(310 days)
The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.
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.
This document is a 510(k) Premarket Notification for medical devices, specifically pen needles. It is not a study proving an AI/ML medical device meets acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be extracted from this document.
This document focuses on demonstrating substantial equivalence of the Unifine® Pentips® and Unifine® Pentips® Plus pen needles to legally marketed predicate devices, primarily K973899 (Unifine® Pentips®). This is a regulatory pathway for Class II medical devices in the US, where the manufacturer needs to show that their new device is as safe and effective as an already cleared device.
Here's what can be extracted based on the provided text, and where the requested information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these pen needles are primarily defined by adherence to ISO standards and internal performance tests. The document states that the devices meet these standards/criteria.
| Test / Characteristic | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| 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 (UK), ISO 11135-1:2006 (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 |
| Force required to remove pen needle from primary container | Established internal acceptance criteria based on device specifications | Meets acceptance criteria |
| Force required to fit pen needle into primary container (UP) | Established internal acceptance criteria based on device specifications | Meets acceptance criteria |
| Force to remove needle shield from pen needle | Established internal acceptance criteria based on device specifications | Meets acceptance criteria |
Note: The document states "The devices comply with the acceptance criteria established based on the specifications of the devices" for internal tests, but does not provide the specific numerical criteria for these tests.
Regarding the study that proves the device meets acceptance criteria (for an AI/ML context):
This document describes a regulatory submission for a physical medical device (pen needles), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC studies" as they apply to AI/ML performance evaluation are not relevant here. The "study" described is a series of non-clinical performance (bench) tests and biocompatibility tests to demonstrate substantial equivalence to existing devices.
Here's why the specific questions are not applicable or cannot be answered from this document:
2. Sample sized used for the test set and the data provenance:
- Not Applicable in AI/ML context: This is a physical device. "Test set" refers to samples tested during bench testing.
- Sample Size: The document does not specify the number of pen needles tested for each performance test. It only states that the tests were performed and results "meet standard" or "meet acceptance criteria."
- Data Provenance: Not applicable in the AI/ML sense. Data is from laboratory bench testing of manufactured pen needles. The manufacturing locations mentioned are the UK (Owen Mumford) and Italy (Artsana S.p.A.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: There is no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for a physical device like a pen needle. The "ground truth" is defined by the objective physical and mechanical properties measured against established ISO standards and internal specifications. Bench testing is typically performed by trained technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No expert adjudication process as would be used for clinical image interpretation or AI model validation. Bench tests have objective, measurable outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This type of study (MRMC, human readers, AI assistance) is for clinical decision support or diagnostic AI devices. This document is for a mechanical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in AI/ML context: The "ground truth" for these pen needles is defined by objective physical and mechanical measurements against established ISO standards (e.g., dimensions, flow rate, bond strength) and internal engineering specifications. Biocompatibility is assessed through standardized biological tests.
8. The sample size for the training set:
- Not Applicable: This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: As above, no training set or AI/ML ground truth. The "ground truth" for manufacturing and quality control of pen needles is based on engineering specifications and adherence to international standards for medical devices.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SECTION 5.0
510(k) SUMMARY: 510k Number: K152339
1. Submitter
| Prepared by: | Patty Cronan - Quality ManagerQuality ManagerOwen Mumford USA Inc.Tel. (770) 977-2226Fax (770) 977-2866 |
|---|---|
| Prepared for: | Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 8021764 |
| Contact Person: | Patty Cronan - Quality ManagerQuality ManagerOwen Mumford USA Inc.Tel. (770) 977-2226Fax (770) 977-2866Email: 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}------------------------------------------------
| DeviceCharacteristic | SubmissionDevice: UnifinePentips & UnifinePentips Plus(K152339) | Primary Predicate:Unifine Pentips &Unifine PentipsPlus (K973899) | ReferencePredicate: ArtsanaInsuPen® InsulinPen Needles(K051783) | ReferencePredicate: BD PenNeedles (K051899& K100005) | |
|---|---|---|---|---|---|
| Intended Use | The Unifine Pentipsrange of penneedles areintended for usewith pen injectordevices for thesubcutaneousinjection of drugs,including insulin. | The Unifine Pentipis single use,disposablehypodermic singlelumen needledesigned for usewith multi-doseinjection devicesthat use prefilledcartridges.The protectivepaper is removedfrom the pentipwhich is thenscrewed onto thedevice cartridgehousing and thenused in theprescribed manner.One of the mainuses of the pentipis for use with peninjectors for thedelivery of insulinwhich is supplied inthe form of prefilledcartridges. Thepatient places afresh pentip needleonto the peninjector, dials adose, inserts thepentip into the skinand delivers thedose. | Artsana disposablesterile pen needlesare used withinsulin pen injectordevices for thesubcutaneousinjection of insulinin the treatment ofdiabetes. | BD Pen Needle isintended for usewith pen injectordevice forsubcutaneousinjection of drugs,including insulinand exenatide. | |
| Prescription orOTC | OTC | Prescription | Prescription | OTC | |
| OperationPrinciple | Manual | Manual | Manual | Manual | |
| Design/Construction | Needle assembly(cannula, needlehub, needle shield,outer container) | Needle assembly(cannula, needlehub, needle shield,outer container) | Needle assembly(cannula, needlehub, needle shield,outer container) | Needle assembly(cannula, needlehub, needle shield,outer container) | |
| Materials | Unifine Pentips byArtsana S.p.A.:• Cannula -Stainless Steel• Lubricant -Silicone | Unifine Pentips byArtsana S.p.Α.:• Cannula -Stainless Steel• Lubricant -Silicone | • Cannula –Stainless Steel• Lubricant –Silicone• Adhesive -Medical GradeAdhesive | • Cannula -Stainless Steel• Lubricant -Silicone Based• Outer Container– Polypropylene | |
| DeviceCharacteristic | SubmissionDevice: UnifinePentips & UnifinePentips Plus(K152339) | Primary Predicate:Unifine Pentips &Unifine PentipsPlus (K973899) | ReferencePredicate: ArtsanaInsuPen® InsulinPen Needles(K051783) | ReferencePredicate: BD PenNeedles (K051899& K100005) | |
| Adhesive• Needle Hub -Polypropylene• Needle Shield -High DensityPolyethylene• Outer Container- High DensityPolyethylene• Sterility Seal -Paper LaminateUnifine Pentips byOwen Mumford:• Cannula -Stainless Steel• Lubricant -Silicone• Adhesive -Medical GradeAdhesive• Needle Hub –Polypropylene• Needle Shield -High DensityPolyethylene• Outer Container- High DensityPolyethylene• Sterility Seal -Paper LaminateUnifine PentipsPlus by OwenMumford:• Cannula -Stainless Steel• Lubricant -Silicone• Adhesive -Medical GradeAdhesive• Needle Hub -Polypropylene• Needle Shield -High DensityPolyethylene• Outer Container- Polypropylene• Sterility Seal -Paper Laminate | Adhesive• Needle Hub -Polypropylene• Needle Shield -High DensityPolyethylene• Outer Container- High DensityPolyethylene• Sterility Seal -Paper Laminate | Polypropylene• Needle Shield -High DensityPolyethylene• Outer Container- High DensityPolyethylene• Sterility Seal -Paper Laminate | available for thesedevices. | ||
| Package | • Plastic outercontainer• Sterility Seal | • Plastic outercontainer• Sterility Seal | • Plastic outercontainer• Sterility Seal | • Plastic outercontainer• Sterility Seal | |
| • Shelf box | • Shelf box | • Shelf box | • Shelf box | ||
| DeviceCharacteristic | SubmissionDevice: UnifinePentips & UnifinePentips Plus(K152339) | Primary Predicate:Unifine Pentips &Unifine PentipsPlus (K973899) | ReferencePredicate: ArtsanaInsuPen® InsulinPen Needles(K051783) | ReferencePredicate: BD PenNeedles (K051899& K100005) | |
| Needle Specifications | NeedleLength | Unifine Pentipsmanufactured forOwen MumfordLtd: 4mm for 32G;5mm, 6mm, 8mmfor 31G; 12mm for29GUnifine Pentips byOwen Mumford:4mm for 32G;5mm, 6mm and8mm for 31G;12mm for 29GUnifine PentipsPlus by OwenMumford: 4mm for32G; 5mm, 6mmand 8mm for 31G;12mm for 29G | Unifine Pentipsmanufactured forOwen MumfordLtd: 8mm for 31G;12mm for 29G | 4mm for 33G,4mm, 6mm and8mm for 32G, 8mmfor 30G, 5mm,6mm and 8mm for31G, 12mm for29G | 4mm for 32G, 5mmand 8mm for 31Gand 12.7mm for29G |
| EffectiveGauge | 29G, 31G and 32G | 29G and 31G | 29G, 30G, 31G,32G and 33G | 29G, 31G and 32G | |
| TipConfigura-tion | Patient-side: Tri-bevel (3) | Patient-side: Tri-bevel (3) | Patient-side: Tri-bevel (3) | Patient-side: 5bevel | |
| Sterilization | Unifine Pentipsmanufactured forOwen MumfordLtd: Ethylene Oxide(validated toachieve SAL 10-6)Unifine Pentips byOwen Mumford:Gamma Radiation(validated toachieve SAL 10-6)Unifine PentipsPlus by OwenMumford: GammaRadiation(validatedto achieve SAL 10-6) | Unifine Pentipsmanufactured forOwen MumfordLtd: Ethylene Oxide(validated toachieve SAL 10-6) | Ethylene Oxide(validated toachieve 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 atpatient end | ISO 11608-2:2012 Section 4.8 | Meets standard |
| Bond between hub and needletube | 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 (manufacturedpen needles in the UK), ISO11135-1:2006(manufactured penneedles 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 (<24 hours) Use, as the cannula is immediately withdrawn after injection into the body. The biocompatibility evaluation for finished devices' blood/body contacting parts were conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1:
{9}------------------------------------------------
Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation ●
- Systemic Toxicity ●
- Hemocompatibility .
- LAL & Rabbit Material Mediated Pyrogen Testing ●
Results of the testing demonstrate the devices are biocompatible.
Sterilization
The sterility of the devices is assured using a sterilization method validated in accordance with ISO 11137 – Medical Devices – Validation and Routine Control of Radiation Sterilization for Unifine Pentips and Unifine Pentips Plus manufactured by Owen Mumford UK. The sterility of Unifine Pentips manufactured for Owen Mumford by Artsana S.p.A. is assured using a sterilization method validated in accordance with ISO 11135 - Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization. Through both sterilization methods used, all Unifine Pentips and Unifine Pentips Plus are sterilized to provide a Sterility Assurance Level (SAL) of 10-6.
8. Clinical Data
Clinical Data per 807.92(b)(2) was not required to establish substantial equivalence for these devices.
9. Conclusions
In summary, the Unifine Pentips and Unifine Pentips Plus devices, subject of this 510(k), are substantially equivalent in their intended use, technology/principle of operation, materials, and performance to the predicate devices.
§ 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).