Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

Q: Who is the manufacturer of Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use?

Shandong Weigao Group Medical Polymer Co., Ltd. filed the 510(k) submission for Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use (K212920).

Q: What is the FDA product code for Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use?

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 Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use?

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

Q: What are the predicate devices for Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use?

Sterile Disposable Syringe with Safety Needle (K170651); BD SoloShot Mini Syringe/ BD Auto Disable Syringe (K201234).

Q: Who can help prepare an FDA 510(k) submission like Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use?

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.

K212920 · Shandong Weigao Group Medical Polymer Co., Ltd. · FMF · Mar 11, 2022 · General Hospital

Device Facts

Record ID	K212920
Device Name	Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
Applicant	Shandong Weigao Group Medical Polymer Co., Ltd.
Product Code	FMF · General Hospital
Decision Date	Mar 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2

Intended Use

The Sterile Safety Syringe with Needle for Single Use is intended for use in the 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 of accidental needlesticks. The Sterile Safety Hypodermic Needle for Single Use 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 of accidental needlesticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

Device Story

Manual, single-use sterile syringes and hypodermic needles; includes safety-shielded and auto-disable variants. Safety-shielded devices feature a manual shield activated post-injection to cover the needle. Auto-disable syringes prevent reuse via integrated design. Used in clinical settings for fluid aspiration and injection. Healthcare providers manually operate the device, including the safety shield activation. Output is the delivery or aspiration of fluids; safety features reduce needlestick injury risk. Materials include polypropylene barrels/hubs, polyisoprene pistons, and stainless steel needles.

Clinical Evidence

No clinical data. Bench testing only, including performance testing per ISO standards, biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, pyrogen), sterile barrier packaging (ASTM F1886, F88, F1929), and simulated clinical study for safety mechanism evaluation per FDA guidance and ISO 23908.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, hub, cap, shield), Polyisoprene (piston), Stainless Steel (needle). Standards: ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-1, ISO 7886-3. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Form factor: Manual syringe/needle combinations with safety shields or auto-disable mechanisms.

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes. Intended for single use by clinicians. Safety-shielded versions are indicated to minimize accidental needlestick risk.

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 (K170651)
BD SoloShot Mini Syringe/ BD Auto Disable Syringe (K201234)

Related Devices

K211329 — Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 15, 2021
K211484 — Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles · Shinva Ande Healthcare Apparatus Co., Ltd. · Mar 1, 2022
K180417 — Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use · Berpu Medical Technology Co., Ltd. · Aug 9, 2018
K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle · Sol-Millennium Medical, Inc. · Sep 20, 2024
K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle · Anhui Tiankang Medical Technology Co., Ltd. · Jul 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency responsible for regulating food and drug products in the United States. March 11, 2022 Shandong Weigao Group Medical Polymer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China Re: K212920 Trade/Device Name: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use.Sterile Auto-Disable Syringe with Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF. FMF. MEG Dated: February 9, 2022 Received: February 11, 2022 Dear Diana Hong: 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CAPT Alan M. 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) K212920 ## Device Name Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use, Sterile Auto-Disable Syringe With Needle for Single Use ## Indications for Use (Describe) The Sterile Safety Syringe with Needle for Single Use is intended for use in the 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 of accidental needlesticks. The Sterile Safety Hypodermic Needle for Single Use 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 of accidental needlesticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Druq 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}------------------------------------------------ #### K212920 510(k) Summary - 1. Date of Preparation: March 11, 2022 - 2. Sponsor Identification: # Shandong Weigao Group Medical Polymer Co., Ltd. No.18 Xingshan Road, Torch Hi-tech Science Park, 264210 Weihai, Shandong Province, PEOPLE'S REPUBLIC OF CHINA. Establishment Registration Number: 3007084575 Contact Person: Lina Liu Position: QA Manager Tel: +86-631-5716818 Fax: +86-631-5620555 Email: liulina@weigaogroup.com - 3. Designated Submission Correspondent: Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ - Identification of Proposed Device: 4. Trade Name: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use Sterile Auto-Disable Syringe with Needle for Single Use Common Name: Piston syringe and antistick needle Classification Name: Piston Syringe Syringe Antistick Classification: II Product Code: FMF; MEG Regulation Number: 21CFR 880.5860 Classification Name: Hypodermic Single Lumen Needle Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 - 5. Identification of Predicate Devices: 510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle (used as predicate device) Sterile Disposable Needle 510(k) Number: K201234 Product Name: BD SoloShot Mini Syringe/ BD Auto Disable Syringe ## Indications for Use: The Sterile Safety Syringe with Needle for Single Use is intended for use in the 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 of accidental needlesticks. The Sterile Safety Hypodermic Needle for Single Use 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 {5}------------------------------------------------ after use to minimize risk of accidental needlesticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. ### Device Description: The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes. The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. The specifications of the proposed devices are provided in following table. | Needle Gauge | Needle Length | |--------------|------------------------| | 30G | 13mm, 16mm, 19mm | | 29G | 13mm, 16mm, 19mm | | 28G | 13mm, 16mm, 19mm | | 27G | 13mm, 16mm, 19mm | | 26G | 13mm, 16mm, 19mm | | 25G | 16mm, 19mm, 25mm, 38mm | | 24G | 16mm, 19mm, 25mm | | 23G | 19mm, 25mm, 32mm, 38mm | | 22G | 19mm, 25mm, 32mm, 38mm | Table 1. Specifications of the Sterile Safety Hypodermic Needle for Single Use {6}------------------------------------------------ | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | |-----|------------------------------| | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | 19G | 25mm, 32mm, 38mm | | 18G | 19mm, 22mm, 32mm, 38mm | Table 2. Specifications of the Sterile Safety Syringe with Needle for Single Use | Syringe volume | Needle Gauge | Needle Length | |----------------|------------------------|------------------------------| | 1mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 2mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | 18G | 19mm, 22mm, 32mm, 38mm | | | 2.5mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | 3mL | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 5mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 10mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 20mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm, 19mm | | | 26G | 13mm, 16mm, 19mm | | | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 25mL | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 30mL | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 50mL | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | | 100mL | 25G | 16mm, 19mm, 25mm, 38mm | | | 24G | 16mm, 19mm, 25mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | | 22G | 19mm, 25mm, 32mm, 38mm | | | 21G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 20G | 19mm, 22mm, 25mm, 32mm, 38mm | | | 19G | 25mm, 32mm, 38mm | | | 18G | 19mm, 22mm, 32mm, 38mm | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Table 3. Specifications of the Sterile Auto-Disable Syringe with Needle for Single Use | Syringe volume | Needle Gauge | Needle Length | |----------------|--------------|------------------------| | 0.2mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm | | | 26G | 16mm, 19mm | | | 25G | 16mm, 19mm, 32mm, 38mm | | | 24G | 16mm, 19mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | 0.5mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm | | | 26G | 16mm, 19mm | | | 25G | 16mm, 19mm, 32mm, 38mm | | | 24G | 16mm, 19mm | | | 23G | 19mm, 25mm, 32mm, 38mm | | 1mL | 30G | 13mm, 16mm, 19mm | | | 29G | 13mm, 16mm, 19mm | | | 28G | 13mm, 16mm, 19mm | | | 27G | 13mm, 16mm | | | 26G | 16mm, 19mm | | | 25G | 16mm, 19mm, 32mm, 38mm | | | 24G | 16mm, 19mm | {10}------------------------------------------------ | | 23G | 19mm, 25mm, 32mm, 38mm | |--|-----|------------------------| |--|-----|------------------------| - 6. Substantially Equivalent (SE) Comparison: | | | Table 4. General Comparison of Sterile Safety Syringe with Needle for Single Use | | |--|--|----------------------------------------------------------------------------------|--| | | | | | | ITEM | Proposed Device | Predicate Device K170651 | Comments | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------| | Product | Sterile Safety Syringe with Needle for Single Use | Sterile Disposable Syringe with Safety Needle | / | | | Product Code | FMF FMI MEG | FMF FMI MEG | Same | | | Regulation Number | 21 CRF 880.5860 21 CRF 880.5570 | 21 CRF 880.5860 21 CRF 880.5570 | Same | | | Class | Class II | Class II | Same | | | Indication for Use | The Sterile Safety Syringe with Needle for Single Use is intended for use in the 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 of accidental needlesticks. | The Sterile Disposable Syringe with Safety Needle is intended for use in the 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 of accidental needle sticks. | Same | | | Configuration | Syringe Barrel (luer lock/luer slip) Plunger Piston Needle Hub Needle tube Needle cap Safety shield | Syringe Barrel (luer lock/luer slip) Plunger Piston Needle Hub Needle tube Needle cap Safety shield | Same | | | Operation Mode | For manual use only | For manual use only | Same | | | Single Use | Single Use | Single Use | Same | | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | | Syringe | 1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 20ml, 25ml, 30ml, 50ml, 100ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | Different Comment #1 | | | Syringe Volume | | | | | | The Syringe volume for proposed device is different from the predicate device. This difference does not affect intended use and this technological difference does not raise new questions of safety and effectiveness. | | | | | | Syringe performance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | | | Needle Type | Connector Luer Lock/Luer Slip | Luer Lock /Luer Slip | Same | | | | Size | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | 16G,18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | Different Comment #2 | | | Length | 13mm, 16mm, 19mm, 22mm, 25mm, 32mm, 38mm | 8mm(5/16"), 13mm(1/2"), 16mm(5/8"), 20mm(3/4"), 25mm(1"), 32mm(1-1/4"), 38mm(1-1/2") | Different Comment #2 | | | Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same | | Comment #2 | | | | | | Needle Size and Length | | | | | | The needle size and length for proposed device is different from the predicate device. However, the needle size and length of the proposed device is included in the range of the needle size and length of the predicate device. | | | | | | Therefore, this difference does not affect safety and effectiveness of the proposed device. | | | | | | Needle Performance | Syringe | Complied with ISO 7886-1 Iso 9626-1 | Complied with ISO 7886-1 Iso 9626-1 | Same | | Material | | Barrel Polypropylene (PP) | Barrel Polypropylene (PP) | Same | | | | Plunger Polypropylene (PP) | Plunger Polypropylene (PP) | Same | | | | Piston Polyisoprene | Piston Polyisoprene | Same | | | | Hub Polypropylene (PP) | Hub Polypropylene (PP) | Same | | | | Needle tube Stainless Steel | Needle tube Stainless Steel | Same | | | | Needle cap Polypropylene (PP) | Needle cap Polypropylene (PP) | Same | | | | Safety shield Polypropylene (PP) | Safety shield Polypropylene (PP) | Same | | | | | | | | Cytotoxicity | | No cytotoxicity | No cytotoxicity | Same | | Irritation | | No intracutaneous reactivity | No intracutaneous reactivity | Same | | Sensitization | | No skin sensitization | No skin sensitization | Same | | Systemic Toxicity | | No systemic toxicity | No systemic toxicity | Same | | Hemolysis | | No Hemolysis | No Hemolysis | Same | | Pyrogen | | No Pyrogen | No Pyrogen | Same | | Method | | | | | | SAL | 10-6 | 10-6 | Same | | | Endotoxin Limit | 20 EU per device | 20 EU per device | Same | | {11}------------------------------------------------ {12}------------------------------------------------ # Table 5. General Comparison of Sterile Safety Hypodermic Needle for Single Use | ITEM | Proposed Device | Predicate Device K170651 | Comment | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Product | Sterile Safety Hypodermic Needle for Single Use | Sterile Disposable Safety Needle | / | | Product Code | FMI | FMI | Same | | Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | Same | | Class | Class II | Class II | Same | | Indication for Use | The Sterile Safety Hypodermic Needle for Single Use 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 of accidental needlesticks. | 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 of accidental needlestick. | Same | | Configuration | Hub Needle tube Needle cap Safety shield | Hub Needle tube Needle cap Safety shield | Same | | Operation Mode | For manual use only | For manual use only | Same | | Single Use | Single Use | Single Use | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Connector Type | Luer Lock/Luer Slip | Luer Lock /Luer Slip | Same | | Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | 16G,18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | Different Comment #3 | | Needle Length | 13mm, 16mm, 19mm, 22mm, 25mm, 32mm, 38mm | 8mm(5/16"), 13mm(1/2"), 16mm(5/8"), 20mm(3/4"), 25mm(1"), 32mm(1-1/4"), 38mm(1-1/2") | Different Comment #3 | | Comment #3 Needle Gauge and length | | | | {13}------------------------------------------------ | Needle Hub | | | | | | |--------------------|------------------------------------------------------------|------------------------------------------------------------|---------------|--------------------|------| | Needle Performance | Complied with ISO 7864 ISO 9626 | Complied with ISO 7864, ISO 9626 | Same | | | | Safety mechanism | Similar safety shield and same manual activated mechanism. | Similar safety shield and same manual activated mechanism. | Same | | | | Material | Needle hub | Polypropylene (PP) | Needle hub | Polypropylene (PP) | Same | | | Needle tube | Stainless Steel | Needle tube | Stainless Steel | Same | | | Safety Shield | Polypropylene (PP) | Safety Shield | Polypropylene (PP) | Same | | | Needle Cap | Polypropylene (PP) | Needle Cap | Polypropylene (PP) | Same | | Biocompatibility | | | | | | | Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | | | | Irritation | No intracutaneous reactivity | No intracutaneous reactivity | Same | | | | Sensitization | No skin sensitization | No skin sensitization | Same | | | | Systemic Toxicity | No systemic toxicity | No systemic toxicity | Same | | | | Hemolysis | No Hemolysis | No Hemolysis | Same | | | | Pyrogen | No Pyrogen | No Pyrogen | Same | | | | Sterilization | | | | | | | Method | EO Sterilized | EO Sterilized | Same | | | | SAL | 10-6…