(65 days)
NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.
NovoFine® 32 G Tip (0.23/0.25) 6 mm ETW needle is designed for single use. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that "No physical change has been made from K062500 cleared on November 21, 2006 and K090111 cleared on February 1, 2010. The only change was to include an additional drug name in the indication for use statement."
Therefore, the "acceptance criteria" discussed are largely in reference to functional compatibility with the new drug (semaglutide) and adherence to existing standards, rather than new performance-based acceptance criteria for the needle itself.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a separate table for the device performance as a whole. Instead, it compares the current device to predicates based on established specifications and reports that functional compatibility tests were performed against an ISO standard.
For the functional compatibility with the semaglutide pen-injector, the acceptance criteria are implicit in the ISO 11608-2:2012 standard and the specific parameters tested:
| Parameter | Acceptance Criteria (Implicit from ISO 11608-2:2012) | Reported Device Performance (for NovoFine® 32G (0.23/0.25 mm) x 6mm) |
|---|---|---|
| Assembly Torque | Specified torque values | No rejections occurred |
| Dose Accuracy | (Standard-defined accuracy) | No rejections occurred |
| Removal Torque | Specified torque values | No rejections occurred |
| Biocompatibility | Adherence to ISO 10993 series | Followed ISO 10993-11:1993, ISO 10993-10:2002, ISO 10993-05, ISO 10993-04 |
| Sterilization | ISO 11135-1:2014, SAL 10-6, ISO 10993-7 (residuals) | Sterilization validated annually, LAL limit ≤ 20 EU/device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Functional Compatibility (Semaglutide): 120 pen needles for each pen-injector variant tested. This means 120 pen needles were tested with Variant 1 and 120 with Variant 3.
- (60 pen needles subsequent to low dose and 60 pen needles subsequent to high dose for each variant).
- Data Provenance: Not explicitly stated, but implies prospective testing conducted by Novo Nordisk (or a contracted lab) as part of the design verification for the 510(k) submission. No country of origin for data is specified, but the manufacturing sites are Nipro Medical Industries Ltd, Japan and Nipro Corporation Ltd, Thailand, which may imply where some testing could have occurred.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to this type of device and study. The testing involves objective physical measurements and adherence to international standards (ISO), not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. The testing involves objective physical measurements and adherence to international standards (ISO), not subjective interpretations requiring adjudication.
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
- This information is not applicable as the device is a hypodermic needle, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is a hypodermic needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's substantial equivalence and performance revolves around objective physical measurements compared against international standards (ISO 11608-2:2012 for pen-needles, ISO 10993 series for biocompatibility, ISO 11135-1:2014 for sterilization) and established internal specifications of the predicate device.
8. The sample size for the training set
- This information is not applicable. The device is a physical medical device (hypodermic needle), not a machine learning algorithm requiring a 'training set'. The "training" data refers to the historical data and performance of the predicate device.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated above. The "ground truth" for the predicate device would have been established through its own rigorous testing and adherence to standards at the time of its initial clearance (K062500 and K090111). The current submission relies on the fact that the physical design is identical to these previously cleared devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2018
Novo Nordisk Inc. Devraj Chakravarty Senior Manager, Regulatory Affairs P.O. Box 846 Plainsboro. New Jersev 08536
Re: K173479
Trade/Device Name: NovoFine® 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 12, 2017 Received: December 13, 2017
Dear Devraj Chakravarty:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina
Kiang-S
Tina Kiang, Ph.D. Acting 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)
Device Name
NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW (extra thin wall)
Indications for Use (Describe)
Indications for Use: NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin,
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."
l
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Novo Nordisk logo with the text "novo nordisk" in blue font. Above the logo is the text "K173479" in black font. The logo features a blue bull with a blue circle above its head.
510(k) Summary
21 CFR 807.87(h)
As required by 21 CFR 807.92(a)
(1) Date Prepared: November 7, 2017
This summary of 510(k) information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The NovoFine® 32 G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) needle meets all applicable product standards for hypodermic single lumen
needle products.
Submitter's Name and Address:
Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536
Contact Person: Devraj Chakravarty Senior Manager, Regulatory Affairs Tel: 609-786-5564 Fax: 609-681-5346
(2) Name of Device:
| Proprietary Name: | NovoFine ® 32 G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) |
|---|---|
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification Name: | Hypodermic single lumen needle (21 CFR 880.5570) |
| Class: | Class II |
| Product Code: | FMI |
(3) Substantial Equivalence:
NovoFine® 32 G Tip 6 mm ETW needles are disposable needles which are substantially equivalent to the NovoFine® 32 G Tip 6 mm ETW cleared under K062500 and K090111.
{4}------------------------------------------------
No physical change has been made from K062500 cleared on November 21, 2006 and K090111 cleared on February 1, 2010. The only change was to include an additional drug name in the indication for use statement.
| Parameters | NovoFine® 32G Tip x 6 mm ETW | NovoFine® 32G Tip x 6 mm ETW |
|---|---|---|
| Marketing Status | Subject of this Premarket Notification | Cleared under [510(k) K062500 and K090111] |
| Intended use | Intended for use with pen injector devices for thesubcutaneous injection of insulin, liraglutide, semaglutideand somatropin | Intended for use with pen injector devices for thesubcutaneous injection of insulin, liraglutide, andsomatropin |
| Product type | Hypodermic single lumen | Hypodermic single lumen |
| Durability | 5 years from production date | 5 years from production date |
| Biocompatibility | EN ISO 10993-1 | EN ISO 10993-1 |
| Reuse | Reuse | Reuse |
| Labeling | See Section 13: Proposed Labeling | See Section 13: Proposed Labeling-predicate labeling |
| Specifications | ||
| Outer diameter, tip | 0.22-0.25 mm | 0.22-0.25 mm |
| Outer diameter, cylindricalpart | 0.22-0.27 mm | 0.22-0.27 mm |
| Inner diameter | 0.145-0.16 mm | 0.145-0.16 mm |
| Wall thickness, tip | 0.03-0.053 mm | 0.03-0.053 mm |
| Wall thickness.cylindrical part | 0.045-0.063 mm | 0.045-0.063 mm |
Table 1 Comparison to a Legally Marketed Device
{5}------------------------------------------------
| Parameters | NovoFine® 32G Tip x 6 mm ETW | NovoFine® 32G Tip x 6 mm ETW |
|---|---|---|
| Total length | 15.82-16.88 mm | 15.82-16.88 mm |
| Length from hub | 6 mm | 6 mm |
| Gauge | 32 | 32 |
| Tip configuration | 1st and 2nd grinding and glass blasting | 1st and 2nd grinding and glass blasting |
| Sealing paper strength | $Pmin = 70 mBar$ | $Pmin = 70 mBar$ |
| Demounting force, outer capfrom hub | Pull force range 1 - 15 N | Pull force range 1 - 15 N |
| Demounting force, inner capfrom hub | Pull force range 0.5 - 7 N | Pull force range 0.5 - 7 N |
| Hub/≤needle ≥ bond strength | $Fmin = 22 N$ | $Fmin = 22 N$ |
| Materials | ||
| Hub | Polypropylene (PP)white master batchColor: White | Polypropylene (PP)white master batchColor: White |
| Parameters | NovoFine® 32G Tip x 6 mm ETW | NovoFine® 32G Tip x 6 mm ETW |
|---|---|---|
| Cannula | Stainless steelAISI / SUS 304DIN-kurzname: X 5 CrNi 18 9 | Stainless steelAISI / SUS 304DIN-kurzname: X 5 CrNi 18 9 |
| Glue | Single component epoxyadhesiveColor: Light yellow | Single component epoxyadhesiveColor: Light yellow |
| Inner needle cap | Polyethylene (PE)Color: White | Polyethylene (PE)Color: White |
| Outer needle cap | Polypropylene (PP)Color: Transparent white | Polypropylene (PP)Color: Transparent white |
| Sealing paper | Bactite 60K 43 g/m² coatedwith PS-118 laquer 6 g/m² forethylene oxide sterilizationColor: Light blue (RAL 5012) | Bactite 60K 43 g/m² coatedwith PS-118 laquer 6 g/m² forethylene oxide sterilizationColor: Light blue (RAL 5012) |
| Lubricating oil for patientneedle end | MDX4-4159 fluid 50 %Medical Grade Dispersion(partly hardened silicone) | MDX4-4159 fluid 50 %Medical Grade Dispersion(partly hardened silicone) |
| Lubricating oil for backneedle end | 360 Medical Fluid Silicone Oil12500 cSt | 360 Medical Fluid Silicone Oil12500 cSt |
(4) Device Description:
NovoFine® 32 G Tip (0.23/0.25) 6 mm ETW needle is designed for single use. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use
{6}------------------------------------------------
disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional.
After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.
The instructions for use are described in the user manuals for Novo Nordisk delivery devices for injection and are the same for all NovoFine® needles.
(5) Intended Use:
NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.
The intended use has been revised to include semaglutide. Performance data was provided to verify compatibility with semaglutide pen injector.
(6) Reprocessing, sterilization, shelf-life:
The sterilization process is identical to the predicate K062500. A summary of the sterilization information is provided below:
Table 1 Sterilization information for NovoFine® 32G (0.23x0.25) x 6 mm ETW needles
| Manufacturing site | Nipro Medical Industries Ltd, JapanNipro Corporation Ltd, Thailand |
|---|---|
| Sterilization method | Ethylene Oxide (EtO or EO) sterilization process |
| Description of the method that will be used to validate thesterilization cycle | The sterilization of NovoFine® 32G 6 mm ETW needles isvalidated annually according to ISO 11135-1:2014Sterilization of health care products - Ethylene oxide -Part 1: Requirements for development, validation androutine control of a sterilization process for medicaldevices. |
| Description of the packaging to maintain the device'ssterility | The needle part that is to be inserted in the skin is placedin an outer cap and sealing paper is welded onto the outercap. The combination of outer cap and sealing papermaintain sterility until usage |
| If the sterilization involves ethylene oxide (EO), themaximum levels of residuals. | Maximum level according to ISO 10993-7 |
| If the product is labeled "pyrogen free", a description ofthe method used to make this determination, e.g., limulusamebocyte lysate (LAL) | The LAL test of NovoFine® needles are made accordingto United States Pharmacopoeia, USP, Chapter <161>"Bacterial Endotoxin Test" with the limit ≤ 20 EU/device. |
| Sterility Assurance Level (SAL) | The SAL will be 10-6. |
| In case of radiation sterilization, the radiation dose | NA |
{7}------------------------------------------------
Endotoxin testing is conducted on every batch of the NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW (extra thin wall), with sample sizes and methods listed in USP general Chapter <161>, that includes and directs to the Bacterial Endotoxin test USP Chapter <85>.
(7) Technological Characteristics:
The NovoFine® 32 G Tip 6 mm ETW needle is considered substantially equivalent to the NovoFine® 32G Tip 6 mm ETW cleared under K062500 and K090111 in intended use, technology, principles of operation, materials and performance. The physical design is identical and only the data that are needed to evaluate substantial equivalence are included. The only modification to the predicate device was to include an additional drug name in the intended use. Because the device is physically identical, biocompatibility and sterility data are only described briefly here.
(8) Non-Clinical Tests Performed:
The NovoFine 32G Tip 6mm ETW needle was tested for compatibility with semaglutide injector (Ozempic) per ISO 11608-2.
Biocompatibility standards ISO 10993-11:1993, ISO 10993-10:2002, ISO 10993-05, ISO 10993-04, including cytotoxicity were followed.
{8}------------------------------------------------
Summarv
The purpose of this Design Verification Test report is to verify the functional compatibility between NovoFine® and DV3326 PDS290 semaglutide pen-injector variants according to clause 11 in ISO 11608-2:2012 (1). Compatibility testing according to clause 11 in ISO 11608-2:2012 (1) is covered by specified torque values for assembly, determination of dose accuracy and specified torque value for removal. This verification report documents tests performed according to the DVT protocol of compatibility of the DV3326 PDS290 semaglutide and NovoFine® (2).
The scope is:
- NovoFine® Portfolio: .
- 30G (0.30) x 8mm .
- 31G (0.25) x 6mm .
- . 32G (0.23/0.25) x 6mm
- 32G (0.23/0.25) x 4mm .
- All four variants of the DV3326 PDS290 semaglutide pen-injector: .
- . Variant 1: 0.25 mg/0.5 mg/1.0 mg
- Variant 2: 1.0 mg .
- . Variant 3: 0.25 mg/0.5 mg
- Variant 4: 1.0 mg. 3 ml .
The compatibility testing was performed with NovoFine® 32G (0.23/0.25) x 6mm and DV3326 PDS290 semaglutide pen-injector variant 1 and variant 3.
The NovoFine® 32G (0.23/025 mm) x 6mm is representative for the NovoFine® Portfolio based on the following:
- There is no difference in the pen-injector interface of the pen needle (needle thread and the length of the back end needle) for all NovoFine® needle variants.
- Flow resistance is proportional with the length of the needle and inverse proportional with the inner diameter of the needle: hence in regard to dose accuracy. NovoFine® 32Gx6 mm is considered the worst case needle and selected for test of compatibility.
Demonstrated compatibility between NovoFine® 32G (0.23/0.25 mm) x 6mm and the identified DV3326 PDS290 semaglutide pen-injector applies for the entire NovoFine® Portfolio.
The compatibility testing for variant 2 and variant 4 are covered by the test results from variant 1. The rationales of the compatibility test results for variant 2 and variant 4 are that all variants 1, 2 and 4:
{9}------------------------------------------------
- have identical maximum dose stop at 74 increments (corresponding to 0.740 ml and 1.0 mg . semaglutide) and therefore these variants are assessed to have identical high dose volume for the dose accuracy test
- . have identical needle interface hub design on the cartridge holder and therefore these variants are assessed to have identical hub assembly and removal characteristics and properties
The differences among variant 1. 2 and 4 are limited to cartidge size (1.5 ml versus 3 ml) and the scale drum imprints. Variant 2 and 4 do not have low dose volume due to that variant 2 and 4 are fixed dose device. These differences are assessed to have no influence on the compatibility test results. Therefore, variant 1 compatibility test results are considered sufficient to cover variant 2 and variant 4.
Following materials were used for the compatibility verification: NovoFine® 32G (0.23/025 mm) x 6mm batch 16F16S
DV3326 PDS290 semaglutide pen-injector variant 1 (0.25 mg/0.5 mg/1.0 mg) batch GV40055 DV3326 PDS290 semaglutide pen-injector variant 3 (0.25 mg/0.5 mg) batch GV40037
120 pen needles (60 pen needles subsequent to low dose and 60 pen needles subsequent to high dose) were tested for each pen-injector variant and no rejections occurred in regard to the stated parameters and tolerances for assembly torque, dose accuracy and removal torque.
It is concluded that NovoFine® is functional compatible with DV3326 PDS290 semaglutide peninjector variants in accordance with clause 11 in ISO 11608-2:2012 (1).
(9) Clinical Tests Performed:
No clinical tests are required.
(10) Conclusion drawn from the non-clinical and clinical tests:
Based on the design equivalency and the functional testing, the NovoFine® 32 G Tip 6 mm ETW is substantially equivalent to NovoFine® 32G Tip 6 mm ETW cleared under K062500 and K090111 which is currently marketed in the United States. The only modification to the predicate device was to include an additional drug name in the intended use.
§ 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).