Disposable Insulin Pen Needle

K181069 · Zhejiang Kindly Medical Devices Co., Ltd. · FMI · Aug 28, 2018 · General Hospital

Device Facts

• Record ID: K181069
• Device Name: Disposable Insulin Pen Needle
• Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Aug 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Device Story

Disposable Insulin Pen Needle; single-use sterile needle; attaches to pen injector devices via threaded hub; facilitates subcutaneous insulin delivery. Components include stainless steel needle tube, polypropylene hub/inner sheath, polyethylene cup, and paper seal. Available in various gauges (28G-33G) and lengths (4mm-12mm). Used by patients or healthcare providers in home or clinical settings. Manual operation; no electronic or software components. Benefits include reliable insulin administration via standard pen injectors.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (cytotoxicity, sensitization, systemic toxicity, pyrogen, hemolysis), mechanical performance (ISO 7864, ISO 9626, ISO 11608-2), and sterile barrier integrity (ASTM F88, ASTM F1929).

Technological Characteristics

Needle: Stainless steel. Hub/Sheath: Polypropylene. Cup: Polyethylene. Seal: Paper. EO sterilized (SAL 10^-6). Manual operation. Complies with ISO 7864:2016, ISO 9626:2016, ISO 11608-2:2012, and ISO 10993 standards.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection using pen injector devices.

Regulatory Classification

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.

Predicate Devices

• Insulin Pen Needle (K133059)

Submission Summary (Full Text)

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August 28, 2018

Zhejiang Kindley Medical Devices Co.,Ltd % Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K181069

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: July 20, 2018 Received: July 30, 2018

Dear Diana Hong:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K181069

Device Name

Disposable Insulin Pen Needle

Indications for Use (Describe)

The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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# Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: __K181069

Date of Preparation: 08/28/2018

# Submitter Identification

Zhejiang kindly medical devices Co., Ltd. No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PRC.

Establishment Registration Number: Not yet registered

Contact Person: Yong Zhang Position: General Manager Tel: [phone] Fax: [phone] Email: zjkdl(@kdlchina.com

#### Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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# Identification of Proposed Device

Trade Name: Disposable Insulin Pen Needle Common Name: Insulin Pen Needle

### Regulatory Information

Classification Name: Needle, Hypodemic, Single Lumen; Classification: 2; Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;

#### Identification of Predicate Device

510(k) Number: K133059 Product Name: Insulin Pen Needle

#### Intended Use Statement

The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

#### Device Description

The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications

| Gauge | Length (mm) | Wall |
|-------|--------------------------------|------|
| 33G | Available in 4mm, 6mm | TW |
| 32G | Available in 4mm, 6mm and 8mm | TW |
| 31G | Available in 4mm, 6mm and 8mm | TW |
| 30G | Available in 4mm, 6mm and 8mm | TW |
| 29G | Available in 6mm, 8mm and 12mm | RW |
| 28G | Available in 6mm, 8mm and 12mm | TW |

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# Non-Clinical Test Summary

Lubrication

Ease of assembly and disassembly

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test result comply with the related standard requirements, the test conducted on proposed devices include following

| Cleanliness | Clause 4.3 of ISO 7864:2016 |
|-----------------------------------------------|--------------------------------|
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Surface finish | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
| Material | Clause 4.1 of ISO 11608-2:2012 |
| Dimensions | Clause 4.2 of ISO 11608-2:2012 |
| Determination of flow rate through the needle | Clause 4.3 of ISO 11608-2:2012 |
| Bond between hub and needle tube | Clause 4.4 of ISO 11608-2:2012 |
| Needle points | Clause 4.5 of ISO 11608-2:2012 |
| Freedom from defects | Clause 4.6 of ISO 11608-2:2012 |

Clause 4.7 of ISO 11608-2:2012 Dislocation of measuring point at patient end Clause 4.8 of ISO 11608-2:2012 Determination of functional compatibility with Clause 4.9 of ISO 11608-2:2012 needle-based injection systems

Clause 4.10 of ISO 11608-2:2012

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Sterile Barrier Packaging Testing performed on the proposed device:

| Seal strength | ASTM F88/F88-15 |
|-----------------|-----------------|
| Dye penetration | ASTM F1929-15 |

Sterilization and Shelf Life Testing performed on the proposed device:

| EO residue | ISO 10993-7:2008 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests<br>were performed on aging samples to verify the<br>claimed shelf life of the device |
| Sterilization validation | ANSI/AAMI/ISO 11135-1:2007 |

Biocompatibility Testing: Biocompatibility testing was performed according to ISO 10993 standards. The test conducted on proposed device include Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogen and Hemolysis Test.

# Clinical Test Summary

No clinical study is included in this submission.

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# Substantially Equivalent (SE) Comparison

| Item | Proposed Device | Predicate Device<br>K133059 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Product Code | FMI | Same |
| Regulation Number | 880.5570 | Same |
| Intended Use | The Disposable Insulin Pen Needle<br>is intended for use with pen injector<br>devices for the subcutaneous<br>injection of insulin. | Same |
| Configuration and material | Needle Tube Stainless Steel<br>Hub Polypropylene<br>Inner Sheath Polypropylene<br>Cup Polyethylene<br>Sealed Paper Paper | Needle Tube Stainless Steel<br>Hub Polypropylene<br>Inner Sheath Polypropylene<br>Cup Polypropylene<br>Sealed Paper Paper |
| Needle Gauge | Available in 28G, 29G, 30G, 31G,<br>32G and 33G | Available in 29G, 30G, 31G and 32G |
| Needle Length | Available in 4mm, 6mm, 8mm and<br>12mm | Available in 4mm, 5mm, 6mm, 8mm<br>10mm, and 12mm |
| Operation mode | Manual | Same |
| Sterile | EO sterilized, SAL: 10-6 | Same |
| Single Use | Single Use | Same |
| Endotoxin Limit | 20EU per device | Same |
| Labeling | Conform with 21 CFR 801 | Same |
| Biocompatibility | | Conform with ISO 10993 standards |
| Cytotoxicity | No Cytotoxicity | |
| Intracutaneous reactivity | No Irritation to Skin | |
| Skin Sensitization | No skin sensitization | |
| Acute Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen | |
| Hemolysis | No hemolysis | |

| | Table 1 Comparison of Technology Characteristics |
|--|--------------------------------------------------|
| | |

From above comparison table, the material, needle gauge and needle length for proposed device is different from predicate device. For the difference material used in the device, biocompatibility test has been performed on proposed device and the test result can meet the requirements of ISO 10993 standards. The propose device has the additional needle gauge of 28G and 33G compared to predicate device. However, the all proposed models have been tested and the test result can meet the standard requirements. For the different in needle length, the proposed needle length can be covered by predicate device. Therefore, these differences will not raise any safety and effectiveness issues.

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# Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, performance testing conducted and passed, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.