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.

AI/ML Overview

The provided text describes the submission for an Insulin Pen Needle for 510(k) clearance, intending to prove substantial equivalence to a predicate device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML model evaluation (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this submission.

However, I can extract information regarding the device's performance criteria and how its compliance was demonstrated through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, focusing on the relevant sections for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria for the Insulin Pen Needle are primarily based on compliance with established international standards for medical devices, specifically needles and injection systems. The reported device performance is that it complies with these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 7864 (Sterile hypodermic needles for single use)	Complies
ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)	Complies
ISO 11608-2 (Needle-based injection systems for medical use - Part 2: Needles)	Complies
ISO 10993-4 (Biological Evaluation - Interactions with Blood)	Complies
ISO 10993-5 (Biological Evaluation - Tests for In Vitro cytotoxicity)	Complies
ISO 10993-7 (Biological Evaluation - Ethylene oxide sterilization residuals)	Complies
ISO 10993-10 (Biological Evaluation - Tests for irritation and skin sensitization)	Complies
ISO 10993-11 (Biological Evaluation - Tests for systemic toxicity)	Complies
ASTM F88/F88M-09 (Seal Strength of Flexible Barrier Materials)	Complies
ISO 11737-2 (Sterilization of medical devices - Tests of sterility)	Complies
USP 35-NF30:2012, <85> (Bacterial Endotoxins Test)	Complies
Sterility Assurance Level (SAL)	10⁻⁶
Shelf Life	5 years
Single Use	Yes
Labeling and Labels	Meets FDA requirements

2. Sample size used for the test set and the data provenance:

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests. The tests were performed to demonstrate compliance with international standards, which typically involve specific sample size requirements as part of the test methodology outlined in those standards. The data provenance is internal testing performed by the manufacturer (Wenzhou Beipu Science & Technology Co., Ltd) implicitly in China, as that is their location. These would be prospective tests performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This is not applicable as this is a physical medical device, not an AI/ML model requiring expert annotation for ground truth. Compliance with performance standards is typically measured by laboratory testing according to defined protocols, not expert consensus on images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for a physical device's performance testing. Test results are typically objective measurements against a defined standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's inherent performance as measured by physical and biological tests against established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is compliance with established, objective, and predefined engineering, materials, and biological standards (e.g., ISO, ASTM, USP). This is demonstrated through laboratory testing, not human expert interpretations or clinical outcomes data in the way an AI model would be validated.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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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

Date of Submission: 08/22/2013
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: 86 577 86651999 Fax: 86 577 86630389 Email: cnbeipu@gmail.com

Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. 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 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°,

1. 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

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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 10993-4:2002/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, <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 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
Performancespecification	Comply with ISO 7864, ISO 9626, and ISO11608-2	Same
Material	Tube: 304 Stainless SteelHub: Polypropylene	Same
Sterilization	SAL: $10^{-6}$	Same

Table 3-1 Comparison of Technology Characteristics

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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).