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.

AI/ML Overview

This document is a 510(k) premarket notification for the NovoFine® hypodermic single lumen needle, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K173479).

Based on the provided text, there is no information regarding acceptance criteria for a device's performance that would typically be measured through sensitivity, specificity, accuracy, or other similar metrics. This document is for a medical device (hypodermic needle), and the "performance" discussed relates to its mechanical and material properties, rather than diagnostic accuracy or algorithmic performance.

Therefore, the following information cannot be extracted from the provided text, as it describes a different type of evaluation:

A table of acceptance criteria and the reported device performance (in terms of clinical outcomes or diagnostic metrics).
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
The sample size for the training set.
How the ground truth for the training set was established.

Instead, the document details non-clinical performance testing to demonstrate the device's physical and material properties meet established standards, thereby supporting its substantial equivalence to a predicate device.

Here's the relevant information that can be extracted concerning the device's characteristics and testing:

Device Acceptance Criteria and Performance (Non-Clinical/Engineering):

The document describes material and mechanical specifications that the device must meet, demonstrating its substantial equivalence to the predicate device. These are more akin to engineering specifications rather than clinical performance metrics.

Acceptance Criteria (Specification)	Reported Device Performance (Subject Device)
Outer diameter, cylindrical part	0.25-0.27 mm for 31G and 32G
	0.298-0.32 mm for 30G
Inner diameter	Minimum 0.146 mm for 31G and 32G
	Minimum 0.165 mm for 30G
Length from hub	4 mm for 32G
	6 mm for 31G and 32G
	8 mm for 30G
Gauge	30G, 31G, 32G
Tip configuration	1st and 2nd grinding and glass blasting
Hub/needle bond strength	Fmin = 22 N
Shelf life	5 years from production date
Biocompatibility	Complies with ISO 10993-1
Performance testing	Complies with ISO 11608-2: 2012, ISO 9626: 2016
Reuse	Single use
Sterilization	Ethylene Oxide
Package integrity	Protection of product and sterility maintenance after environmental conditioning and simulated transportation
Compatibility	Functional compatibility with all leading pen injectors on the market, maintaining dose accuracy

Study Information (Non-Clinical/Engineering):

Non-Clinical Tests Performed: The device underwent non-clinical performance testing to support the determination of substantial equivalence.
Testing Standards:
- ISO 10993-1: 2018 (Biological evaluation of medical devices)
- DS EN/ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
- ISO 11608-2: 2012 (Needle-based injection systems for medical use)
- ISO 9626: 2016 (Stainless steel needle tubing for the manufacture of medical devices)
- Particulates per ISO 11040-4:2015 (Prefilled syringes)
- ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices for shelf-life validation)
Biocompatibility Tests: In vitro cytotoxicity, intracutaneous reactivity, skin sensitisation, acute systemic toxicity, and haemocompatibility (haemolysis).
Functional Compatibility: Tested with a list of pen injectors (e.g., Autopen® 24, FlexPen®, Ozempic®, etc.) to demonstrate connectivity and maintenance of dose accuracy.
Package Integrity Testing: Conducted after environmental conditioning and simulated transportation in accordance with ISTA 3A, on final, packaged, and sterile devices.

The document does not describe a clinical study measuring diagnostic performance or AI algorithm effectiveness, as it pertains to a physical medical device.

Summary

{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)

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}------------------------------------------------

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 Devicethin 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

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 mmETW (extra thin wall) Predicate device
Parameter
Marketing status	K210258	K173479
Indication for use	Intended for use with pen injectordevices for the subcutaneousinjection of drugs	Intended for use with pen injector devicesfor 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 andthe following tests wereperformed- in vitro cytotoxicityintracutaneous reactivity,skin sensitisation,acute systemic toxicity andhaemocompatibility(haemolysis)	Comply with ISO 10993-1 andthe following tests wereperformed- in vitro cytotoxicityintracutaneous reactivity,skin sensitisation,acute systemic toxicity andhaemocompatibility(haemolysis)
Performance testing	ISO 11608-2: 2012ISO 9626: 2016	ISO 11608-2: 2012ISO 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 32G0.298-0.32 mm for 30G	0.25-0.27 mm 1
Inner diameter2	Minimum 0.146 mm for 31G and32GMinimum 0.165 mm for 30G	0.145-0.16 mm
Length from hub2	4 mm for 32G6 mm for 31G and 32G8 mm for 30G	4 mm
Gauge2	30G31G32G	32G
Tip configuration	1st and 2nd grinding and glassblasting	1st and 2nd grinding and glass blasting
Hub/<needle ≥ bondstrength	Fmin = 22 N	Fmin = 22 N
Materials
Hub	Polypropylene (PP) with PE whitemaster batchColor: White	Polypropylene (PP) with PE white masterbatchColor: White
	NovoFine®Subject device	NovoFine® 32G Tip (0.23/0.25) x 6 mmETW (extra thin wall) Predicate device
Cannula 3	Stainless steelAISI / SUS 304DIN-kurzname: X 5 CrNi 18 10 3	Stainless steelAISI / SUS 304DIN-kurzname: X 5 CrNi 18 9
Glue	Single component epoxy adhesiveColor: Light yellow	Single component epoxy adhesiveColor: 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 paper4	Gas permeable paperSterikraft 558 with coating: 5810A	Bactite 60K 43 g/m2 coatedwith PS-118 laquer 6 g/m2 forethylene oxide sterilizationColor: Light blue (RAL 5012)
Lubricating oil forpatient needle end	Medical grade silicone	Medical grade silicone
Lubricating oil forback needle end	Medical grade silicone	Medical grade silicone

Table 1 Side by side comparison of the subject device and predicate device

{6}------------------------------------------------

1 By administrative error, the outer diameter and pull force of inner cap from hub were described incorrectly in the predicate 510(k) (K173479) and corrected here.

2 These differences were assessed by performance testing, and there were no different questions of safety and effectiveness.

3 In ISO 15510:2014, the name of the stainless-steel material is stated both as X5CrNi-18-10.

4 The material of the sealing paper is identical between proposed device and predicate device. Only the name of the sealing paper has been changed by the supplier of the sealing paper.

6.1 Non-Clinical Tests Performed

The different indications for use of the subject pen needle device, do not raise different questions of safety and effectiveness compared to the indications for use of the predicate device. 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.

List of all ISO standards used in non-clinical performance testing (sterility, biocompatibility, and performance):

ISO 10993-1: 2018 Biological evaluation of medical devices-Part 1: Evaluation and ● testing within a risk management process.
DS EN/ISO 11607-2:2019 Packaging for terminally sterilized medical devices-Part 2: ● Validation requirements for forming, sealing and assembly processes
ISO 11608-2: 2012 Needle-based injection systems for medical use Requirements . and test methods -- Part 2: Needles
ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices ●
Particulates per ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for ● injectables and sterilized sub assembled syringes ready for filling

{7}------------------------------------------------

Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.

The sterilization process and shelf-life for NovoFine® remains the same as the predicate device, K173479. The sterilization method is Ethylene Oxide.

Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

7 Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Novofine® is substantially equivalent to the NovoFine® 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 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).