Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a physical needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is a needle used for injecting insulin, which is a drug, but the device itself does not provide therapeutic action.

Diagnostic

No
The device is an insulin pen needle, which is used for injection and not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (needle tube, needle hub, spring, etc.) and mentions manufacturing processes like EO sterilization, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "hypodermic injection of insulin and medicinal fluids." This describes a device used for administering substances into the body, not for testing samples taken from the body.
Device Description: The description details a needle and its components, designed for injection. It doesn't mention any components or processes related to analyzing biological samples.
Performance Studies: The performance studies focus on the physical and biological safety of the needle for injection (needle performance, biocompatibility, sterility). They do not involve testing or analyzing biological samples.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body, which is a different category of medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FMI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

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.

Key Metrics

Not Found

Predicate Device(s)

K181447

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

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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

1

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 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.

| Gauge (G) x Length (mm) | Out Diameter
(mm) | Inner Diameter
(mm) | Point
Type | Wall
Type | Color of
positioning
ring |
|-----------|-------- | 28G | 0.36×4 | 28G | 0.36×5 | 28G | 0.36×6 | 28G | 0.36×8 | 28G | 0.36×12 | 29G | 0.33×4 | 29G | 0.33×5 | 29G | 0.33×6 | 29G | 0.33×8 | 29G | 0.33×12 | 30G | 0.30×4 | 30G | 0.30×5 | 30G | 0.30×6 | 30G | 0.30×8 | 31G | 0.25×4 | 31G | 0.25×5 | 31G | 0.25×6 | 31G | 0.25×8 | 32G | 0.23×4 | 32G | 0.23×5 | 32G | 0.23×6 | Specifications Diameter
----------------------------------|----------------------|------------------------|---------------|--------------|---------------------------------|
| 0.349-0.370 | ≥0.190 | LB | TW | Blue-green |
| 0.349-0.370 | ≥0.190 | LB | TW | Blue-green |
| 0.349-0.370 | ≥0.190 | LB | TW | Blue-green |
| 0.349-0.370 | ≥0.190 | LB | TW | Blue-green |
| 0.349-0.370 | ≥0.190 | LB | TW | Blue-green |
| 0.324-0.351 | 0.133-0.189 | LB | RW | Red |
| 0.324-0.351 | 0.133-0.189 | LB | RW | Red |
| 0.324-0.351 | 0.133-0.189 | LB | RW | Red |
| 0.324-0.351 | 0.133-0.189 | LB | RW | Red |
| 0.324-0.351 | 0.133-0.189 | LB | RW | Red |
| 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow |
| 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow |
| 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow |
| 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow |
| 0.254-0.267 | 0.125-0.145 | LB | TW | White |
| 0.254-0.267 | 0.125-0.145 | LB | TW | White |
| 0.254-0.267 | 0.125-0.145 | LB | TW | White |
| 0.254-0.267 | 0.125-0.145 | LB | TW | White |
| 0.229-0.241 | 0.105-0.124 | LB | TW | Deep green |
| 0.229-0.241 | 0.105-0.124 | LB | TW | Deep green |
| 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 Device
Safety Insulin Pen Needle | Predicate Device
Safety insulin needle for
single use | Remark |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| K number | K213183 | K181447 | |
| Classification | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Common name | Hypodermic single lumen
needle | Hypodermic single lumen
needle | Same |
| Intended use | Safety Insulin Pen Needle is
intended to be used with
Insulin Pen for hypodermic
injection of insulin and
medicinal fluids. | The Safety insulin needle for
single use is intended for use
with pen injector devices for
the
subcutaneous injection of
insulin. | Similar
Note 1 |
| Indications for use | Safety Insulin Pen Needle is
intended to be used with
Insulin Pen for hypodermic
injection of insulin and | The Safety insulin needle for
single use is intended for use
with pen injector devices for
the | Similar
Note 1 |
| | | | |
| | medicinal fluids. | subcutaneous injection of
insulin. | |
| Configuration | needle tube, needle hub, spring,
needle hub sheath, safety
protective sheath, positioning
ring, outer protective cap and
sealing paper | needle tube, hub, safety
protective cover,
self-destruction seat, spring,
hub sheath, safety seat and
sealed paper. | Different
Note 2 |
| Needle Gauge | 28G, 29G, 30G, 31G, 32G,
33G, 34G | 29G, 30G, 31G, 32G, 33G,
34G | Different
Note 3 |
| Needle Length | 4mm, 5mm, 6mm, 8mm,12mm | 4mm, 5mm, 6mm, 8mm | Different
Note 3 |
| Wall type | Regular walled
Thin-walled | Thin-walled
Extra-thin-walled | Different
Note 4 |
| Patient-contact
Material | Needle tube SUS 304
Needle hub PP
Safety
protective ABS
sheath | Needle tube SUS 304
Hub PP
Safety
protective MABS
cap | Different
Note 5 |
| Design | Compared with traditional
insulin pen needle, this product
is designed with a safety feature
that could help avoid accidental
needle stick injury between
patients and healthcare
professionals. | Compared with traditional
insulin pen needle, this
product is designed with a
safety feature that could help
avoid accidental needle stick
injury between patients and
healthcare professionals. | Same |
| Single Use | Single use | Single use | Same |
| Performance
testing | Comply with ISO 7864, ISO
9626 and ISO 11608-2 | Comply with ISO 7864, ISO
9626 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.

8

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 Bacterial Endotoxins Test
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for A systemic toxicity
USP 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.