Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
Device Facts
| Record ID | K212857 |
|---|---|
| Device Name | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use |
| Applicant | Jiangsu Zhiyu Medical Instrument Co, Ltd. |
| Product Code | FMF · General Hospital |
| Decision Date | May 9, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
Indications for Use
The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Device Story
Sterile, single-use, manual hypodermic syringe and needle assembly; consists of polypropylene barrel, plunger, stopper, and austenitic stainless steel (SUS304) needle. Used in general hospital settings by medical professionals or trained caregivers for fluid injection or aspiration. Operates via manual plunger movement within the barrel to draw or expel fluids. Device provides a sterile, single-use delivery system for medications or fluid withdrawal. Benefits include standardized, sterile fluid management for patient care. No electronic or automated components.
Clinical Evidence
No clinical data. Bench testing only. Conformance demonstrated via ISO 7886-1 (syringes), ISO 7864 (needles), ISO 9626 (tubing), and biocompatibility testing per ISO 10993-4/5/10/11/7/12. Sterilization validated per ISO 11135 and packaging per ISO 11607-2. Particulate matter testing per USP 788.
Technological Characteristics
Materials: Polypropylene (barrel, plunger, hub), Isoprene/Synthetic rubber (stopper), SUS304 stainless steel (needle), Epoxy resin (adhesive). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Manual operation. No software or electronics. Dimensions: Syringes 1mL-50mL; Needles 18G-30G, 13mm-38mm length.
Indications for Use
Indicated for medical professionals and trained caregivers for general purpose fluid injection into or aspiration from the body using syringes and needles.
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 Hypodermic Syringe for Single use, with/without needle; luer/luer-lock (K201284)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Jiangsu Zhiyu Medical Instrument Co, Ltd. Ellen Guan Official Correspondent No 88, Nanyuan Road, Industrial Park Taixing, Jiangsu 225400 China
### Re: K212857
Trade/Device Name: Sterile Syringe for Single Use (with Needle). Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: April 12, 2023 Received: April 12, 2023
Dear Ellen Guan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney Evans -S
Digitally signed by Courtnev Evans -S Date: 2023.05.09 14:10:13 -04'00'
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}------------------------------------------------
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K212857
Device Name
Sterile Syringe for Single Use (with Needle) Sterile Hypodermic Needle for Single Use
#### Indications for Use (Describe)
The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
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}------------------------------------------------
# K212857 510(K) Summary
[As required by section 807.92(c)]
# I. SUBMITTER (OWNER)
Name: Jiangsu Zhiyu Medical Instrument Co., Ltd. Address: No.88, Nanyuan Road, Industrial Park, West Taixing City, 225400, Jiangsu Province, China Phone: +86-0523-82565715, +86-0523-82565758 Contact person: Ellen Guan Contact email: gxyellen1004@aliyun.com Date of preparation: May 4, 2023
# II. DEVICE IDENTIFICATION
2.1 Trade name: Sterile Syringe for Single Use (with Needle) Common name: Hypodermic Syringe Classification name: Piston Syringe Classification regulation: 21 CFR 880.5860 Product code: FMF Classification: II 2.2 Trade name: Sterile Hypodermic Needle for Single Use Common name: Hypodermic Needle Classification name: Hypodermic Single Lumen Needle Classification regulation: 21 CFR 880.5570 Product code: FMI Classification: II
{4}------------------------------------------------
# III. PREDICATE DEVICE IDENTIFICATION
- 3.1 510(k) number: K201284
- 3.2 Trade name: Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock
Sterile Hypodermic needle for Single use
- 3.3 Common name: Hypodermic Syringe
Hypodermic Needle
- 3.4 Classification regulation: 21 CFR 880.5860, 21 CRF 880.5570
- 3.5 Product code: FMF, FMI
- 3.6 Classification: II
### IV. DEVICE DESCRIPTION
### 4.1 Overview
The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle.
The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.
### 4.2 Models
Syringe: 1mL, 2mL, 5mL, 10mL, 20mL, 50mL
| Needle Gauge | Outer Diameter of Stylet | | |
|--------------|--------------------------|-----------|-----------------|
| | Normal wall | Thin wall | Ultra-thin wall |
| 30G x 1/2" | X | X | - |
| 29G x 1/2" | X | X | - |
| 28G x 1/2" | X | X | - |
| 27G x 1/2" | X | X | - |
| 27G x 5/8" | X | X | - |
| 26G x 1/2" | X | X | - |
| 26G x 5/8" | X | X | - |
| 25G x 5/8" | X | X | - |
| 25G x 3/4" | X | X | - |
{5}------------------------------------------------
| 25G x 1" | X | X | - |
|------------|---|---|---|
| 24G x 3/4" | X | X | - |
| 24G x 1" | X | X | - |
| 23G x 1" | X | X | X |
| 23G x 5/4" | X | X | X |
| 23G x 3/2" | X | X | X |
| 22G x 1" | X | X | X |
| 22G x 5/4" | X | X | X |
| 22G x 3/2" | X | X | X |
| 21G x 5/4" | X | X | X |
| 21G x 3/2" | X | X | X |
| 20G x 5/4" | X | X | X |
| 20G x 3/2" | X | X | X |
| 19G x 5/4" | X | X | X |
| 19G x 3/2" | X | X | X |
| 18G x 5/4" | X | X | X |
| 18G x 3/2" | X | X | X |
#### 1ml, 2ml and 5ml syringe can use the needles:
30G x 1/2″, 29G x 1/2″, 28G x 1/2″, 27G x 1/2″, 27G x 5/8″, 26G x 1/2″, 26G x 5/8″, 25G x 5/8″, 25G x 3/4″, 25G x 1″, 24G x 3/4″, 24G x 1″, 23G x 5/4″, 23G x 3/2″, 22G x 1″, 22G x 5/4″, 22G x 3/2″, 21G x 5/4″, 21G x 3/2″;
#### 10ml syringe can use the needles:
25G x 5/8″, 25G x 3/4″, 25G x 1″, 24G x 3/4″, 24G x 1″, 23G x 5/4″, 23G x 3/2″, 22G x 1", 22G x 5/4", 22G x 3/2", 21G x 5/4", 21G x 3/2", 20G x 3/2″, 19G x 5/4", 19G x 3/2″, 18G x 5/4″, 18G x 3/2″;
#### 20ml and 50ml syringe can use the needles:
21G x 5/4″, 21G x 3/2″, 20G x 5/4″, 20G x 3/2″, 19G x 3/2″, 18G x 5/4″, 18G x 3/2".
#### 4.3 Device Characteristics
The device is EO sterilized and for single use only.
- 4.4 Environment of Use
General hospital
- 4.5 Operation Principle
{6}------------------------------------------------
The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. For Manual Use Only.
- 4.6 Materials of Use
Medical polypropylene, Natural rubber or Synthetic rubber, austenitic stainless steel (SUS304)
Contact type: Tissue/bone/dentin
Duration: Limited exposure (less than 24h)
### V. INDICATIONS FOR USE
The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
# VI. COMPARISON WITH THE PREDICATE DEVICE
### 5.1 Technical Characteristics
Table 1: Hypodermic Syringe
| Item | proposed device | Predicate Device | Comparison | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------|
| Product name | Sterile Syringe for<br>Single Use (with<br>Needle) | Sterile Hypodermic<br>Syringe for Single<br>use, with/without<br>needle; luer/luer-lock | / | |
| Product code | FMF | FMF | similar | |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | similar | |
| Class | II | II | similar | |
| Indication for<br>use | The Sterile<br>Hypodermic Syringe<br>for Single Use<br>with/without needle<br>is intended to be<br>used for medical<br>purposes to inject | The Sterile<br>Hypodermic Syringe<br>for Single Use<br>with/without needle is<br>intended to be used<br>for medical purposes<br>to inject fluid into or | similar | |
| | fluid into or withdraw<br>fluid from body. | withdraw fluid<br>from body. | | |
| Configuration | Piston<br>Plunger<br>Barrel | Piston<br>Plunger<br>Barrel | similar | |
| Volume | 1mL, 2mL, 5mL,<br>10mL, 20mL, 50mL | 1ml, 3ml, 5ml, 6ml,<br>10ml, 20ml, 30ml,<br>35ml, 50ml, 60 ml | Difference 1 | |
| Needle size | 18G, 19G, 20G,<br>21G, 22G, 23G,<br>24G, 25G, 26G,<br>27G, 28G, 29G,<br>30G | 18G, 19G, 20G, 21G,<br>22G, 23G, 24G, 25G,<br>26G, 27G, 28G, 29G,<br>30G | similar | |
| Needle length | 13mm-38mm | 4–38 mm | Difference 2 | |
| Intended user | Medical<br>professionals and<br>trained care givers | Medical professionals<br>and<br>trained care givers | similar | |
| Environment of<br>use | Hospital | Hospital | similar | |
| Single use | Yes | Yes | similar | |
| | For Manual Use<br>Only. | For Manual Use Only. | | |
| Operation mode | The plunger of<br>syringe can be<br>pulled and pushed<br>along inside the<br>barrel, allowing<br>the syringe to take<br>in and expel the | The plunger of syringe<br>can be pulled and<br>pushed along inside<br>the barrel, allowing<br>the syringe to take in<br>and expel the fluids<br>through the connector | similar | |
| | fluids through the<br>connector to the | to the patient. | | |
| | patient. | | | |
| Label/labeling | Complied with 21<br>CFR part 801 | Complied with 21<br>CFR part 801 | similar | |
| Performance | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | similar | |
| | Biocompatibility | Complied with ISO<br>10993-4/5/10/11 | Complied with ISO<br>10993-4/5/10/11 | similar |
| | Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | similar | |
| Barrel | PP | PP | similar | |
| Plunger | PP | PP | similar | |
| Needle | PP, SUS304 | PP, SUS304 | similar | |
| Sterilization | | | | |
| Sterility<br>condition | EO sterilized | EO sterilized | similar | |
| SAL | 10-6 | 10-6 | similar | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | similar | |
{7}------------------------------------------------
{8}------------------------------------------------
### Table 2: Hypodermic Needle
| Item | proposed device | Predicate Device | Comparison |
|----------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------|
| Product Name | Sterile Hypodermic<br>Needle for Single Use | Sterile Hypodermic<br>needle for Single<br>use | similar |
| Product code | FMI | FMI | similar |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | similar |
| Class | II | II | similar |
| Indication for<br>use | The Sterile<br>Hypodermic Needle<br>for Single Use is<br>intended for use with | The Sterile<br>Hypodermic Needle<br>for single use is<br>intended for use with | similar |
| | | | |
| | syringes and injection<br>devices for general<br>purpose fluid<br>injection/aspiration. | syringes and<br>injection devices for<br>general purpose<br>fluid<br>injection/aspiration. | |
| Configuration | Protective cap<br>Needle<br>Adhesives<br>Needle hub | Protective cap<br>Needle<br>Adhesives<br>Needle hub | similar |
| | | | |
| | | | |
| | | | |
| Intended user | Medical professionals<br>and<br>trained care givers | Medical<br>professionals and<br>trained care givers | similar |
| | | | |
| Environment of<br>use | Hospital | Hospital | similar |
| Single use | Yes | Yes | similar |
| Operation mode | For Manual Use Only<br>For Single Use only | For Manual Use Only<br>For Single Use only | similar |
| Label/labeling | Complied with 21<br>CFR part 801 | Complied with 21<br>CFR part 801 | similar |
| Performance | Complied with:<br>ISO 7864<br>ISO 9626 | Complied with:<br>ISO 7864<br>ISO 9626 | similar |
| | | | |
| | | | |
| Biocompatibility | Complied with ISO<br>10993-4/5/10/11 | Complied with ISO<br>10993-4/5/10/11 | similar |
| | | | |
| Needle size | 18G, 19G, 20G, 21G,<br>22G, 23G, 24G, 25G,<br>26G, 27G, 28G, 29G,<br>30G | 18G, 19G, 20G,<br>21G, 22G, 23G,<br>24G, 25G, 26G,<br>27G, 28G, 29G, 30G | similar |
| | | | |
| | | | |
| | | | |
| Needle length | 13mm-38mm | 4mm-38mm | Difference 1 |
| Patient contact component and material | | | |
| Protective cap | PP | PP | similar |
| Adhesive | Epoxy resin | Epoxy resin | similar |
| Needle Hub | PP | PP | similar |
| Needle | SUS304 | SUS304 | similar |
| Sterilization | | | |
| Sterility condition | EO sterilized | EO sterilized | similar |
| SAL | 10-6 | 10-6 | similar |
| Endotoxin Limit | 20 EU per device | 20 EU per device | similar |
{9}------------------------------------------------
{10}------------------------------------------------
### Substantial Equivalence Discussion
- Hypodermic Syringe discussion: There are 2 differences between the proposed device and the predicated device related to the volume and needle length.
Difference 1: The proposed device includes 2ml volume syringes which the predicate device doesn't have. But this difference have no adverse effect on clinical safety and performance as the size is within the range of 1mL to 10mL syringes cleared under the predicate. Additionally, the proposed device has been tested according to the standard ISO 7886-1. The requirements of the standard are met.
Difference 2: The needle lengths of the proposed device range from 13mm to 38mm, which is covered by the predicated device's (4mm - 38mm). The needles meet the requirements of the ISO 9626 and ISO 7864 standards.
- Hypodermic Needle discussion: There is one difference between the proposed device and the predicated device related to the needle length. The needle lengths of the proposed device range from 13mm to 38mm, which is covered by the predicated device's (4mm - 38mm). The needle meets the requirements of ISO 9626 and ISO 7864 standards.
### 5.2 Performance Testing
The Hypodermic Syringe and Hypodermic Needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
{11}------------------------------------------------
- ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
- ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use -Requirements and test methods
- ISO 10993-4:2017 Biological Evaluation Of Medical Devices Part 4: Selection Of Tests For Interactions With Blood
- 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: Tests For Irritation And Skin Sensitization
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices Part 11: Tests For Systemic Toxicity
- USP 788 Particulate Matter in Injections
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices -- Part 2: Validation
The device is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "Tissue/Bone". Thus, cytotoxicity (ISO 10993-5:2009), irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), hemocompatibility (ISO 10993-4:2017) , pyrogen test (USP 43-NF38 <151>) and microscopic particle count test (USP 43-NF38 <788>) were carried out for the device in question.
### 5.3 Clinical Test
No clinical study is included in this submission.
{12}------------------------------------------------
## VIII. CONCLUSIONS
The intended use, technological characteristics and method of operation are similar in the subject device and predicate device. Through performance testing, the subject device has demonstrated substantial equivalence to the predicate device.
