K Number

Device Name

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Manufacturer

Jiangsu Zhiyu Medical Instrument Co, Ltd.

Date Cleared

2023-05-09

(608 days)

Product Code

FMF FMI

Regulation Number

880.5860

Intended 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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K201284

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biological compatibility of a standard syringe and needle, with no mention of AI/ML or related concepts.

Therapeutic

No.
Explanation: A syringe and needle are used for administering or withdrawing fluids, which are procedures, but they do not directly provide therapy. The therapeutic agent is the fluid being injected, not the device itself.

Diagnostic

Explanation: The device is described as a sterile syringe and needle intended for injecting or withdrawing fluids from the body. Its stated purpose is for fluid management (injection/aspiration), not for identifying or assessing a disease, condition, or health status.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (barrel, plunger, stopper, needle, protective cap, needle seat, needle tube connection) made of materials like polypropylene and austenitic steel, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for injecting or withdrawing fluid from the body. This is a direct interaction with the patient's body, not for examining specimens in vitro (outside the body).
Device Description: The description details a syringe and needle, which are instruments for administering or collecting substances from a living organism.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro to diagnose a condition.
Performance Studies: The performance studies focus on the physical and biological compatibility of the device with the body (cytotoxicity, irritation, hemocompatibility, etc.), which are relevant for devices used in vivo.

IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FMF, FMI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical professionals and trained care givers / Hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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 ) and microscopic particle count test (USP 43-NF38 ) were carried out for the device in question.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201284

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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

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

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)

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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

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	-

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

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
Single Use (with
Needle)	Sterile Hypodermic
Syringe for Single
use, with/without
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
use	The Sterile
Hypodermic Syringe
for Single Use
with/without needle
is intended to be
used for medical
purposes to inject	The Sterile
Hypodermic Syringe
for Single Use
with/without needle is
intended to be used
for medical purposes
to inject fluid into or	similar
	fluid into or withdraw
fluid from body.	withdraw fluid
from body.
Configuration	Piston
Plunger
Barrel	Piston
Plunger
Barrel	similar
Volume	1mL, 2mL, 5mL,
10mL, 20mL, 50mL	1ml, 3ml, 5ml, 6ml,
10ml, 20ml, 30ml,
35ml, 50ml, 60 ml	Difference 1
Needle size	18G, 19G, 20G,
21G, 22G, 23G,
24G, 25G, 26G,
27G, 28G, 29G,
30G	18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G,
26G, 27G, 28G, 29G,
30G	similar
Needle length	13mm-38mm	4–38 mm	Difference 2
Intended user	Medical
professionals and
trained care givers	Medical professionals
and
trained care givers	similar
Environment of
use	Hospital	Hospital	similar
Single use	Yes	Yes	similar
	For Manual Use
Only.	For Manual Use Only.
Operation mode	The plunger of
syringe can be
pulled and pushed
along inside the
barrel, allowing
the syringe to take
in and expel the	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	similar
	fluids through the
connector to the	to the patient.
	patient.
Label/labeling	Complied with 21
CFR part 801	Complied with 21
CFR part 801	similar
Performance	Complied with
ISO 7886-1
ISO 7864
ISO 9626	Complied with
ISO 7886-1
ISO 7864
ISO 9626	similar
	Biocompatibility	Complied with ISO
10993-4/5/10/11	Complied with ISO
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
condition	EO sterilized	EO sterilized	similar
SAL	10-6	10-6	similar
Endotoxin Limit	20 EU per device	20 EU per device	similar

Table 2: Hypodermic Needle

Item	proposed device	Predicate Device	Comparison
Product Name	Sterile Hypodermic
Needle for Single Use	Sterile Hypodermic
needle for Single
use	similar
Product code	FMI	FMI	similar
Regulation No.	21 CFR 880.5570	21 CFR 880.5570	similar
Class	II	II	similar
Indication for
use	The Sterile
Hypodermic Needle
for Single Use is
intended for use with	The Sterile
Hypodermic Needle
for single use is
intended for use with	similar

	syringes and injection
devices for general
purpose fluid
injection/aspiration.	syringes and
injection devices for
general purpose
fluid
injection/aspiration.
Configuration	Protective cap
Needle
Adhesives
Needle hub	Protective cap
Needle
Adhesives
Needle hub	similar



Intended user	Medical professionals
and
trained care givers	Medical
professionals and
trained care givers	similar

Environment of
use	Hospital	Hospital	similar
Single use	Yes	Yes	similar
Operation mode	For Manual Use Only
For Single Use only	For Manual Use Only
For Single Use only	similar
Label/labeling	Complied with 21
CFR part 801	Complied with 21
CFR part 801	similar
Performance	Complied with:
ISO 7864
ISO 9626	Complied with:
ISO 7864
ISO 9626	similar


Biocompatibility	Complied with ISO
10993-4/5/10/11	Complied with ISO
10993-4/5/10/11	similar

Needle size	18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G,
26G, 27G, 28G, 29G,
30G	18G, 19G, 20G,
21G, 22G, 23G,
24G, 25G, 26G,
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

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

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

5.3 Clinical Test

No clinical study is included in this submission.

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.