The proposed device, Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. It consists of needle tube, needle hub, spring, needle hub sheath, safety protective sheath, positioning ring, outer protective cap and sealing paper. The needle hub is clear, and the positioning ring and sealing paper contains colorants for the different gauge sizes. The Safety insulin 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 10-6.

AI/ML Overview

The provided text does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to such a device's performance based on a test set. Instead, it is a 510(k) premarket notification for a medical device (Safety Insulin Pen Needles), primarily focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing against established ISO and ASTM standards.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI/ML device performance, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Safety Insulin Pen Needle, as clinical studies are not required for this medical device."

However, I can provide the acceptance criteria and performance data as presented in the document, which are related to non-clinical tests for a physical medical device, not an AI/ML diagnostic or predictive tool.

Here's a summary of the non-clinical performance data and criteria as per the document:

A. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria (Reference Standard)	Reported Device Performance
ISO 7864:2016 (Sterile hypodermic needles for single use.)	Complies with the standard requirements.
ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices.)	Complies with the standard requirements.
ISO 11608-2:2012 (Needle-based injection systems for medical use - Part 2: Needles)	Complies with the standard requirements.
ISO 10993-5:2009(R) (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.)	Complies with the standard requirements.
ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)	Complies with the standard requirements.
ISO 10993-7:2008 (Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.)	Complies with the standard requirements.
ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials.)	Complies with the standard requirements.
ASTM F1140/F1140M-13 (Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages)	Complies with the standard requirements.
USP <85> (Bacterial Endotoxins Test)	Complies with the standard requirements.
ISO 10993-11:2017 (Biological evaluation of medical devices Part 11: Tests for systemic toxicity)	Complies with the standard requirements.
USP <788> (Particulate Matter Test)	Complies with the standard requirements.
Sterility Assurance Level (SAL)	Achieves a SAL of 10-6.
Needle Performance Testing (across all proposed gauge and length sizes)	Test results comply with ISO 7864 and ISO 9626 standards requirements.
Biocompatibility Testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, subchronic toxicity, Particulate Matter)	Test results demonstrate biocompatibility and compliance with relevant ISO 10993 series standards and USP monographs as listed above.

B. Information Not Applicable to this Submission (AI/ML Specifics)

The following information is not present in the provided document, as it pertains to AI/ML device studies, which this submission does not involve:

Sample size used for the test set and data provenance: Not applicable. The tests are physical/chemical evaluations of the device, not performance on a data set.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there is no "ground truth" established by experts in the context of an AI/ML model for this device. The ground truth refers to the physical and chemical properties conforming to established engineering and biological standards.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. This is for AI-assisted human reading performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used: For this device, the "ground truth" is defined by compliance with the referenced ISO, ASTM, and USP standards for manufacturing quality, performance characteristics (e.g., fluid flow, needle strength), sterility, and biocompatibility.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Zhejiang Kindly Medical Devices 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: K213183

Trade/Device Name: Safety Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 14, 2022 Received: September 15, 2022

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 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

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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,

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

Enclosure

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Indications for Use

510(k) Number (if known)

K213183

Device Name

Safety Insulin Pen Needles

Indications for Use (Describe)

Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.

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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K213183 510(K) Summary

I. SUBMITTER:

Zhejiang Kindly Medical Devices Co. Ltd No.758, 5th Binhai Road, Binhai Industrial Park Longwan District Wenzhou City, Zhejiang Province, China. Tel: +0086 13806556169 Fax: +86-0577- 86374972

Contact Person: Yong Zhang Title:General Manager Phone: +86 13806556169 Email: zhangyong(@kdlchina.com

Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor , No 1399, Jiangyue Road, Minhang District, Shanghai

Summary prepared: 10/14/2022

II. DEVICE

Name of Device: Safety Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Common Name: Hypodermic single lumen needle Classification Panel: General Hospital Regulatory Class: II Product Code: FMI

III. PREDICATE DEVICE

Primary predicate device: K181447 Safety insulin needle for single use

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IV. DEVICE DESCRIPTION

The Safety insulin 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 10-6.

Gauge (G)	Specifications Diameterx Length (mm)	Out Diameter(mm)	Inner Diameter(mm)	PointType	WallType	Color ofpositioningring
28G	0.36×4	0.349-0.370	≥0.190	LB	TW	Blue-green
28G	0.36×5	0.349-0.370	≥0.190	LB	TW	Blue-green
28G	0.36×6	0.349-0.370	≥0.190	LB	TW	Blue-green
28G	0.36×8	0.349-0.370	≥0.190	LB	TW	Blue-green
28G	0.36×12	0.349-0.370	≥0.190	LB	TW	Blue-green
29G	0.33×4	0.324-0.351	0.133-0.189	LB	RW	Red
29G	0.33×5	0.324-0.351	0.133-0.189	LB	RW	Red
29G	0.33×6	0.324-0.351	0.133-0.189	LB	RW	Red
29G	0.33×8	0.324-0.351	0.133-0.189	LB	RW	Red
29G	0.33×12	0.324-0.351	0.133-0.189	LB	RW	Red
30G	0.30×4	0.298-0.320	0.165-0.189	LB	TW	Yellow
30G	0.30×5	0.298-0.320	0.165-0.189	LB	TW	Yellow
30G	0.30×6	0.298-0.320	0.165-0.189	LB	TW	Yellow
30G	0.30×8	0.298-0.320	0.165-0.189	LB	TW	Yellow
31G	0.25×4	0.254-0.267	0.125-0.145	LB	TW	White
31G	0.25×5	0.254-0.267	0.125-0.145	LB	TW	White
31G	0.25×6	0.254-0.267	0.125-0.145	LB	TW	White
31G	0.25×8	0.254-0.267	0.125-0.145	LB	TW	White
32G	0.23×4	0.229-0.241	0.105-0.124	LB	TW	Deep green
32G	0.23×5	0.229-0.241	0.105-0.124	LB	TW	Deep green
32G	0.23×6	0.229-0.241	0.105-0.124	LB	TW	Deep green

Table 1 Specification of Safety Insulin Pen Needle

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33G	0.20×4	0.203-0.216	0.105-0.124	LB	TW	Black
33G	0.20×5	0.203-0.216	0.105-0.124	LB	TW	Black
33G	0.20×6	0.203-0.216	0.105-0.124	LB	TW	Black
34G	0.18×4	0.178-0.191	0.091-0.104	LB	TW	Orange
34G	0.18×5	0.178-0.191	0.091-0.104	LB	TW	Orange
34G	0.18×6	0.178-0.191	0.091-0.104	LB	TW	Orange

V. INDICATIONS FOR USE

Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. Additionally, the Safety Insulin Pen Needle is similar to the Safety Insulin Needle For Single Use (K181447) in regard to insertion, design, size ranges, and material.

Item	Proposed DeviceSafety Insulin Pen Needle	Predicate DeviceSafety insulin needle forsingle use	Remark
K number	K213183	K181447
Classification	Class II	Class II	Same
Product Code	FMI	FMI	Same
Common name	Hypodermic single lumenneedle	Hypodermic single lumenneedle	Same
Intended use	Safety Insulin Pen Needle isintended to be used withInsulin Pen for hypodermicinjection of insulin andmedicinal fluids.	The Safety insulin needle forsingle use is intended for usewith pen injector devices forthesubcutaneous injection ofinsulin.	SimilarNote 1
Indications for use	Safety Insulin Pen Needle isintended to be used withInsulin Pen for hypodermicinjection of insulin and	The Safety insulin needle forsingle use is intended for usewith pen injector devices forthe	SimilarNote 1

	medicinal fluids.	subcutaneous injection ofinsulin.
Configuration	needle tube, needle hub, spring,needle hub sheath, safetyprotective sheath, positioningring, outer protective cap andsealing paper	needle tube, hub, safetyprotective cover,self-destruction seat, spring,hub sheath, safety seat andsealed paper.	DifferentNote 2
Needle Gauge	28G, 29G, 30G, 31G, 32G,33G, 34G	29G, 30G, 31G, 32G, 33G,34G	DifferentNote 3
Needle Length	4mm, 5mm, 6mm, 8mm,12mm	4mm, 5mm, 6mm, 8mm	DifferentNote 3
Wall type	Regular walledThin-walled	Thin-walledExtra-thin-walled	DifferentNote 4
Patient-contactMaterial	Needle tube SUS 304Needle hub PPSafetyprotective ABSsheath	Needle tube SUS 304Hub PPSafetyprotective MABScap	DifferentNote 5
Design	Compared with traditionalinsulin pen needle, this productis designed with a safety featurethat could help avoid accidentalneedle stick injury betweenpatients and healthcareprofessionals.	Compared with traditionalinsulin pen needle, thisproduct is designed with asafety feature that could helpavoid accidental needle stickinjury between patients andhealthcare professionals.	Same
Single Use	Single use	Single use	Same
Performancetesting	Comply with ISO 7864, ISO9626 and ISO 11608-2	Comply with ISO 7864, ISO9626 and ISO 11608-2	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Sterility Condition	10-6	10-6	Same

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Discussion in details:

Note 1: Intended Use and Indications for use

Safety insulin pen needle and safety insulin needle for single use have similar intended use and indications for use, which are intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. This device is EO sterilized and intended for single use.

Note 2: Configuration

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The components name of proposed device are different to that of the predicate, however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

Note 3: Needle gauge and Needle length

The needle gauge and needle length of proposed device is more than that of predicate devices. This difference in needle size will not affect the performance of the needle. 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 4: Wall type

The wall thickness of the proposed device is different than the predicate device. The needles including both wall thickness (i.e., Regular walled and Thin-walled) of proposed device have been tested and the test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

Note 5: Patient-contact Material

Although the material of proposed and the predicate device is different, 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.

VII.PERFORMANCE DATA

Non-Clinical Performance Data

To verify that the Safety Insulin Pen Needle is as safe and effective as the predicate device, representative samples of Safety Insulin Pen Needle were underwent a series of tests including bench testing (needle performance testing), and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, subchronic toxicity and Particulate Matter).

The test results demonstrated that the proposed device complies with the following standards:

A ISO 7864:2016, Sterile hypodermic needles for single use.

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ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices. A
ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical A use - Requirements and test methods - Part 2: Needles
A ISO 10993-5: 2009(R), Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for A irritation and skin sensitization
A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
A ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
USP <85> Bacterial Endotoxins Test
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for A systemic toxicity
USP <788> Particulate Matter Test A

Clinical Performance Data

No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Safety Insulin Pen Needle, as clinical studies are not required for this medical device.

VIII. CONCLUSION

The same intended use, the similarity in overall technological characteristics, and performance data result in that Safety Insulin Pen Needle are substantially equivalent to legally marketed device, Safety insulin needle for single use.

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).