Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

Q: Who is the manufacturer of Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle?

Perfect Medical Industry (Vn) Co., Ltd. filed the 510(k) submission for Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950).

Q: What is the FDA product code for Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K232950 · Perfect Medical Industry (Vn) Co., Ltd. · FMF · Jun 12, 2024 · General Hospital

Device Facts

Record ID	K232950
Device Name	Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Applicant	Perfect Medical Industry (Vn) Co., Ltd.
Product Code	FMF · General Hospital
Decision Date	Jun 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Device Story

Manual piston-style syringe system consisting of barrel, plunger, and piston; available in luer slip or luer lock configurations. Used in hospital settings by clinicians to withdraw and inject fluids. Models include standard syringes, syringes with attached needles, and syringes with safety needles. Safety needle variants feature a manually activated shield to cover the needle post-use. Device operation is entirely manual; no electronic or automated components. Benefits include precise fluid delivery and reduced risk of sharps injury for healthcare providers.

Clinical Evidence

Bench testing only. Compliance with ISO 10993 (biocompatibility), ISO 7886-1 (syringes), ISO 7864 (needles), ISO 80369-7 (connectors), and ISO 23908 (sharps injury protection) verified performance. Testing included sterility, seal integrity (ASTM F88, F1929), and mechanical strength.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, cap), Polyisoprene (gasket), Stainless Steel 304 (needle). Manual operation. EO sterilization. Connectivity: Luer slip/lock per ISO 80369-7. Dimensions/specs comply with ISO 7886-1, ISO 7864, ISO 9626, and ISO 6009.

Indications for Use

Indicated for use in patients requiring aspiration and injection of fluids. Sterile Disposable Syringe with safety needle includes a manual safety shield to minimize accidental needlestick risk after use.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (K211329)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 12, 2024 Perfect Medical Industry (VN) Co., Ltd. % Thomas Huang Lead Consultant, Quality and Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin. Texas 78746 # Re: K232950 Trade/Device Name: Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe with Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, MEG Dated: May 9, 2024 Received: May 9, 2024 # Dear Thomas Huang: 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 (QS) 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) K232950 #### Device Name Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe with Safety Needle #### Indications for Use (Describe) Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-----------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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 # 510(k) Submitter [K232950] | Device Submitter: | Perfect Medical Industry (VN) Co., Ltd. Block D7/I, No. 1B Road, Vinh Loc Industrial Zone, Binh Hung Hoa B Ward, Binh Tan District, Ho Chi Minh City, 700000 Vietnam Telephone: +0084.915.521.775 Fax: +0084.283.765.3135 2017@pwuhui.com.tw | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Thomas Huang Lead Consultant, Quality and Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 USA Telephone: (512) 327-9997 Fax: (512) 327-9998 LST.AUS.ProjectManagement@ul.com | | Date Prepared | May 03, 2024 | ### l Device | Trade Name of Device: | Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe with Safety Needle | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------| | Regulation Number: | 21 CFR 880.5860, 21 CFR 880.5570 | | Classification Name: | Piston syringe | | Product Code: | FMF, FMI, MEG | | Regulation Name: | Piston Syringe | | Common name | Syringes with Needle | | Regulatory Class | II | | Review Panel | Injection | {4}------------------------------------------------ #### II Predicate Devices | 510k Number | K211329 | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name of Device: | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | | Regulation Number: | 21 CFR 880.5860, 880.5570 | | Regulation Name: | Piston Syringe | | Regulatory Class | II | | Product Code: | MEG, FMF, FMI | #### III Device Descriptions The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually. {5}------------------------------------------------ # IV Indications for use V Technological Characteristics Comparison Sterile Disposable Syringe are intended to be used to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | Attribute | Subject Device | Predicate Device, K211329 | Comparison | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Syringe Type: | FMF, FMI, MEG | FMF, FMI, MEG | Same | | Indications for Use: | 1. Sterile Disposable Syringe are intended to be used to withdraw solutions and insert solutions into patient's body. 2. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. 3. Sterile Disposable Syringe with safety needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert | 1. The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. 2. The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. 3. The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration | Same | # VI-1: Comparison of Piston Syringe {6}------------------------------------------------ | solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. 4. The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. 5. The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {7}------------------------------------------------ | | | of accidental needle | | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | | | sticks. | | | Principle of Operation | For manual use only | For manual use only | Same | | Specific Drug Use | N/A | N/A | Same | | Length | Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same | | Diameter | Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same | | Tip Type | Luer lock, luer slip, fixed | Luer lock, luer slip | Different, see analysis below | | Volume | 1mL, 3mL, 5mL, 10mL, 20mL, 30mL, 50mL | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30mL, 50ml, 60ml | Different, see discuss below | | Needle Length | 3/8", 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2", 2" | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | Different, see discuss below | | Needle Gauge | 18G, 19G, 21G, 22G, 23G, 24G, 25G, 26G | 23G | Different, see discuss below | | Needle Tip Configuration | Bevel tip Complied with ISO 7864:2016 | Complied with ISO 7864:2016 | Same, see analysis below | | Nozzle Type | Luer lock, luer slip | Luer lock, luer slip | Same | | Barrel Marking Spec | Graduated scale: 1cc: 0.01 mL; 3cc:0.1 mL; 5cc, 10cc:0.2 mL; 20cc, 30cc, 50cc:1mL. Length of scale (Min): 1cc: 57mm, 3cc: 27mm, 5cc: 36mm, 10cc: 44mm, 20cc: 52mm, 30cc:67mm, 50cc: 75mm Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same, see analysis below | | Gradations Legibility | Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same | | Needle Cover Dimensions | ID : min 5.9mm; OD: min 7.2mm; Length: 42mm~70mm Complied with ISO 7864:2016 | Complied with ISO 7864:2016 | Same, see analysis below | | Needle Cover Color | unpigmented Complied with ISO 7864:2016 | Complied with ISO 7864:2016 | Same, see analysis below | | Lubricant Composition | Silicone oil | Silicone oil | Same | | Lubricant Amount/cm2 | Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same | | Barrel Transparency | Transparent Complied with ISO 7886-1:2017 | Complied with ISO 7886-1:2017 | Same, see analysis below | | Delivery Accuracy | 1cc and 3cc: ±5% of expelled volume when it filled equal to or greater than half nominal capacity; ±(1.5% of volume + 2% of expelled volume when it filled less than half nominal capacity 5cc, 10cc, 20cc, 30cc, 50cc: ±4% of expelled volume when it filled equal to or greater than half nominal capacity; ±(1.5% of volume + 1% of expelled volume when it filled less than half nominal capacity | Complied with ISO 7886-1:2017 | Same, see analysis below | | | Complied with ISO 7886-1:2017 | | | | Reuse Durability | Single use | Single use | Same | | Needle Cover Strength | 0.4-1.8kgf Complied with ISO 7864:2016 | Complied with ISO 7864:2016 | Same, see analysis below | | Hub/Needle Bond Strength | Min. 22-69N Complied with ISO 7864:2016 | Complied with ISO 7864:2016 | Same, see analysis below | | Biocompatibility | Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen | Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen | Same | | Materials | Gasket: Polyisoprene Rubber; Barrel: Polypropylene (PP); Plunger: Polypropylene (PP); Needle: Stainless Steel 304; Needle cap: Polypropylene (PP) | Gasket: Polyisoprene Rubber; Barrel: Polypropylene (PP); Plunger: Polypropylene (PP); Needle: Stainless Steel SUS 304; Needle cap: Polypropylene (PP) | Same | | Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Sterilization method | EO Sterilized | EO Sterilized | Same | | Environment of use | Hospital | Hospital | Same | | Shelf life | 3 years. Complied with ASTM F1980-07 | 5 years. Complied with ASTM F1980-07 | Different, see analysis below | | Transport conditions | Complied with ISTA 2A:2011 | Not public | Different, see analysis | {8}------------------------------------------------ {9}------------------------------------------------ # Difference Analysis: Tip Type: The tip configuration of the proposed device is similar to the predicate device. However, this difference is in a fixed connector. The difference in technological characteristics does not raise new questions of safety and effectiveness. Connectivity to the needle is {10}------------------------------------------------ assessed with performance data. Volume: The Syringe volume for the subject device is different from the predicate device. However, this difference is in dimension. Different volume devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle Length: The needle length for the subject device is different from the predicate device. This difference is in dimension. Different length devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle Gauge: The needle size for the subject device is different from the predicate device. This difference is in dimension. Different size devices will be selected by the physician per the patient's condition. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle Tip Configuration: The needle tip for the subject device is different in needle point geometry from the predicate device. This difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Barrel Marking Spec: The Syringe Barrel Marking Spec for the subject device is different from the predicate device. However, different Marking Specs will be dependent on the Syringe volume. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle Cover Dimensions: The Needle Cover Dimensions for the subject device is different from the predicate device. However, this difference is in dimension. Different Needle Cover Dimensions will be dependent on the Needle Length. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle Cover Color: The Needle Cover Color for the subject device is different from the predicate device. However, this difference is in Color. Different colors will be dependent on either pigmented or unpigmented material. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Barrel transparency: The Barrel transparency for the subject device is different from the predicate device. However, this difference is in color. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. {11}------------------------------------------------ Delivery accuracy: The Delivery accuracy for the subject device is different from the predicate device. However, this accuracy is dependent on the Syringe volume. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Needle cover strength: The needle cover strength for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Hub/needle bond strength: The hub/needle bond strength for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Shelf life: The Shelf life for subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. Transport conditions: The Transport conditions for the subject device is different from the predicate device. However, differences are assessed via performance data and conformance to the same ISO standards as the predicate device. Therefore, this difference will not raise new questions of safety and effectiveness of the subject device. #### VI Summary of Non-clinical Testing (Bench) Nonclinical tests were conducted to verify that the proposed device met all design specifications to establish Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - 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 skin sensitization - ISO 10993-23:20212021 Biological evaluation of medical devices- Part 23: Test for irritation - ISO 10993-11:2017 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 F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials - ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for ● {12}------------------------------------------------ Flexible Packaqinq by Visual Inspection - . ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility) - . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration - ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods - ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices ● - ISO 6009:2016 Hypodermic needles for single use Colour coding for identification ● - ISO 80369-7:2016 Small-bore connectors for liguids and gases in healthcare applications ● — Part 7: Connectors for intravascular or hypodermic applications - ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual . use - ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide ● Sterilization Residuals - . ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - USP<85> Bacterial Endotoxins Test - USP<151> Pyrogen Test - USP<788> Particulate Matter in Injections ● - Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic ● Single Lumen Needles - Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Svringes - Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff #### VII Conclusion The subject device has the same indications for use as the predicate device. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device does not raise any new questions of safety and effectiveness. Therefore, the subject device has been determined to be substantially equivalent to the predicate device.

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!