Insulin Pen Needle

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them. The emblem is black and white. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 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. 55<br>Shizhou 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 | {4}------------------------------------------------ ## Product: Insulin Pen Needle ### Device Description 4. 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. ### 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:<br>Insulin Pen Needle | Predicate Device:<br>Insulin Pen Needle<br>(K133059) | Comments | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------| | Product Code | FMI | FMI | Same | | Intended Use | The Insulin Pen Needle is<br>intended for use with pen<br>injector device for<br>subcutaneous injection of<br>insulin. | The Insulin Pen Needle is<br>intended for use with pen<br>injector devices for the<br>subcutaneous injection of<br>insulin. | Same | | Configuration | Needle tubing (Needle Tube),<br>Needle tip shield (Tube<br>Sheath), Needle base (Hub),<br>Needle base shield (Hub<br>Sheath), Sealing dialysis paper<br>(Sealed Paper). | Needle Tube, Hub, Tube<br>Sheath, Hub Sheath and<br>Sealed Paper. | Same | | Operation mode | Manual | Manual | Same | | Needle Gauge | 29G/30G/31G/32G | 29G/30G/31G/32G | Same | | Material | Tube: 304 Stainless Steel<br>Needle base:<br>Polyformaldehyde | Tube: 304 Stainless Steel<br>Hub: Polypropylene | Similar (*1) | | Sterilization | SAL: 10-6<br>Method: Radiation Sterilized | SAL: 10-6<br>Method: EO Sterilized | Same<br>Different (*2) | | Performance | Complied with ISO 7864, ISO<br>9626, and ISO 11608-2 | Complied with ISO 7864, ISO<br>9626, and ISO 11608-2 | Same | | Shelf Life | 5 years | 5 years | Same | | Single Use | Yes | Yes | Same | | Biocompatibility | Complied with ISO10993<br>series standards | Complied with ISO10993<br>series standards | Same | | Cytotoxicity | Under the conditions of the | Under the conditions of the | Same | #### 6. Substantial Equivalence Comparison {5}------------------------------------------------ Product: Insulin Pen Needle | | study, the subject device<br>showed no evidence of<br>cytotoxicity | study, the subject device<br>showed no evidence of<br>cytotoxicity | | |----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------| | Skin Irritation | Under the conditions of the<br>study, the subject device<br>showed no evidence of skin<br>irritation | Under the conditions of the<br>study, the subject device<br>showed no evidence of skin<br>irritation | Same | | Skin<br>Sensitization | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>sensitization | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>sensitization | Same | | Acute Systemic<br>Toxicity | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>systemic toxicity | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>systemic toxicity | Same | | Hemolysis | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>hemolysis | Under the conditions of the<br>study, the subject device<br>showed no evidence of<br>hemolysis | 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 specified<br>in ISO 9626. | | Dimensions | The needles shall fit the test apparatus specified in item<br>7.3 of ISO 11608-2. | {6}------------------------------------------------ Product: Insulin Pen Needle | Flow rate through the needle | The needles were tested in accordance with Annex A<br>to ISO 11608-2. | | |-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Binding force between needle base and<br>needle tubing | The union of the hub and needle tube shall not break<br>when tested in accordance with Clause 9 of ISO<br>11608-2. | | | Needle tip appearance, needle tubing<br>flawlessness, size of inside and outside<br>diameter and puncturing force | The needle tip appearance shall fulfil the 4.5 of ISO<br>11608-2.The needle tubing flawlessness shall fulfil the<br>requirements of ISO 7864:1993, 11.3. | | | Dislocation of measuring point patient end | Dislocation of the cannula point at the patient end shall<br>be in accordance with Table 2 (ISO 11688-2) when<br>tested in accordance with Clause 8 of ISO 11608-2. | | | Functional compatibility with needle-based<br>injected systems | Compatibility with any NIS shall be claimed only after<br>testing in accordance with Clause 11 of ISO 11608-2. | | | Easy of assemble and disassembly | Attachment of the needle shall be possible without<br>removing the needle from its opened unit packaging.<br>Compliance is checked according to the requirements<br>of Clause 11 of ISO 11608-2. | | | Biocompatibility | | | | | Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices<br>-Part 5: Tests for in vitro cytotoxicity | | | Sensitization | ISO 10993-10 Biological evaluation of medical devices<br>-Part 10:Tests for irritation and skin sensitization | | | Irritation | ISO 10993-10 Biological evaluation of medical devices<br>-Part 10:Tests for irritation and skin sensitization | | | Haemocompatibility | ISO 10993-4 Biological evaluation of medical devices<br>Part 4: Selection of tests for interactions with blood<br>ASTM F765 Standard Practice for Assessment of<br>Hemolytic Properties of Materials | | | System toxicity (acute) | ISO 10993-11:2006/(R)2010, Biological evaluation of<br>medical 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).