Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, sterilization, and sharps injury protection features, with no mention of AI or ML.

Therapeutic

Yes.
The Disposable Insulin Pen Needle is intended for the subcutaneous injection of insulin, which is a therapeutic action.

Diagnostic

No

Explanation: The device is described as a "Disposable Insulin Pen Needle" used for the "subcutaneous injection of insulin." Its function is to deliver a substance (insulin) and protect against sharps injuries (for Model ST), not to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like needles, hubs, shields, and springs, and the performance studies focus on physical properties, sterilization, and biocompatibility. There is no mention of software.

IVD (In Vitro Diagnostic)

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 insulin" using a pen injector device. This is a therapeutic action, delivering a substance into the body.
Device Description: The description details the physical components of a needle designed for injection. It focuses on features related to delivering a substance and preventing sharps injuries.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to test things like blood, urine, or tissue samples.

The device is clearly designed for the administration of medication, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable Insulin Pen Needle (Model CT): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle (Model ST): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Product codes

FMI

Device Description

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider, protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

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

Home, Health center. For self-administration or by a caregiver.

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

Sterilization: Disposable Insulin Pen Needle is sterilized by EO gas and the sterility assurance level (SAL) is 10⁻⁶. The process has been validated according to ISO 11135: 2014. The maximum EO residual that remain on the device is less than 0.8mg, the maximum ECH residual that remain on the device should be less than 1.8mg according to ISO 10993-7:2008.

Product performance: After sterilization, Disposable Insulin Pen Needle meets criteria specified in ISO 11608-2: 2012; ISO 9626: 2016; ISO 7864: 2016 and other applicable standards.

Functional compatibility with needle-based injection systems: Selected the insulin pens of commonly used in the U.S. market for compatibility verification. The tests have been completed, the insulin pens which are declared in the label are compatible with the needle.

Transport: The simulated transportation test has been completed according to the requirements of ASTM D4169-16. Model CT and Model ST of the products are implemented simulated transportation test. The test result is passed.

Shelf life: The performance of ISO 11608-2, chemical properties, bacterial endotoxin and leakage test (according to ASTM F1929-2015) of Model CT and Model ST have been tested individually before accelerated aging, after 4 years of accelerated aging and 5 years of accelerated aging. According to the accelerated aging test results, the shelf life of the product is determined to be 5 years.

Biocompatibility: Disposable Insulin Pen Needle meets the requirements of ISO 10993 series standards, and the following tests are performed: Cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, subchronic toxicity and material-mediated pyrogenicity. With the requirement of USP , particulate matter for injections also is performed.

Sharps protection features: Model ST product meets the requirements of safe-lock guard activation and safety overriding/unlocking force after activation(triggering performance) as per ISO 23908:2011.

Clinical simulated use testing: Model ST of Disposable Insulin Pen Needle is a sterile, single-use medical device with an integral sharps injury prevention feature, intended for use with pen injector device for subcutaneous injection of insulin. According to ISO 23908:2011 and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection. The test results show that Model ST of the product has well sharps injury prevention feature.

The compatible pen injectors: 1. NovoPen Echo, K162602, Novo Nordisk Inc. 2. Humapen Luxura, K142518, Eli Lilly and Company 3. Humapen Luxura HD, K100988, Eli Lilly and Company 4. HumanPen Ergo II, K151686, Eli Lilly and Company

Key Metrics

Not Found

Predicate Device(s)

K170846, K192677

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

November 17, 2022

Ningbo Medsun Medical Co., Ltd. % Marvin Li Consultant Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313. No. 620 Zhennan Road (Building 9, Tongji University Science Park), Putuo District Shanghai, 200331 China

Re: K221178

Trade/Device Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 18, 2022 Received: October 21, 2022

Dear Marvin Li:

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).

CAPT. Alan M. Stevens 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

Sincerely,

Alan M.
Stevens -
S3
Alan Str

Image /page/1/Picture/8 description: The image shows the word "Sincerely," followed by a signature and the name "Alan M. Stevens - S3". The signature is in black ink and is difficult to read. The name is in a simple, sans-serif font. The image is likely a scan of a document.

2

Indications for Use

510(k) Number (if known) K221178

Device Name Disposable Insulin Pen Needle

Indications for Use (Describe)

Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

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

K221178

510(k) Summary

1.Date Prepared: November 17th, 2022

2.Submitter

Ningbo Medsun Medical Co., Ltd.

No.55 Jinxi Road, Zhenhai, 315221, Ningbo, P.R.China

Contact Person: Liu Ping, Regulation Affairs Manager

Tel: +86-574-86301708 Fax:+86-574-86301778

Primary correspondent: Marvin Li, Consultant Tel:+86-15257179656 E-mail: leeking0908@126.com Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313, No. 620 Zhennan Road(Building 9, Tonqii University Science Park), Putuo District, 200331, Shanghai, P.R.China Date Prepared: November 17th, 2022

3.Device

Trade Name: Disposable Insulin Pen Needle Common Name: Hypodermic single lumen needle Classification Name: Needle, Hypodermic, Single Lumen Regulation Number:21 CFR 880.5570 Regulatory Class: II Product Code: FMI Review Panel: General Hospital 4. Predicate device 4.1 Primary Predicate device A Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Disposable Insulin Pen Needle 510(k) number: K170846 Secondary Predicate device B Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Safety Pen Needle 510(k) number: K192677

5.Device description

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider,

4

510(k) Notification document-Disposable Insulin Pen Needle

protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

6.Indications for use

Disposable Insulin Pen Needle (Model CT): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle (Model ST): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

7.Comparison of technological characteristics with the predicate device

7.1Comparison between Model CT Disposable Insulin Pen Needle and Predicate Device A

| Description | Subject Device (Model CT)
(K221178) | Predicate Device A
(K170846) | Remark |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary/
trade name | Disposable Insulin
Pen Needle | Disposable Insulin
Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation
Number | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Indications
for use | Disposable Insulin Pen
Needle is intended for use
with pen injector device for
subcutaneous injection of
insulin. | The Disposable Insulin
Pen Needle is intended for
use with pen injector
devices for the
subcutaneous injection of
insulin. | Same |
| Prescription/over
-the counter use | Over-the counter use | Over-the counter use | Same |
| Operation Mode | Manual | Manual | Same |
| Environment
of use | Home, Health center | Home, Health center | Same |
| 510(k) Notification document-Disposable Insulin Pen Needle | | | K221178 |
| Intended users | For self-administration
or by a caregiver | | Same |
| Hub/needle
bond strength | Conform with ISO 11608-2 | | Same |
| Method of
attachment to
pen injector | Screw structure, conform with ISO 11608-2 | | Same |
| Needle tip
configuration | Tri-bevel edge needle | | Same |
| Shelf life | 5 years | | 3 years
(Note 1) |
| Size(s) | Outer
diameter | Length | Similar
(Note 2) |
| | 0.33mm | 10mm,
12mm | |
| | 0.30mm | 5mm | |
| | 0.25mm | 5mm,6mm,8
mm | |
| | 0.23mm
0.20mm | 4mm,5mm,
6mm,8mm
4mm | |
| Configuration
and Material | Needle tube | Stainless
steel
SUS304 | Cannula
304 Stainless Steel |
| | Needle hub | PP | Hub
Polypropylene |
| | Needle
container | PP | Needle
Cap
Polyethylene |
| | Needle
shield | PP | Needle Hub
Protector
Polypropylene
(Note 3) |
| | Lubricant | Silicon oil | Lubricant
Polydimethyls iloxane |
| | Adhesive | UV glue | / |
| | Seal | Medical
dialyzing
paper | Sealed
Paper
Paper |
| | | | Needle Gauge:29G, 30G,
31G, 32G
Needle Dimension (mm):
0.23×4, 0.25×4, 0.25×5,
0.25×6, 0.25×8, 0.30×8,
0.30×10, 0.33×12 |
| 510(k) Notification document-Disposable Insulin Pen Needle | | | K221178 |
| Performance | Meet the requirements of
ISO 7864, ISO 9626, ISO
11608-2 | Comply with ISO 7864,
ISO 9626, and ISO
11608-2 | Same |
| Sterilization | EO Sterilization | EO sterilized, SAL: 10-6 | Same |
| | SAL:10-6 | | |
| Labeling | Conform with 21 CFR 801 | Conform with 21 CFR 801 | Same |
| Biocompatibility | Meet the requirements of
ISO10993 series
standards, and the
following tests are
performed: In vitro
cytotoxicity, skin
sensitization,
intracutaneous reactivity,
acute systemic toxicity,
hemocompatibility,
subchronic toxicity,
particulate matter for
injections and pyrogen. | Conform with ISO 10993
standards | Similar
(Note 4) |
| Reuse or
single use | Single use | Single use | Same |

5

6

Note 1: The shelf life of the predicate device A is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.

Note 2: The outer diameter (gauge) of the predicate device A is covered by the subject device. The subject device has a 0.20mm(33G) type, while the predicate device A doesn't have. The lengths of the subject device for each outer diameter(gauge) have some differences that are physical, the performance bench testing of needle tube with lengths for subject device are demonstrated to meet the requirements of ISO 11608-2.

Note 3: The configuration and material of the predicate device A are mostly the same as the subject device. For the subject device, the adhesive is UV glue, where the predicate device's adhesive is unknown. UV glue is widely used for Insulin Pen Needle hub and needle tube. The safety of UV glue is demonstrated with the biocompatibility of final product.

Note 4: Subject Device has been tested for all required biocompatibility endpoints per ISO 10993.

| Description | Subject Device (Model
ST) (K221178) | Predicate Devices B
(K192677) | Remark |
|----------------------------|----------------------------------------|----------------------------------|--------|
| Proprietary/
trade name | Disposable Insulin
Pen Needle | Safety Insulin Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |

7.2Comparison between Model ST Disposable Insulin Pen Needle and Predicate Device B

7

510(k) Notification document-Disposable Insulin Pen Needle			K221178
Indications
for use	Disposable Insulin Pen
Needle is intended for use
with pen injector device for
subcutaneous injection of
insulin. Additionally, it has
sharps injury protection
feature that it can reduce the
occurrence of accidental
needlesticks from the patient
end of the needle due to the
effect of safe-lock guard.	The Safety Insulin Pen
Needle is intended for use
with pen injector devices
for the subcutaneous
injection of insulin. The
attached safety shield
automatically locks after
injection and reduces the
occurrence of accidental
needle sticks from the
patient end of the needle.	Same
Prescription/over
-the counter use	Over-the counter use	Over-the counter use	Same
Environment
of use	Home, Health center	Home, Health center	Same
Intended users	For self-administration
or by a caregiver	For self-administration
or by a caregiver	Same

| Hub/needle bond

strength	Conform with ISO 11608-2	Conform with ISO 11608-2	Same
Method of
attachment to
pen injector	Screw structure, conform with
ISO 11608-2	Screw structure,
conform with ISO 11608-2	Same
Needle tip
configuration	Tri-bevel edge needle	Tri-bevel edge needle	Same
Shelf life	5 years	3 years	Different
(Note 5)
Method of
activation for
the safety
mechanism	Before use, red slider is
hidden in the protective cap,
needle tip is in protective
jacket and seen. In use,
protective jacket is pressed
down and the needle tip is
exposed for injection.
After use, protective jacket
will rebound and red slider is
exposed in the transparent
protective jacket. The red
slider will be seen by user
and indicate that safe-lock
guard have be activated.
The needle cannot be used
again.	Before use, red slider is
exposed in the protective
cap, needle tip is in
protective jacket and seen.
In use, protective jacket is
pressed down and the
needle tip is exposed for
injection. After use,
protective jacket will
rebound and red slider is
hidden in the transparent
protective jacket. The red
slider will be not seen by
user and indicate that
safe-lock guard have be
activated. The needle
cannot be used again.	Similar
(Note 6)
Design
specifications
of the safety
mechanism	Dimensions	Slider:3.4mm
Protective
jacket:
10.3mm	Similar
(Note 7)
	Dimensions	unknown
	Color	Slider:red
Protective
jacket:
colorless
	Color	Slider:red
Protective
jacket:
colorless
	Strength	$\leq$ 6N
	Strength	unknown

8

510(k) Notification document-Disposable Insulin Pen Needle				K221178
	Outer
diameter	Length
Size(s)	0.30mm	5mm,8mm	Needle gauge:29G, 30G,
31G, 32G
Needle length:4mm, 5mm,
6mm, 8mm, 10mm	Similar
(Note 8)
	0.25mm	6mm,8mm
	0.23mm	4mm,8mm
Wall type	Thin-walled		Thin-walled,
Extra-thin-walled	Similar
(Note 9)
Configuration
and Material	Needle tube	Stainless
steel
SUS304
	Needle hub	PP
	Protective
cap	PP
	Spring	Stainless
steel
SUS304H
	Slider	PP	Needle tube ,Hub ,Spring,
Safety seat, Seal paper,
Outer container, Safety
shield, Housing	Similar
(Note 10)
	Protective
jacket	PP
	Needle
container	PP
	Lubricant	Silicon oil
	Adhesive	UV glue
	Seal	Medical
dialyzing
paper
Performance	Meet the requirements of
ISO 7864, ISO 9626, ISO
11608-2, ISO 23908		Complied with
ISO 7864:2016
ISO 9626:2016
ISO 11608-1:2014
ISO 11608-2:2012	Similar
(Note 11)
Sterilization	EO Sterilization
SAL:10-6		EO Sterilization
SAL: 10-6	Same
Biocompatibility	Meet the requirements of
ISO10993 series standards,
and the following tests are
performed: In vitro
cytotoxicity, skin
sensitization, intracutaneous
reactivity, acute systemic
toxicity, hemocompatibility,
subchronic toxicity,
particulate matter for
injections and pyrogen.		Conform with ISO 10993
standards	Similar
(Note 12)
Reuse or
single use	Single use		Single use	Same
	510(k) Notification documents-Disposable Insulin Pen Needle		K221178
Sharps injury
protection feature	Meet the requirements of
safe-lock guard activation
and safety overriding/
unlocking force after
activation (triggering
performance) as per ISO

                                                                                                                                  | With safety feature              | Same                                                                                                |                      |

9

Note 5: The shelf life of the predicate device B is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.

Note 6: The method of activation for the safety mechanism is similar between the subject device and predicate device B. In fact, the structure of the safety mechanism is same, but the design of red slider (show the status of the activation) is opposite. Functionality of the safety mechanism has been verified by performing testing per ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

Note 7: The design specifications of the safety mechanism is similar between the subject device and predicate device B. The color is the same. The dimensions and strength of the subject device is unknown. The design specifications of the safety mechanism of subject device can achieve the function of preventing needlesticks, which is proved by various performance testing.

Note 8: The outer diameter(gauge) and length of the subject device are covered by the predicate device B. The performance bench testing of the outer diameter(gauge) and length for subject device are demonstrated to meet the requirements of ISO 7864, ISO 9626 and ISO 11608-2.

Note 9: The wall type of the subject device are covered by the predicate device B. The predicate device B has extra-thin-walled type, which is a difference. The performance bench testing of the thin-walled for subject device are demonstrated to meet the requirements of ISO 9626. This difference does not impact safety and effectiveness.

Note 10: The configuration of the subject device is mostly the same as the predicate device B, just the name is different. The materials of subject device are common materials and widely used for Insulin Pen Needle in the market, such as stainless steel SUS304,

PP, silicon oil, UV glue and Medical dialyzing paper. The safety of materials is demonstrated with the biocompatibility of final product.

Note 11: There are some differences in standards cited for conformance. These differences do not raise new questions of safety and effectiveness.

Note 12: Subject Device has been tested for additional subchronic toxicity and particulate matter for injections compared to the predicate device A.

10

8.Performance testing summary

Items	Summary
Sterilization	Disposable Insulin Pen Needle is sterilized by EO gas and
the sterility assurance level (SAL) is 10⁻⁶. The process has
been validated according to ISO 11135: 2014 Sterilization of
health-care products – Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization
process for medical devices. The maximum EO residual that
remain on the device is less than 0.8mg, the maximum ECH
residual that remain on the device should be less than
1.8mg according to ISO 10993-7:2008 Biological evaluation
of medical devices - Part 7: Ethylene oxide sterilization
residuals.
Product performance	After sterilization, Disposable Insulin Pen Needle meets
criteria specified in 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 -
Requirements and test methods; ISO 7864: 2016 Sterile
hypodermic needles for single use - Requirements and test
methods and other applicable standards.
Functional compatibility with
needle-based injection
systems	Selected the insulin pens of commonly used in the U.S.
market for compatibility verification. The tests have been
completed, the insulin pens which are declared in the label
are compatible with the needle.
Transport	The simulated transportation test has been completed
according to the requirements of ASTM D4169-16
Standard Practice for Performance Testing of Shipping
Containers and Systems. Model CT and Model ST of the
products are implemented simulated transportation test.
The test result is passed.
Shelf life	The performance of ISO 11608-2, chemical properties,
bacterial endotoxin and leakage test (according to ASTM
F1929-2015) of Model CT and Model ST have been tested
individually before accelerated aging, after 4 years of
accelerated aging and 5 years of accelerated aging.
According to the accelerated aging test results, the shelf
life of the product is determined to be 5 years.
Biocompatibility	Disposable Insulin Pen Needle meets the requirements of
ISO 10993 series standards, and the following tests are
performed: Cytotoxicity, skin sensitization, intracutaneous
reactivity, acute systemic toxicity, hemocompatibility,
subchronic toxicity and material-mediated pyrogenicity.
With the requirement of USP , particulate matter for
injections also is performed.
Sharps protection features	Model ST product meets the requirements of safe-lock
guard activation and safety overriding/unlocking force after
activation(triggering performance) as per ISO 23908:2011
Sharps injury protection-Requirements and test methods-
Sharps protection features for single-use hypodermic
needles, introducers for catheters and needles used for
blood sampling
Clinical simulated use testing	Model ST of Disposable Insulin Pen Needle is a sterile, single-use medical device with an integral sharps injury prevention feature, intended for use with pen injector device for subcutaneous injection of insulin. According to ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection. The test results show that Model ST of the product has well sharps injury prevention feature.
The compatible pen injectors	1. NovoPen Echo, K162602, Novo Nordisk Inc.

Humapen Luxura, K142518, Eli Lilly and Company
Humapen Luxura HD, K100988, Eli Lilly and Company
HumanPen Ergo II, K151686, Eli Lilly and Company |

11

510(k) Notification documents-Disposable Insulin Pen Needle

K221178

Conclusions

Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate device.