Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, sterilization, and safety mechanisms, with no mention of AI or ML.

Therapeutic

No
The devices described (syringes and needles) are used for aspiration and injection of fluids, which are procedures, but they themselves do not directly provide a therapeutic effect. Their function is to administer or withdraw substances.

Diagnostic

No

The device is described as a syringe and needle system intended for the aspiration and injection of fluids for medical purposes. It is explicitly designed for fluid handling rather than analyzing substances or providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like pistons, barrels, plungers, needles, and safety mechanisms, indicating it is a hardware 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 consistently describes the devices for the "aspiration and injection of fluids for medical purpose." This refers to drawing fluids from or injecting fluids into the body, which is a clinical procedure, not an in vitro diagnostic test.
Device Description: The description focuses on the physical components of syringes and needles used for these clinical procedures.
Lack of IVD Language: There is no mention of analyzing samples outside the body, detecting specific substances, or providing diagnostic information based on the analysis of biological samples.

IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical manipulation of fluids within or from the body.

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 Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or 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 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 Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle.

Syringe volume: 1ml, 2ml, 3ml, 10ml, 20ml, 30ml, 50ml, 60ml

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 length. The proposed device is compatible for use with a luer slip or 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 The Sterile Disposable Syringe with Safety Needle.

Needle specification: 23G1/2", 23G5/8", 23G1", 23G1-1/4" and 23G*1-1/2"

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

The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which 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.

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

The proposed devices are sterilized by Ethylene Oxide 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 Test Conclusion:
Nonclinical 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 6009:2016 Hypodermic needles for single use Colour coding for identification
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

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

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)
Color 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)
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)
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)
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 Tests 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2021

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

Re: K211329

Trade/Device Name: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, 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: October 28, 2021 Received: October 29, 2021

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

542 of the Act); 21 CFR 1000-1050.

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-

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,

CAPT 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) K211329

Device Name

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, 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 Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or 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 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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:

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information unless it displays a currently valid OMB number."

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Expiration Date: 06/30/2023

See PRA Statement below.

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: K211329

1. Date of Preparation: 11/03/2021
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

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4. Identification of Proposed Device

Trade Name: Sterile Disposable Syringe with Safety Needle

Sterile Disposable Syringe with Needle Sterile Disposable Syringe 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 Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

5

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 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 Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle.

Syringe volume: 1ml, 2ml, 3ml, 10ml, 20ml, 30ml, 50ml, 60ml

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 length. The proposed device is compatible for use with a luer slip or 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 The Sterile Disposable Syringe with Safety Needle.

Needle specification: 23G1/2", 23G5/8", 23G1", 23G1-1/4" and 23G*1-1/2"

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

The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which 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.

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

The proposed devices are sterilized by Ethylene Oxide a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

6

న్. Identification of Predicate Device
510(k) Number: K193526 Product Name: Syringe with safety needle, Safety needle

6. Non-Clinical Test Conclusion

Nonclinical 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.
A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
A 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
A 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 6009:2016 Hypodermic needles for single use Colour coding for identification A
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
A USP Pyrogen Test
USP Particulate Matter in Injections

7

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

Item	Standard
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
Color 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

Item	Standard
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

General requirements

Clause 5 of ISO 7886-1:2017

8

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
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.

Item	Standard
EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP
Shelf-Life Evaluation	Physical, Mechanical, Chemical, Package Tests
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,
Intracutaneous,
Acute Systemic Toxicity,
Hemolysis,
A Pyrogen,

9

ア In vivo thromboresistance,
Complement activation.

Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance, 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 test data of the proposed device is very close to the test data of the predicate device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Summary of Technology Characteristics

ITEM	Proposed Device	Predicate Device	Remark
Product	Sterile Disposable Syringe with Safety Needle	Syringe with Safety Needle	/
Product Code	FMF
FMI
MEG	FMF
FMI
MEG	SE
Regulation Number	21 CRF 880.5860
21 CRF 880.5570	21 CRF 880.5860
21 CRF 880.5570	SE
Class	Class II	Class II	SE
Indication 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 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 stick.	SE
Configuration	Syringe	Syringe
Barrel (luer lock)	Analysis 1
	Barrel (luer lock/luer slip)
Plunger
Piston
Needle
Needle hub
Needle tube
Needle cap
Safety mechanism	Plunger
Piston
Needle hub
Needle tube
Needle cap
Safety shield
Operation Mode	For manual use only	For manual use only	SE
Sterilized	Yes	Yes	SE
Single Use	Single Use	Single Use	SE
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	SE
Syringe Volume	1ml 2ml 3ml 5ml 10ml	1ml 3ml 5ml 10ml 20ml 30ml	Analysis 2
		20ml, 30ml, 50ml, 60ml	60ml
	Connector
Type	Luer Lock and Luer Slip	Luer Lock	Analysis 1
Needle	Size	23G	16G,18G, 19G, 20G, 21G, 22G,
23G, 25G, 26G, 27G, 28G, 29G,
30G, 31G	Analysis 3
	Length	1/2", 5/8", 3/4", 1", 1-1/4",
1-1/2"	13mm(1/2"), 16mm(5/8"),
20mm(3/4"), 25mm(1"),
32mm(1-1/4"), 38mm(1-1/2")	SE
	Syringe Performance	Complied with
ISO 7886-1	Complied with
ISO 7886-1	SE
	Needle Performance	Complied with
ISO 7864,
ISO 9626	Complied with
ISO 7864,
ISO 9626	SE
Luer	Connector
Performance	Complied with
ISO 80369-7	Complied with
ISO 80369-7	SE
Patient-contact Materials
Barrel		Polypropylene (PP)	Polypropylene (PP)	Analysis 4
Plunger		Polypropylene (PP)	Polypropylene (PP)
Piston		Polyisoprene Rubber	Polyisoprene
Needle hub		Polypropylene (PP) and blue
pigment	Polypropylene (PP)
Needle tube		Stainless Steel SUS 304	Stainless Steel 304
Needle cap		Polypropylene (PP)	Polypropylene (PP)
Safety mechanism		Polypropylene (PP) and blue
pigment	Polypropylene (PP)
Lubricants		Silicone oil	Polydimethylsiloxane
Adhesive		UV adhesive	Epoxy adhesive
Biocompatibility
Cytotoxicity		No cytotoxicity	Conforms to ISO 10993 series
standards	SE
Irritation		No intracutaneous reactivity
Sensitization		No sensitization
Systemic Toxicity		No systemic toxicity
Hemolysis		No Hemolysis
Pyrogen		No Pyrogen
Complement
Activation		Not show potentials to
activate complete system
In vivo
Thrombogenicity		No thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized	SE
SAL	$10^{-6}$	$10^{-6}$	SE
Endotoxin Limit	20 EU per device	20 EU per device	SE
ITEM	Proposed Device	Predicate Device	Remark
Product	Sterile Disposable Syringe with Needle	Sterile Disposable Syringe with Safety Needle	/
Product Code	FMF
FMI	FMF
FMI
MEG	Analysis 5
Regulation Number	21 CRF 880.5860
21 CRF 880.5570	21 CRF 880.5860
21 CRF 880.5570	Analysis 5
Class	Class II	Class II	SE
Indication for Use	The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.	The 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 stick.	Analysis 6
Configuration	Syringe
Barrel (luer lock/luer slip)
Plunger
Piston
Needle
Needle hub
Needle tube
Needle cap
/	Syringe
Barrel (luer lock
Plunger
Piston
Needle
Needle hub
Needle tube
Needle cap
Safety Shield	Analysis 7
Operation Mode	For manual use only	For manual use only	SE
Sterilized	Yes	Yes	SE
Single Use	Single Use	Single Use	SE
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	SE
Syringe Volume	1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml	1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 60ml	Analysis 8
Connector Type	Luer Lock and Luer Slip	Luer Lock	Analysis 7
Needle Size	23G	16G, 18G, 19G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G	Analysis 9
			30G, 31G
	Length	1/2", 5/8", 3/4", 1", 1-1/4",
1-1/2"	13mm(1/2"),
20mm(3/4"),
32mm(1-1/4"), 38mm(1-1/2")	16mm(5/8"),
25mm(1"),
SE
	Syringe Performance	Complied with
ISO 7886-1	Complied with
ISO 7886-1	SE
	Needle Performance	Complied with
ISO 7864,
ISO 9626	Complied with
ISO 7864,
ISO 9626	SE
	Luer Connector
Performance	Complied with
ISO 80369-7	Complied with
ISO 80369-7	SE
	Patient-contact Materials
Barrel		Polypropylene (PP)	Polypropylene (PP)	Analysis
Plunger		Polypropylene (PP)	Polypropylene (PP)	10
Piston		Polyisoprene Rubber	Polyisoprene
Needle hub		Polypropylene (PP) and blue
pigment	Polypropylene (PP)
Needle tube		Stainless Steel SUS 304	Stainless Steel 304
Needle cap		Polypropylene (PP)	Polypropylene (PP)
Lubricants		Silicone oil	Polydimethylsiloxane
Adhesive		UV adhesive	Epoxy adhesive
Biocompatibility
Cytotoxicity		No cytotoxicity	Conforms to ISO 10993 series
standards	SE
Irritation		No intracutaneous reactivity
Sensitization		No sensitization
Systemic Toxicity		No systemic toxicity
Hemolysis		No Hemolysis
Pyrogen		No Pyrogen
Complement Activation		Not show potentials to activate
complete system
In Thrombogenicity	vivo	No thrombogenicity
Sterilization
Method		EO Sterilized	EO Sterilized	SE
SAL		10-6	10-6	SE
Endotoxin Limit		20 EU per device	20 EU per device	SE

Table 1. Comparison of Sterile Disposable Syringe with Safety Needle

11

12

Analysis 1- Configuration

The configuration of the proposed device is similar to the predicate device. The predicate device has luer lock connector, the proposed device has luer lock or luer slip connector. The difference in technological characteristics does not raise new questions of safety and effectiveness. Connectivity to the needle is assessed with performance data.

Analysis 2-Syringe Volume

The syringe volume for proposed device is different from the predicate devices. However, this difference is in dimension. Different volume device will be selected by physician per patient's condition. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 3-Needle Size

The needle size for proposed device is different from the predicate devices. This difference is in dimension. Different size device will be selected by physician per patient's condition. Moreover, the needle size of the proposed syringe with safety needle is included in the range of the needle size of the predicate device. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 4- Patient-contact Materials

Although the patient-contact material for proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

13

Table 2. Comparison of Sterile Disposable Syringe with Needle

14

Analysis 5-Product Code

The predicate device has a syringe with safety needle, so the corresponding product codes are MEG, FMF and FMI. The proposed syringe with needle consists of a syringe and needle, so the 12 / 22

15

corresponding product codes is FMF and FMI. Because the proposed syringe with needle has no safety mechanism, there is no MEG code, the product codes of proposed products are included in the codes of predicate device.

Based on above analysis, the difference on product code will not raise new questions on safety and effectiveness of the proposed device.

Analysis 6-Indication for Use

The indication for use of the proposed device and the predicate device differs in the verbal descriptions, and the actual indication for use of both devices is exactly the same. Both devices are intended for use in the aspiration and injection of fluids for medical purpose. The main difference in the indication for use is that there is no safety mechanism for the syringe with the needle, whether there is a safety mechanism or not will not affect the intended use of the equipment itself. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

Analysis 7- Configuration

The configuration of the proposed device is similar to the predicate device. The predicate device has luer lock connector, the proposed device has luer lock or luer slip connector. The difference in technological characteristics does not raise new questions of safety and effectiveness. Connectivity to the needle is assessed with performance data.

Analysis 8-Syringe Volume

The Syringe volume for the proposed device is different from the predicate devices. However, this difference is in dimension. Different volume device will be selected by physician per patient's condition. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device, Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 9-Needle Size

The needle size for proposed device is different from the predicate devices. This difference is in dimension. Different size device will be selected by physician per patient's condition. Moreover, the needle size of the proposed syringe with needle is included in the range of the needle size of the predicate device. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 10- Patient-contact Materials

Although the patient-contact material for proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed

16

device.

17

| ITEM | Proposed Device | Predicate Device
K193526 | Remark | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------|
| Product | Disposable Sterile Syringe | Syringe with Safety Needle | / | |
| Product Code | FMF | FMF
FMI
MEG | Analysis 11 | |
| Regulation Number | 21 CRF 880.5860 | 21 CRF 880.5860
21 CRF 880.5570 | Analysis 11 | |
| Class | Class II | Class II | SE | |
| Indication for Use | The Disposable Sterile Syringe
is a sterile luer lock syringe
which is intended to be used
with a hypodermic needle for
the aspiration and injection of
fluids for medical purpose. | The 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 stick. | Analysis 12 | |
| Configuration | Barrel (luer lock/luer slip)
Plunger
Piston | Barrel (luer lock)
Plunger
Piston | Analysis 13 | |
| Operation Mode | For manual use only | For manual use only | SE | |
| Sterilized | Yes | Yes | SE | |
| Single Use | Single Use | Single Use | SE | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SE | |
| Syringe | Volume | 1ml, 2ml, 3ml, 5ml, 10ml,
20ml, 30ml, 50ml, 60ml | 1ml, 3ml, 5ml, 10ml, 20ml,
30ml, 60ml | Analysis 14 |
| | Connector Type | Luer Lock and Luer Slip | Luer Lock | Analysis 13 |
| Syringe Performance | | Complied with
ISO 7886-1 | Complied with
ISO 7886-1 | SE |
| Luer | Connector Performance | Complied with
ISO 80369-7 | Complied with
ISO 80369-7 | SE |
| | | | | |
| Patient-contact Materials | | | | |
| Barrel | | Polypropylene (PP) | Polypropylene (PP) | Analysis 15 |
| Plunger | | Polypropylene (PP) | Polypropylene (PP) | |
| | | | | |
| Piston | Polyisoprene Rubber | Polyisoprene | | |
| Lubricants | Silicone oil | Polydimethylsiloxane | | |
| Biocompatibility | | | | |
| Cytotoxicity | No cytotoxicity | Conforms to ISO 10993 series standards | SE | |
| Irritation | No intracutaneous reactivity | | | |
| Sensitization | No sensitization | | | |
| Systemic Toxicity | No systemic toxicity | | | |
| Hemolysis | No Hemolysis | | | |
| Pyrogen | No Pyrogen | | | |
| Complement Activation | Not show potentials to activate complete system | | | |
| In vivo Thrombogenicity | No thrombogenicity | | | |
| Sterilization | | | | |
| Method | EO Sterilized | EO Sterilized | SE | |
| SAL | 10-6 | 10-6 | SE | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | SE | |

Table 3. Comparison of Sterile Disposable Syringe

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Analysis 11-Product Code

In the submission, the predicate device has syringe with safety needle and safety needle, so the corresponding product codes are MEG, FMF and FMI. The propose syringe consisting of barrel, piston, and plunger, so the corresponding product codes is FMF. Different product codes are caused by different applied products, but the product codes of applied products are included in the codes of predicate device.

Based on above analysis, the difference on product code will not raise new questions on safety and effectiveness of the proposed device.

Analysis 12-Indication for Use

The indication for use of the proposed device and the predicate device differs only in the verbal descriptions, and the actual indication for use of both devices is exactly the same. Both devices are intended for use in the aspiration and injection of fluids for medical purpose. Only the proposed syringe needs to be connected with the needle in order to fully achieve the intended use of aspiration and injection of liquid medicine. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

Analysis 13- Configuration

The configuration of the proposed device is similar to the predicate device. The predicate device has luer lock connector, the proposed device has luer lock or luer slip connector. The difference in technological characteristics does not raise new questions of safety and effectiveness. Connectivity to the needle is assessed with performance data.

19

Analysis 14-Syringe Volume

The Syringe volume for proposed device is different from the predicate devices. However, this difference is in dimension. Different volume device will be selected by physician per patient's condition. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 15- Patient-contact Materials

Although the patient-contact material for proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

20

ITEM	Proposed Device	Predicate Device K193526	Remark
Product	Sterile Disposable Safety Needle	Safety Needle	/
Product Code	FMI	FMI	SE
Regulation Number	21 CRF 880.5860	21 CRF 880.5860	SE
Class	Class II	Class II	SE
Indication 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 Safety Needle is intended for use with 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 needle stick.	SE
Configuration	Needle hub	Needle hub	SE
	Needle tube	Needle tube
	Needle cap	Needle cap
	Safety mechanism	Safety shield
Operation Mode	For manual use only	For manual use only	SE
Sterilized	Yes	Yes	SE
Single Use	Single Use	Single Use	SE
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	SE
Needle	Size	23G	16G, 18G, 19G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G, 30G, 31G	Analysis 16
	Length	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"	13mm(1/2"), 16mm(5/8"), 20mm(3/4"), 25mm(1"), 32mm(1-1/4"), 38mm(1-1/2")	SE
Needle	Performance	Complied with
ISO 7864,
ISO 9626	Complied with
ISO 7864,
ISO 9626	SE
	Patient-contact Materials
	Needle hub	Polypropylene (PP) and blue pigment	Polypropylene (PP)	Analysis 17
	Needle tube	Stainless Steel SUS 304	Stainless Steel SUS 304
	Needle cap	Polypropylene (PP)	Polypropylene (PP)
	Safety mechanism	Polypropylene (PP) and blue	Polypropylene (PP)
	pigment
Lubricants	Silicone oil	Polydimethylsiloxane
Adhesive	UV adhesive	Epoxy adhesive
Biocompatibility
Cytotoxicity	No cytotoxicity	Conforms to ISO 10993 series	SE
Irritation	No intracutaneous reactivity	standards	SE
Sensitization	No sensitization
Systemic Toxicity	No systemic toxicity
Hemolysis	No Hemolysis
Pyrogen	No Pyrogen
Complement
Activation	Not show potentials to activate
complete system
In
vivo
Thrombogenicity	No thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized	SE
SAL	10-6	10-6	SE
Endotoxin Limit	20 EU per device	20 EU per device	SE
ITEM	Proposed Device	Predicate Device K193526	Remark
Product	Sterile Disposable Needle	Safety Needle	/
Product Code	FMI	FMI	SE
Regulation
Number	21 CRF 880.5860	21 CRF 880.5860	SE
Class	Class II	Class II	SE
Indication for Use	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.	The Safety Needle is intended for
use with 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 needle stick.	Analysis 18
Configuration	Needle hub	Needle hub	Analysis 19
	Needle tube	Needle tube
	Needle cap	Needle cap
	/	Safety shield
Operation Mode	For manual use only	For manual use only	SE
Sterilized	Yes	Yes	SE
Single Use	Single Use	Single Use	SE
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	SE
Needle	Size	23G	16G, 18G, 19G, 20G, 21G, 22G,
23G, 25G, 26G, 27G, 28G, 29G,
30G, 31G	Analysis 20
	Length	1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2"	13mm(1/2"), 16mm(5/8"),
20mm(3/4"), 25mm(1"),
32mm(1-1/4"), 38mm(1-1/2")	SE
	Needle
Performance	Complied with
ISO 7864,
ISO 9626	Complied with
ISO 7864,
ISO 9626	SE
Patient-contact Materials
Needle hub	Polypropylene (PP) blue pigment	Polypropylene (PP)	Analysis 21
Needle tube	Stainless Steel SUS 304	Stainless Steel SUS 304
Needle cap	Polypropylene (PP)	Polypropylene (PP)
Lubricants	Silicone oil	Polydimethylsiloxane
Adhesive	UV adhesive	Epoxy adhesive
Biocompatibility
Cytotoxicity	No cytotoxicity	Conforms to ISO 10993 series	SE
Irritation	No intracutaneous reactivity	standards	SE
Sensitization	No sensitization
Systemic Toxicity	No systemic toxicity
Hemolysis	No Hemolysis
Pyrogen	No Pyrogen
Complement	Not show potentials to activate
Activation	complete system
In
vivo	No thrombogenicity
Thrombogenicity
Sterilization
Method	EO Sterilized	EO Sterilized	SE
SAL	10-6	10-6	SE
Endotoxin Limit	20 EU per device	20 EU per device	SE

Table 4. Comparison of Sterile Disposable Safety Needle

21

Analysis 16-Needle Size

The needle size for proposed device is different from the predicate devices. This difference is in dimension. Different size device will be selected by physician per patient's condition. Moreover, the needle size of the proposed syringe with safety needle is included in the range of the needle size of the predicate device. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 17- Patient-contact Materials

Although the patient-contact material for proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

22

Table 5. Comparison of Sterile Disposable Needle

23

Analysis 18-Indication for Use

The indication for use of the proposed device and the predicate device differs in the verbal descriptions, and the actual indication for use of both devices is exactly the same. Both devices are intended for use in the aspiration and injection of fluids for medical purpose. Whether there is a safety mechanism or not will not affect the intended use of the equipment itself. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

Analysis 19- Configuration

The configuration of proposed device is similar as the configurations of predicate device. Whether there is a safety mechanism or not will not affect the intended use of the equipment itself. Based on above analysis, the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

Analysis 20-Needle Size

The needle size for proposed device is different from the predicate devices. This difference is in dimension. Different size device will be selected by physician per patient's condition. Moreover, the needle size of the proposed syringe with safety needle is included in the range of the needle size of the predicate device. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device. Differences are assessed via performance data and conformance to the same ISO standards as the predicate device.

Analysis 21- Patient-contact Materials

24

Although the patient-contact material for proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

9. Conclusion

The conclusion drawn from the comparison to the predicate device and the non-clinical tests demonstrates that the subject device in 510(k) submission, The Sterile Disposable Syringe with Safety Needle, The Sterile Disposable Syringe with Needle, The Sterile Disposable Syringe, The Sterile Disposable Safety Needle and The Sterile Disposable Needle are substantially equivalent to the legally marketed predicate device cleared under K193526.