Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of syringes and needles, with no mention of AI or ML.

Therapeutic

No
The device is described as a sterile disposable syringe and needle system intended for the aspiration and injection of fluids, along with safety mechanisms to prevent needle sticks. Its function is to deliver or remove substances from the body, not to directly treat a condition or disease.

Diagnostic

No

The device, a syringe and needle, is intended for the aspiration and injection of fluids, which are clinical procedures. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as needle tubes, hubs, safety mechanisms, pistons, barrels, and plungers, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the devices are for "aspiration of fluids for medical purpose" and "aspiration and injection of fluids for medical purpose." This describes a procedure performed on a patient, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
Device Description: The description focuses on the physical components of syringes and needles, their safety mechanisms, and their compatibility with different syringe types. It does not mention any reagents, test strips, or analytical components typically associated with IVD devices.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information. The purpose is to facilitate the physical act of withdrawing or injecting fluids.

Therefore, the device falls under the category of a medical device used for procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sterile Disposable Syringe with Safety Needle 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.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

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 safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

Product codes (comma separated list FDA assigned to the subject device)

MEG, FMF, FMI

Device Description

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Needle specification:

Needle Gauge	Needle length
18G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
20G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
21G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
22G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
25G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
27G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Syringe volume: 0.5ml,1ml,2ml,3ml,5ml,10ml,20ml,30ml,50ml and 60ml
Needle specification:

Needle Gauge	Needle length
18G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
20G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
21G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
22G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
25G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
27G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

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

Not Found

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)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
USP Bacterial Endotoxins Test
USP Pyrogen Test
USP Particulate Matter in Injections
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems (DC-13, Level II)

Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.

General requirements	Clause 5 of ISO 7886-1:2017
Extraneous matter	Clause 6 of ISO 7886-1:2017
Lubricant	Clause 7 of ISO 7886-1;2017
Tolerance on graduated capacity	Clause 8 of ISO 7886-1:2017
Graduated scale	Clause 9 of ISO 7886-1:2017
Barrel	Clause 10 of ISO 7886-1:2017
Piston/ plunger assembly	Clause 11 of ISO 7886-1:2017
Nozzle	Clause 12 of ISO 7886-1:2017
Performance	Clause 13 of ISO 7886-1:2017
Cleanliness	Clause 4.3 of ISO 7864:2016
Limits for acidity or alkalinity	Clause 4.4 of ISO 7864:2016
Limits for extractable metals	Clause 4.5 of ISO 7864:2016
Size designation	Clause 4.6 of ISO 7864:2016
Colour coding	Clause 4.7 of ISO 7864:2016
Needle hub	Clause 4.8 of ISO 7864:2016
Needle Cap	Clause 4.9 of ISO 7864:2016
Needle tube	Clause 4.10 of ISO 7864:2016
Needle point	Clause 4.11 of ISO 7864:2016
Bond between hub and needle tube	Clause 4.12 of ISO 7864:2016
Patency of lumen	Clause 4.13 of ISO 7864:2016
Surface finish and appearance	Clause 5.2 of ISO 9626:2016
Cleanliness	Clause 5.3 of ISO 9626:2016
Limits for acidity and alkalinity	Clause 5.4 of ISO 9626:2016
Size designation	Clause 5.5 of ISO 9626:2016
Dimensions	Clause 5.6 of ISO 9626:2016
Stiffness	Clause 5.8 of ISO 9626:2016
Resistance to breakage	Clause 5.9 of ISO 9626:2016
Resistance to corrosion	Clause 5.10 of ISO 9626:2016
Item	Standard
Fluid leakage	Clause 6.1 of ISO 80369-7:2016
Sub-atmospheric pressure air leakage	Clause 6.2 of ISO 80369-7:2016
Stress cracking	Clause 6.3 of ISO 80369-7:2016
Resistance to separation form axial load	Clause 6.4 of ISO 80369-7:2016
Resistance to separation form unscrewing	Clause 6.5 of ISO 80369-7:2016
Resistance to overriding	Clause 6.6 of ISO 80369-7:2016
Particulate testing	USP

Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.

Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.

EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package Test were performed on aging samples to verify the claimed shelf life of the device

Biocompatibility testing: The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2022

Jiangsu Kangbao Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K221247

Trade/Device Name: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: September 30, 2022 Received: September 30, 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K221247

Device Name

Sterile Disposable Syringe with Safety Needle; Sterile Disposable Syringe with Needle; Sterile Disposable Safety Needle; Sterile Disposable Needle

Indications for Use (Describe)

The Sterile Disposable Syringe with Safety Needle 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.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

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 safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

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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3

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K221247

1. Date of Preparation: November 1, 2022
1. Sponsor Identification

Jiangsu Kangbao Medical Equipment Co., Ltd.

78#, North Suzhong Road Baoying 225800 Yangzhou PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3009742443

Contact Person: Rujun Tang

Position: Management Representative

Tel: +86-514-88223540

Fax: +86-514-88232089

Email: 76823131@qq.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person)

Ms. Tingting Su (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

4. Identification of Proposed Device

Trade Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Safety Needle Sterile Disposable Needle

Common Name: Syringes with Needle

Regulatory Information Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;

Classification Name: Needle, Hypodermic, Single Lumen Classification: II Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;

Classification Name: Piston Syringe Classification: II; Product Code: MEG; Regulation Number: 21 CFR 880. 5860; Review Panel: General Hospital

Indications for use:

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.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.

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

5

minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.

Device Description

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Needle Gauge	Needle length
18G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
20G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
21G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
22G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
25G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
27G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"

Needle specification:

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Syringe volume: 0.5ml,1ml,2ml,3ml,5ml,10ml,20ml,30ml,50ml and 60ml Needle specification:

Needle Gauge	Needle length
18G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
20G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
21G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
22G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
25G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"
27G	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"

6

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

રું. Identification of Predicate Device

Predicate Device

510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle Sterile Disposable Needle

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)

7

ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices >
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
USP Bacterial Endotoxins Test
USP Pyrogen Test
USP Particulate Matter in Injections
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems (DC-13, Level II)

Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.

General requirements	Clause 5 of ISO 7886-1:2017
Extraneous matter	Clause 6 of ISO 7886-1:2017
Lubricant	Clause 7 of ISO 7886-1;2017
Tolerance on graduated capacity	Clause 8 of ISO 7886-1:2017
Graduated scale	Clause 9 of ISO 7886-1:2017
Barrel	Clause 10 of ISO 7886-1:2017
Piston/ plunger assembly	Clause 11 of ISO 7886-1:2017
Nozzle	Clause 12 of ISO 7886-1:2017
Performance	Clause 13 of ISO 7886-1:2017
Cleanliness	Clause 4.3 of ISO 7864:2016
Limits for acidity or alkalinity	Clause 4.4 of ISO 7864:2016
Limits for extractable metals	Clause 4.5 of ISO 7864:2016
Size designation	Clause 4.6 of ISO 7864:2016
Colour coding	Clause 4.7 of ISO 7864:2016
Needle hub	Clause 4.8 of ISO 7864:2016
Needle Cap	Clause 4.9 of ISO 7864:2016
Needle tube	Clause 4.10 of ISO 7864:2016
Needle point	Clause 4.11 of ISO 7864:2016
Bond between hub and needle tube	Clause 4.12 of ISO 7864:2016

8

Patency of lumen	Clause 4.13 of ISO 7864:2016
Surface finish and appearance	Clause 5.2 of ISO 9626:2016
Cleanliness	Clause 5.3 of ISO 9626:2016
Limits for acidity and alkalinity	Clause 5.4 of ISO 9626:2016
Size designation	Clause 5.5 of ISO 9626:2016
Dimensions	Clause 5.6 of ISO 9626:2016
Stiffness	Clause 5.8 of ISO 9626:2016
Resistance to breakage	Clause 5.9 of ISO 9626:2016
Resistance to corrosion	Clause 5.10 of ISO 9626:2016
Item	Standard
Fluid leakage	Clause 6.1 of ISO 80369-7:2016
Sub-atmospheric pressure air leakage	Clause 6.2 of ISO 80369-7:2016
Stress cracking	Clause 6.3 of ISO 80369-7:2016
Resistance to separation form axial load	Clause 6.4 of ISO 80369-7:2016
Resistance to separation form unscrewing	Clause 6.5 of ISO 80369-7:2016
Resistance to overriding	Clause 6.6 of ISO 80369-7:2016
Particulate testing	USP

Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.

Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.

EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package Test
were performed on aging samples to verify the
claimed shelf life of the device

Biocompatibility testing

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact ( Cytotoxicity,

Sensitization,
Irritation,
Acute Systemic Toxicity, >
Hemolysis,
Complement activation,
Thromboresistance study
Pyrogen

Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

Safety Feature Test

The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.

7. Clinical Test Conclusion

No clinical study is included in this submission.

10

Summary of Technology Characteristics 8.

| ITEM | Proposed Device | Predicate Device
K170651 | Remark |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Disposable Syringe with
Safety Needle | 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 |
| Indications for
Use | 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. | 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) | Different |
| | | Plunger
Piston
Needle hub
Needle tube
Needle cap
Safety sheath | |
| Operation Mode | For manual use only | For manual use only | Same |
| Sterilized | Yes | Yes | Same |

11

	Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801		Same
Syringe	Volume	0.5ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml	1ml, 2ml 3ml, 5ml, 10ml, 20ml, 30ml, 50ml,60ml	Different
	Connector Type	0.5ml,1ml: Luer Lock, Luer Slip, Fixed needle; Others: Luer Lock and Luer Slip	Luer Lock/ Luer slip
Needle	Size	18G, 20G, 21G, 22G, 25G, 27G	16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G	Different
	Length	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"	5/16", 1/2", 5/8", 1", 1-1/4", 1-1/2" 3/4",
Syringe Performance		Complied with ISO 7886-1	Complied with ISO 7886-1	Same
Needle Performance		Complied with ISO 7864, ISO 9626	Complied with ISO 7864, ISO 9626	Same
Luer Connector Performance		Complied with ISO 80369-7	Complied with ISO 594-2	Different
Barrel		Polypropylene (PP)	Polypropylene (PP)
Plunger		Polypropylene (PP)	Polypropylene (PP)
Piston		Polyisoprene	Polyisoprene
Needle hub		Polypropylene (PP)	Polypropylene (PP)	Same
Needle tube		Stainless Steel SUS 304	Stainless Steel SUS 304	Same
Lubricants		Silicone oil	Silicone Oil
Adhesive		UV adhesive	UV glue
Cytotoxicity		No cytotoxicity	No cytotoxicity
Irritation		No intracutaneous reactivity	No intracutaneous reactivity
Sensitization		No sensitization	No skin sensitization	Same
Systemic Toxicity		No systemic toxicity	No systemic toxicity

12

Hemolysis	No Hemolysis	No Hemolysis	No Hemolysis
Pyrogen	No Pyrogen	No Pyrogen	No Pyrogen
Complement
Activation	Not show potentials to
activate complete system	Not show potentials to
activate complete system	Not show potentials to
activate complete
system
In-vivo
Thrombogenicity	No thrombogenicity	No thrombogenicity	No thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	10-6	Same
Endotoxin
Limit	20 EU per device	20 EU per device	20 EU per device	Same

Different - Configuration

The configuration of proposed device is similar to the configurations of predicate device. For 0.5ml and 1ml syringe, the proposed device has luer lock connector and fixed needle, the other volumes have luer lock and luer slip connector. The predicate device only has luer slip connector. The proposed device has luer lock connector, luer slip connector and fixed needle have been tested and meet the requirements of relevant standards. Based on above analysis, the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

Different -Syringe Volume

The syringe volume for proposed device is similar to the predicate devices. The predicate device does not have a 0.5ml syringe. This difference will not raise new questions on safety and effectiveness of the proposed device.

Different - Syringe Connector Type

The syringe connector type of proposed device is similar as the predicate device. For 0.5ml and 1ml syringe, the proposed device has luer lock connector, luer slip connector and fixed needle, the other volumes have luer lock connector and luer slip. The predicate device has luer lock or luer slip connector.

13

In addition, the proposed device has luer lock connector, luer slip connector and fixed needle have been tested and meet the requirements of relevant standards. Based on above analysis, the difference on connector type will not raise new questions on safety and effectiveness of the proposed device.

Different -Needle Size and Length

The needle size and length for proposed device is different from the predicate device. The needle length is very close to that of the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.

Different -Luer Connector Performance

Although the proposed device and the predicate device follow different luer connector standards - this is because ISO 594-1,594-2 is replaced by ISO 80369-7. The test results of the proposed device show that the connector performance meet the requirements of ISO 80369-7. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

14

| ITEM | Proposed Device | Predicate Device
K170651 | Remark |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Disposable Syringe with
Safety Needle | Sterile Disposable Syringe with
Safety Needle | / |
| Product Code | FMF
FMI | FMF
FMI | 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 Disposable Syringe with
Needle is intended for use in the
aspiration and injection of fluids
for medical purpose. | The Sterile Disposable Syringe
with Needle is intended for use in
the aspiration and injection of
fluids for medical purpose. | Same |
| Configuration | Syringe | Barrel (luer lock/luer
slip)
Plunger
Piston | Different |
| | Syringe | Barrel (luer lock/ luer
slip/ fixed needle)
Plunger
Piston | |
| | Needle | Needle hub
Needle tube
Needle cap | |
| | Needle | Needle hub
Needle tube
Needle cap | |
| Operation Mode | For manual use only | | Same |
| Sterilized | Yes | | Same |
| Single Use | Single Use | | Same |
| Label/Labeling | Complied with 21 CFR part 801 | | Same |
| Syringe | Volume | 0.5ml, 1ml, 2ml, 3ml, 5ml, 10ml,
20ml, 30ml, 50ml, 60ml | Different |
| | Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,
30ml, 50ml, 60ml | |
| Syringe | Connector
Type | Luer Lock and Luer Slip | Same |
| Needle | Size | 18G, 20G, 21G, 22G, 25G, 27G | Different |
| Needle | Size | 16G, 18G, 19G, 20G, 21G, 22G,
23G, 24G, 25G, 26G, 27G,
28G, 29G, 30G | |
| | Length | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | |
| | Length | 5/16", 1/2", 5/8", 3/4", 1", 1-1/4",
1-1/2" | |
| Syringe
Performance | Complied with
ISO 7886-1 | | Same |
| Needle Performance | Complied with ISO 7864 | | Same |
| | ISO 9626 | ISO 9626 | |
| Luer
Connector
Performance | Complied with
ISO 80369-7 | Complied with
ISO 594-2 | Different |
| Patient-contact materials | | | |
| Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | |
| Piston | Polyisoprene | Polyisoprene | |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | |
| Lubricants | Silicone oil | Silicone Oil | |
| Adhesive | UV adhesive | UV glue | |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No skin sensitization | Same |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Pyrogen | No Pyrogen | |
| Pyrogen | Not show potentials to activate
complete system | Not show potentials to activate
complete system | |
| Complement
Activation | No thrombogenicity | No thrombogenicity | |
| In-vivo
Thrombogenicity | No thrombogenicity | No thrombogenicity | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | |
| Endotoxin
Limit | 20 EU per device | 20 EU per device | |

Table 2. Comparison of Sterile Disposable Syringe with Needle

15

510(k) Summary

16

Different -Syringe Volume

The syringe volume for proposed device is similar to the predicate devices. The predicate device does not have a 0.5ml syringe. This difference will not raise new questions on safety and effectiveness of the proposed device.

Different -Needle Size and Length

The needle size and length for proposed device is different from the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.

Different - Luer Connector Performance

The luer connector performance of proposed device is complied with ISO 80369-7, the predicate device is complied with complied with ISO 594-2. They are all the test standards of luer connector. At present, ISO 594-2 has been replaced by ISO 80369-7. The predicate device was tested according to ISO 594-2 because the application time was earlier. The proposed devices are tested according to the latest version of the standard ISO 80369-7. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

17

ITEM		Proposed Device	Predicate Device K170651	Remark
Product		Sterile Disposable Safety
Needle	Sterile Disposable Safety
Needle	/

Product Code		FMI	FMI	Same
Regulation Number		21 CRF 880.5860	21 CRF 880.5860	Same
Class		Class II	Class II	Same
Indication for Use		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.	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		Needle hub	Needle hub	Same
		Needle tube	Needle tube
		Needle cap	Needle cap
		Safety machine	Safety sheath
Operation Mode		For manual use only	For manual use only	Same
Sterilized		Yes	Yes	Same
Single Use		Single Use	Single Use	Same
Label/Labeling		Complied with 21 CFR part
801	Complied with 21 CFR part
801	Same

Needle	Size	18G, 20G, 21G, 22G, 25G,
27G	16G, 18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G, 26G,
27G, 28G, 29G, 30G	Different
	Length	1/2", 5/8", 3/4", 1", 1-1/4",
1-1/2"	5/16", 1/2", 5/8", 3/4", 1",
1-1/4", 1-1/2"
Needle Performance		Complied with ISO 7864,
ISO 9626	Complied with ISO 7864,
ISO 9626	Same
Patient-contact Materials
Needle hub		Polypropylene (PP)	Polypropylene (PP)	Same
Needle tube		Stainless Steel SUS 304	Stainless Steel SUS 304
Lubricants		Silicone oil	Silicone oil
Adhesive		UV adhesive	UV glue
Biocompatibility
Cytotoxicity	No cytotoxicity	No cytotoxicity
Irritation	No intracutaneous reactivity	No intracutaneous reactivity
Sensitization	No sensitization	No skin sensitization
Systemic Toxicity	No systemic toxicity	No systemic toxicity
Hemolysis	No Hemolysis	No Hemolysis	Same
Pyrogen	No Pyrogen	No Pyrogen
Complement Activation	Not show potentials to activate complete system	Not show potentials to activate complete system
In vivo Thrombogenicity	No thrombogenicity	No thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same
ITEM		Proposed Device	Predicate Device K170651	Remark
Product		Sterile Disposable Needle	Sterile Disposable Needle	/
Product Code		FMI	FMI	Same
Regulation Number		21 CRF 880.5860	21 CRF 880.5860	Same
Class		Class II	Class II	Same
Indication for Use		The Sterile Disposable Needle
is intended to be used with a	The Sterile Disposable Needle
is intended to be used with a	Same
		luer slip or luer lock syringe for	luer slip or luer lock syringe
		aspiration and injection of	for aspiration and injection of
		fluids for medical purpose.	fluids for medical purpose.
Configuration		Needle hub	Needle hub	Same
		Needle tube	Needle tube
		Needle cap	Needle cap
Operation Mode		For manual use only	For manual use only	Same
Sterilized		Yes	Yes	Same
Single Use		Single Use	Single Use	Same
Label/Labeling		Complied with 21 CFR part
801	Complied with 21 CFR part
801	Same
Needle	Size	18G, 20G, 21G, 22G, 25G,
27G	16G, 18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G, 26G,
27G, 28G, 29G, 30G	Different

	Length	1/2", 5/8", 3/4", 1", 1-1/4",
1-1/2"	5/16", 1/2", 5/8", 3/4", 1",
1-1/4", 1-1/2"


Needle Performance		Complied with
ISO 7864,
ISO 9626	Complied with
ISO 7864,
ISO 9626	Same
Patient-contact Materials
Needle hub		Polypropylene (PP)	Polypropylene (PP)	Same
Needle tube		Stainless Steel SUS 304	Stainless Steel SUS 304
Lubricants		Silicone oil	Silicone oil	Same
Adhesive		UV adhesive	UV glue
Biocompatibility
Cytotoxicity		No cytotoxicity	No cytotoxicity	Same
Irritation		No intracutaneous reactivity	No intracutaneous reactivity
Sensitization		No sensitization	No skin sensitization
Systemic Toxicity		No systemic toxicity	No systemic toxicity
Hemolysis		No Hemolysis	No Hemolysis
Pyrogen	No Pyrogen	No Pyrogen
Complement Activation	Not show potentials to activate complete system	Not show potentials to activate complete system
In vivo Thrombogenicity	No thrombogenicity	No thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same

Table 3. Comparison of Sterile Disposable Safety Needle

18

Different -Needle Size and Length

The needle size and length for proposed device is different from the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.

19

Table 4. Comparison of Sterile Disposable Needle

20

Different -Needle Size and Length

The needle size and length for proposed device is different from the predicate devices. This difference will not raise new questions on safety and effectiveness of the proposed device.

9. Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle and Sterile Disposable is as safe and effective as the legally marketed predicate device cleared under K170651.