The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

Device Description

The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube. The insulin pen needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

AI/ML Overview

The provided document is a 510(k) summary for an Insulin Pen Needle. It details the device, its intended use, comparison with a predicate device, and performance data from non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists standards that the device conforms to, and states that testing results were in conformance or met acceptance criteria. Specific quantitative acceptance criteria or reported performance values are generally not provided in this 510(k) summary format, which often focuses on demonstrating compliance with recognized standards rather than presenting raw data or detailed performance metrics.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 11608-2: 2012 (Bench Testing)	In conformance with the standard
ISO 9626: 2016 (Bench Testing)	In conformance with the standard
ISO 7864: 2016 (Bench Testing)	In conformance with the standard
ISO 11135 (Sterilization)	Validated in compliance with ISO 11135
ISO 10993-7 (EO Residual)	EO residual doesn't exceed the limit
ASTM F1980-16 (Shelf-life via accelerated aging)	Verified the claimed 5 years shelf-life
ASTM D3078-02 (Package: Vacuum Leak Test)	Performed in compliance with the standard
ASTM F1929-15 (Package: Dye Penetration Test)	Performed in compliance with the standard
DIN 58953-6: 2016 (Package: Microbial Barrier Properties Test)	Performed in compliance with the standard
ASTM F88/F88M-21 (Package: Seal Strength Test)	Performed in compliance with the standard
ISO 10993 series (Biocompatibility)	Conforms to the ISO 10993 series of standards (Patient-contact material)
Cytotoxicity (Biocompatibility)	No Cytotoxicity
Sensitization (Biocompatibility)	No Skin Sensitization
Irritation (Biocompatibility)	No Irritation to Skin
Systemic Toxicity (Biocompatibility)	No Systemic Toxicity (Acute and Subacute)
Hemolysis (Biocompatibility)	No Hemolysis
Pyrogen (Biocompatibility)	No pyrogen
Particulate Matter (USP <788>)	Met the USP acceptance criteria
FDA Guidance: Medical Devices with Sharps Injury Prevention Features, August 9, 2005 (Simulated Clinical Use Testing)	Conducted in compliance with the FDA Guidance
Bond between hub and needle tube (Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016)	Adherence to these clauses
Needle tip configuration (ISO 7864 standards)	Conform with ISO 7864 standards
SAL (Sterility Assurance Level)	10-6
Endotoxin Limit	20 EU per device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the tests conducted. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. It only mentions that the manufacturer is in Anhui, China, and the correspondent is in Shanghai, China, implying the tests were likely performed or managed from China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The device is an Insulin Pen Needle, which is a physical medical device. Its performance is evaluated through bench testing against recognized standards (e.g., ISO, ASTM, USP) and biocompatibility testing, not through expert-reviewed diagnostic outputs that require a "ground truth" derived from human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As explained above, the device's performance is determined by objective physical and chemical tests, not by human interpretation or clinical adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. MRMC studies are relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like an Insulin Pen Needle. The document explicitly states "Clinical testing: Not Applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This question pertains to AI/algorithm performance. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable for this device. Ground truth is generally used in diagnostic studies or AI performance evaluations against a known correct answer. For an Insulin Pen Needle, performance is assessed against established engineering and biological standards.

8. The sample size for the training set

This information is not applicable and not provided. A training set is used for machine learning algorithms. The device is a physical medical device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. This question pertains to machine learning.

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".

September 20, 2023

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road, Minhang District Shanghai, 201114 China

Re: K230043

Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 20, 2023 Received: August 23, 2023

Dear Alice Huang:

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

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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 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,

Image /page/1/Picture/7 description: The image shows the text "Courtney Evans -S" in a large, sans-serif font. The text is arranged vertically, with "Courtney" on the top line, "Evans" on the second line, and "-S" on the third line. The background of the image is white, with a faint, light blue watermark pattern.

Digitally signed by Courtney Evans -S Date: 2023.09.20 11:28:53 -04'00'

For CAPT Alan 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

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Indications for Use

510(k) Number (if known) K230043

Device Name Insulin Pen Needle

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K230043- 510(K) Summary

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I. SUBMITTER:

Manufacture Name: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Address : No.2 Guanyin Road, Taihu Economic Development Zone, Anqing City, Anhui Province, China. Tel: +86-556 5129666 Fax: +86-556 4249999 Contact Person: Bingyi Xiang Title:General Manager Phone: +86-556 5129666 Email:hwj1@hongyu-wuzhou.cn

Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai

Summary prepared: September 15, 2023

II. DEVICE

Name of Device:Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Common Name: Insulin Pen Needle for single use Classification Panel: General Hospital Regulatory Class: II Product Code: FMI

III. PREDICATE DEVICE

Primary predicate device: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319)

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DEVICE DESCRIPTION IV.

The insulin pen needle for single use is offered in various gauge sized and length.

The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

Designatedmetric size(mm)	Gauge	Bevelangle		Outerdiameter ofstylet (mm)		Nominal length of needle tube(mm)						ID(mm)		OD(mm)		Color
		LB	SB	RW	TW	4	5	6	8	10	12	RW	TW	MIN	MAX
0.18	34G	√	√	/	/	√	√	√	–	–	–	0.064	0.091	0.178	0.191	Orange
0.20	33G	√	√	/	/	√	√	√	√	–	–	0.089	0.105	0.203	0.216	Black
0.23	32G	√	√	/	/	√	√	√	√	√	–	0.089	0.105	0.229	0.241	Deep green
0.25	31G	√	√	/	/	√	√	√	√	√	–	0.114	0.125	0.254	0.267	White
0.30	30G	√	√	0.11	0.13	√	√	√	√	√	√	0.133	0.165	0.298	0.320	Yellow
0.33	29G	√	√	0.11	0.15	√	√	√	√	√	√	0.133	–	0.324	0.351	Red
0.36	28G	√	√	0.11	0.15	√	√	√	√	√	√	0.133	–	0.349	0.370	Blue-green

Table 1 Specification of Insulin Pen Needle

V. INDICATIONS FOR USE

The Insulin Pen Needle is intended for use with pen iniector devices for subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. Additionally, the Insulin Pen Needle is similar to the Insulin Pen Needle (Ordinary Type) (K202319) in regard to insertion, design, size ranges, and material.

Table 2 General Comparison for Insulin Pen Needle

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Item	Proposed DeviceInsulin Pen Needle	Predicate DeviceInsulin Pen Needle(Ordinary Type)	Remark
K number	TBD	K202319
Classification	Class II	Class II	Same
Product Code	FMI	FMI	Same
Regulation No.	880.5570	880.5570	Same
Intended use	Insulin pen needle and insulininjection pen are usecooperatively to inject insulininto the human body.	The Insulin Pen Needle(Ordinary Type) is intendedfor use with pen injectordevices for thesubcutaneous injectionof insulin.	SimilarNote 1
Indications for use	The Insulin Pen Needle isintended for use with peninjector devices forsubcutaneous injection ofinsulin. The intended userpopulation of insulin penneedle is for “Adult Use Only”(ages 21yrs old and above).	The Insulin Pen Needle(Ordinary Type) is intendedfor use with pen injectordevices for thesubcutaneous injectionof insulin.	SimilarNote 1
User population	“Adult Use Only” (ages 21yrsold and above)	Adult and Pediatric	DifferentNote 2
Type-of-use	Prescription only	Over the counter	DifferentNote 3
Configuration andmaterials ofconstruction for allcomponents	Needle tube 304 stainlesssteel	Needle tube 304 stainlesssteel
	Needle hub Polypropylene	Needle hub Polypropylene
	Needle container Polypropylene	Outer Sheath Polypropylene	Same
	Needle shield Polypropylene	Inner Sheath Polypropylene
	Sealed Paper Paper	Sealed Paper Paper
Operation Mode	For Manual Use Only	For Manual Use Only	Same
Method ofattachment to peninjector	Through threaded connection	Through threadedconnection	Same
Item	Proposed DeviceInsulin Pen Needle	Predicate DeviceInsulin Pen Needle (OrdinaryType)	Remark
Needle Gauge	28G, 29G, 30G, 31G, 32G, 33G,34G	29G, 30G, 31G, 32G, 33G	DifferentNote 4
Needle Length	4mm, 5mm, 6mm, 8mm, 10mm,12mm	4mm, 5mm, 6mm, 8mm, 10mm,12mm	Same
Patient-contact materials
Needle Tube	304 stainless steel	304 stainless steel	DifferentNote 5
Needle Hub	PP	Polypropylene	Note 5
Lubricant	Silicone oil	MDX4-4159
adhesive	Uv-curable adhesive	UV glue
Designspecification ofthe inner sheath(dimensions,color, materialsand strength)	14.55.85.8mm;Transparent color; Polypropylene;Tensile stress at yield>24MPa;Flexural Modulus:>1000MPa;Charpy Notched ImpactStrength (23°C) >7kJ/m2	14.35.85.8mm;Transparent color; Polypropylene;Tensile stress at yield>20MPa;Flexural Modulus:>800MPa;Charpy Notched ImpactStrength (23°C) >2.8kJ/m2	Similar
Designspecification ofthe outer sheath(dimensions,color, materialsand strength)	301616mm;Transparent color; Polypropylene;Tensile stress at yield>24MPa;Flexural Modulus:>1000MPa;Charpy Notched ImpactStrength (23°C) >7kJ/m2	30.313.413.4mm;Transparent color; Polypropylene;Tensile stress at yield>20MPa;Flexural Modulus:>800MPa;Charpy Notched ImpactStrength (23°C) >2.8kJ/m2	Similar
Bond betweenhub and needletube	Clause 4.4 of ISO 11608-2:2012;Clause 4.12 of ISO 7864:2016	Clause 4.4 of ISO 11608-2:2012;Clause 4.12 of ISO 7864:2016	Same
Needle tipconfiguration	Conform with ISO 7864 standards	Conform with ISO 7864 standards	Same
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Intracutaneousreactivity	No Irritation to Skin	No Irritation to Skin
SkinSensitization	No Skin Sensitization	No Skin Sensitization
Acute SystemicToxicity	No Systemic Toxicity	No Systemic Toxicity
Pyrogen	No pyrogen	No pyrogen
Hemolysis	No Hemolysis	No Hemolysis

SubacuteSystemic Toxicity	No Subacute Systemic Toxicity	No Subacute Systemic Toxicity

Method	EO Sterilized	Irradiation Sterilized	DifferentNote 6
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same
Shelf life	5 years	5 years	Same
Label/ Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same

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Table 3 Safety and Performance Comparison for Insulin Pen Needle

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Discussion in details:

Note 1: Intended Use and Indications for use

Insulin pen needle and insulin pen needle (Ordinary Type) have similar intended use and indications for use, which are intended to be used with Insulin Pen for injection of insulin.

Note 2: User population

The subject device' s user population is covered by the range of user population in the predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and the Instruction for Use.

Note 3: Type-of-use

The subject device' s type-of use is more rigorous than predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and Instruction for Use.

Note 4: Needle gauge

The needle gauge of proposed device is more than that of predicate devices. The difference in needle gauges is made of the same raw materials and the same manufacturing process. Different gauge of needle tube will be selected by users. This difference does not affect intended use and not affect substantially equivalence on safety and effectiveness. In addition, all the needle size of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantially Equivalency (SE) between the proposed and predicate device.

Note 5: Patient-contact Material

Although the material of proposed and the predicate device is different, the MSDS of Silicone oil and UV-curable adhesive is provided, and the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

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Note 6: Sterilize Method

Although the Sterilize Method of proposed and the predicate device is different, the sterilize of the proposed device conforms to the ISO 11135:2014 of standards. And the EO residue result was comply with ISO 10993-7 standard requirement. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

VII. PERFORMANCE DATA

The non-clinical tests of the proposed device are tested in conformance with the following standards.

Bench Testing

The chemical performance and physical performance have been tested in compliance with the following standard:

. ISO11608-2: 2012,
ISO 9626: 2016 and ●
ISO 7864: 2016. ●

The testing results are in conformance with the corresponding standard.

Sterility and Shelf-life

The sterilization process of the proposed device has been validated in compliance with ISO 11135. The EO residual doesn't exceed the limit according to ISO 10993-7. The shelf-life validation study was conducted under the accelerated ageing condition in compliance with ASTM F1980-16 to verify the claimed 5 years shelf-life.

Package Testing

The packaging testing has been performed in compliance with the following FDA recognized consensus standards.

Vacuum Leak Test, ASTM D3078-02;
Dye Penetration Test ASTM F1929-15.
Microbial Barrier Properties Test DIN 58953-6: 2016;
Seal Strength Test ASTM F88/F88M-21.

Biocompatibility Testing

The biocompatibility evaluation for the insulin pen needles were conducted in accordance with the guidance that is "Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within Risk Management Process," as

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recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
· Sensitization
· Irritation
Systemic Toxicity
Hemolysis
Pyrogen
Subacute Toxicity
Particulate Matter

Particulate testing was conducted in accordance with USP <788>. The testing results and met the USP acceptance criteria.

Simulated Clinical Use Testing

Simulated clinical use testing of the proposed device has been conducted in compliance with the FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.

Clinical testing

Not Applicable.

VIII. CONCLUSION

The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use, technological characteristics, and performance.

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).