K Number

Device Name

neria guard Infusion Set

Manufacturer

Unomedical a/s

Date Cleared

2019-12-13

(80 days)

Product Code

FPA

Regulation Number

880.5440

Intended Use

The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

Device Description

The neria™ guard 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 preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the neria™ guard 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 is then automatically retracted after use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K032854

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical infusion set with automatic needle retraction, and there is no mention of AI or ML capabilities.

Therapeutic

No.
This device is an infusion set designed to deliver medication, not to treat a disease or condition itself. Therapeutic devices actively treat or mitigate a disease.

Diagnostic

Explanation: The device is an infusion set used for administering medication, not for diagnosing medical conditions. Its function is to facilitate the delivery of substances into the body, not to detect or identify diseases or conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a sterile, non-pyrogenic, single use subcutaneous infusion set with a soft cannula and insertion device, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 substances into the body, not to test samples taken from the body.
Device Description: The description details a sterile, single-use infusion set with a cannula and insertion mechanism. This aligns with a device for administering medication, not for performing diagnostic tests on biological samples.
Lack of IVD Characteristics: The document 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 biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.

The device is clearly intended for the delivery of medication, which falls under the category of therapeutic or drug delivery devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The neria™ guard 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 insertion needle and soft cannula of the neria™ guard 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 is then automatically retracted after use.

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.

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 safety and effectiveness of neria™ guard Infusion Set and in showing substantial equivalence to the predicate device, Unomedical completed a number of non-clinical performance tests. The neria™ guard Infusion Set meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design inputs and specifications for the device.

The neria™ guard 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:

Sterilization Testing: The sterility of the neria™ guard Infusion Set is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014.
Biocompatibility testing: The biological safety of the neria™ guard Infusion Set was demonstrated by testing in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016. The battery of testing included the following tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute and 14-day Systemic toxicity, Material Mediated Pyrogenicity, Hemolysis, Particulate Testing, Chemical Characterization, Genotoxicity (AMES and MLA).
Shelf Life Determination: A maximum shelf life of 3 years was determined based on an assessment of the seal integrity of the sterile barrier packaging and functional testing of the device in accordance with ASTM F1980:2011.
Functional Testing: Placement Introducer Needle before and after activation, Tensile Test Base-Connector, Functional Test Adhesive Liner, Contents in Blister Package, Functional Test Serter, Tensile Test Needle Hub, Tensile Test Soft Cannula, Tensile Test Base-Adhesive Patch Peel Test, Packaging Disassemble fluid part from base, Disassemble base from cylinder, Serter Activation Force, Leak Test, Flow Test, Distance Introducer Needle bevel to Soft Cannula tip, Distance Soft Cannula tip to bottom fluid part, Visual Test of IFU, Blister Lid and Inner and Outer box label, Disassemble Cylinder from Cover, Drug Compatibility Testing, Tensile Strength Packaging and Labelling tests.

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 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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 13, 2019

Unomedical a/s % Deirdre Barrow Senior Consultant. Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K192647

Trade/Device Name: neria™ guard Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 23, 2019 Received: September 24, 2019

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. 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

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) 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 medical devices and radiation-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,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192647

Device Name neria™ guard infusion set

Indications for Use (Describe)

The neria™ guard infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k)Summary

K192647

1. Submission Sponsor

Unomedical a/s

Aaholmvej 1-3, Osted

DK-4320 Lejre,

Denmark

Contact: Mette Henningsen

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

Contact: Deirdre Barrow

Title: Senior Consultant, RA

3. Date Prepared

Dec-11-2019

4. Device Identification

Trade/Proprietary Name: neria™ guard 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. Legally Marketed Predicate Device(s)

Table 5A: Legally Marketed Predicate Device

| Device
Name | 510(k) No. | Product Code | Classification
Regulation | Classification
Name | Sponsor |
|---------------------------------------------------------------------------------------------------------------------------|------------|--------------|------------------------------|----------------------------------------|------------|
| Unomedical
Inset™
Subcutaneous
Infusion Set
(formerly
known asthe
Unomedical
Monica
Infusion Set) | K032854 | FPA | 880.5440 | Intravascular
administration
set | Unomedical |

6. Indication for Use Statement

The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the neria™ guard Infusion Set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.

It should be noted that the cannula from the subject device and the predicate are identical (same materials from the same suppliers, same manufacturing process, same intended use). Differences between the subject device and predicate device include difference in the insertion method, needle retraction mechanism, additional available lengths, and material differences.

Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	neriaTM guard Infusion Set	Unomedical InsetTM Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
510(k) Number	K192647	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 neriaTM guard Infusion Set is
indicated for subcutaneous infusion of
medication administered by an
external pump.	The Unomedical InsetTM Subcutaneous
Infusion Sets are indicated for the
subcutaneous infusion of medication
from an external pump.	Similar- Difference in the name of the
subject device. Does not impact safety
or effectiveness
Mechanism of Action	The neriaTM guard Infusion Set is an
infusion administration set, connecting
to a reservoir/infusion pump and
inserted in the subcutaneous tissue of
a user.	The Unomedical InsetTM 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	Unomedical	Device Comparison
Trade Name	neria™ guard Infusion Set	Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
	• insertion of soft cannula: 2 user
steps for insertion: remove
protective cap for base and press
release button	• insertion of soft cannula: 3 manual
user steps for insertion: loading,
inserting and retraction.	• 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 new
questions of safety or
effectiveness.
	• The Base Set in neria™ guard
Infusion Set is made of two
components, the Fluid Part and the
Base Part	• The Base Set used in Unomedical
inset™ is moulded as one	• The fluid part of the neria™ guard
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
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	neria™ guard Infusion Set	Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
	• The neria™ guard 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.	• The insertion needle and soft
cannula of neria™ guard 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 effectiveness
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
is introduced into the subcutaneous	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
is introduced into the subcutaneous	Same technology used in both
devices for the administration set. It
should be noted that the cannula
from the subject device and the
predicate are identical (same
materials from the same suppliers,
same manufacturing process, same
sterilization, same intended use).
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	neriaTM guard Infusion Set	Unomedical InsetTM Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
	tissue by a removable 27 gauge
introducer needle (cannula) made of
AISI 304 stainless steel.	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
occasionally the chest when others
sites have edema.	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.	Same
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	neria™ guard Infusion Set	Unomedical Inset™ Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
	particularly important in patients with
many years use, since the overuse of
skin sites has an influence on
absorption variability.	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,
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, Stainless Steel,
Polyethylene, Polyurethane, Silicone,
Polycarbonate,
Polytetrafluoroethylene, Methyl
Methacrylate Acrylonitrile Butadiene
Styrene(MABS), Terlux 2802 HD,
transp., Medical Grade Paper, UV-
cured Glue, Colour Pigments	Differences in material were
evaluated with the appropriate
biocompatibility testing per ISO
10993-1.
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
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	0.68 mm	0.68 mm	Same
Manufacturer	Unomedical	Unomedical	Device Comparison
Trade Name	neriaTM guard Infusion Set	Unomedical InsetTM Subcutaneous
Infusion Sets (formerly known as The
Unomedical Monica Infusion Set)
Needle Gauge	27 gauge	27 gauge	Same
Tubing Length	12 cm, 30 cm, 60 cm, 80 cm and 110
cm	60 and 110 cm	Additional tubing lengths of 12, 30
and 80 cm have been made available
for the proposed device. Does not
impact safety or effectiveness.
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

Non-Clinical Performance Data 9.

• Sterilization Testing

The sterility of the neria™ guard Infusion Set is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014.

Biocompatibility testing .

The biological safety of the neria™ guard Infusion Set was demonstrated by testing in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016.

The battery of testing included the following tests:

. Cytotoxicity
Sensitization ●
Intracutaneous Reactivity/Irritation
Acute and 14-day Systemic toxicity
Material Mediated Pyrogenicity ●
Hemolysis
Particulate Testing
Chemical Characterization ●
Genotoxicity (AMES and MLA)

. Shelf Life Determination

A maximum shelf life of 3 years was determined based on an assessment of the seal integrity of the sterile barrier packaging and functional testing of the device in accordance with ASTM F1980:2011.

● Functional Testing

Placement Introducer Needle before and after activation Tensile Test Base-Connector Functional Test Adhesive Liner Contents in Blister Package Functional Test Serter Tensile Test Needle Hub Tensile Test Soft Cannula Tensile Test Base-Adhesive Patch Peel Test Packaging Disassemble fluid part from base Disassemble base from cylinder Serter Activation Force Leak Test Flow Test Distance Introducer Needle bevel to Soft Cannula tip Distance Soft Cannula tip to bottom fluid part Visual Test of IFU, Blister Lid and Inner and Outer box label Disassemble Cylinder from Cover Drug Compatibility Testing Tensile Strength Packaging and Labelling tests

Standards used:

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 ASTM F1980:2011; Standard Guide or Accelerated Aging of Sterile Barrier Systems 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 10993-1:2009; Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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

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

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

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

10. Conclusion

The neria™ guard Infusion Set, as designed and manufactured, is determined to be substantially equivalent to the predicate device.