Lone Vestergaard Jepsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210544

Device Name Medtronic Extended infusion set

Indications for Use (Describe)

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

Device Name:

Medtronic Extended infusion set

5.1 Submission Sponsor

Unomedical a/s Aaholmvej 1-3, Osted DK-4320 Lejre, Denmark Primary contact: Lone Sylvest Vestergaard Jepsen Title: Regulatory Affairs Specialist

Secondary contact: Mette Busk Henningsen Title: Regulatory Affairs Specialist

5.2 Date Prepared

July 13, 2021

5.3 Device Identification

Trade/Proprietary Name:	Medtronic Extended infusion set
Common/Usual Name:	Set, Administration, Intravascular
Classification Name:	Intravascular administration set
Regulation Number:	880.5440
Product Code:	FPA, Intravascular administration set
Device Class:	Class II
Classification Panel:	General Hospital

5.4 Legally Marketed Predicate Device(s)

Table 5.1: Legally Marketed Predicate Device.

| Device Name | 510(k)
No. | Product
Code | Classification
Regulation | Sponsor |
|------------------------------------|---------------|-----------------|------------------------------|------------|
| MiniMed™ Mio™ Advance Infusion Set | K173879 | FPA | 880.5440 | Unomedical |

5.5 Indication for Use Statement

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

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5.6 Device Description

The Medtronic Extended infusion set manufactured by Unomedical a/s 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 preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.

The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent 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 Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

5.7 Substantial Equivalence

The following table compares the Medtronic Extended infusion set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The proposed device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed™ Mio™ Advance
Infusion Sets
(predicate device)	Medtronic Extended infusion
set
(proposed device)	N/A
510(k)
Number	K173879	K210544	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 Medtronic Extended
infusion set is indicated for the
subcutaneous infusion of
medication from an external
pump.
The infusion set is indicated for
single use	Same
"The infusion set is
indicated for single
use" has been
moved from
"Warnings" section
for clarification.
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 Medtronic Extended
infusion set is an infusion
administration set, connecting
to a reservoir/infusion pump
and inserted in the
subcutaneous tissue of a user.	Same
Manufacturer	Unomedical a/s	Unomedical a/s	Device Comparison
Trade Name	MiniMed™ Mio™ Advance
Infusion Sets
(predicate device)	Medtronic Extended infusion
set
(proposed device)	N/A
Technology
Overview	Serter:
• Subcutaneous insertion of
soft cannula by introducer
needle situated inside soft
cannula at a 90° insertion
angle.
• 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
• The MiniMed™ Mio™
Advance infusion set is
delivered ready to use in a
pre-loaded insertion device
with automatic needle
retraction. This mechanism
allows the needle to be hidden
from the user and/or caregiver
before and after insertion.	Serter:
• Subcutaneous insertion of
soft cannula by introducer
needle situated inside soft
cannula at a 90° insertion
angle.
• insertion of soft cannula: 2
user steps for insertion:
remove protective cap for base
and press release button
• The Base Set in Medtronic
Extended infusion set is made
of two components, the Fluid
Part and the Base Part
• The Medtronic Extended
infusion set is delivered ready
to use in a pre-loaded
insertion device with automatic
needle retraction. This
mechanism allows the needle
to be hidden from the user
and/or caregiver before and
after insertion.	Serter:
Visually identical,
with identical mode
of operation.

The design of the
Medtronic Extended
infusion set is
detailed in section 11
of this 510K. |
| | Administration Set:
The administration set
attaches to the reservoir by
means of a "tubing connector",
and subcutaneously into the
user through an indwelling
cannula made of
polytetrafluoroethylene
(PTFE).
The tubing is made of two
layers: the inner layer is
polyethylene; the outer is
polyurethane.
The indwelling cannula is
introduced into the
subcutaneous tissue by a
removable 27-gauge
introducer needle (catheter)
made of AISI 304 stainless
steel. | Administration Set:
The administration set
attaches to the reservoir by
means of a "tubing connector",
and subcutaneously into the
user through an indwelling
cannula made of
polytetrafluoroethylene
(PTFE).
The tubing connector and the
adhesive patch are updated to
facilitate an extended wear
time. The tubing is made of
three layers: the inner layer is
polypropylene; the middle layer
is polyethylene and the outer is
polyurethane.
The indwelling cannula is
introduced into the
subcutaneous tissue by a
removable 27-gauge
introducer needle (catheter)
made of AISI 304 stainless
steel. | Administration Set:
Same technology |
| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
| Trade Name | MiniMed ™™ Mio™™ Advance
Infusion Sets
(predicate device) | Medtronic Extended infusion
set
(proposed device) | N/A |
| 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 occasionally the
chest when other sites have
edema.
The area to place the infusion
set is particularly important in
patients with many years of
use, since the overuse of skin
sites has an influence on
absorption variability. | 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
other sites have edema.
The area to place the infusion
set is particularly important in
patients with many years of
use, since the overuse of skin
sites has an influence on
absorption variability. | Same |
| Material | Materials include:
Polypropylene,
polyoxymethylene, stainless
steel, polytetraflouroethylene,
nonwoven
polyester/polyacrylate,
polyethylene, silicone, Methyl
Methacrylate Acrylonitrile
Butadiene
Styrene (MABS), Terlux 2802
HD, transp., medical grade
paper, polycarbonate | Materials include:
Polypropylene,
polyoxymethylene, stainless
steel, polytetraflouroethylene,
nonwoven
polyester/polyacrylate,
polyethylene, silicone, Methyl
Methacrylate Acrylonitrile
Butadiene
Styrene (MABS), Terlux 2802
HD, transp., medical grade
paper, polycarbonate,
polyvinylalcohol | Essentially identical,
with the notable
addition of
polyvinylalcohol.
Appropriate
biocompatibility
testing has been
conducted on the
proposed device. |
| Sterile | Yes - EO – SAL 10-6 | Yes - EO - SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 2 years | Shelf life reduced |
| Complies
with ISO
10993-1 | Yes | Yes | Same |
| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance
Infusion Sets | Medtronic Extended infusion
set | N/A |
| | (predicate device) | (proposed device) | |
| Soft Cannula
Length | 6 and 9 mm | 6 and 9 mm | Same |
| Tubing:
ID
OD | 0.385 mm,
1.50 mm | 0.406 mm,
1.52 mm | Change due to
added middle layer in
tubing. Substantially
equivalent based on
bench testing. |
| Soft Cannula
OD | 0.68 mm | 0.68 mm | Same |
| Needle Gauge | 27 gauge | 27 gauge | Same |
| Tubing
Length | 46, 60 and 110 cm | 46, 60, 80 and 110 cm | Same tubing length
range. Added
intermediate size. |
| 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. | 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. | Same |
| Time of Use | Up to 72 hours (3 days) | Up to 168 hours (7 days) | Recommended
maximum wear time
extended. The claim
is supported by the
clinical performance
testing (see section
20). |

Table 5.2: Comparison of Characteristics.

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5.8 Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Medtronic Extended infusion set and in showing substantial equivalence to the predicate device, Unomedical completed a number of non-clinical performance tests. The Medtronic Extended 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 Medtronic Extended 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:

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Testing:

1. Functional tests
- Leak/Tightness o
- o Flow (Occlusion)
- Tensile tests of introducer needle hub, tubing connections, soft cannula from o Fluid Part assembly, adhesive tape from base, connector from base, connector needle from connector
- O Strength tests of Fluid Part assembly from base assembly, base assembly from cylinder, serter activation force (intended and unintended), disassembly of cylinder from cover
- Serter functionality tests O
1. Packaging tests:
- Dynamic and Visual Peel Test O
- Print on Packaging and labelling o
1. Transportation Tests:
- Transportation tests general o
1. Compatibility Tests:
- Drug and Device Compatibility O
1. Dimensional Tests:
- Distance soft cannula to set o
- Distance of introducer needle bevel to soft cannula O
- Length of tubes O
Biocompatibility Testing in accordance with ISO 10993-1 6.
1. EO/ECH residuals Testing
Pyrogen/Endotoxin Testing 8.
Shelf life Testing 9.
1. Sterilization Testing
1. Usability Testing

5.9 Clinical Evaluation

A clinical study has been conducted in the US. A total of 291 subjects were enrolled at 15 investigational centers.

The results of the clinical study demonstrated that the use of the Medtronic Extended infusion set was safe and effective for the full 7 days. There were no device-related serious adverse events.

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5.10 Standards Used

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

ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11737-1:2018, Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products

ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation, and maintenance of a sterilization process

ASTM F1980-16: 2016, Standard Guide for Accelerated Aging Sterile Barrier Systems for Medical Devices

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"

EN ISO 11138-1: 2017, "Sterilization of heath care products – Biological indicators – Part 1: General Requirements"

EN ISO 11138-2: 2017, "Sterilization of heath care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes"

ISO 11607-1:2019, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for forming, sealing and assembly processes

ISO 15223-1:2016, Medical devices – Symbols to be used with medical devices labeling, and information to be supplied - Part 1: General requirements

EN ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

ISO 10993-3:2014, Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity and Reproductive Toxicity

ISO 10993-4:2017, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood

ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for in-vitro Cytotoxicity

ISO 10993-6:2016, Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects after Implantation

EN ISO 10993-7:2008 & EN ISO 10993-7/AC:2009, Biological Evaluation of Medical Devices – Part 7: Ethylene oxide sterilization residuals

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

EN ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity

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ISO 10993-12:2012, Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials

ISO 10993-17:2002, Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances

EN ISO 10993-18:2009, Biological Evaluation of Medical Devices – Part 18: Chemical characterization of materials

EN ISO 8536-8:2015 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed

ISO 8536-9:2015 Infusion Equipment for Medical Use – Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment

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

IEC 62366-1:2015/AC, "Medical devices – Part 1: Application of usability engineering to medical devices"

ISO 14971:2019, Medical devices – Application of risk management to medical devices.

5.11 Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The Medtronic Extended infusion set, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.