Hypodermic Syringes & Needle

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. July 18, 2023 Lifelong Meditech Private Limited % Atonu Dutta CEO Alceon Saarthi Complex, Nutan Bharat Society, Alkapuri Vadodara, Gujarat 390007 India Re: K222925 Trade/Device Name: Hypodermic Syringes & Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, MEG Dated: July 10, 2023 Received: July 14, 2023 Dear Atonu Dutta: 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, Image /page/1/Picture/5 description: The image shows the text "Courtney Evans-S" in a simple, sans-serif font. The name is stacked vertically, with "Courtney" on top and "Evans-S" below. There is a light blue vertical bar partially obscuring the right side of the text, creating a visual interruption. Digitally signed by Courtney Evans -S Date: 2023.07.18 15:07:10 -04'00' For CAPT 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K222925 #### Device Name Sterile Hypodermic Syringe Without Needle for Single use, Sterile Hypodermic Safety Syringe (Clip Type) With Needle or Without Needle for Single use, Sterile Hypodermic Safety Syringe (Needle Retractable) With Needle for Single Use, Sterile Hypodermic Needle for Single Use #### Indications for Use (Describe) Sterile hypodermic single use syringe with needle or without needle: The Sterile Hypodermic syringe with needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. Sterile hypodermic safety syringe (clip type) for single use with needle or without needle: The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. A fler injection, the anti-needle stick feature is manually activated to aid in the prevention of accidental needle stick injuries. Sterile hypodermic safety syringes (needle retractable type) for single use with needle: The needle retractable safety syringe is to be used for intra-muscular or subcutaneous injections into a patient and is intended to prevent needle stick injuries. Needle retractable safety syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented. Sterile hypodermic needle for single use: The Sterile Hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> 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 {4}------------------------------------------------ ## 1. Submission Sponsor Hamendra Nath Srivastava, (Director and CEO) Tel:+91 9810661915; Email: hsrivastava@lifelongindia.com LIFELONG MEDITECH PVT LTD Plot No. 18, Sector - 5, IMT Manesar, Gurgaon – 122050, Haryana (INDIA), Mfg. License No. MFG/MD/2019/000203 # 2. Primary Correspondent Alceon Medtech Consulting 1008, 10th Floor, "OCEAN", Sarabhai Compound, Near Centre Square mall, Dr. V.S. Marg, Vadodara, Gujarat-390023, India. Phone: (+91) 9925023428 Email: regulatory@alceonconsulting.com # 3. Date of preparing the summary 19/06/2022 ## 4. Device Details | Device name (Generic): | 1. Sterile Hypodermic Syringe With Needle or<br>Without Needle for Single use<br>2. Sterile Hypodermic Safety Syringe (Clip Type) With Needle or Without Needle for Single use<br>3. Sterile Hypodermic Safety Syringe (Needle Retractable Type) With Needle for Single use<br>4. Sterile Hypodermic Needle for Single use | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name (Trade Name): | None | | Classification Regulation: | 21 CFR 880.5860, 21 C.F.R. 880.5570 | | Device Class: | Class II | | Product Code: | FMF, FMI, MEG | | Panel: | General hospital | Lifelong Meditech Pvt. Ltd. {5}------------------------------------------------ ## 5. Predicate Device #### Predicate device for Hypodermic Syringes: | Subject Device<br>Manufacturer | Subject Device | Primary<br>Predicate Device<br>510K | Reference<br>Device | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------| | Lifelong<br>Meditech Pvt.<br>Ltd. | 1. Sterile hypodermic syringe<br>with needle or without<br>needle for single use | | - | | | 2. Sterile hypodermic safety<br>syringe (clip type) with<br>needle or without needle<br>for single use | K060211 | K163162 | | | 3. Sterile hypodermic safety<br>syringe(Needle<br>Retractable type) with<br>needle or without needle<br>for single use | | K051694 | #### Predicate device for Hypodermic Needle: | Subject Device<br>Manufacturer | Subject Devices | Predicate Device | |-----------------------------------|---------------------------------------------|------------------| | Lifelong<br>Meditech Pvt.<br>Ltd. | 4. Sterile Hypodermic needle for single use | K102584 | ## 6. Device Description The syringe consists of a plunger & gasket that's fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take-in and expel liquid or gas through a discharge nozzle at the front (open) end of the barrel. The open end of the syringe may be fitted with a hypodermic needle, a nozzle or tubing to help direct the flow into and out of the barrel. It has three different models of syringe along with needle as below: - 1. Sterile Hypodermic Syringe with/ without needle for single use - 2. Sterile Hypodermic Safety Syringe (Clip Type) with/ without needle for single use - 3. Sterile Hypodermic Safety Syringe (Needle Retractable Type) with needle for single use - 4. Sterile Hypodermic Needle for single use In safety syringes a safety feature available, which is activated either manually or automatically. In clip type safety syringe, a clip is attached to the barrel and it is activated manually after use of syringe, which helps to prevent needle stick injury. In retractable type safety syringe a needle #### Lifelong Meditech Pvt. Ltd. {6}------------------------------------------------ retract after use of syringe, which helps to prevent needle stick injury. This feature is activated when plunger is pressed to expel the contents, the base of the plunger attached with the needle and pulling back of the plunger will cause the needle to retract in to the barrel of the syringe. Tables 1,2 & 3 below gives information about the available lengths for each needle gauge and which syringe can use with what needles. ## Proposed device: The Hypodermic Syringes and Needle manufactured by Lifelong Meditech Pvt. Ltd. available with different sizes which described below. | Needle Size | | | Length | | | | | | |----------------|-------------------|---------------|---------------------|--------------|------------|------------|--------------|--------------| | Metric<br>(mm) | British<br>System | Colour | 13mm<br>½" | 16mm<br>5/8" | 19mm<br>¾" | 25mm<br>1" | 32mm<br>1 ¼" | 38mm<br>1 ½" | | 0.45 | 26G | Brown | | | | | | | | 0.50 | 25G | Orange | | | | | | | | 0.55 | 24G | Purple | | | | | | | | 0.60 | 23G | Deep<br>Blue | | | | | | | | 0.70 | 22G | Black | | | | | | | | 0.80 | 21G | Deep<br>Green | | | | | | | | 0.90 | 20G | Yellow | | | | | | | | 1.10 | 19G | Cream | | | | | | | | 1.20 | 18G | Pink | | | | | | | | 1.60 | 16G | White | | | | | | | | Syringe Sizes | | | 30ml, 50ml and 60ml | | | | | | Table 1: Sterile hypodermic syringe with needle or without needle for single use {7}------------------------------------------------ | Needle Size | | | Metric system (mm) / British System (in)<br>Length | | | | | | |----------------|-------------------|---------------|----------------------------------------------------|--------------|------------|------------|--------------|--------------| | Metric<br>(mm) | British<br>System | Colour | 13mm<br>½" | 16mm<br>5/8" | 19mm<br>¾" | 25mm<br>1" | 32mm<br>1 ¼" | 38mm<br>1 ½" | | 0.45 | 26G | Brown | | | | | | | | 0.50 | 25G | Orange | | | | | | | | 0.55 | 24G | Purple | | | | | | | | 0.60 | 23G | Deep<br>Blue | | | | | | | | 0.70 | 22G | Black | | | | | | | | 0.80 | 21G | Deep<br>Green | | | | | | | | 0.90 | 20G | Yellow | | | | | | | | 1.10 | 19G | Cream | | | | | | | | 1.20 | 18G | Pink | | | | | | | | 1.60 | 16G | White | | | | | | | | Syringe Sizes | | | 1ml, 2ml, 3ml, 5ml, 10ml and 20ml. | | | | | | Table 2: Sterile hypodermic safety syringe (clip type) with needle or without needle for single use: ## Table 3: Sterile hypodermic safety syringes (needle retractable) with needle for single use: | Needle Size | | Colour | Length<br>Metric system (mm) / British System (in) | | | | | | |----------------|-------------------|-------------------------------------|----------------------------------------------------|--------------|------------|------------|--------------|--------------| | Metric<br>(mm) | British<br>System | | 13mm<br>½" | 16mm<br>5/8" | 19mm<br>¾" | 25mm<br>1" | 32mm<br>1 ¼" | 38mm<br>1 ½" | | 0.45 | 26G | Brown | | | | | | | | 0.50 | 25G | Orange | | | | | | | | 0.55 | 24G | Purple | | | | | | | | 0.60 | 23G | Deep<br>Blue | | | | | | | | 0.70 | 22G | Black | | | | | | | | 0.80 | 21G | Deep<br>Green | | | | | | | | 0.90 | 20G | Yellow | | | | | | | | 1.10 | 19G | Cream | | | | | | | | 1.20 | 18G | Pink | | | | | | | | 1.60 | 16G | White | | | | | | | | Syringe Sizes | | 2ml, 2.5ml, 3ml, 5ml, 10ml and 20ml | | | | | | | Lifelong Meditech Pvt. Ltd. {8}------------------------------------------------ # Every gauge size needle available with every needle length and every needle can be used with every syringe. The materials used in manufacturing of syringe & needle are have been found to be biocompatible following evaluation as outlined in Section 8 below. Table 1 below provides the information about raw material. | Components | Material | Grade | |-------------------------------------------------------|---------------------------------------------------------------------|-----------------------------| | Barrel | Polypropylene | H200MK | | Plunger | Polypropylene | H200MK | | Gasket | Thermoplastic elastomer | 8058, 8065 & SS<br>2165BKLL | | Safety clip (Only for clip type<br>model) | Polypropylene | H200MK | | Molded Component Plunger | Polypropylene | (H110MA) | | Scale Printing on barrel | Black ink | Not applicable | | Dilution of black ink for scale<br>printing on barrel | Thinner | Not applicable | | Gasket Lubrication | Polydimethylsiloxane | DMC 1000cst | | Barrel Lubrication | Polydimethylsiloxane | DMC 12500cst | | Needle Hub | Polypropylene | H200MK | | Needle cap | Polypropylene | H200MK | | Needle tube | Stainless steel | 304 | | Needle holder (only for needle<br>retractable model) | Poly Oximethylene | HOSTAFORM C<br>9021 | | Adhesive/glue | Trimethylolpropanepolyglycidyl<br>ether polymer | Not applicable | | | Isobenzofurandione /<br>diethylene tri - amine reaction<br>products | Not applicable | | | Bisphenol A diglycidyl ether | Not applicable | | Needle tube lubrication | Polydimethylsiloxane | DMC 10000cst | #### Table: 1 Raw Material {9}------------------------------------------------ #### Indications For Use: - 1. Sterile hypodermic syringe with needle or without needle for single use: The sterile hypodermic syringe with needle or without needle is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. - 2. Sterile hypodermic safety syringe (Clip Type) with needle or without needle for single use: The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the antineedle stick feature is manually activated to aid in the prevention of accidental needle stick injuries. - 3. Sterile hypodermic safety syringes (Needle Retractable Type) with needle for single use: The needle retractable safety syringe to be used for intra-muscular or subcutaneous injection of medications into a patient and is intended to prevent needle stick injuries. Needle Retractable Safety Syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented. #### 4. Sterile hypodermic needle for single use: The sterile hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. ## 7. Comparison to a predicate device | Description | Subject Devices<br>(K222925) | Primary Predicate<br>Device(K060211) | Comparison | |--------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------|------------| | Generic Name | 1. Sterile Hypodermic<br>Syringe With Needle<br>or Without Needle for<br>Single use | Sterile Piston Syringe | - | | | 2. Sterile Hypodermic<br>Safety Syringe (Clip<br>Type) With Needle or<br>Without Needle for<br>Single use | | | | | 3. Sterile Hypodermic<br>Safety Syringe (Needle<br>Retractable Type)<br>With<br>Needle for Single use | | | ## 7.1 Comparison to Predicate Device for Hypodermic Syringes {10}------------------------------------------------ | Manufacturer | Lifelong Meditech Pvt.<br>Ltd. | Wenzhou Wuzhou Group<br>Co., Ltd. | - | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------| | 510 (K) | K222925 | K060211 | - | | | Class | II | II | - | | | Regulation<br>Number | 21 CFR 880.5860,<br>21 C.F.R. 880.5570 | 21 CFR 880.5860<br>21 C.F.R. 880.5570 | - | | | Product Code | FMF, FMI, MEG | FMF, FMI | Difference #1 | | | Indications for<br>Use | The Sterile Hypodermic<br>syringe with needle or<br>without needle is<br>intended to be used for<br>medical purposes to<br>inject fluids into or<br>withdraw fluids from the<br>body. | The Wuzhou Syringe,<br>with/without needle is<br>intended to be used for<br>medical purposes to inject<br>fluids into or withdraw<br>fluids from the body. | Difference #2 | | | | The Sterile Hypodermic<br>Safety Syringe (Clip<br>Type) With Needle or<br>Without Needle for<br>Single use is intended to<br>be used for medical<br>purpose to inject fluids<br>into or withdraw fluids<br>from the body. After<br>injection, the anti-<br>needle stick feature is<br>manually activated to<br>aid in the prevention of<br>accidental needle stick<br>injuries. | | | | | | The Sterile Hypodermic<br>Safety Syringe (Needle<br>Retractable Type) With | | | | | | Needle for Single use is<br>to be used for intra-<br>muscular or<br>subcutaneous<br>injection of medications | | | | | | | into a patient and is<br>intended to prevent<br>needle stick injuries.<br>Needle Retractable<br>Safety Syringe is not<br>intended to be used for<br>withdrawing blood. In<br>addition, when the<br>syringe user breaks the<br>plunger, reuse of the<br>syringe is prevented. | | | | Configuration | | Plunger<br>Barrel<br>Gasket<br>Needle Hub<br>Needle Cover<br>Needle Tube<br>Safety Clip<br>Needle Holder | Plunger<br>Barrel<br>Gasket<br>Needle Hub<br>Needle Cover Needle Tube | Difference #3 | | Syringe Size | | 1, 2, 2.5, 3, 5, 10, 20, 30,<br>50, and 60 ml | 1, 2, 3, 5, 10, 20, 30, 50, 60<br>and 100ml | Difference #4 | | Needle Gauge | | 16G,18G, 19G 20G, 21G,<br>22G, 23G, 24G, 25G, &<br>26G | 16G, 18G, 19G 20G, 21G,<br>22G, 23G, 24G, 25G, &<br>26G | Same | | Needle Length | | ½", ¾", ⅝", 1", 1¼", 1½" | ½", ¾", ⅝", 1", 1¼", 1½" | Same | | Needle<br>wall<br>type | 18G<br>to 25G | Thin wall<br>Regular wall | Thin wall<br>Regular wall | Same | | Operation Mode | 26G | For manual Single use<br>only | For manual Single use only | Same | | Connector Type | | Luer Slip and Luer Lock | Luer Slip and Luer Lock | Same | | Sterility<br>condition | | EO Sterilized | EO Sterilized | Same | {11}------------------------------------------------ ## 7.2 Comparison to Predicate Device for Hypodermic Needle | Description | Subject Device | Predicate Device | Comparison | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Generic Name | Sterile Hypodermic Needle<br>for Single use | Hypodermic Needle | - | | Manufacturer | Lifelong Meditech Pvt. Ltd. | International Medsurg<br>Connection | - | | Class | II | II | Same | | Regulation<br>Number | 21 C.F.R. 880.5570 | 21 C.F.R. 880.5570 | Same | | Description | Subject Device | Predicate Device | Comparison | | Product Code | FMI | FMI | Same | | Clinical | | | | | Intended Use | The Sterile Hypodermic<br>needle intended to be used<br>with a luer slip or luer lock<br>syringe for aspiration and<br>injection of fluids for<br>medical purpose. | This device is intended for<br>use to inject fluids into or<br>withdraw fluids from parts<br>of the body below the<br>surface of the skin. | Same | | Technical Specification | | | | | Configuration | Needle Hub<br>Needle Cover/Cap Needle<br>Tube | Needle Hub<br>Needle Protector Cannula | Same | | Needle Gauge | 16G,18G, 19G 20G, 21G,<br>22G, 23G, 24G, 25G, &<br>26G | 16G,17G,18G, 19G, 20G,<br>21G, 22G, 23G, 24G, 25G,<br>26G, 27G, 28G, 29G, 30G | Similar, the<br>predicate<br>device<br>include<br>additional<br>models of<br>27G,28G.29G,<br>30G | | Needle<br>16 G-<br>length<br>26 G | 1/2", 5/8", 1", 1.1/4",<br>1.1/2" | 1/2", 5/8", ¾", 7/8", 1",<br>1.1/4", 1.1/2" | Similar, the<br>predicate<br>device<br>include<br>additional<br>needle length<br>of ¾", 7/8". | {12}------------------------------------------------ {13}------------------------------------------------ #### Summary of Substantial equivalence ## Difference #1: The intended use of subject device is the same as the primary predicate. The subject device has three variations in which two variations have additional safety feature indications. The safety feature does not impact the devices' intended use and further mitigates the risk of accidental needle sticks. Hence, the difference does not raise new or different questions of safety and effectiveness as compared to the predicate. ## Difference #2: The intended use of subject devices is the same as the primary predicate. Moreover, the subject device has three variations in which two variations (Clip type & Needle Retractable Type) have additional safety feature indications. The addition of the safety feature is a technological characteristic that is intended to further mitigate the risk of accidental needle stick injuries, which is not a new or different question of safety and effectiveness. ## Difference #3: The intended use of the subject devices is the same as primary predicate but due to additional safety features in subjected device variants the configuration have some additional component (Safety clip, Needle Holder). The addition of the safety feature is a technological characteristic that is intended to further mitigate the risk of accidental needle stick injuries, which is not a new or different question of safety and effectiveness. The variants of hypodermic syringes are manufactured from same raw material as predicate and are all within the scope and the size of the cleared predicate. The subject devices were tested in accordance with ISO7886-1:2017, ISO 7886-4: 2018, ISO 80369-7:2016 and ISO 23908:2011 standards. ## Difference #4: The intended use of the different sizes are the same as the predicate device. The difference in sizes are made of the same raw materials and the same manufacturing process. The differences in size does not raise new or different questions of safety and effectiveness. Additionally, the proposed sizes are within the cleared range of the predicate. All syringes are designed and tested in accordance with ISO 7886-1:2017, ISO 7886-4: 2018 and ISO 80369-7:2016 standards. Considering these factors, sizes of syringes do not add any additional safety issues and would perform as intended. {14}------------------------------------------------ # 8. Summary of non-clinical performance data Non-clinical tests were conducted to verify that the proposed devices met all design specifications. The test results demonstrated that the proposed device complies with the following standards: | STANDARDS | TEST PARAMETERS | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual<br>use | | ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test<br>methods | | ISO7886-4:2018 | Sterile hypodermic syringes for single use — Part 4: Syringes with re-<br>use prevention feature | | ISO 80369-7: 2016 | Small-bore connectors for liquids and gases in healthcare applications<br>— Part 7: Connectors for intravascular or hypodermic applications | | ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps<br>protection features for single-use hypodermic needles, introducers for<br>catheters and needles used for blood sampling | | ISO 6009:2016 | Hypodermic needles for single use — Colour coding for identification | | USP <71> | Sterility | | IP-2022 & USP <85> | Bacterial Endotoxin test | | USP <788> | Particulate Contamination | ## Bio Compatibility Test: ISO 10993-5: 2009 - In-vitro Cytotoxicity ISO 10993-10:2010 - Skin sensitization ISO 10993-10:2010 - Intracutaneous reactivity ISO10993-4, 2002/Amd 1:2006 - Hemocompatibility ISO 10993-11:2017 (E) USP 43 <151> - Material mediated pyrogenicity ISO 10993-11:2017- Acute systematic toxicity ## Packaging & Transit Test: ISO 11607-1:2019 2nd edition - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems ISO 11607-2:2019 2nd edition -Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems {15}------------------------------------------------ #### Sterilization Test: ISO 11135:2014/AMD 1:2018 2nd edition - Sterilization of health care products - Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices. #### EO Residual Test & BET: ISO 10993-7:2008/Amd1:2019 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants The Bacterial endotoxin testing of subject devices was performed by the "Gel-Clot Method" and meets the requirement of IP-2022 & USP <85>. # 9. Summary of clinical performance data No clinical data is included in this premarket application submission. ## 10. Conclusion The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.