Insulin Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 6, 2024 SPM Medicare Pvt. Ltd. % Prithul Bom, Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114 # Re: K233794 Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: March 6, 2024 Received: March 6, 2024 # Dear Prithul Bom: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Shruti N. Mistry -S Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233794 Device Name Insulin Syringe Indications for Use (Describe) The sterile Insulin Syringe is for single use, with the callbrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="unicode-bidi:isolate; direction:ltr;"> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="unicode-bidi:isolate; direction:ltr;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ #### K233794 510k Summary This 510k summary is being prepared in accordance with the requirements of 21 CFR 807.92. ### I. SUBMITTER | Device Submitter: | SPM Medicare Pvt. Ltd<br>B-40, Phase II<br>Gautam Budh Nagar<br>Noida -201305,Uttar Pradesh, India | |-------------------|----------------------------------------------------------------------------------------------------| | Contact Person: | Mr. Umang Mathur | | Contact Person: | Mr. Umang Mathur | |-----------------|----------------------------------------------------------------------------| | Position: | Managing Director<br>Tel : +91-971-100-8401<br>Email:umang@spmmedicare.com | Designation Submission Correspondent Primary contact Person: Sanjay Kumar Position: Deputy Manager & (Management Representative) MR Tel:+91-8384011434 Email : sanjay.qa@spmmedicare.com Date of Preparation: February 7, 2024 ### II. DEVICE ldentification of proposed device: Trade Name: Insulin syringe Common name: Insulin syringe {4}------------------------------------------------ ### Regulatory Information: Regulation Name: Piston syringe Requlatory Class: Class II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital ### III Predicate Device 1. 510(k) Number K223453 Product Name: Insulin Svringe Regulation Number: 21 CFR 880.5860 Product Code: FMF #### Manufacturer Name: Promisemed Hangzhou Meditech Co., Ltd. Zearou Yanq Requlatory affairs manager No. 1388, Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, Zhejiang 311121, China #### IV: Device Description: The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made up of polypropylene. ### Device Range: The proposed Insulin Syringe will be distinguished on the basis of their size and units. The 1 ml U-40 & U-100 syringes are being manufactured with different needle gauges, U-40 means 40 units of insulin in every Lm and U-100 means there are 100 units of insulin in every mL. The color code is used to identify the strength, where the red cap is used to identify U-40 units & the orange cap is used to identify U-100 units. | S. No. | Gauge | O.D of Needle | Length of Needle | |--------|-------|------------------|--------------------| | 1 | 28G | 0.349 – 0.370 mm | 6 mm, 8 mm, 12.7mm | | 2 | 29G | 0.324 – 03.51 mm | 6 mm, 8 mm, 12.7mm | | 3 | 30G | 0.298 – 0.320 mm | 6 mm, 8 mm, 12.7mm | | 4 | 31G | 0.254 – 0.267 mm | 6 mm, 8 mm, 12.7mm | | 5 | 32G | 0.229 – 0.241mm | 6 mm, 8 mm, 12.7mm | Nominal Capacity: 1 ml (U-40). 1 ml (U-100) {5}------------------------------------------------ # V. INDICATIONS FOR USE The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only. # VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: | Item | Proposed Device (K233794) | Predicate Device<br>K223453 | | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Insulin Syringe | Insulin Syringe | Comments | | Manufacturer | SPM Medicare Pvt. Ltd. | Promisemed Hangzhou Meditech<br>Co., Ltd | | | Device Class | Class II | Class II | Same | | Product Code | FMF | FMF | Same | | Regulation<br>number | 880.5860 | 880.5860 | Same | | Regulation Name | Piston syringe | Piston syringe | Same | | Intended Use/<br>Indications for<br>Use | The sterile insulin syringe for<br>single use, with the calibrated unit<br>of insulin for U-40 & U-100 is a<br>device intended for medical<br>purposes for the manual<br>aspiration of insulin, and for the<br>injection of insulin into parts of the<br>body below the surface skin. The<br>device is intended to be used for<br>adults only. | Insulin Syringe is intended<br>for subcutaneous injection of<br>U-40 and U-100 insulin in<br>the treatment of diabetes. | Same | | Type of use | Prescription use and over the-<br>counter use | Prescription use and over the-<br>counter use | Same | | Operating Principle | The insulin is injected to<br>subcutaneous tissue by pushing<br>force generated through pushing<br>plunger rod 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 | 118mm | 120mm | Different.<br>Proposed device has<br>118 mm length and<br>predicate device has<br>120 mm length. This<br>does not impact the<br>intended use of<br>device. | | Volume | 1.0ml | 0.3ml, 0.5ml, 1.0ml | Different<br>Only 1.0ml insulin<br>syringe is included for<br>the subject device | | Needle length | 6mm, 8mm, 12.7mm | 6mm, 8mm, 12mm | Different.<br>Compared to the<br>predicate device, the<br>proposed device has<br>a difference in needle<br>length. The 12.7mm<br>needle length of<br>theinsulin syringe<br>safety and<br>performance has<br>been confirmed by<br>testing. This<br>difference does not<br>raise new question of<br>safety and<br>effectiveness. | | Needle gauge | 32G, 31G, 30G, 29G, 28G | 32G, 31G, 30G, 29G, 28G | Same | | Needle tip<br>configuration | 3 bevels | 3 bevels | Same | | Nozzle type | Not applicable | Not applicable | Same | | Numbering of scale | At every 10units for 1.0ml | At every five units for the 0.3mL<br>and 0.5mL syringes, and at every<br>10units for 1.0mL | Same<br>The proposed<br>device has only<br>the 1.0 ml<br>capacity & the<br>predicate device<br>includes a 0.5mL<br>and 0.3ml model.<br>The difference in<br>capacity device<br>will be selected<br>by the physician<br>per the<br>patient's condition.<br>This difference does<br>not affect intended<br>use. | | Gradations<br>legibility | Legible | Legible | Same | | Needle cover<br>dimensions | Length: 25mm, Diameter: 6mm | Length: 25mm, Diameter: 6mm | Same | | Needle cover<br>colour | Red (U-40) and orange (U-100) | Red (U-40) and orange (U-100) | Same | | Lubricant<br>composition | Aminofuntional siloxane | Aminofuntional siloxane | Same | | Lubricant<br>amount/cm2 | The lubricant does not form pools<br>of fluid on the interior surface of the<br>syringe or outside surfaces of the | The lubricant does not form<br>of fluid on the interior<br>surface of the syringe or outside | Same | | | needle tube. | surfaces of the needle tube. | | | Barrel transparency | Transparent | Transparent | 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<br>of skin sensitization<br>No significant evidence<br>of systemic toxicity<br>No evidence of Hemolysis | No cytotoxicity<br>No irritation reactivity No<br>significant evidence of<br>skin sensitization<br>No significant evidence<br>of systemic toxicity<br>No evidence of Hemolysis | Same | | Configuration and<br>Material | Needle: Stainless Steel (SS304)<br>Barrel: Polypropylene<br>Plunger: Polypropylene<br>Piston: Polyisoprene rubber<br>Needle cap: Polypropylene<br>Protective end cap:<br>Polypropylene | Needle: Stainless Steel<br>(SS304)<br>Barrel: Polypropylene<br>Plunger: Polypropylene<br>Piston: Polyisoprene rubber<br>Needle cap: Polyethylene<br>Protective end cap:<br>Polyethylene | Different.<br>The materials of<br>the needle cap<br>and protective<br>end cap are<br>different<br>between the<br>proposed device<br>and predicate<br>device. The<br>biocompatibility<br>test of the<br>proposed device<br>was conducted<br>to demonstrate<br>that the subject<br>device met the<br>biocompatibility<br>requirements.<br>This difference<br>does not raise<br>any new safety<br>and<br>effectiveness<br>questions. | | Label | Brand Name, Device name,<br>indication, instruction for use,<br>precaution, warning, shelf life,<br>manufacturer | Device name, indication,<br>instruction for use,<br>precaution, warning,<br>shelf life, manufacturer | Same | | Sterilization<br>method and SAL | Sterilized by ethylene oxide gas<br>SAL = 10-6 | Sterilized by ethylene oxide gas<br>SAL = 10-6 | Same | | Sterilization<br>method | EO Sterilization | EO Sterilization | Same | | EO and ECH<br>residues testing | Conform ISO 10993-7 | Conform ISO 10993-7 | Same | #### Table 1 Comparison of Technology Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices. ## VII. Performance Data Performance testing was conducted to ensure the substantial equivalence of the Insulin syringe throughout the shelf life and verify conformity to the applicable parts of ISO standards. No new question of safety and effectiveness were raised with the testing performed on the subject device when compared to the predicate device. The following performance tests were performed on the Insulin syringe using a fixed needle: (i) ISO 7864:2016, Sterile hypodermic needles for single use -- Requirements and test methods (ii) ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods (iii) ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin # Biocompatibility In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (<24hours). The following testing was conducted: - Cytotoxicity ● - . Sensitization - Irritation or intracutaneous reactivity ● - Acute systemic toxicity - Pyrogenicity ● - Hemocompatibility ● - . Subacute systemic toxicity ### Sterilization, Shipping and shelf life - (i) EO sterilization validation as per ISO11135-2014 - (ii) Pyrogen testing as per USP <85> Bacterial Endotoxin Test - (iii) EO residual as per ISO 10997-7 - (iv) Stimulated shipping as per ASTM D4169 - (v) Sterile barrier Package testing performed on the proposed device (ISO 11138, IP) - (vi)Seal strength EN 868-5 - Bubble test ASTM 2096 (vii) - Dye Penetration ASTM F1929-15 (viii) Shelf life: Shelf life of 5 years validated using FDA recognized ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. ### VIII. CONCLUSION The difference between the predicate and subject device do not raise any new different questions of safety or effectiveness. The SPM manufactured Insulin syringe is substantially equivalent to Insulin Syringe in K223453. ### IX. Summary of Similarities & Difference of subject device with the predicate device and Justification: The subject device shares equivalent indications for use, device operation, and overall technical and {9}------------------------------------------------ functional capabilities to the predicate device. The difference in some materials of components, configuration, and sizes have been evaluated through non-clinical testing; the tests are in accordance with those established in the standards, ISO 7864-2016, ISO 9626:2016 & ISO 8537:2016. Therefore, the differences between the predicate device (K223453) and the subject device do not raise any new or different questions of safety or effectiveness. Performance testing data demonstrates that the proposed device is substantially equivalent to the predicate device with respect to the indications for use, target populations, and technological characteristics.