The Sterile Hypodermic Syringes for Single Use with Safety Needles 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 needlesticks.

Device Description

The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

AI/ML Overview

The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.

However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.

1. Table of acceptance criteria and the reported device performance:

Test / Performance Characteristic	Acceptance Criteria / Standard	Reported Device Performance
Syringe Performance	ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use- Part 1: Syringes for manual use	Demonstrated that the syringe meets the requirements of ISO 7886.
Luer Connector Performance	ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications	Demonstrated that the luer connector meets the requirements of ISO 80369-7. Also tested with ISO 80369-20:2015 (Common test methods).
Needle Performance	ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.	Demonstrated that the needle meets the requirements of ISO 7864.
Needle Tubing Performance	ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices	Demonstrated that the needle meets the requirements of ISO 9626.
Safety Mechanism	FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011	Demonstrated that the proposed device met the pre-established criteria (for simulated clinical study) and the acceptance criteria (for safety feature test).
Biocompatibility	ISO10993-1 (classification: Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24hrs))	Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogen, Hemolysis, Material Mediated Toxicity tests were conducted and presumably met the acceptance criteria (standard practice for 510(k)).
Particulate Matter	USP <788> Particulate Matter in Injections	Met the USP acceptance criteria.
Sterility (SAL)	ISO 11135:2014	Achieved a sterility assurance level (SAL) of 10-6.
EO and ECH Residuals	ISO 10993-7:2008	Below the limits specified in ISO 10993-7.
Bacterial Endotoxin Levels	USP <85>	Below the level of 20 EU/device.
Shelf-life	ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	Both baseline and accelerated shelf life testing were conducted, demonstrating the device will perform as intended to support the proposed 5-year shelf-life.
Sterile Barrier Packaging	Visual Inspection ASTM F1886 / F1886M-16, Seal Strength ASTM F88/F88-15, Dye penetration ASTM F1929-15	Performed on the proposed device (results implicitly met standards).
Simulated Transportation	ASTM D4169-16	Performed on final, packaged, and sterile device (results implicitly met standards).

The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:

Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This refers to expert review for AI/ML model training/validation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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October 4, 2022

Sichuan Prius Biotechnology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K221073

Trade/Device Name: Sterile Hypodermic Syringes for Single Use with Safety Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: August 26, 2022 Received: September 7, 2022

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

510(k) Number (if known) K221073

Device Name

Sterile Hypodermic Syringes for Single Use with Safety Needles

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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K221073 -510(k) Summary

1. Date of Preparation: 10/08/2022
1. Sponsor Identification

Sichuan Prius Biotechnology Co., Ltd.

No.2 Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: Not registered yet

Contact Person: Yan Liu Position: Management Representative Tel: +86-831-3839889 Fax: +86-831-3839887 Email: 48363603@qq.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. TingtingSu (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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Identification of Proposed Device 4.

Trade Name: Sterile Hypodermic Syringes for Single Use with Safety Needles Common Name: Safety Piston Syringe with Needle

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

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

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

న. Identification of Predicate Device

510(k) Number: K193526 Product Name: Syringe with Safety Needle

1. Device Description
  The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Syringe Volume	Needle Sizes
	Needle Length (mm)	Needle gauge	Wall
1ml,	32	16G	TW
2ml,	38	16G	TW

3ml,	32	18G	TW
5ml,	38	18G	TW
10ml,	32	19G	TW
20ml,	38	19G	TW
30ml,	32	20G	TW
50ml,	38	20G	TW
60ml,	32	21G	TW
100ml	38	21G	TW
	32	22G	TW
	38	22G	TW
	19	23G	TW
	25	23G	TW
	32	23G	TW
	19	24G	RW
	25	24G	RW
	32	24G	RW
	16	25G	RW
	19	25G	RW
	25	25G	RW
	13	26G	RW
	16	26G	RW
	19	26G	RW
	13	27G	RW
	16	27G	RW
	19	27G	RW
	13	28G	RW
	16	28G	RW
	13	29G	RW
	16	29G	RW
	13	30G	RW
	16	30G	RW

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All gauges can be used with 1mL, 2mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL, 100mL syringe.

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

1. Indication for Use

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Characterization	Proposed device	Predicate Device
	Sterile Hypodermic Syringes for SingleUse with Safety NeedlesK221073	Syringe With Safety NeedleK193526
Indication for Use	The Sterile Hypodermic Syringes forSingle Use with Safety Needles is intendedfor use in the aspiration and injection offluids for medical purpose. Afterwithdrawal of the needle from the body,the attached needle safety shield can bemanually activated to cover the needleimmediately after use to minimize risk ofaccidental needlesticks.	The Syringe with Safety Needle isintended for use in the aspiration andinjection of fluids for medicalpurpose. After withdrawal of theneedle from the body, the attachedneedle safety shield can be manuallyactivated to cover the needleimmediately after use to minimizerisk of accidental needle stick.
Prescription orOTC (over thecounter)	Prescription use	Prescription use

8. Technology Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate.

TechnologicalCharacteristic	Table 1 Comparison of Technology CharacteristicsProposed device	Predicate Device
	Sterile Hypodermic Syringes for	Syringe With Safety Needle	Remark
	Single Use with Safety Needles	K193526
	K221073
Configuration	Barrel	Barrel	Same
	Plunger	Plunger
	Piston	Piston
	Needle hub	Needle hub
	Protective cap	Protective cap
	Needle	Needle
	Safety shield	Safety shield
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Volume	1ml, 2ml, 3ml, 5ml, 10ml, 20ml,30ml, 50ml, 60ml, 100ml	1ml, 3ml, 5ml, 10ml, 20ml, 30ml,60ml	DifferentSeecomment# 1

Connector Type	Luer Lock/ Luer Slip	Luer Lock	DifferentSeecomment# 2
SyringePerformance	Complied withISO 7886-1	Complied withISO 7886-1	Same
Luer ConnectorPerformance	Complied withISO 80369-7	Complied withISO 80369-7	Same
NeedlePerformance	Complied withISO 7864,ISO 9626	Complied withISO 7864,ISO 9626	Same
Needle Gauge	16G, 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G, 28G,29G, 30G	16G, 18G, 19G, 20G, 21G, 22G,23G, 25G, 26G, 27G, 28G, 29G,30G, 31G	SimilarSeecomment# 3
Needle Length	13mm, 16mm, 19mm, 25mm,32mm, 38mm	13mm, 16mm, 20mm, 25mm,32mm, 38mm	SimilarSeecomment# 4
Wall type	TW: 16G, 18G, 19G, 20G, 21G,22G, 23GRW: 24G, 25G, 26G, 27G, 28G,29G, 30G	TW: 16G, 18G, 19G, 20G, 21G,22G, 23G, 25G, 26G, 27G, 28G,29G, 30G, 31GRW: 16G, 18G, 19G, 20G, 21G,22G, 23G, 25G, 26G, 27G, 28G,29G, 30G, 31G	SimilarSeecomment# 5
Bevel Design	LB/SB	LB/SB	Same
Barrel	Polypropylene (PP)	Polypropylene (PP)	Same
Plunger	Polypropylene (PP)	Polypropylene (PP)	Same
Piston	Polyisoprene	Polyisoprene	Same
Needle	Stainless Steel SUS304	Stainless Steel SUS304	Same
Needle hub	Polypropylene (PP)	Polypropylene (PP)	Same
Needle cap	Polypropylene (PP)	Polypropylene (PP)	Same
Safety shield	Polypropylene (PP)	Polypropylene (PP)	Same
Lubricants	Polydimethylsiloxane	Polydimethylsiloxane	Same

Table 1 Comparison of Technology Characteristic

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Discussions of differences in technological characteristics Comment #1 – Syringe Volume

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The proposed device is available in three additional syringe volumes, which are 2ml, 50ml and 100ml. For proposed 2ml and 50ml syringe, these two specifications can be covered by the predicate device. And 100ml syringe is out of the volume range of predicate device. This does not change the intended use and does not raise new questions of safety and effectiveness. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886.

Comment #2- Connector Type

The subject device is available in luer slip and luer lock connectors and luer slip connector is not covered by the predicate device. This does not change the intended use and does not raise new questions of safety and effectiveness. The luer connector has been tested per ISO 80369-7 and the test results demonstrate that the luer connector meets the requirements of ISO 80369-7.

Comment #3 – Needle Gauge

The subject device has the additional gauge 24G compared to the predicate device, while other gauges can be covered by the predicate device. Additionally, the needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

Comment #4 - Needle Length

The needle length of proposed device is similar as the needle length of predicate device. The proposed needle length can be covered in the range of predicate device. In addition, the needle performance has been tested and the results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

Comment #5— Wall Type

The proposed device is available in thin wall and normal wall. The predicate device also has thin wall and normal wall. There are more needle gauges for the predicate device than for the proposed device under the same wall type, and the needle gauges for the proposed device can be covered by the predicate device. In addition, the wall type of proposed devices have been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

9. Non-Clinical Test Conclusion

The device described in this summary the Sterile Hypodermic Syringes for Single Use with Safety Needles.were tested and demonstrated to be in conformance with the following FDA recognized standards:

A ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods
A ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.

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ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use- Part 1: Syringes for manual use

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 proposed device and predicate device meet the acceptance criteria.

Biocompatibility testing

In accordance with ISO10993-1 the syringe and needle are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24hrs). The following testing was conducted:

Cytotoxicity
Irritation >
Skin Sensitization
A Acute Systemic Toxicity
Pyrogen
Hemolysis
Material Mediated Toxicity

Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.

Sterility, Shipping, and Shelf -life

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10th. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life.

. Sterile Barrier Packaging performed on the proposed device:
- Visual Inspection ASTM F1886 / F1886M-16
- 0 Seal Strength ASTM F88/F88-15
- o Dye penetration ASTM F1929-15
. Simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and

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sterile device.

. Shelf-life of 5-years is validated using FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Conclusion
  The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Hypodermic Syringes for Single Use with Safety Needles is as safe, as effective, and performs as well as the legally marketed predicative device cleared under K193526.

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).