INSULIN PEN NEEDLE

K133058 · Wenzhou Wuzhou Import & Export Co., Ltd. · FMI · Feb 25, 2014 · General Hospital

Device Facts

• Record ID: K133058
• Device Name: INSULIN PEN NEEDLE
• Applicant: Wenzhou Wuzhou Import & Export Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Feb 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Insulin Pen Needle is a single-use, sterile, hypodermic needle designed for attachment to pen injector devices. It consists of a stainless steel needle tube, a polypropylene hub, a tube sheath, and a hub sheath. The device is manually operated by the user to deliver insulin subcutaneously. It is available in various gauges (29G-32G) and lengths. The device is provided sterile (SAL 10^-6) via ethylene oxide. It is intended for both prescription and over-the-counter use.

Clinical Evidence

Bench testing only. The device demonstrated compliance with ISO 7864 (sterile hypodermic needles), ISO 9626 (stainless steel tubing), ISO 11608-2 (needle-based injection systems), ISO 10993-7 (EO residuals), ASTM F88/F88M-09 (seal strength), ISO 11737-2 (sterility), and USP <85> (bacterial endotoxins).

Technological Characteristics

Materials: 304 Stainless Steel (tube), Polypropylene (hub). Dimensions: 29G/30G/31G/32G gauges. Energy: Manual. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-7, ASTM F88/F88M-09, ISO 11737-2, USP <85>.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection via 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 (K120690)

Submission Summary (Full Text)

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## FEB 2 5 2014

## Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number:

- Date of Submission: 09/10/2013 l .
- Sponsor Identification 2.

Wenzhou Wuzhou Import & Export Co., Ltd. Room 1703 Fortune Center Chezhan Avenue Wenzhou, Zhejiang Province, 325000, China

Establishment Registration Number: 9681901

Contact Person: Bingyi Xiang Position: General Manager Tel: [phone] Fax: [phone] Email: birrell [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

.

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- Proposed Device Identification 4.
Proposed Device Name: Insulin Pen Needle Proposed Device Common Name: Insulin Pen Needle

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

Intended Use Statement:

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

- Predicate Device Identification 5.
510(k) Number: K120690 Product Name: insulin pen needle Manufacturer: Tiger Medical Products Ltd.

## 6. Device Description

The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen.

The Insulin Pen Needle is offered in various gauge sized and length.

They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

- 7. Non-Clinical Test Conclusion
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 results demonstrated that the proposed device complies with the following standards:

ISO 7864 Third edition 1993-05-15, Sterile hypodermic needles for single use. ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the

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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 10993-7:2008(R) 2012, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.

ISO 11737-2:2009, Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

USP 35-NF30:2012, <85> Bacterial Endotoxins Test.

- Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device | Predicate Device |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | FMI | Same |
| Regulation Number | 21 CFR 880.5570 | Same |
| Class | Class II | Same |
| Intended Use | The Insulin Pen Needle is intended for use<br>with pen injector devices for the<br>subcutaneous injection of insulin. | Same |
| Configuration | Needle Tube, Hub, Tube Sheath, Hub Sheath<br>and Sealed Paper | Similar |
| Operation mode | Manual | Same |
| Needle Gauge | 29G/30G/31G/32G | Same |
| Performance<br>specification | Comply with ISO 7864, ISO 9626, and ISO<br>11608-2 | Same |
| Material | Tube: 304 Stainless Steel | Same |
| | Hub: Polypropylene | Same |
| Sterilization | SAL:10-6 | Same |
| | EO Sterilized | Same |
| Shelf Life | 5 years | Same |
| Single Use | Yes | Same |
| Labeling and Labels | Meet FDA requirements | Same |

Table 3-1 Comparison of Technology Characteristics

The proposed device, Insulin Pen Needle, is determined to be Substantially Equivalent (SE) to the predicate device, insulin pen needle (K120690), in respect of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

February 25, 2014

Wenzhou Wuzhou Import & Export Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K133058

Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 18, 2013 Received: September 27, 2013

Dear Ms. 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. 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 from 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.

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Page 2 - Ms. Hong

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133058

Device Name Insulin Pen Needle

Indications for Use (Describe)

The 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)

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[x] Over-The-Counter Use (21 CFR 801 Subpart C)

## Please do not write Below This Line - continue on a separate page if needed.

CHE RESEARCH PORTEDAL FORFORFOALUSE ONLY FORFORFORIUSE ONLY CONTROLLERS OF CONSTITUTION OF

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.02.25 12:54:03 -05'00'

FORM FDA 3881 (9/13)