Sure-Fine Insulin Syringes

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September 6, 2019 Shina Med Corporation Park Sung-Soon Manager 455-30 Bogaewonsam-ro, Bogae-myun Anseong-si, 456-871 KOREA Re: K191531 Trade/Device Name: Sure-Fine Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: August 6, 2019 Received: August 9, 2019 Dear Park Sung-Soon: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, Alan Stevens 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191531 Device Name Sure-Fine Insulin Syringes Indications for Use (Describe) Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 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. 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Submitted by : Sung-soon, Park / Quality Management Representative # SHINA MED CORPORATION 455-30, Bogaewonsam-ro Bogae-myeon, Anseong-si, Gyeonggi-do, 17509, Rep. of Korea Phone : +82 31 8057 2125 Fax : + 82 31 8057 2150 ### 2. Device Name : | - Trade Name | : | Sure-Fine Insulin Syringes | |-----------------------|---|----------------------------| | - Classification | : | Class II | | - Classification Name | : | Piston syringe | | - Product Code | : | FMF | | - Regulation Number | : | 21 CFR 880.5860 | | - Review Panel | : | General Hospital | ### 3. 510(k) Premarket Notification: K152879 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for SHINA MED CORPORATION. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a circle with a wavy line at the bottom. The company name is written in a bold, sans-serif font. ## 510(k) Premarket Notification | | | CFR Title 21 Radiation-Emitting Products X-Ray Assembler Medsun Reports CLIA TPLC | | |------------|------------------------------|---------------------------------------------------------------------------------------------|------------------------| | New Search | | | Back To Search Results | | | Device Classification Name | Syringe, Piston | | | | 510(K) Number | K152879 | | | | Device Name | Sure-Fine Insulin Syringes | | | | Applicant | SHINA MED CORPORATION<br>455-30, BOGAWONSAM-RO BOGAE-MYUN<br>Anseong-Si, KR 456-871 | | | | Applicant Contact | Sung-Soon Park | | | | Correspondent | LK CONSULTING GROUP USA, INC.<br>2651 E CHAPMAN AVE STE 110<br>Fullerton, CA 92831 | | | | Correspondent Contact | Priscilla Chung | | | | Regulation Number | 880.5860 | | | | Classification Product Code | FMF | | | | Date Received | 09/30/2015 | | | | Decision Date | 09/09/2016 | | | | Decision | Substantially Equivalent (SESE) | | | | Regulation Medical Specialty | General Hospital | | | | 510k Review Panel | General Hospital | | | | Summary | Summary | | | | Type | Traditional | | | | Reviewed By Third Party | No | | #### Device Description: 4 ### 4.1 Predicate Device Description(K152879) Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. | Category | Insulin syringe | Needle Gauge | Needle Length | Cap color | | |----------|-----------------------|--------------|---------------|------------|-----------------| | | | | | Needle cap | Protective cap | | U-100 | 1/2cc and 1cc | 28Gauge | 1/2" | Orange | Orange or white | | | 3/10cc, 1/2cc and 1cc | 29Gauge | 1/2" | Orange | Orange or white | | | 3/10cc, 1/2cc and 1cc | 30Gauge | 1/2" | Orange | Orange or white | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for SHINA MED CORPORATION. The logo consists of a circle with a wavy line at the bottom left, followed by the text "SHINA MED CORPORATION" in bold, sans-serif font. The logo is simple and professional, and the text is easy to read. | 3/10cc, 1/2cc and 1cc | 30Gauge | 5/16" | Orange | Orange or white | |-----------------------|---------|-------|--------|-----------------| | 3/10cc, 1/2cc and 1cc | 31Gauge | 5/16" | Orange | Orange or white | ### 4.2 Device description for Special 510(k), K191531 The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The design features and sizing of the components were compared and the Sure-Fine Insulin Syringe is found to be substantially equivalent to the predicate device. The similarity in design between modified Sure-Fine Insulin Syringes and the previous device supports the substantial equivalence of Sure-Fine Insulin Syringe for the indicated use. Therefore, modified Sure-Fine Insulin Syringe is substantially equivalent to the previous device in terms of indications, compositions, material, design, safety and effectiveness. The syringes are available in the following sizes and cap color. | Category | Insulin syringe | Needle<br>Gauge | Needle<br>Length | Cap color | | |----------|------------------|-----------------|------------------|------------|-----------------| | | | | | Needle cap | Protective cap | | U-100 | 3/10cc and 1/2cc | 30Gauge | 1/4" | Orange | Orange or white | | U-100 | 3/10cc and 1/2cc | 31Gauge | 1/4" | Orange | Orange or white | | U-100 | 1cc | 27Gauge | 1/2" | Orange | Orange or white | The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable. ### 4.3 Substantial Equivalence Discussion Modified Sure-Fine Insulin syringe is substantially equivalent to the predicate Sure-Fine Insulin Syringes device(K152879). The design features and sizing of the components were also compared and the Sure-Fine {6}------------------------------------------------ Insulin Syringe is substantially the same as the predicate device product. The similarity in design between modified Sure-Fine Insulin Syringes and the previous device supports the safety and effectiveness of Sure-Fine Insulin Syringe for the indicated use. The biggest difference between modified device and previous device is the addition of needle gauge (27G) and the addition of needle length (1/4"). Therefore, modified Sure-Fine Insulin Syringe is substantially equivalent to the previous device in terms of indications, compositions, material, design, safety and effectiveness. | Device Name | | Subject Device<br>(Special 510(k)) | Predicate Device#1<br>(Existing Traditional<br>510(k)) | |--------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Manufacturer | | SHINA MED CORPORATION | SHINA MED<br>CORPORATION | | 510(k) Number | | N/A | K152879 | | Product Code | | FMF | FMF | | Intended Use | | Sure-Fine Insulin Syringes are<br>hypodermic insulin syringes for<br>subcutaneous injection of U100<br>insulin. | Sure-Fine Insulin<br>Syringes are hypodermic<br>insulin syringes for<br>subcutaneous injection of<br>U100 insulin. | | Design (Syringe) | Needle<br>/ Barrel | Image: Needle / Barrel | Image: Needle / Barrel | | | Gasket<br>/ Plunger | Image: Gasket / Plunger | Image: Gasket / Plunger | | | Needle<br>Cap | Image: Needle Cap | Image: Needle Cap | | | Protective<br>end<br>cap | Image: Protective end cap | Image: Protective end cap | | | Volume | 0.3cc, 0.5cc, 1.0cc | 0.3cc, 0.5cc, 1.0cc | | Design<br>(Needle) | Needle<br>Tip<br>shape | Image: Needle Tip shape | Image: Needle Tip shape | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for SHINA MED CORPORATION. The logo consists of a stylized graphic to the left of the company name. The company name is written in a bold, sans-serif font. The logo is simple and professional. ## Special 510(K) Submission | | Gauge | 27, 30, 31 Gauge | 28, 29, 30,31Gauge | |--------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------| | | Length | 1/2", 1/4" | 1/2", 5/16" | | Materials | Needle | STS304 | STS304 | | | Barrel | Polypropylene | Polypropylene | | | Plunger | Polypropylene | Polypropylene | | | Piston | Isoprene Rubber | Isoprene Rubber | | | Needle<br>Cap | Polyethylene | Polyethylene | | | Protective end cap | Polyethylene | Polyethylene | | | Silicon | Polydimethylsiloxane | Polydimethylsiloxane | | Biocompatibility | Conform ISO10993 -1 | Conform ISO10993-1 | Conform ISO10993-1 | | Sterilization method and S.A.L | Sterilized by ethylene oxide gas SAL = $10^{-6}$ | Sterilized by ethylene oxide gas SAL = $10^{-6}$ | Sterilized by ethylene oxide gas SAL = $10^{-6}$ | #### ട് Indication for Use : Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin. ( The indication for use is substantially equivalent to the predicate device.) {8}------------------------------------------------ ### Special 510(K) Submission Image /page/8/Picture/1 description: The image shows the logo for SHINA MED CORPORATION. The logo consists of a circle with a wavy line at the bottom left, followed by the text "SHINA MED CORPORATION" in bold, sans-serif font. The logo is simple and professional, and it is likely used to represent the company's brand. ### 6. Technological Characteristics : Sure-fine insulin syringe and predicate device have the substantially equivalent technological characteristics and perform as piston syringes. Risks associated with the changes were identified and appropriate design controls implemented to mitigate the risks. Based on the change assessment, it is concluded that the risks are associated with the mechanical performance of the needle. To mitigate these risks, appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards: - ISO7864 Sterile hypodermic needles for single use Requirements and test methods ● - . ISO9626 - Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods - ISO8537 Sterile single-use syringes, with or without needle, for insulin . ### 8. Conclusion Based on the information provided in this special 510(k), the Sure-fine insulin syringes are substantially equivalent to the previous devices (K152879).