INSULIN PEN NEEDLE

• K Number: K133059
• Device Name: INSULIN PEN NEEDLE
• Manufacturer: WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD.
• Date Cleared: 2014-02-25 ( 151 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

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

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. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

Predicate Devices

K120690

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, sterility, and mechanical properties of a simple needle, with no mention of AI/ML or data processing.

Therapeutic

No
The device is an insulin pen needle, which facilitates the injection of insulin but does not itself provide therapy. It is an accessory to a therapeutic regimen rather than a therapeutic device.

Diagnostic

No
Explanation: The device is an Insulin Pen Needle, which is used for the injection of insulin. Its purpose is to deliver medication, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (needle tube, hub, tube sheath, sealed paper) and mentions sterilization, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the "subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
• Device Description: The description details a needle designed to connect to an insulin pen for injection. This aligns with a device used for drug delivery, not for in vitro testing.
• Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
• Performance Studies: The performance studies focus on the physical and biological properties of the needle itself (sterility, biocompatibility, seal strength, etc.), which are relevant to a device used for injection, not for in vitro diagnostics.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This insulin pen needle does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FMI

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.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 10993-4:2002/Amd 1:2006, Biological Evaluation of Medical Device, Part 4: Selection of test for Interactions with Blood.
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-7:2008(R) 2012, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.
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, Bacterial Endotoxins Test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120690

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

0

Project #: MD0412012_

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: _K133059

1. Date of Submission: 08/22/2013

2. Sponsor Identification

Wenzhou Beipu Science & Technology Co., Ltd No. 7, Jinshui Road, Wenzhou Industrial Park, Wenzhou, Zhejiang, 325013, China

Establishment Registration Number: 3004496829

.

Contact Person: Xingguo Wang Position: Sales Manager Tel: [phone] Fax: [phone] Email: [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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• 4. Proposed Device Identification
     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.

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

Device Description 6.

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.

The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10°,

• 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 3-2

2

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 10993-4:2002/Amd 1:2006, Biological Evaluation of Medical Device, Part 4: Selection of test for Interactions with Blood.

ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

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

ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

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, 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 with pen injector devices for the subcutaneous injection of insulin.	Same
Configuration	Needle Tube, Hub, Tube Sheath, Hub Sheath and Sealed Paper	Similar
Operation mode	Manual	Same
Needle Gauge	29G/30G/31G/32G	Same
Performance
specification	Comply with ISO 7864, ISO 9626, and ISO
11608-2	Same
Material	Tube: 304 Stainless Steel
Hub: Polypropylene	Same
Sterilization	SAL: $10^{-6}$	Same

Table 3-1 Comparison of Technology Characteristics

3

.

Project #: MD0412012

	EO Sterilized	Same
Shelf Life	5 years	Same
Single Use	Yes	Same
Labeling and Labels	Meet FDA requirements	Same

The proposed device, Insulin Pen Needle, is determined to be Substantially Equivalent (SE) to the predicate device, insulin pen needle (K 120690), in respect of safety and effectiveness.

4

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

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

Re: K133059

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 22, 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 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.

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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.gov/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/ReportalProblem/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/ResourcesforYou/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) K133059

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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR A STATE A BEACH STORE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR ార్యం గ్రామం నుండి 1 -

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

201333

Digitally signed by Richard C. Chapman Date: 2014.02.25 13:00:02 -05'00'

FORM FDA 3881 (9/13)

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