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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Syringe with Safety Needle, Safety Needle). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a de novo study proving a device meets specific clinical acceptance criteria through a novel study design. Therefore, much of the requested information regarding clinical study setup (sample size, ground truth, expert opinions, MRMC studies) is not applicable to this type of submission.

The document focuses on non-clinical performance data and a simulated clinical study for the safety mechanism.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are generally based on compliance with international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 7864 for hypodermic needles, ISO 7886-1 for syringes, ISO 23908 for sharps injury protection, ASTM standards for packaging integrity). The reported device performance is stated as meeting these standards. Specific numerical acceptance criteria or performance metrics for each test are not explicitly detailed in a single table, but rather implied by the statement "The test results demonstrated that the proposed device complies with the following standards" and "The test results show that the device meets the requirements of related standards."

Non-Clinical Acceptance Criteria (Implied by Standards Compliance):

Test Category	Standard / Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO 10993-5: No cytotoxicity	No cytotoxicity
Irritation	ISO 10993-10: No intracutaneous reactivity	No intracutaneous reactivity
Sensitization	ISO 10993-10: No skin sensitization	No skin sensitization
Systemic Toxicity	ISO 10993-11: No systemic toxicity	No systemic toxicity
Hemolysis	ISO 10993-4, ASTM F756-17: No Hemolysis	No Hemolysis
Pyrogen (Endotoxin)	USP <85>: Endotoxin Limit <= 20 EU per device	No Pyrogen, Endotoxin limit not exceeded (<= 20 EU/device)
Material/Physical
EO Residue	ISO 10993-7: Residue within limits	EO/ECH residue did not exceed limit
SAL (Sterility Assurance)	10^-6	10^-6
Particulate Matter	USP <788>: Within limits for injections	(Tested, outcome implied compliant)
Device Performance	(Based on various ISO standards listed on page 12)
Needle Characteristics	ISO 7864 (Cleanliness, Acidity/Alkalinity, Metals, Size, Color Coding, Hub, Cap, Tube, Point, Bond, Patency)	Meets requirements of related standards
Needle Tubing	ISO 9626 (Surface, Cleanliness, Acidity/Alkalinity, Size, Dimensions, Stiffness, Resistance to Breakage/Corrosion)	Meets requirements of related standards
Connectors	ISO 80369-7 (Fluid leakage, Sub-atmospheric air leakage, Stress cracking, Resistance to separation (axial/unscrewing), Overriding)	Meets requirements of related standards
Syringe Characteristics	ISO 7886-1 (General req., Extraneous matter, Lubricant, Capacity tolerance, Scale, Barrel, Piston/plunger, Nozzle, Performance)	Meets requirements of related standards
Packaging & Shelf Life
Shelf Life	Verified through aging samples, maintains performance during claimed shelf life	Maintains performance during 5-year claimed shelf life
Package Integrity	ASTM F1886/F1886M-16 (Visual), ASTM F88/F88M-15 (Seal Strength), ASTM F1929-15 (Dye Penetration)	Can maintain its integrity
Safety Feature	FDA Guidance (Medical Device with Sharps Injury Prevention Feature, Aug 2005), ISO 23908:2011	Met pre-established criteria

2. Sample size used for the test set and the data provenance

Non-Clinical/Bench Testing: The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications" and "Physical. Mechanical, Chemical testing listed in following table were performed on the proposed device." Specific sample sizes for each non-clinical test (e.g., biocompatibility lot sizes, mechanical test numbers) are not provided in this summary.
Simulated Clinical Study: "A simulated clinical study was performed... to evaluate the safety mechanism of the proposed device." Similarly, the specific sample size for this simulated study is not provided.
Data Provenance: The manufacturer is Jiangsu Caina Medical Co., Ltd in China. The testing was conducted internally or by contract labs consistent with international standards. The document does not specify country of origin for any "data" beyond the manufacturer's location. The studies are by nature prospective (testing the new device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there was no clinical study involving expert interpretation of patient data to establish ground truth. The "ground truth" for the non-clinical tests is adherence to established international and ASTM standards.
For the "Simulated Clinical Study," the ground truth would be objectively measured performance against the safety mechanism's functional requirements as per FDA guidance and ISO 23908:2011. No human expert interpretation with ground truth labels is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical study with human readers/interpreters requiring adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (syringe/needle), not an AI-enabled diagnostic device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the performance specifications and acceptance criteria outlined in recognized industrial and medical device standards (ISO, ASTM, USP), as well as relevant FDA guidance documents for sharps injury prevention. For the simulated clinical study, the ground truth was the objective performance of the safety mechanism against pre-established criteria based on these standards and guidance.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. (See point 8).

Summary of what the document does provide regarding acceptance:

The acceptance of this device for 510(k) clearance is primarily based on:

Demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (K170651 for "Sterile Disposable Syringe with Safety Needle" and "Sterile Disposable Safety Needle"). The "Indications for Use" are shown to be the same.
Compliance with recognized consensus standards (listed on page 12-14) for biocompatibility, sterility, physical/mechanical performance, packaging, and sharps injury prevention.
Non-clinical testing results affirming that the proposed device performs comparably to the predicate device and meets the performance requirements of applicable standards.
A Simulated Clinical Study (details not provided beyond its existence and outcome) to evaluate the safety mechanism's compliance with FDA guidance and ISO 23908:2011, demonstrating it "met the pre-established criteria."
A Safety Feature Test comparing the proposed device to the predicate, showing "the test data of the proposed device is very close to the test data of the predicate device."

No human clinical trials or complex multi-reader studies were required or conducted, as indicated by "No clinical study is included in this submission."

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

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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

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Indications for Use

510(k) Number (if known) K193526

Device Name Syringe with Safety Needle Safety Needle

Indications for Use (Describe)

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;

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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.

7. Device Description

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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	FMFFMIMEG	FMFFMIMEG	FMI	Same
Regulation Number	21 CRF 880.586021 CRF 880.5570	21 CRF 880.586021 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 needlecover guards againstaccidental needlesticks during normalhandling and disposalof the used needle/syringe combination.
Configuration	Syringe	Barrel(luerlock)	Syringe	Barrel(luerlock/luerslip)	/	Different
		Plunger		Plunger	/
		Piston		Piston	/
	Needle	hub	Needle	hub	hub
		Needle tube		Needletube	Needle tube
		Needle cap		Needlecap	Needle cap
		Safety shield		Safetyshield	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	ConnectorTypeSize	Luer Lock16G,18G,	Luer Lock /Luer Slip / 19G, /	Different

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	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")	/
Needlehub	Color-codedper ISO6009	Color-coded perISO 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 /

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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	HubNeedle tubeNeedle capSafety shield	HubNeedle tubeNeedle capSafety 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 samemanual activated mechanism.	Similar safety shield and samemanual 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<788> 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 airleakage	Clause 6.2 of ISO 80369-7:2016
Stress cracking	Clause 6.3 of ISO 80369-7:2016
Resistance to separation form axialload	Clause 6.4 of ISO 80369-7:2016
Resistance to separation formunscrewing	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 <85>
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device

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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

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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 (<24 hours). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

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

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).