Who is the manufacturer of Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. submitted the Traditional clearance for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe (K190183).

What is the FDA product code for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

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

What is the regulatory pathway for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

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

What are the predicate devices for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle (K113422); Terumo Surguard 2 Safety Needle (K051865).

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

K190183 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · MEG · Oct 4, 2019 · General Hospital

Device Facts

Record ID	K190183
Device Name	Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
Applicant	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Product Code	MEG · General Hospital
Decision Date	Oct 4, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Hypodermic Safety Needle with Syringe The Hypodermic Safety Needle with Syringe 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. Hypodermic Safety Needle The Hypodermic Safety Needle is intended to be used with a 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.

Device Story

Device consists of hypodermic needle with integrated manual safety shield and optional syringe; used for subcutaneous or intravenous injection and fluid aspiration. Operator (medical professional) manually rotates hinged safety shield over needlepoint post-withdrawal to prevent needlestick injuries. Device features luer lock connection; color-coded hub/shield for gauge identification. Single-use; sterile; disposable. Output is physical delivery or withdrawal of fluids; safety mechanism provides passive/active protection during disposal. Benefits include reduced risk of occupational sharps injury for clinicians.

Clinical Evidence

No clinical data. Bench testing performed per ISO 9626, ISO 7864, ISO 594-1/2, ISO 23908, ISO 7886-1, and ISO 6009. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, reactivity, toxicity, coagulation, hemolysis, pyrogenicity). Simulated clinical study conducted per FDA guidance 'Medical Devices with Sharps Injury Prevention Features' confirmed safety feature functionality.

Technological Characteristics

Materials: Polypropylene (1100N, R3260T), Stainless Steel (SUS304), Rubber Piston, Silicone oil lubricant, Epoxy resin adhesive. Manual operation; luer lock connector. Sterilization: Ethylene Oxide (SAL 10^-6). Dimensions: 21G x 1 1/2". Complies with ISO 6009 (color coding) and ISO 7886-1 (syringes).

Indications for Use

Indicated for adult patients in clinical environments requiring aspiration or injection of fluids. Contraindications not specified.

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

Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle (K113422)
Terumo Surguard 2 Safety Needle (K051865)

Related Devices

K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe · Medline Industries, Inc. · Dec 9, 2022
K213535 — Sterile Safety Hypodermic Needles for Single Use · Zhejiang Kangkang Medical-Devices Co., Ltd. · May 13, 2022
K220603 — Disposable Medical Safety Hypodermic Needle · Hantech Medical Device Co., Ltd. · Aug 23, 2022
K051865 — TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR · Terumo Medical Corp. · Sep 27, 2005
K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 18, 2021

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". October 4, 2019 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K190183 Trade/Device Name: Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: September 03, 2019 Received: September 06, 2019 Dear Charles Mack: 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, For 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) K190183 #### Device Name Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe #### Indications for Use (Describe) Hypodermic Safety Needle with Syringe The Hypodermic Safety Needle with Syringe 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. #### Hypodermic Safety Needle The Hypodermic Safety Needle is intended to be used with a 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. | 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 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}------------------------------------------------ # K190183 510(K) SUMMARY | Preparation Date: | October 3rd 2019 | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer's Name: | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Economic Development Zone, Taihu, Anqing City Anhui Province China 246400 | | Corresponding Official: | Mr. Charles Mack Principal Engineer | | Telephone Number: | 931-625-4938 | | E-mail Address: | charliemack@irc-us.com | | Trade Name: | Hypodermic Safety Needle with Syringe Hypodermic Safety Needle | | Common Name(s): | syringe, antistick syringe, piston needle, hypodermic, single lumen | | Regulation Name(s): | Piston syringe Hypodermic single lumen needle | | Regulation Number(s): | 21 CFR 880.5860 21 CFR 880.5570 | | Product Code: | MEG FMF FMI | | Device Class: | Class II | | Primary Predicate Device: | K113422; Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle | | Secondary Predicate Device: | K051865, Teumo Surguard 2 Safety Needle | # Device Description The device is used for subcutaneous injection, intravenous injection of blood and preparation of liquid medicine. The needle tube will be pushed into safety cap after use. It is designed to aid in the prevention of needle stick injuries. This device is a single use device, which is delievered sterile. The device is a disposable anti-needle stick syringe made of the following components: - 1. Needle cap: Covers the needle tube until the syringe is to be used. {4}------------------------------------------------ - 2. Needle tube: The needle tube penetrates the patient's skin to inject/withdraw fluid from the body. - 3. Safety shield: It is connected to the needle will be pushed into safety shield after use, it is designed to aid in the prevention of needle stick injuries. It is colored to distinguish the gauge of the needle. - 4. Needle hub: The needle hub is connected to the syringe by 6% luer connector, and it is colored to distinguish the gauge of the needle. - న్. Barrel: The barrel has a scale showing the capacity of the syringe. It is connected to the Hypodermic Safety Needle by 6% luer connector. - 6. Plunger: Assembled with the plunger stopper to inject/withdraw fluid from the body. - 7. Plunger stopper: Sealing when injecting/withdrawing fluid from the body. | Name | Material | Material Specification | |-------------------------|--------------------------|------------------------| | Needle cap | Polypropylene | 1100N | | Needle tube | Stainless Steel | SUS304 | | Needle hub | Polypropylene | 1100N | | Safety shield | Polypropylene | 1100N | | Barrel | Polypropylene | R3260T | | Plunger stopper | Rubber Piston | n/a | | Plunger | Polypropylene | 1100N | | Hub colorant | Colorant | PP-S1003 | | Ink | Organic chemical ink | HBL-100 709-V Black | | Lubricant of syringe | Silicone oil for syringe | Polydimethylsiloxane | | Lubricant of needle | Silicone oil for needles | Polydimethylsiloxane | | Adhesive | Epoxy Resin | ZS-H-623 | ## Indications for Use ### Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration 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. ### Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a 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. The device is prescription only. Intended Use {5}------------------------------------------------ This device is intended to be used in a clinical environment by a medical professional. # Substantial Equivalence Discussion # Intended Use Comparison The table below includes a comparison of the intended use between the new device and those of the predicate device: | Characteristic | Predicate Device TERUMO® SurGuard®3 K133422 | Predicate Device TERUMO® SurGuard2TM SAFETY NEEDLE K051865 | Subject Device Hypodermic Safety Needle with/without Syringe K190183 | Technological Characteristic | Predicate Device TERUMO® SurGuard®3 Safety Needle TERUMO® SurGuard®3 Hypodermic Syringe with Safety Needle K113422 | Subject Device Hypodermic Safety Needle with/without Syringe K190183 | Comments | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Indications for Use | The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO® SurGuard®3 Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, 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. | The TERUMO® SurGuard2TM SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, 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. | Hypodermic Safety Needle with Syringe The Hypodermic Safety Needle with Syringe 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. Hypodermic Safety Needle The Hypodermic Safety Needle is intended to be used with a 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. | Principles of operation | The Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint, making the product safe for disposal. These needles have a regular, short, or intradermal bevel type. The needle assembly is protected with a polypropylene shield. The Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position, the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/ syringe combination. | The Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint, making the product safe for disposal. These needles have a regular, short, or intradermal bevel type. The needle assembly is protected with a polypropylene shield. The Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position, the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/ syringe combination. | Same | | Prescription Only or Over the Counter | Prescription Use | Prescription Use | Prescription Use | Safety feature | The attached needle safety shield can be manually activated to cover the needle immediately after use | The attached needle safety shield can be manually activated to cover | Same | | Intended Population | Adult | Adult | Adult | | | | | | Environment of Use | Clinical Use | Clinical Use | Clinical Use | | | | | {6}------------------------------------------------ ### Discussions of differences in Indications for Use statement The major difference between the Subject Device's Indications for Use and the predicate deviices lies in the use of the syringe. The Subject device can be provided with a syringe, where this is not identified in the predicate devices. All other aspects of the Indications for Use are the same. #### Discussions of differences in intended population The intended population for the subject device is identical to the predicate device. #### Discussions of differences in environment of use The environment of use for the subject device is identical to the predicate device. ### Technological Characteristics The table below includes a comparison of the technological characteristics between the new device and those of the predicate device: {7}------------------------------------------------ | Technological Characteristic | Predicate Device TERUMO® SurGuard®3 Safety Needle TERUMO® SurGuard®3 Hypodermic Syringe with Safety Needle K113422 | Subject Device Hypodermic Safety Needle with/without Syringe K190183 | Comments | | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------|--| | Operation Mode | Manual use only | Manual use only | Same | | | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | | | Syringe Volume | 3,5,10 ml | 5 ml | Comment 1 | | | | Connector Type | Luer Lock and luer slip | Luer Lock | Comment 2 | | | | Syringe Performance | Complied with ISO 7886-1: 1993 | Complied with ISO 7886-1: 2017 | Same | | | | Configuration | A hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. | A hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. | Same | | | | Marking/ Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | | | Material | Polypropylene, Stainless Steel, Rubber Piston | Polypropylene, Stainless Steel, Rubber Piston | Same | | | | Operation Mode | Manual Use | Manual Use | Same | | | | Lubricant for needle | None | Silicone oil | N/A | | | | Adhesive | Epoxy Resin | N/A | N/A | | | | Needle Hub colors | Complies with ISO 6009-2010 | Complies with ISO 6009-2010 | Same | | | | Single Patient Use | Yes | Yes | Same | | | | Needle Gauge and Length | 18G-25G 1" - 2" | 21G x 1 1/2" | Comment 3 | | | | How Supplied | Sterile Single Patient Use | Sterile Single Patient Use | Same | | | | Method of Sterilization | Rx | Ethylene Oxide | Comment 4 | | | | SAL | 10-6 | 10-6 | Same | | | | Technological Characteristic | Predicate Device TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR K051865 | Subject Device Hypodermic Safety Needle with/without Syringe K190183 | Comments | | | | Principles of operation | The Terumo SurGuard2TM Safety Needle device with and without syringe manufactured by Terumo (Philippines) Corporation and Terumo Medical Corporation, USA (K040531 and K031453) and all referenced predicate devices are operated manually. | The Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint, making the product safe for disposal. These needles have a regular, short, or intradermal bevel type. The needle assembly is protected with a polypropylene shield. The Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position, the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/ syringe combination. | Same | | | | | Safety feature | The attached needle safety shield can be manually activated to cover the needle immediately after use | The attached needle safety shield can be manually activated to cover | Same | | | | | | Predicate Device | Subject Device | | | | | Technological | TERUMO SURGUARD 2 SAFETY | Hypodermic Safety Needle | | | | Characteristic | NEEDLE OR SIMILAR | with/without Syringe | | | | | | K051865 | K190183 | Comments | | | | Operation Mode | Manual use only | Manual use only | Same | | | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | | | Syringe Volume | 1,3,5,10 ml | 5 ml | Comment 5 | | | | Connector Type | Luer Lock and luer slip | Luer Lock | Comment 6 | | | | Syringe | Complied with ISO 7886-1: 1993 | Complied with ISO 7886-1: 2017 | Same | | | Performance | | | | | | | Configuration | A hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. | A hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. | Same | | | | Marking/ | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | | | | | | | | | | Labeling | | | | | | | Material | Polypropylene, Stainless Steel, Rubber Piston | N/A | N/A | | | | Operation Mode | Manual Use | Manual Use | Same | | | | Lubricant for needle | None | Silicone oil | N/A | | | | Adhesive | Epoxy Resin | N/A…