(116 days)
No
The summary describes a sterile single-use needle for subcutaneous injection and focuses on material, dimensional, and performance standards (ISO 9626, ISO 11608-2). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is a needle intended for drug injection, not for treating a disease or condition itself.
No
Explanation: The device, NovoFine® Plus, is a single-use needle for subcutaneous injection of drugs. Its intended use is to deliver drugs, not to diagnose diseases or conditions. The performance studies focus on technological characteristics, compliance to material/dimension requirements, and performance as a drug delivery needle, not on diagnostic capabilities.
No
The device description clearly states it is a "sterile single use needle for subcutaneous injection of drugs," which is a physical hardware component. The performance studies also focus on material, dimension, and performance testing of the needle itself.
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." This is a therapeutic purpose, delivering medication into the body.
- Device Description: The device is described as a "sterile single use needle for subcutaneous injection of drugs." This aligns with a device used for administering substances into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens for diagnostic purposes.
Therefore, the NovoFine® Plus needle is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes
FMI
Device Description
NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
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 subject device NovoFine® Plus (subject needle) has the substantially equivalent technological characteristics as the predicate device NovoFine® Plus cleared under K202005.
Novo Nordisk has verified the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included confirmation of compliance to material and dimension requirements, as per ISO 9626 Stainless steel needle tubing for the manufacture of medical devices, and to performance, as per ISO 11608-2: Needle-based injection systems for medical use – Requirements and test methods– Part 2: Needles.
The 29G gauge needle does not introduce critical differences or new risks to the intended use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2023
Novo Nordisk Inc. Hiral Shah Manager, Regulatory Affairs P.O Box 846 Plainsboro, New Jersey 08536
Re: K231255
Trade/Device Name: NovoFine® Plus Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 9, 2023 Received: August 11, 2023
Dear Hiral Shah:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan Sthe
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery, General Hospital, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231255
Device Name NovoFine® Plus
Indications for Use (Describe)
Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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5 510(k) Summary
21 CFR 807.87(h)
As required by 21 CFR 807.92(a)
(1) Date Prepared: August 25, 2023
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The subject of this Special 510(k) submission is the NovoFine® Plus with gauge 29G, hereafter named 'NovoFine® Plus (subject needle)'. The NovoFine® Plus (subject needle) meets all applicable product and quality standards for hypodermic single lumen needle products. NovoFine® Plus product family will be expanded to include NovoFine® Plus (subject needle).
Submitter's Name and Address
Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536
Contact Person: Hiral Palkhiwala Shah Senior Manager, Regulatory Affairs Tel: 609-787-7603 Email: hpaw@novonrdisk.com
(2) Name of Device
Proprietary Name: Common or usual name: Classification:
Product Code:
NovoFine® Plus Pen Needle Class II device; 21 CFR 880.5570, (hypodermic single lumen needle) FMI (hypodermic single lumen needle)
(3) Substantial Equivalence
Predicate Device: NovoFine® Plus 32G 4 mm ETW cleared under K202005 on December 19, 2020.
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(4) Device Description
NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
Mode of operation
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.
(5) Intended Use
Intended for use with pen injector devices for the subcutaneous injection of drugs.
Comparison with Predicate Devices
The NovoFine® Plus (subject needle) has the same intended use, indications for use, intended users, basic design, principle of operation, component materials, biocompatibility, shelf life and application of design controls for its development as the NovoFine® Plus cleared under K202005.
Specifically for biocompatibility, an evaluation according to ISO 10993-1:2018 'Biological evaluation of medical devices Part 1 : Evaluation and testing within a risk management process' has been made, which is valid for both the NovoFine® Plus (subject needle) and the NovoFine® Plus cleared under K202005. The evaluation, performed considering all parts of the device having direct or indirect contact with the patient, concludes that NovoFine® Plus does not pose a risk of cytotoxicity, skin irritation, skin sensitisation, material-mediated pyrogenicity, acute or subacute toxicity, genetic toxicity, implantation reactions or any other biological hazard as defined in ISO 10993-1:2018 when used as intended.
In addition, the manufacturing, quality control and clinical evaluation process for the NovoFine® Plus (subject needle) are the same as for the NovoFine® Plus cleared under K202005.
The purpose of this submission is to introduce the 29G gauge needle into the NovoFine® Plus product family, where the predicate device has a 32G gauge needle (see Table 1).
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Table 1 Comparison of the characteristics of the NovoFine® Plus (subject needle) and the NovoFine® Plus cleared under K202005 (predicate needle)
| Feature | NovoFine® Plus (subject needle)* | NovoFine® Plus cleared under
K202005 (predicate needle) |
|-------------------------|----------------------------------|-------------------------------------------------------------------------------------------|
| 510(k)Number | K231255 | K202005 |
| Intended Use | Same as predicate | Intended for use with pen injector
devices for the subcutaneous injection
of drugs. |
| Needle Gauge Size (s) | 29G | 32 G |
| Needle Length Size (s) | Same as predicate | 4 mm |
| Needle insertion method | Same as predicate | Manual |
| Provided Sterile | Same as predicate | Sterile - steam |
- The NovoFine® Plus product family will include the 32G and 29G gauge needle. Only the 29G gauge needle information is presented in this column
(6) Testing
The subject device NovoFine® Plus (subject needle) has the substantially equivalent technological characteristics as the predicate device NovoFine® Plus cleared under K202005.
Novo Nordisk has verified the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included confirmation of compliance to material and dimension requirements, as per ISO 9626 Stainless steel needle tubing for the manufacture of medical devices, and to performance, as per ISO 11608-2: Needle-based injection systems for medical use – Requirements and test methods– Part 2: Needles.
The 29G gauge needle does not introduce critical differences or new risks to the intended use of the device.
(7) Conclusion
Based on the design equivalency and the functional testing. Novo Nordisk has determined that the NovoFine® Plus (subject needle) is substantially equivalent to the NovoFine® Plus cleared under K202005, which is currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.