(65 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a disposable needle for pen injectors, with no mention of AI or ML technologies.
No
Explanation: This device is a needle intended for use with pen injector devices to administer substances like insulin. It is an accessory to a therapeutic process but is not therapeutic itself.
No
The device is a needle intended for subcutaneous injection of medication using a pen injector. It is used for administering treatment, not for diagnosing conditions.
No
The device description clearly describes a physical needle intended for subcutaneous injection, which is a hardware component. There is no mention of software as the primary or sole component of the 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 various medications (insulin, liraglutide, semaglutide, and somatropin) using pen injector devices. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The description details a needle designed for injection, not for collecting or analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for drug delivery, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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 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.
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
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)
The NovoFine 32G Tip 6mm ETW needle was tested for compatibility with semaglutide injector (Ozempic) per ISO 11608-2.
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.
The scope of testing for the NovoFine® Portfolio included:
- 30G (0.30) x 8mm
- 31G (0.25) x 6mm
- 32G (0.23/0.25) x 6mm
- 32G (0.23/0.25) x 4mm
And for 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 32G x 6mm needle was considered representative for the entire NovoFine® Portfolio due to no difference in the pen-injector interface and being the worst-case needle for flow resistance. Compatibility testing for variant 2 and variant 4 was covered by the results of variant 1 due to identical maximum dose stop, hub design, and assessment that cartridge size/scale drum differences would not influence compatibility.
Materials used:
- 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 for low dose and 60 for high dose) were tested for each pen-injector variant. No rejections occurred regarding the stated parameters and tolerances for assembly torque, dose accuracy, and removal torque.
Key result: It is concluded that NovoFine® is functional compatible with DV3326 PDS290 semaglutide pen-injector variants in accordance with clause 11 in ISO 11608-2:2012 (1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/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 the | |
| subcutaneous injection of insulin, liraglutide, semaglutide | ||
| and somatropin | Intended for use with pen injector devices for the | |
| subcutaneous injection of insulin, liraglutide, and | ||
| somatropin | ||
| 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, cylindrical | ||
| part | 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 cap | ||
| from hub | Pull force range 1 - 15 N | Pull force range 1 - 15 N |
| Demounting force, inner cap | ||
| from 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 batch | ||
| Color: White | Polypropylene (PP) | |
| white master batch | ||
| Color: White |
| Parameters | NovoFine® 32G Tip x 6 mm ETW | NovoFine® 32G Tip x 6 mm ETW |
|---|---|---|
| Cannula | Stainless steel | |
| AISI / SUS 304 | ||
| DIN-kurzname: X 5 CrNi 18 9 | Stainless steel | |
| AISI / SUS 304 | ||
| DIN-kurzname: X 5 CrNi 18 9 | ||
| Glue | Single component epoxy | |
| adhesive | ||
| Color: Light yellow | Single component epoxy | |
| adhesive | ||
| Color: 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 coated | |
| with PS-118 laquer 6 g/m² for | ||
| ethylene oxide sterilization | ||
| Color: Light blue (RAL 5012) | Bactite 60K 43 g/m² coated | |
| with PS-118 laquer 6 g/m² for | ||
| ethylene oxide sterilization | ||
| Color: Light blue (RAL 5012) | ||
| Lubricating oil for patient | ||
| needle end | MDX4-4159 fluid 50 % | |
| Medical Grade Dispersion | ||
| (partly hardened silicone) | MDX4-4159 fluid 50 % | |
| Medical Grade Dispersion | ||
| (partly hardened silicone) | ||
| Lubricating oil for back | ||
| needle end | 360 Medical Fluid Silicone Oil | |
| 12500 cSt | 360 Medical Fluid Silicone Oil | |
| 12500 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, Japan
Nipro Corporation Ltd, Thailand |
|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization method | Ethylene Oxide (EtO or EO) sterilization process |
| Description of the method that will be used to validate the
sterilization cycle | The sterilization of NovoFine® 32G 6 mm ETW needles is
validated annually according to ISO 11135-1:2014
Sterilization of health care products - Ethylene oxide -
Part 1: Requirements for development, validation and
routine control of a sterilization process for medical
devices. |
| Description of the packaging to maintain the device's
sterility | The needle part that is to be inserted in the skin is placed
in an outer cap and sealing paper is welded onto the outer
cap. The combination of outer cap and sealing paper
maintain sterility until usage |
| If the sterilization involves ethylene oxide (EO), the
maximum levels of residuals. | Maximum level according to ISO 10993-7 |
| If the product is labeled "pyrogen free", a description of
the method used to make this determination, e.g., limulus
amebocyte lysate (LAL) | The LAL test of NovoFine® needles are made according
to United States Pharmacopoeia, USP, Chapter
"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 , that includes and directs to the Bacterial Endotoxin test USP Chapter .
(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.