The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set.

The neria™ soft 90 is a 90 degree soft cannula infusion set with a standard luer-lock connection. The neria™ soft 90 subcutaneous infusion set consists of an introducer needle/insertion handle that inserts the soft cannula into the skin and is removed immediately after insertion, a cannula housing that rests upon the skin with adhesive tape, securing the soft cannula in place under the skin, tubing with disconnect option and a reservoir connector (standard luer lock) and disconnect cover for the tubing and cannula housing.

The proposed configurations are:

includes tubing and cannula . Infusion Set
Tubing Only ●
. Cannula only

AI/ML Overview

Acceptance Criteria and Device Performance for neria™ soft 90 Infusion Set

This document details the acceptance criteria and study information for the neria™ soft 90 Infusion Set, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as being substantially equivalent to its predicate devices based on non-clinical performance data. Therefore, the "acceptance criteria" are implied by the successful execution of these tests and compliance with relevant standards. The "reported device performance" is that the device passed all tests.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance (Target/Outcome)
Functional Performance	Leak/Tightness Test	Passed (Meets requirements)
	Flow (Occlusion) Test	Passed (Meets requirements)
	Tensile Test (introducer needle, tubing connections, soft cannula, adhesive tape, connector from cannula housing, connector needle)	Passed (Meets requirements for overall design)
Packaging Integrity	Dynamic Peel Test	Passed (Meets requirements)
	Visual Peel Test	Passed (Meets requirements)
	Print on Packaging and Labeling Inspection	Passed (Meets requirements)
Transportation Durability	Transportation Tests (General)	Passed (Meets requirements)
	Drop Test	Passed (Meets requirements)
Dimensional Accuracy	Distance soft cannula to set	Passed (Meets requirements)
	Distance of introducer needle bevel to soft cannula	Passed (Meets requirements)
	Length of tubes	Passed (Meets requirements)
Biocompatibility	Biocompatibility Testing (in accordance with ISO 10993-1)	Passed (Complies with ISO 10993-1)
Sterilization & Residuals	EO/ECH residuals Testing	Passed (Meets requirements)
	Pyrogen/Endotoxin Testing	Passed (Meets requirements)
	Sterilization Testing	Passed (Complies with applicable standards)
Shelf Life	Shelf Life Testing	Passed (Results demonstrate 3 years shelf life)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the non-clinical tests. It only indicates that "a number of tests" were completed. Given that this is a 510(k) submission for substantial equivalence based on non-clinical data, it is highly likely that standard testing protocols and sample sizes specified by relevant national and international standards (e.g., ISO, ASTM) were followed.

The data provenance is from Unomedical A/S (the manufacturer) and is retrospective in the sense that these tests were performed on the device prototypes and finalized designs prior to submission. The country of origin of the data is Denmark (where Unomedical A/S is located), as well as any external testing facilities used for specific tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation relies on non-clinical performance data (functional, mechanical, material, and sterilization tests) rather than human interpretation of medical images or clinical outcomes requiring clinical ground truth establishment. These tests are assessed against predefined specifications and industry standards by qualified laboratory personnel and engineers.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical performance data presented. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters where there is an element of subjective judgment, and discrepancies need to be resolved. The non-clinical tests involve objective measurements and pass/fail criteria based on established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no effect size related to human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, there was no standalone algorithm performance study conducted. The neria™ soft 90 Infusion Set is a physical medical device, not an AI/software-as-a-medical-device (SaMD) or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on pre-established physical, chemical, and biological specifications and standards. For example:

Engineering specifications: Tensile strength limits, flow rates, dimensional tolerances.
Material standards: Biocompatibility according to ISO 10993 standards.
Sterilization standards: Assurance of sterility.
Packaging standards: Peel strength, integrity.

These standards and specifications serve as the "ground truth" against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The neria™ soft 90 Infusion Set is a physical medical device. It does not employ machine learning or AI algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

Summary

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510(k) Summary

1. Submission Sponsor

Unomedical A/S Infusion Devices Aaholmvej 1-3 Osted DK-4320 Lejre Denmark Søren Melsted Vice President QA/RA Office number: +45 46 42 79 18

2. Submission Correspondent

Emergo Consulting (UK) Limited Unit B9, Taylors Court Parkgate, Rotherham South Yorkshire 562 ENU UK Cell Phone: +353 (0) 91 670 170 Office Phone: +44 (0)01709 52 52 56 Fax: +44 (0)844 811 8148 Contact: Deirdre Barrow, Senior Regulatory Consultant, RA Email: PMTEurope@emergogroup.com

OCT 08 2013

3. Date Prepared

August 30, 2013

4. Device Identification

Trade/Proprietary Name:	neria™ soft 90 Infusion Set
Common/Usual Name:	Subcutaneous Infusion Set
Classification Name:	Intravascular administration set.
Classification Regulation:	21 CFR 880.5440, Set, Administration, Intravascular
Product Code:	FPA
Device Class:	Class II
Classification Panel:	General Hospital

5. Predicate Devices

K032854	Unomedical Inset™ Subcutaneous Infusion Sets(Formerly known as The Unomedical Monica Set)
K991759	Unomedical Quick-Set® Subcutaneous Infusion Sets(Formerly known as Maersk Medical Contour™ Infusion Set)

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6. Device Description

The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set.

The proposed configurations are:

includes tubing and cannula . Infusion Set
Tubing Only ●
. Cannula only

7. Intended Use

The neria™ soft 90 infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

8. Substantial Equivalence Discussion

The following table compares the neria™ soft 90 infusion set to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Please note that the two predicates included within their indications for use the following statement "The infusion set is neither intended nor indicated for use with blood or blood products" whereas the neria™ soft 90 product includes a very similar statement within the contraindications included in its instructions for use manual.

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Manufacturer	Unomedical	Unomedical	Unomedical
Trade Name	neria™ soft 90 infusionset	Unomedical Inset™Subcutaneous InfusionSets (formerly known asThe Unomedical MonicaSet)	Unomedical Quick-Set™Subcutaneous InfusionSets (Formerly known asMaersk MedicalContour™ Infusion Set)
510(k) Number	K132147	K032854	K991759
Product Code	FPA	FPA	FPA
Regulation Number	880.5440	880.5440	880.5440
Regulation Name	IntravascularAdministration Set	IntravascularAdministration Set	IntravascularAdministration Set
Indications for Use	The neria™ soft 90infusion set is indicatedfor subcutaneousinfusion of medicationadministered by anexternal pump.Please Note:The IFU for this productincludes the followingcontraindication:"The infusion set isneither intended norindicated for intravenousinfusion (I.V.) ofmedication, includingblood and bloodproducts"	The Unomedical Inset™Subcutaneous InfusionSets are intended for thesubcutaneous infusion ofmedication, includinginsulin from an externalpump. The infusion setis neither intended norindicated for use withblood or blood products.	The Unomedical Quick-Set® SubcutaneousInfusion Sets areintended for thesubcutaneous infusion ofmedicine, includinginsulin, from an externalinfusion pump. Theinfusion set is neitherintended nor indicatedfor use with blood orblood products.
Material	Materials includePolypropylene, StainlessSteel, Polyethylene,Polyurethane, Silicone,Polycarbonate,Polytetrafluoroethylene,Meta AcrylonitrileButadiene Styrene,Medical Grade Paper,UV-cured Glue, ColourPigments	Materials includePolypropylene, StainlessSteel, Polyethylene,Polyurethane, Silicone,Polycarbonate,Polytetrafluoroethylene,Meta AcrylonitrileButadiene Styrene, UV-cured Glue, ColourPigments	Materials includePolypropylene, StainlessSteel, Polyethylene,Polyurethane, Silicone,Polycarbonate,Polytetrafluoroethylene,Meta AcrylonitrileButadiene Styrene,Medical Grade Paper,UV-cured Glue, ColourPigments
Sterile	Yes	Yes	Yes
Single-Use	Yes	Yes	Yes
Shelf Life	3 years	3 years	3 years
Complies with ISO10993-1	Yes	Yes	Yes
Soft Cannula Length	6 and 9mm	6 and 9mm	6 and 9mm
Tubing Length	30, 60, and 110 cm	60 and 110 cm	60 and 110 cm
Angle of Insertion	90 degrees,perpendicular	90 degrees,perpendicular	90 degrees,perpendicular
Insertion Method	Insertion handle -manual insertion of	Insertion device, whichenables the user not to	Insertion handle -manual insertion of
Manufacturer	Unomedical	Unomedical	Unomedical
Trade Name	neriaTM soft 90 infusion set	Unomedical InsetTMSubcutaneous Infusion Sets (formerly known as The Unomedical Monica Set)	Unomedical Quick-SetTMSubcutaneous Infusion Sets (Formerly known as Maersk Medical ContourTM Infusion Set)
	needle into tissue by user	place the soft cannula in the tissue manually	needle into tissue by user

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

Testing performed to support substantial equivalence included:

· Functional tests:
- Leak/Tightness
- o Flow (Occlusion)
- o Tensile test of introducer needle, tubing connections, soft cannula, adhesive tape, connector from cannula housing, connector needle
· Packaging tests
- o Dynamic Peel Test
- o Visual Peel Test
- Print on Packaging and labelling
· Transportation Tests
- o Transportation tests general
- o Drop test
· Dimensional Tests
- o Distance soft cannula to set
- Distance of introducer needle bevel to soft cannula o
- Length of tubes
. Biocompatibility Testing in accordance with ISO 10993-1
EO/ECH residuals Testing .
· Pyrogen/Endotoxin Testing
Shelf life Testing and Sterilization Testing .

As part of demonstrating safety and effectiveness of neria™ soft 90 infusion set and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Unomedical completed a number of tests. The neria™ soft 90 infusion set meets all the requirements for overall design, sterilization and biocompatibility. The neria™ soft 90 infusion set passed all testing stated above as shown by the acceptable results obtained.

The neria™ soft 90 infusion set complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

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10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Human Factors/Usability Testing

A Human Factors/Usability Engineering study was conducted to support the use of the neria™ soft 90 subcutaneous infusion set for its intended uses and the use environment.

The purpose of this evaluation was to demonstrate that users can perform critical tasks while using the product in a safe and effective manner. Unomedical has concluded that the neria™ soft 90 infusion sets can be used without a pattern of preventable use errors that would cause harm.

12. Statement of Substantial Equivalence

This device has the same overall intended use "are intended for the subcutaneous infusion of medication" as that of the predicates. The device incorporates features from each of the predicates listed which are also manufactured by this submission sponsor. Therefore by definition, this device, neria™ soft 90 infusion set, is substantially equivalent to the referenced predicate devices as the device has the same intended use and the same technological characteristics as the previously cleared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 10903 Now Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2013

Unomedical A/S C/O Ms. Deirdre Barrow Senior Regulatory Consultant Emergo Group Unit B9, Taylors Court Parkgate Rotherham, South Yorkshire United Kingdom S62 6NU

Re: K132142

Trade/Device Name: neria™ soft 90 Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 10, 2013 Received: July 11, 2013

Dear Ms. 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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Page 2 - Ms. Barrow

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySBunner-S

Kwame Ulmer M.S. Acting Division 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 Statement

510(k) Number (if known): K132142

Device Name: neria™ soft 90 Infusion Set

Indications for Use:

The neria™ soft 90 infusion set is Indicated for subcutaneous infusion of medication administered by an external pump.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sajjad+
Syed

Digitally signed by Sajjad H. Syed DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Saliad H. Sved. 42.19200300.100.1.1=2000 Date: 2013.10.07 13:25:06 -04'00'

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.