Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is operated manually, and there are no mentions of AI, ML, or related concepts in the summary.

Therapeutic

Yes.
The device is intended for the aspiration and injection of fluids for medical purposes, which are therapeutic actions.

Diagnostic

No

The device is a syringe with a safety needle used for aspiration and injection of fluids, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (syringe, needle, safety shield, packaging) and manual operation, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "aspiration of fluids for medical purpose" and "injection of fluids for medical purpose." This describes a device used for collecting or delivering substances within the body, not for testing samples outside the body to diagnose a condition.
Device Description: The description focuses on the physical mechanism of aspiration and injection, and the safety feature for preventing needle sticks. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other typical characteristics of an IVD device.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for the physical act of fluid transfer into or out of the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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 stick.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Product codes

FMI, FMF, MEG

Device Description

The proposed devices are provided in two types of configurations; one type is a syringe with safety needle contained in a sterility maintenance package, the other is one safety needle contained in a sterility maintenance package.

The Syringe with Safety Needle is available in various combination of syringe volume and needle size. The proposed device is operated manually. The liquid is aspiration into the syringe by pulling the plunger manually and injected into the body by pushing the plunger manually. When the needle is pulled out from the body, push the safety shield to cover the 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 five 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
A 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)
A 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 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
A 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.

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.

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

A Sensitization,
Intracutaneous,
Acute Systemic Toxicity,
Hemolysis.
Pyrogen
Particulate testing

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 test data of the proposed device is very close to the test data of the predicate device.

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K170651

Reference Device(s)

K161170

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).

Summary

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 17, 2020

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

Re: K193526

Trade/Device Name: Syringe with safety needle, Safety needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FMF, MEG Dated: June 5, 2020 Received: June 23, 2020

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,

For CAPT Alan M. Stevens Acting 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

3

Indications for Use

510(k) Number (if known) K193526

Device Name Syringe with Safety Needle Safety Needle

Indications for Use (Describe)

The 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 stick.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

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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510(k) Summary: K193526

1. Date of Preparation: 07/17/2020
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jianwei Pan Position: Management Representative Tel: +86-510-8686 6666-8027 Fax: +86-510-8686 6666-8009 Email:jianwei.pan@cainamed.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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: Syringe with Safety Needle, Safety Needle Common Name: Piston syringe and antistick 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: Syringe, Antistick Classification: II; Product Code: MEG: Regulation Number: 21 CFR 880. 5860; Review Panel: General Hospital

Identification of Predicate Device and Reference Device

Predicate Device Information:

510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle (used as predicate device) Sterile Disposable Needle

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

6

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

Classification Name: Syringe, Antistick Classification: II; Product Code: MEG; Regulation Number: 21 CFR 880.5860; Review Panel: General Hospital;

Reference Device Information:

510(k) Number: K161170 Product Name: BD Eclipse™ Hypodermic Needle

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

6. Indications for Use:

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.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

7. Device Description

The proposed devices are provided in two types of configurations; one type is a syringe with safety needle contained in a sterility maintenance package, the other is one safety needle contained in a sterility maintenance package.

The Syringe with Safety Needle is available in various combination of syringe volume and needle size. The proposed device is operated manually. The liquid is aspiration into the syringe by pulling the

7

plunger manually and injected into the body by pushing the plunger manually. When the needle is pulled out from the body, push the safety shield to cover the needle.

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

Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate Device	Referenced Device	Remark
		K170651	K161170
Product	Syringe with Safety Needle	Sterile Disposable Syringe with Safety Needle	BD EclipseTM / Hypodermic Needle
Product Code	FMF
FMI
MEG	FMF
FMI
MEG	FMI	Same
Regulation Number	21 CRF 880.5860
21 CRF 880.5570	21 CRF 880.5860
21 CRF 880.5570	21 CRF 880.5570	Same
Class	Class II	Class II	Class II	Same
Indication for Use	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.	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	The BD EclipseTM Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes. The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated	Same

Table 1 General Comparison of Syringe with Safety Needle

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| | | | needle sticks. | | position the needle
cover guards against
accidental needle
sticks during normal
handling and disposal
of the used needle/
syringe combination. | |
|---------------|---------|--------------------------|----------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Configuration | Syringe | Barrel
(luer
lock) | Syringe | Barrel
(luer
lock/luer
slip) | / | Different |
| | | Plunger | | Plunger | / | |
| | | Piston | | Piston | / | |
| | Needle | hub | Needle | hub | hub | |
| | | Needle tube | | Needle
tube | Needle tube | |
| | | Needle cap | | Needle
cap | Needle cap | |
| | | Safety shield | | Safety
shield | Safety shield | |

Different-Configuration

The configuration of proposed syringe with safety needle is similar as predicate device, considering the needle may become disengaged from the syringe when activating the safety shield for the syringe with luer-slip connector, therefore the proposed syringe with safety needle doesn't have the configuration of barrel with luer-slip connector. We think the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

Operation Mode
	For manual use only	For manual use only	For manual use only	Same
Sterilized	Yes	Yes	Yes	Same
Single Use	Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Syringe	1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 60ml	1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml	/	Different
Needle	Connector
Type
Size	Luer Lock
16G,18G,	Luer Lock /Luer Slip / 19G, /	Different

9

| | 19G, 20G,
21G, 22G,
23G, 25G,
26G, 27G,
28G, 29G,
30G, 31G | 20G, 21G, 22G,
23G, 24G, 25G,
26G, 27G, 28G,
29G, 30G | |
|---------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------|
| Length | 13mm,
16mm,
20mm,
25mm,
32mm,
38mm | 8mm(5/16"),
13mm(1/2"),
16mm(5/8"),
20mm(3/4"),
25mm(1"),
32mm(1-1/4"),
38mm(1-1/2") | / |
| Needle
hub | Color-coded
per ISO
6009 | Color-coded per
ISO 6009 | Same |

Different- Syringe Volume and Connector Type

The Syringe volume for proposed device is different from the predicate devices. However, this difference is just in dimension. Different volume device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the syringe volume of the proposed syringe with safety needle is covered by the range of the syringe volume of the predicate device. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different-Needle Size and Length

The needle size and length for proposed device is different from the predicate device. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the needle length of the proposed syringe with safety needle is included in the range of the needle length of the predicate device. The needle size of the syringe with safety needle is very close to that of the comparison product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Cytotoxicity	No cytotoxicity	No cytotoxicity /
Irritation	No intracutaneous reactivity	No intracutaneous reactivity /
Sensitization	No skin sensitization	No skin sensitization /
Systemic Toxicity	No systemic toxicity	No systemic toxicity /
Hemolysis	No Hemolysis	No Hemolysis /

10

Pyrogen	No Pyrogen	No Pyrogen	/
Method	EO Sterilized	EO Sterilized	/	Same
SAL	10-6	10-6	/	Same
Endotoxin Limit	20 EU per device	20 EU per device	/	Same

Table 2 General Comparison of Safety Needle

ITEM	Proposed Device	Predicate Device	Remark
		K170651
Product	Safety Needle	Sterile Disposable Safety Needle	/
Product Code	FMI	FMI	Same
Regulation No.	21 CRF 880.5570	21 CRF 880.5570	Same
Class	Class II	Class II	Same
Indication for Use	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.	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	Hub
Needle tube
Needle cap
Safety shield	Hub
Needle tube
Needle cap
Safety shield	Same
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Connector Type	Luer Lock	Luer Lock /Luer Slip	Different
Needle Gauge	31G, 30G, 29G, 28G, 27G, 26G,
25G, 23G, 22G, 21G, 20G, 19G,
18G, 16G	16G,18G, 19G, 20G, 21G, 22G,
23G, 24G, 25G, 26G, 27G, 28G,
29G, 30G	Different
Needle Length	13mm, 16mm, 20mm, 25mm,
32mm, 38mm	8mm(5/16"),
16mm(5/8"),
25mm(1"),
38mm(1-1/2")
13mm(1/2"),
20mm(3/4"),
32mm(1-1/4")
Needle Hub	Color-coded per ISO 6009	Color-coded per ISO 6009	Same
Safety mechanism	Similar safety shield and same
manual activated mechanism.	Similar safety shield and same
manual activated mechanism.	Same
Cytotoxicity	No cytotoxicity	No cytotoxicity	Same
Irritation	No intracutaneous reactivity	No intracutaneous reactivity	Same
Sensitization	No skin sensitization	No skin sensitization	Same
Systemic Toxicity	No systemic toxicity	No systemic toxicity	Same
Hemolysis	No Hemolysis	No Hemolysis	Same
Pyrogen	No Pyrogen	No Pyrogen	Same
Method	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same

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Different-Connector type

The connector type of proposed needle is covered by the predicated device. Considering the needle may become disengaged from the syringe when activating the safety shield for the syringe with luer-slip connector, therefore the proposed safety needle is not available in luer-slip connector. Therefore, we think the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

Different-Needle Gauge and length

The proposed needle has extra 31G than the predicate device. And the 31G needle is similar the 30G in dimension. The needle gauge and length will be selected by physician per patient's condition. This difference does not affect intended use. Therefore, this difference does not affect substantially equivalence on safety and effectiveness

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9. 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
A 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)
A 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 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
A 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.

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
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
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
Item	Standard
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
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

13

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

14

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.

Biocompatibility testing

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

A Sensitization,
Intracutaneous,
Acute Systemic Toxicity,
Hemolysis.
Pyrogen
Particulate testing

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 test data of the proposed device is very close to the test data of the predicate device.

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10. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the legally marketed predicate device