(89 days)
No
The document describes a mechanical infusion set and its testing, with no mention of AI or ML capabilities.
Yes.
Explanation: The device is an infusion set that facilitates the subcutaneous delivery of medication, which directly serves a therapeutic purpose by administering treatment.
No
Explanation: The device is an infusion set used for the subcutaneous delivery of medication, not for diagnosing medical conditions. It facilitates the administration of medication from an external pump.
No
The device description clearly outlines physical components like a cannula, tubing, and connectors, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous infusion of medication administered by an external pump." This describes a device used to deliver substances into the body, not to test samples from the body.
- Device Description: The description details a physical device for inserting a cannula under the skin and connecting to a pump. It does not mention any components or processes related to analyzing 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 samples
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The device is clearly designed for the delivery of medication, which falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The neria™ soft 90 infusion set is indicated for subcutaneous infusion of medication administered by an external pump.
Product codes
FPA
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Non-Clinical Performance Data: Testing performed to support substantial equivalence included:
- Functional tests: Leak/Tightness, Flow (Occlusion), Tensile test of introducer needle, tubing connections, soft cannula, adhesive tape, connector from cannula housing, connector needle
- Packaging tests: Dynamic Peel Test, Visual Peel Test, Print on Packaging and labelling
- Transportation Tests: Transportation tests general, Drop test
- Dimensional Tests: Distance soft cannula to set, Distance of introducer needle bevel to soft cannula, Length of tubes
- Biocompatibility Testing in accordance with ISO 10993-1
- EO/ECH residuals Testing
- Pyrogen/Endotoxin Testing
- Shelf life Testing and Sterilization Testing
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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) |
1
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 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
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.
2
| Manufacturer | Unomedical | Unomedical | Unomedical |
|---|---|---|---|
| Trade Name | neria™ soft 90 infusion | ||
| set | Unomedical Inset™ | ||
| Subcutaneous Infusion | |||
| Sets (formerly known as | |||
| The Unomedical Monica | |||
| Set) | Unomedical Quick-Set™ | ||
| Subcutaneous Infusion | |||
| Sets (Formerly known as | |||
| Maersk Medical | |||
| Contour™ Infusion Set) | |||
| 510(k) Number | K132147 | K032854 | K991759 |
| Product Code | FPA | FPA | FPA |
| Regulation Number | 880.5440 | 880.5440 | 880.5440 |
| Regulation Name | Intravascular | ||
| Administration Set | Intravascular | ||
| Administration Set | Intravascular | ||
| Administration Set | |||
| Indications for Use | The neria™ soft 90 | ||
| infusion set is indicated | |||
| for subcutaneous | |||
| infusion of medication | |||
| administered by an | |||
| external pump. |
Please Note:
The IFU for this product
includes the following
contraindication:
"The infusion set is
neither intended nor
indicated for intravenous
infusion (I.V.) of
medication, including
blood and blood
products" | The Unomedical Inset™
Subcutaneous Infusion
Sets are intended for the
subcutaneous infusion of
medication, including
insulin from an external
pump. The infusion set
is neither intended nor
indicated for use with
blood or blood products. | The Unomedical Quick-
Set® Subcutaneous
Infusion Sets are
intended for the
subcutaneous infusion of
medicine, including
insulin, from an external
infusion pump. The
infusion set is neither
intended nor indicated
for use with blood or
blood products. |
| Material | Materials include
Polypropylene, Stainless
Steel, Polyethylene,
Polyurethane, Silicone,
Polycarbonate,
Polytetrafluoroethylene,
Meta Acrylonitrile
Butadiene Styrene,
Medical Grade Paper,
UV-cured Glue, Colour
Pigments | Materials include
Polypropylene, Stainless
Steel, Polyethylene,
Polyurethane, Silicone,
Polycarbonate,
Polytetrafluoroethylene,
Meta Acrylonitrile
Butadiene Styrene, UV-
cured Glue, Colour
Pigments | Materials include
Polypropylene, Stainless
Steel, Polyethylene,
Polyurethane, Silicone,
Polycarbonate,
Polytetrafluoroethylene,
Meta Acrylonitrile
Butadiene Styrene,
Medical Grade Paper,
UV-cured Glue, Colour
Pigments |
| Sterile | Yes | Yes | Yes |
| Single-Use | Yes | Yes | Yes |
| Shelf Life | 3 years | 3 years | 3 years |
| Complies with ISO
10993-1 | 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, which
enables the user not to | Insertion handle -
manual insertion of |
| Manufacturer | Unomedical | Unomedical | Unomedical |
| Trade Name | neriaTM soft 90 infusion set | Unomedical InsetTM
Subcutaneous Infusion Sets (formerly known as The Unomedical Monica Set) | Unomedical Quick-SetTM
Subcutaneous 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
3
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.
4
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.
5
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.
6
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
7
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'