The proposed device, 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 tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.

The Pen Needle is offered in various gauge size and length.

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

AI/ML Overview

This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "Easy Drip Disposable Insulin Needle" to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Material	The needle shall be made of tubing materials specified in ISO 9626.	Complied
Dimensions	The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.	Complied
Flow rate through the needle	The needles were tested in accordance with Annex A to ISO 11608-2.	Complied
Binding force between needle base and needle tubing	The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.	Complied
Needle tip appearance, needle tubing flawlessness, size of inside and outside diameter and puncturing force	The needle tip appearance shall fulfil the 4.5 of ISO 11608-2. The needle tubing flawlessness shall fulfil the requirements of ISO 7864:1993, 11.3.	Complied
Dislocation of measuring point patient end	Dislocation of the cannula point at the patient end shall be in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2.	Complied
Functional compatibility with needle-based injected systems	Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11 of ISO 11608-2.	Complied
Ease of assembly and disassembly	Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11 of ISO 11608-2.	Complied
Biocompatibility - Cytotoxicity	ISO 10093-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Under the conditions of the study, the subject device showed no evidence of cytotoxicity.
Biocompatibility - Sensitization	ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Under the conditions of the study, the subject device showed no evidence of sensitization.
Biocompatibility - Irritation	ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Under the conditions of the study, the subject device showed no evidence of skin irritation.
Biocompatibility - Hemocompatibility	ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F765 Standard Practice for Assessment of Hemolytic Properties of Materials	Under the conditions of the study, the subject device showed no evidence of hemolysis.
Biocompatibility - Systemic toxicity (acute)	ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.	Under the conditions of the study, the subject device showed no evidence of systemic toxicity.
Biocompatibility - Pyrogen	USP 34 NF 29 <151> Pyrogen Test & USP <85>.	non-pyrogenic
Sterility Assurance Level (SAL)	Achieve a SAL of 10^-6	The validation report demonstrates that the sterilization of the proposed device can achieve a Sterility Assurance Level (SAL) of 10^-6. The radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10^-6 SAL was acceptable according to ISO 11737-2:2012. (Note: The document states 10^8 in one place but implies 10^-6 is met).

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

The document does not specify the exact sample sizes used for each non-clinical test. However, it indicates that "nonclinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective; these are laboratory bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These were non-clinical bench tests performed against established international standards (ISO, ASTM, USP). Expert consensus is not typically used to establish ground truth for these types of tests; rather, the ground truth is defined by the objective pass/fail criteria of the specified standards.

4. Adjudication method for the test set

Not applicable. As noted above, these were objective non-clinical bench tests against standardized criteria.

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 document pertains to a medical device (insulin needle) and its non-clinical performance and biocompatibility, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests was established by adherence to and compliance with relevant international and national standards, including:

ISO 7864 (Sterile hypodermic needles for single use)
ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
ISO 10993 series (Biological evaluation of medical devices, including parts 4, 5, 10, 11)
ASTM F765 (Standard Practice for Assessment of Hemolytic Properties of Materials)
USP <151> Pyrogen Test
USP <85> Bacterial Endotoxins Test

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model, so there is no "training set."

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

Not applicable, for the same reason as above.

Summary

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

August 29, 2016

SteriLance Medical (Suzhou) Inc. c/o Mr. Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. No. 55 Shizhou Middle Road Nanshan District, Shenzhen, GD755 CHINA

Re: K153706

Trade/Device Name: Easy Drip Disposable Insulin Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 15, 2016 Received: July 28, 2016

Dear Mr. Fu:

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 - Mr. Field Fu

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Tina Kiang

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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Indications for Use

510(k) Number (if known) K153706

Device Name Easy Drip Disposable Insulin Needle

Indications for Use (Describe)

The Insulin Pen Needle is intended for use with pen injector device for 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)

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510(k) Summary

1. Contact Details

1.1 Applicant information

Applicant Name	SteriLance Medical (Suzhou) Inc.
Address	No.68 LiTangHe Rd, XiangCheng, Suzhou, China
Phone No.	+86-512-65799308
Fax No.	+86-512-67217663
Contact person	Juanjuan Sun
Contact person's e-mail	juanjuans@sterilance.com
Company e-mail	smc@sterilance.com
Date Prepared	July 22, 2016
Website	www.sterilance.com

1.2 Submission Correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd


Address	Room 2032, International Mayors Communication Centre, NO. 55Shizhou middle road, Nanshan District, Shenzhen
Phone No.	+86-755-86069197
Contact person	Field Fu
Contact person's e-mail	cefda13485@163.com; elly@cefda.com
Website	http://www.cefda.com

2. Device information

Trade name	Easy Drip Disposable Insulin Needle
Common name	Insulin Pen Needle
Model	29G/30G/31G/32G
Classification	II
Classification name	Needle, Hypodermic, Single Lumen
Product code	FMI
Regulation No.	880.5570

3. Legally Marketed Predicate Device

Trade Name	Insulin Pen Needle
510(k) Number	K133059
Product Code	FMI
Manufacturer	Wenzhou Beipu Science & Technology Co., Ltd

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Product: Insulin Pen Needle

Device Description 4.

The Pen Needle is offered in various gauge size and length.

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

Intended Use/Indication for Use 5.

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

Item	Proposed Device:Insulin Pen Needle	Predicate Device:Insulin Pen Needle(K133059)	Comments
Product Code	FMI	FMI	Same
Intended Use	The Insulin Pen Needle isintended for use with peninjector device forsubcutaneous injection ofinsulin.	The Insulin Pen Needle isintended for use with peninjector devices for thesubcutaneous injection ofinsulin.	Same
Configuration	Needle tubing (Needle Tube),Needle tip shield (TubeSheath), Needle base (Hub),Needle base shield (HubSheath), Sealing dialysis paper(Sealed Paper).	Needle Tube, Hub, TubeSheath, Hub Sheath andSealed Paper.	Same
Operation mode	Manual	Manual	Same
Needle Gauge	29G/30G/31G/32G	29G/30G/31G/32G	Same
Material	Tube: 304 Stainless SteelNeedle base:Polyformaldehyde	Tube: 304 Stainless SteelHub: Polypropylene	Similar (*1)
Sterilization	SAL: 10-6Method: Radiation Sterilized	SAL: 10-6Method: EO Sterilized	SameDifferent (*2)
Performance	Complied with ISO 7864, ISO9626, and ISO 11608-2	Complied with ISO 7864, ISO9626, and ISO 11608-2	Same
Shelf Life	5 years	5 years	Same
Single Use	Yes	Yes	Same
Biocompatibility	Complied with ISO10993series standards	Complied with ISO10993series standards	Same
Cytotoxicity	Under the conditions of the	Under the conditions of the	Same

6. Substantial Equivalence Comparison

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Product: Insulin Pen Needle

	study, the subject deviceshowed no evidence ofcytotoxicity	study, the subject deviceshowed no evidence ofcytotoxicity
Skin Irritation	Under the conditions of thestudy, the subject deviceshowed no evidence of skinirritation	Under the conditions of thestudy, the subject deviceshowed no evidence of skinirritation	Same
SkinSensitization	Under the conditions of thestudy, the subject deviceshowed no evidence ofsensitization	Under the conditions of thestudy, the subject deviceshowed no evidence ofsensitization	Same
Acute SystemicToxicity	Under the conditions of thestudy, the subject deviceshowed no evidence ofsystemic toxicity	Under the conditions of thestudy, the subject deviceshowed no evidence ofsystemic toxicity	Same
Hemolysis	Under the conditions of thestudy, the subject deviceshowed no evidence ofhemolysis	Under the conditions of thestudy, the subject deviceshowed no evidence ofhemolysis	Same
Pyrogen	non-pyrogenic	non-pyrogenic	Same

*1: The needle base materials are different, but Polyformaldehyde and Polypropylene are all the common plastic materials. The biocompatibility and performance testing reports of the proposed device demonstrate that subject device is biocompatible and the performance as intended.

*2: The sterilization methods between the proposed device and the predicate device are different. The radiation sterilization method for the proposed device is proved by the Microbiological Validation Report of Gamma Radiation Sterilization and Radiation Sterilization Dose Audit Test reports. The validation report demonstrates that the sterilization of the proposed device can achieve a Sterility Assurance Level (SAL) of 108, and the radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10° SAL was acceptable according to ISO 11737-2:2012. Therefore, the difference does not affect substantially equivalency between the proposed device and predicate device.

Non-clinical Testing 7.

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:

Test	Requirements
Materials	The needle shall be made of tubing materials specifiedin ISO 9626.
Dimensions	The needles shall fit the test apparatus specified in item7.3 of ISO 11608-2.

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Product: Insulin Pen Needle

Flow rate through the needle	The needles were tested in accordance with Annex Ato ISO 11608-2.
Binding force between needle base andneedle tubing	The union of the hub and needle tube shall not breakwhen tested in accordance with Clause 9 of ISO11608-2.
Needle tip appearance, needle tubingflawlessness, size of inside and outsidediameter and puncturing force	The needle tip appearance shall fulfil the 4.5 of ISO11608-2.The needle tubing flawlessness shall fulfil therequirements of ISO 7864:1993, 11.3.
Dislocation of measuring point patient end	Dislocation of the cannula point at the patient end shallbe in accordance with Table 2 (ISO 11688-2) whentested in accordance with Clause 8 of ISO 11608-2.
Functional compatibility with needle-basedinjected systems	Compatibility with any NIS shall be claimed only aftertesting in accordance with Clause 11 of ISO 11608-2.
Easy of assemble and disassembly	Attachment of the needle shall be possible withoutremoving the needle from its opened unit packaging.Compliance is checked according to the requirementsof Clause 11 of ISO 11608-2.
Biocompatibility
	Cytotoxicity	ISO 10093-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
	Sensitization	ISO 10993-10 Biological evaluation of medical devices-Part 10:Tests for irritation and skin sensitization
	Irritation	ISO 10993-10 Biological evaluation of medical devices-Part 10:Tests for irritation and skin sensitization
	Haemocompatibility	ISO 10993-4 Biological evaluation of medical devicesPart 4: Selection of tests for interactions with bloodASTM F765 Standard Practice for Assessment ofHemolytic Properties of Materials
	System toxicity (acute)	ISO 10993-11:2006/(R)2010, Biological evaluation ofmedical devices - Part 11: Tests for systemic toxicity.
	Pyrogen	USP 34 NF 29 <151> Pyrogen Test & USP <85>.

All nonclinical testing performed on new devices demonstrate the substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices.

8. Clinical Testing

Substantial equivalence does not depend on the clinical test data.

9. Conclusions

Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device (K133059).

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).