(142 days)
Not Found
No
The device description and performance studies focus on the mechanical function and compatibility of a sterile needle for subcutaneous injection, with no mention of AI or ML technologies.
No
The device, a needle, is used for drug delivery but does not directly treat a condition. It is an accessory to a therapeutic device (the pen injector and the drug).
No
The device is a needle intended for subcutaneous injection of drugs, not for diagnosing conditions.
No
The device description clearly describes a physical needle for subcutaneous injection, which is a hardware component.
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 a substance into the body.
- Device Description: The description details a needle for injecting drugs using a pen injector. This is a delivery mechanism for medication.
- 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. This device does not perform any such analysis of bodily specimens.
The device is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. 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.
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 non-clinical performance testing supports the determination of substantial equivalence. NovoFine® has been tested for functional compatibility according to ISO 11608-2:2012 with all leading pen injectors available on the market. This testing has shown connectivity to NovoFine® and maintenance of the dose accuracy through the needle of all leading pen-injectors on the market covering different types of drugs.
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.
June 23, 2021 Novo Nordisk Inc. Hiral Shah Associate Manager, Regulatory Affairs P.O Box 846 Plainsboro, New Jersey 08536
Re: K210258
Trade/Device Name: NovoFine Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: May 21, 2021 Received: May 24, 2021
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 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
1
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 mediation-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,
For Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K210258
Device Name NovoFine®
Indications for Use (Describe)
NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K210258 510(k) Summary
As required by 21 CFR 807.92(a)
Date Prepared: June 23, 2021
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The NovoFine® needle portfolio meets all applicable product and quality standards for hypodermic single lumen needle products.
Submitter's Name and Address: 1
Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536
Contact Person: Hiral Palkhiwala Shah Manager, Regulatory Affairs Tel: 609-787-7603 Email: hpaw@novonordisk.com
Name of Device: 2
| Trade Name: | NovoFine® |
|---|---|
| Common or usual name: | Pen Needle |
| Classification: | Class II device; |
| Regulation Name: | Hypodermic single lumen needle |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI (hypodermic single lumen needle) |
| Predicate Device | |
| thin wall) | K173479, NovoFine® 32G Tip (0.23/0.25) x 6 mm ETW (extra |
3 Substantial Equivalence:
Predicate Device: NovoFine® 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479, cleared January 17, 2018)
The main purpose of this submission is to expand the indications for use, which is not restricted to the drugs listed in the predicate device's indications for use.
Additionally, following minor changes have been implemented between the subject device and the predicate NovoFine®:32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479, cleared January 17, 2018)
4
- a. Addition of the additional NovoFine® needle variants (30 G 8mm, 31 G 6mm and 32 G 4mm)
- b. Tightened specification for minimum inner diameter of the cannula for 32G
The above changes do not affect intended use, materials, principle of operation, shelf life, and biocompatibility. The technological differences do not raise different questions of safety and effectiveness. Additionally, the data demonstrate equivalence and support the indications for use. Therefore, NovoFine® subject of this 510(k) is substantial equivalent to NovoFine® 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall cleared on January 17, 2018) (K173479) the predicate device.
Device Description: ব
NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. 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 device has demonstrated compatibility with the following pen injectors: Autopen® 24. Autopen® Classic, BerliPen® 302, BerliPen® aero 2, Byetta® Pen, ClickStar®, FlexPen® Levemir, FlexPro® 5mg, FlexPro® 15mg, FlexTouch® NovoRapid, HumaPen® LuxuraTM, HumaPen® LuxuraTM HD, InnoLet®, KwikPen®, NordiFlex® 15 mg, NordiPen® 15mg, NovoPen Echo®, NovoPen® 4, NovoPen® 5, Ozempic® (0.25mg/0.5mg/1.0mg), Saxenda®, SoloStar® Lantus, TactiPen®, Victoza® Pen (GLP-1), and Xultophy®.
5 Indication for use:
NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Technological Characteristics: 6
The NovoFine® is considered substantially equivalent to the predicate NovoFine® disposable needle in intended use, technology, principles of operation, materials and performance. Differences between the devices do not raise any sigmificant issues of safety and effectiveness. For a detailed side by side comparison to the predicate needle cleared by the Agency, please see Table 1.
5
Comparison with Predicate Devices:
The subject device is considered substantially equivalent in device design, materials, fundamental scientific technology and device performance as the predicate devices (K173479). The purpose of this submission is to expand the indications for use, which is not restricted to the drugs listed in the predicate device's indications for use. The table below provides a side by side comparison of the subject device compared to its predicate.
| | NovoFine®
Subject device | NovoFine® 32G Tip (0.23/0.25) x 6 mm
ETW (extra thin wall) Predicate device |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | | |
| Marketing status | K210258 | K173479 |
| Indication for use | Intended for use with pen injector
devices for the subcutaneous
injection of drugs | Intended for use with pen injector devices
for the subcutaneous injection of insulin,
liraglutide, semaglutide and somatropin |
| Product type | Hypodermic single lumen needle | Hypodermic single lumen needle |
| Shelf life | 5 years from production date | 5 years from production date |
| Biocompatibility | Comply with ISO 10993-1 and
the following tests were
performed
- in vitro cytotoxicity
intracutaneous reactivity,
skin sensitisation,
acute systemic toxicity and
haemocompatibility
(haemolysis) | Comply with ISO 10993-1 and
the following tests were
performed - in vitro cytotoxicity
intracutaneous reactivity,
skin sensitisation,
acute systemic toxicity and
haemocompatibility
(haemolysis) |
| Performance testing | ISO 11608-2: 2012
ISO 9626: 2016 | ISO 11608-2: 2012
ISO 9626: 2016 |
| Reuse | Single use | Single use |
| Labelling | 100 needles (trade)
7 needles (sample) | 100 needles (trade)
7 needles (sample) |
| Specifications | | |
| Outer diameter,
cylindrical part2 | 0.25-0.27 mm for 31G and 32G
0.298-0.32 mm for 30G | 0.25-0.27 mm 1 |
| Inner diameter2 | Minimum 0.146 mm for 31G and
32G
Minimum 0.165 mm for 30G | 0.145-0.16 mm |
| Length from hub2 | 4 mm for 32G
6 mm for 31G and 32G
8 mm for 30G | 4 mm |
| Gauge2 | 30G
31G
32G | 32G |
| Tip configuration | 1st and 2nd grinding and glass
blasting | 1st and 2nd grinding and glass blasting |
| Hub/