(310 days)
Unifine® Pentips®, K973899
No
The device description and performance studies focus on the mechanical and material properties of a pen needle, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a pen needle used for drug injection, not for treatment itself.
No
The device is a pen needle intended for the subcutaneous injection of drugs, not for diagnosis. Its description and intended use clearly state its function in drug delivery.
No
The device description clearly details physical components like cannulas, hubs, shields, and containers, and the performance studies focus on physical characteristics and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of drugs, including insulin." This describes a device used for administering substances into the body, not for examining specimens from the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a pen needle assembly designed to attach to a pen injector and facilitate the delivery of medication. It focuses on the physical components and their function in injection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Unifine Pentips range of pen needles falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.
Product codes
FMI
Device Description
Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).
The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.
The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.
Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumers, caregivers, and healthcare professionals
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:
Bench testing was performed against various ISO standards. The tests included: Dimensions for needles (ISO 11608-2:2012 Section 4.2.2), Needle points (ISO 11608-2:2012 Section 4.5), Freedom from defects (ISO 11608-2:2012 Section 4.6), Lubrication (ISO 11608-2:2012 Section 4.7), Dislocation of measuring point at patient end (ISO 11608-2:2012 Section 4.8), Bond between hub and needle tube (ISO 11608-2:2012 Section 4.4), Ease of assembly/disassembly (ISO 11608-2:2012 Section 4.10), Sterilization (ISO 11608-2:2012 Section 4.11, ISO 11137-2:2007 (manufactured pen needles in the UK), ISO 11135-1:2006 (manufactured pen needles in Italy)), Flow rate (ISO 11608-2:2012 Section 4.3), Needle dose accuracy (ISO 11608-2:2012 Section 4.9, 11.4.2), Needle hub torque removal (ISO 11608-2:2012 Section 4.9, 11.4.3). All tests met the respective standards.
Internal Performance Tests included: Force required to remove pen needle from primary container, Force required to fit pen needle into primary container (UP), Force to remove needle shield from pen needle. All met acceptance criteria.
Results of these tests demonstrate that the Unifine Pentips and Unifine Pentips Plus devices perform equivalent to the predicate devices when used as intended.
Biocompatibility:
In accordance with ISO 10993-1, the devices are classified as Externally Communicating Device, Blood Path Indirect, Short Term (
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Owen Mumford Ltd % Ms. Patty Cronan Owen Mumford USA, Inc. 1755 West Oak Commons Court Marietta, Georgia 30062
Re: K152339
Trade/Device Name: Unifine® Pentips® and Unifine® Pentips® Plus Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 17, 2016 Received: June 20, 2016
Dear Ms. Cronan:
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.
1
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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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, Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152339
Device Name Unifine Pentips/ Unifine Pentips Plus
Indications for Use (Describe)
The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5.0
510(k) SUMMARY: 510k Number: K152339
1. Submitter
| Prepared by: | Patty Cronan - Quality Manager
Quality Manager
Owen Mumford USA Inc.
Tel. (770) 977-2226
Fax (770) 977-2866 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/ Operator
Owen Mumford Ltd
Brook Hill
Woodstock
Oxfordshire
OX20 1TU
United Kingdom
Establishment Registration Number: 8021764 |
| Contact Person: | Patty Cronan - Quality Manager
Quality Manager
Owen Mumford USA Inc.
Tel. (770) 977-2226
Fax (770) 977-2866
Email: p.cronan@owenmumfordinc.com |
Date Prepared: October 16, 2015
2. Device
Name of Device: Unifine® Pentips® & Unifine® Pentips® Plus Common Name: Pen Needles Classification Name: Needle, Hypodermic, Single Lumen (21 CFR 880.5570) Regulatory Class: II Product Code: FMI
3. Predicate Devices
Primary Predicate Device 1 Name: Unifine® Pentips®, K973899
Reference Predicate Device 2 Name: Artsana InsuPen® Insulin Pen Needles, K051783
Reference Predicate Device 3 Name: BD Pen Needles, K051899
Reference Predicate Device 4 Name: BD 32G x 4mm Pen Needle, K100005
4. Description Of The Device
Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).
The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.
4
The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.
Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.
The purpose of this 510(k) Premarket Notification is to obtain Over-the-Counter (OTC) clearance for Unifine Pentips and Unifine Pentips Plus, to add additional needle lengths of 4mm, 5mm & 6mm, and to document some material changes. Though the Indications for Use are worded slightly different, the intended use for Unifine Pentips and Unifine Pentips Plus is substantially equivalent to the primary predicate and multiple predicate devices.
5. Indications for Use
The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.
6. Technological Characteristics
A comparison of the intended use and technological characteristics is summarized in the table below. Table 6.1. For the table, the BD Predicates, K051899 & K100005, were combined in the third column as the only difference between the two is the length and gauge of the needle. K051899 included needle lengths of 5mm, 8mm & 12.7mm; and gauge sizes of 31G, 30G & 29G. K100005 covers length of 4mm, and gauge size of 32G.
The changes for Owen Mumford included in this submission are the addition of the lengths (4mm, 5mm & 6mm) and gauge sizes (31G & 32G) to the contract manufactured Unifine Pentip product line. This submission also includes the full range of sizes and gauges selfmanufactured by Owen Mumford, including lengths (4mm, 5mm, 8mm &12mm) and qauge sizes (32G, 31G & 29G).
The full range of Unifine Pentips and Unifine Pentips Plus pen needles are substantially equivalent to intended use, device description, appearance, function, principle of operation, and basic composition to the predicate devices. Though the sizes and gauges are not exactly the same as the predicate device sizes and gauges, the range of Unifine Pentips and Unifine Pentips Plus (4mm - 12mm, 32G - 29G) fall within the range of the predicate device sizes and gauges (4mm - 12.7mm, 32G - 29G). The sizes included in this submission do not represent a difference in product technology or product performance versus the predicate devices.
Table 6.1: Comparison of Device Characteristics between Submission Devices and Predicate Devices
5
| Device
Characteristic | Submission
Device: Unifine
Pentips & Unifine
Pentips Plus
(K152339) | Primary Predicate:
Unifine Pentips &
Unifine Pentips
Plus (K973899) | Reference
Predicate: Artsana
InsuPen® Insulin
Pen Needles
(K051783) | Reference
Predicate: BD Pen
Needles (K051899
& K100005) | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Intended Use | The Unifine Pentips
range of pen
needles are
intended for use
with pen injector
devices for the
subcutaneous
injection of drugs,
including insulin. | The Unifine Pentip
is single use,
disposable
hypodermic single
lumen needle
designed for use
with multi-dose
injection devices
that use prefilled
cartridges.
The protective
paper is removed
from the pentip
which is then
screwed onto the
device cartridge
housing and then
used in the
prescribed manner.
One of the main
uses of the pentip
is for use with pen
injectors for the
delivery of insulin
which is supplied in
the form of prefilled
cartridges. The
patient places a
fresh pentip needle
onto the pen
injector, dials a
dose, inserts the
pentip into the skin
and delivers the
dose. | Artsana disposable
sterile pen needles
are used with
insulin pen injector
devices for the
subcutaneous
injection of insulin
in the treatment of
diabetes. | BD Pen Needle is
intended for use
with pen injector
device for
subcutaneous
injection of drugs,
including insulin
and exenatide. | |
| Prescription or
OTC | OTC | Prescription | Prescription | OTC | |
| Operation
Principle | Manual | Manual | Manual | Manual | |
| Design/
Construction | Needle assembly
(cannula, needle
hub, needle shield,
outer container) | Needle assembly
(cannula, needle
hub, needle shield,
outer container) | Needle assembly
(cannula, needle
hub, needle shield,
outer container) | Needle assembly
(cannula, needle
hub, needle shield,
outer container) | |
| Materials | Unifine Pentips by
Artsana S.p.A.:
• Cannula -
Stainless Steel
• Lubricant -
Silicone | Unifine Pentips by
Artsana S.p.Α.:
• Cannula -
Stainless Steel
• Lubricant -
Silicone | • Cannula –
Stainless Steel
• Lubricant –
Silicone
• Adhesive -
Medical Grade
Adhesive | • Cannula -
Stainless Steel
• Lubricant -
Silicone Based
• Outer Container
– Polypropylene | |
| Device
Characteristic | Submission
Device: Unifine
Pentips & Unifine
Pentips Plus
(K152339) | Primary Predicate:
Unifine Pentips &
Unifine Pentips
Plus (K973899) | Reference
Predicate: Artsana
InsuPen® Insulin
Pen Needles
(K051783) | Reference
Predicate: BD Pen
Needles (K051899
& K100005) | |
| | Adhesive
• Needle Hub -
Polypropylene
• Needle Shield -
High Density
Polyethylene
• Outer Container
- High Density
Polyethylene
• Sterility Seal -
Paper Laminate
Unifine Pentips by
Owen Mumford:
• Cannula -
Stainless Steel
• Lubricant -
Silicone
• Adhesive -
Medical Grade
Adhesive
• Needle Hub –
Polypropylene
• Needle Shield -
High Density
Polyethylene
• Outer Container - High Density
Polyethylene
• Sterility Seal -
Paper Laminate
Unifine Pentips
Plus by Owen
Mumford:
• Cannula -
Stainless Steel
• Lubricant -
Silicone
• Adhesive -
Medical Grade
Adhesive
• Needle Hub -
Polypropylene
• Needle Shield -
High Density
Polyethylene
• Outer Container - Polypropylene
• Sterility Seal -
Paper Laminate | Adhesive
• Needle Hub -
Polypropylene
• Needle Shield -
High Density
Polyethylene
• Outer Container - High Density
Polyethylene
• Sterility Seal -
Paper Laminate | Polypropylene
• Needle Shield -
High Density
Polyethylene
• Outer Container - High Density
Polyethylene
• Sterility Seal -
Paper Laminate | available for these
devices. | |
| Package | • Plastic outer
container
• Sterility Seal | • Plastic outer
container
• Sterility Seal | • Plastic outer
container
• Sterility Seal | • Plastic outer
container
• Sterility Seal | |
| | • Shelf box | • Shelf box | • Shelf box | • Shelf box | |
| Device
Characteristic | Submission
Device: Unifine
Pentips & Unifine
Pentips Plus
(K152339) | Primary Predicate:
Unifine Pentips &
Unifine Pentips
Plus (K973899) | Reference
Predicate: Artsana
InsuPen® Insulin
Pen Needles
(K051783) | Reference
Predicate: BD Pen
Needles (K051899
& K100005) | |
| Needle Specifications | Needle
Length | Unifine Pentips
manufactured for
Owen Mumford
Ltd: 4mm for 32G;
5mm, 6mm, 8mm
for 31G; 12mm for
29G
Unifine Pentips by
Owen Mumford:
4mm for 32G;
5mm, 6mm and
8mm for 31G;
12mm for 29G
Unifine Pentips
Plus by Owen
Mumford: 4mm for
32G; 5mm, 6mm
and 8mm for 31G;
12mm for 29G | Unifine Pentips
manufactured for
Owen Mumford
Ltd: 8mm for 31G;
12mm for 29G | 4mm for 33G,
4mm, 6mm and
8mm for 32G, 8mm
for 30G, 5mm,
6mm and 8mm for
31G, 12mm for
29G | 4mm for 32G, 5mm
and 8mm for 31G
and 12.7mm for
29G |
| | Effective
Gauge | 29G, 31G and 32G | 29G and 31G | 29G, 30G, 31G,
32G and 33G | 29G, 31G and 32G |
| | Tip
Configura-
tion | Patient-side: Tri-
bevel (3) | Patient-side: Tri-
bevel (3) | Patient-side: Tri-
bevel (3) | Patient-side: 5
bevel |
| Sterilization | Unifine Pentips
manufactured for
Owen Mumford
Ltd: Ethylene Oxide
(validated to
achieve SAL 10-6)
Unifine Pentips by
Owen Mumford:
Gamma Radiation
(validated to
achieve SAL 10-6)
Unifine Pentips
Plus by Owen
Mumford: Gamma
Radiation(validated
to achieve SAL 10-6) | Unifine Pentips
manufactured for
Owen Mumford
Ltd: Ethylene Oxide
(validated to
achieve SAL 10-6) | Ethylene Oxide
(validated to
achieve SAL 10-6) | Gamma Radiation | |
Medical Grade
Medical Grade
• Needle Hub –
information publicly
6
7
Though there are minor differences in the Indications for Use between the Predicate Device, Reference Predicate Devices and the Submission Device, the intended use is substantially equivalent. The differences are that the Predicate Device uses terminology of "for use with multi-dose injection devices that use pre-filled cartridges" and the Submission Device uses terminology of "pen injector devices for the subcutaneous injection of drugs, including insulin". Multi-dose injection pens used with pre-filled cartridges were the injectors available at the time of the original 510(k). Since that time injector pens that are disposable that include the pre-filled cartridge have become prevalent in the market. Both injectors operate using the same principle, a pen needle is screwed onto the end and the drug is then injected.
We have tested our pen needles with both a re-useable pen injectors (which we referred to as "multi-dose injection device" in the original 510(k)) and disposable pen injectors. Our pen needles operate as intended on both re-useable pen injectors and disposable pen injectors.
8
The differences in the Indications for Use do not affect performance of the devices, or the safety and effectiveness of the devices. Therefore, Unifine Pentips and Unifine Pentips Plus are substantially equivalent to the Predicate Device and the Reference Predicate Devices in the device characteristics.
7. Performance Data
Non-clinical Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing
Table 7.1: List of Performance Tests to Standards
| Test | Standard | Result |
|---|---|---|
| Dimensions for needles | ISO 11608-2:2012 Section 4.2.2 | Meets standard |
| Needle points | ISO 11608-2:2012 Section 4.5 | Meets standard |
| Freedom from defects | ISO 11608-2:2012 Section 4.6 | Meets standard |
| Lubrication | ISO 11608-2:2012 Section 4.7 | Meets standard |
| Dislocation of measuring point at | ||
| patient end | ISO 11608-2:2012 Section 4.8 | Meets standard |
| Bond between hub and needle | ||
| tube | ISO 11608-2:2012 Section 4.4 | Meets standard |
| Ease of assembly/ disassembly | ISO 11608-2:2012 Section 4.10 | Meets standard |
| Sterilization | ISO 11608-2:2012 Section 4.11, | |
| ISO 11137-2:2007 (manufactured | ||
| pen needles in the UK), ISO | ||
| 11135-1:2006(manufactured pen | ||
| needles in Italy) | Meets standard | |
| Flow rate | ISO 11608-2:2012 Section 4.3 | Meets standard |
| Needle dose accuracy | ISO 11608-2:2012 Section 4.9, | |
| 11.4.2 | Meets standard | |
| Needle hub torque removal | ISO 11608-2:2012 Section 4.9, | |
| 11.4.3 | Meets standard |
Additionally, performance testing other than the above ISO Standards was performed on the devices. The devices comply with the acceptance criteria established based on the specifications of the devices.
Table 7.2: List of Internal Performance Tests
| Performance Test | Results |
|---|---|
| Force required to remove pen needle from primary container | Meets acceptance criteria |
| Force required to fit pen needle into primary container (UP) | Meets acceptance criteria |
| Force to remove needle shield from pen needle | Meets acceptance criteria |
The results of these tests demonstrate that the Unifine Pentips and Unifine Pentips Plus devices perform equivalent to the predicate devices when used as intended.
Biocompatibility
In accordance with ISO 10993-1, Unifine Pentips and Unifine Pentips Plus are classified as: Externally Communicating Device, Blood Path Indirect, Short Term (