Insulin Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. February 26, 2021 Promisemed Hangzhou Meditech Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town. Nanshan Shenzhen, Guangdong 518000 China Re: K193273 Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dear Christy Young: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 5, 2021. Specifically, FDA is updating this SE Letter (E.G., typo in manufacturer name) as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Rumi Young, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-6005, Rumi. Young@fda.hhs.gov. > Sincerely. Digitally signed by Rumi Rumi Young -S Date: 2021.02.26 Young -S Date: 2021.02.2 Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 5, 2021 Prominsemed Hangzhou Meditech Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town. Nanshan Shenzhen, 518000 Cn Re: K193273 Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 14, 2020 Received: December 8, 2020 Dear Christy Young: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {2}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Rumi Young - Digitally signed by Rumi Young -S Date: 2021.01.05 09:58:10 -05'00' Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193273 Device Name Insulin Syringe Indications for Use (Describe) Insulin Syringe is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Contact Details ### 1.1 Applicant information | Applicant Name | Promisemed Hangzhou Meditech Co., Ltd. | | | |----------------|--------------------------------------------------------------------------------------------------|--|--| | Address | No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City<br>311121 Zhejiang, China. | | | | Phone No. | + 86(0571)88772985 | | | | Fax No. | + 86(0571)88772985 | | | | Contact person | Liqing Yang | | | | Date Prepared | October 12, 2020 | | | #### 1.2 Submission Correspondent | Image: logo<br>卓远天成 | Shenzhen Joyantech Consulting Co., Ltd<br>1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town,<br>Nanshan District, Shenzhen, Guangdong Province, China. | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone No. | +86-755-86069197 | | Contact person | Joyce Yang; | | Contact person's e-mail | joyce@cefda.com; cefda@foxmail.com | | Website | http://www.cefda.com | #### 2. Device information | Trade name | Insulin Syringe | |---------------------|-----------------| | Common name | Insulin Syringe | | Model/Type | Type7, Type8 | | Classification | II | | Classification name | Piston syringe | | Product code | FMF | | Regulation No. | 21 CFR 880.5860 | #### 3. Legally Marketed Predicate Device | | Primary Predicate Device | |---------------|-----------------------------------| | Trade Name | Disposable Insulin Syringes | | 510(k) Number | K162180 | | Product Code | FMF | | Manufacturer | Berpu Medical Technology Co.,Ltd. | {5}------------------------------------------------ #### 4. Device Description The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. #### 5. Intended Use/Indications for Use Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. | Element of<br>comparison | Proposed Device:<br>Insulin Syringe | Predicate Device:<br>Disposable Insulin Syringe<br>(K162180) | Comment | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Product Code | FMF | FMF | Same | | Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | | Syringe type | Piston syringe | Piston syringe | Same | | Intended use | Insulin Syringe is intended for<br>subcutaneous injection of<br>U-40 and U-100 insulin in the<br>treatment of diabetes. | The disposable insulin<br>syringe is intended for<br>medical purposes for the<br>manual aspiration of U-100<br>insulin, and for the injection of<br>insulin into parts of the body<br>below the surface skin. | Similar<br>(Note1) | | Principle of operation | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated<br>through pushing plunger rod<br>of the insulin syringe. | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated<br>through pushing plunger rod<br>of the insulin syringe. | Same | | Specific drug use | Insulin | Insulin | Same | | Length | 120mm | 120mm | Same | | Volume | 0.3ml, 0.5ml, 1.0ml | 0.3ml, 0.5ml, 1.0ml | Same | | Needle length | 6mm, 8mm,12mm | 5mm, 6mm, 8mm, 12mm | Similar<br>(Note2) | | Needle gauge | 32G, 31G, 30G, 29G, 28G | 31G, 30G, 29G, 28G, 27G | Similar<br>(Note2) | | Needle dimensions | 0.23mm,0.25mm, 0.30mm,<br>0.33mm, 0.36mm, | 0.25mm, 0.30mm, 0.33mm,<br>0.36mm, 0.40mm | Similar<br>(Note2) | | Needle tip<br>configuration | 3 bevels<br>Primary bevel length:<br>(0.84±0.15) mm<br>Primary bevel angle: 10° ± 2° | 3 bevels | Same | | Element of<br>comparison | Proposed Device:<br>Insulin Syringe | Predicate Device:<br>Disposable Insulin Syringe<br>(K162180) | Comment | | | | | | | | Secondary bevel length:<br>$(0.64±0.15)$ mm<br>Secondary bevel angle: 17°<br>$±2°$<br>(The secondary bevel is<br>rotated 35° $±2°$ to form 2<br>bevels) | | | | Nozzle type | Not applicable | Not applicable | Same | | Numbering of scale | At every five units for the<br>0.3mL and 0.5mL syringes,<br>and at every 10units for<br>1.0mL | At every five units for the<br>0.3mL and 0.5mL syringes,<br>and at every 10units for<br>1.0mL | Same | | Gradations legibility | Legible | Legible | Same | | Needle cover<br>dimensions | Length:25mm, Diameter:<br>6mm | Length:25mm, Diameter:<br>6mm | Same | | Needle cover color | Red (U-40) and orange<br>(U-100) | Orange (U-100) | Similar<br>(Note 1) | | Lubricant<br>composition | Aminofuntional siloxane | Aminofuntional siloxane | Same | | Lubricant<br>amount/cm² | The lubricant is not form pools<br>of fluid on the interior surface<br>of the syringe or outside<br>surfaces of the needle tube | The lubricant is not form pools<br>of fluid on the interior surface<br>of the syringe or outside<br>surfaces of the needle tube | Same | | Barrel transparency | Transparent | Transparent | Same | | Reuse durability | Single Use | Single Use | Same | | Needle cover<br>strength | <15N | <15N | Same | | Hub/needle bond<br>strength | >22N | >22N | Same | | Biocompatibility | No cytotoxicity<br>No irritation reactivity<br>No significant evidence of<br>skin sensitization<br>No significant evidence of<br>systemic toxicity<br>No evidence of Hemolysis<br>No evidence of pyrogens | No cytotoxicity<br>No irritation reactivity<br>No significant evidence of<br>skin sensitization<br>No significant evidence of<br>systemic toxicity<br>No evidence of Hemolysis<br>No evidence of pyrogens | Same | | Configuration<br>and<br>Materials | Needle: Stainless Steel<br>(SUS304)<br>Barrel: Polypropylene | Needle: Stainless Steel<br>(SUS304)<br>Barrel: Polypropylene (PP) | Similar<br>(Note3) | | Element of<br>comparison | Proposed Device:<br>Insulin Syringe | Predicate Device:<br>Disposable Insulin Syringe<br>(K162180) | Comment | | | Plunger: Polypropylene<br>Piston: Polyisoprene rubber<br>Needle cap: Polyethylene<br>Protective end cap(only type<br>8): Polyethylene | Plunger: Polypropylene (PP)<br>Piston: Polyisoprene Rubber<br>Needle cover: Polypropylene (PP)<br>Protective end cap:<br>Polypropylene (PP) | Same | | Label | Device name, indication,<br>instruction for use,<br>precaution, warning, shelf life,<br>manufacturer | Device name, indication,<br>instruction for use,<br>precaution, warning, shelf life,<br>manufacturer | | | Sterilization method<br>and SAL | Sterilized by ethylene oxide<br>gas SAL = 10-6 | Sterilized by ethylene oxide<br>gas SAL = 10-6 | | | Sterilization<br>validation standard | ISO 11135 | ISO 11135 | | #### 6. Substantial Equivalence Comparison {6}------------------------------------------------ {7}------------------------------------------------ lssue: Note1: The subject device and predicate device have the same indication, that is, for insulin injection. The subject device has another type of syringe for injection of U-40 insulin. The sizes, graduated scale and tolerance on graduated capacity of U-40 insulin syringe are same as the U-100 insulin syringe. The difference between U-40 and U-100 insulin syringe is delivery different insulin concentration. For U-40 insulin syringe, a red needle cap is used for color marking in accordance with ISO 8573. In addition, the tolerance on graduated capacity has been validated per ISO 8573 Annex H. Therefore, this difference does not affect the Substantially Equivalent between the subject device and predicate device. Note 2: The needle length of proposed device is covered by the predicate device. The proposed device has extra 32G than the predicate device, and the 32G needle is similar the 31G in dimension. This difference does not affect intended use. In addition, the legally marketed similar device such as Safety Insulin Needle (K181447) has the same needle gauge. The gauge (32G) for proposed device is different from the predicate device. However, this difference is just in dimension. Different gauge will be selected by physician per patient's condition. This difference does not affect intended use. Differences in needle length and gauge between the predicate and subject device were addressed through ISO 8537:2016 performance testing. Therefore, this difference does not affect substantially equivalence on safety and effectiveness. Note 3: The materials of needle cap and protective end cap are different between the subject device and predicate device. The biocompatibility test of the subject device was conducted to demonstrate that the subject device met the biocompatibility requirements. So this difference does not raise any safety and effectiveness problems. #### 7. Non-clinical studies and tests performed The Insulin Syringes have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate device. The results {8}------------------------------------------------ of the non-clinical testing supported the conclusion of substantial equivalence. #### Performance Testing The Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin. #### Biocompatibility Testing The material of the Insulin Syringes have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External communicating devices, Limited exposure. ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization ISO 10993-11: 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity ISO 10993-4:2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood. ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials The United States Pharmacopeia <151> (Pyrogen test) The United States Pharmacopeia <788> Particulate matters #### Sterilization and Shelf-life Testing Sterilization of the Insulin Syringes has been validated according to ISO 11135.Testing demonstrated maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization. #### 8. Clinical study No prospective clinical trials were conducted in support of this 510(K). #### 9. Conclusion Based on the comparison and analysis above, the proposed devices Insulin Syringes are determined to be Substantially Equivalent (SE) to the predicate devices.