The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.

Device Description

The Sterile Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.

AI/ML Overview

This information is pertaining to a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needles for Single Use." This is a regulatory submission for a device, not a study of an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device was tested against recognized international standards for hypodermic needles. The "reported device performance" is essentially that the device "complied with" these standards.

Acceptance Criteria (Standards)	Reported Device Performance
ISO 80369-7: 2016	Complied
ISO 80369-20:2015	Complied
ISO 7864: 2016	Complied
ISO 9626: 2016	Complied
ISO 10993-1	Complied (Biocompatibility)
USP <788>	Met acceptance criteria
ISO 11135:2014	Complied (Sterility)
ISO 10993-7:2008	Complied (EO/ECH residuals)
USP <85>	Complied (Bacterial Endotoxins)
ASTM F1886 / F1886M-16	Performed
ASTM F88/F88-15	Performed
ASTM F1929-15	Performed
ASTM D4169-16	Performed
ASTM F1980-16	Performed

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

The document does not specify the exact sample sizes for each non-clinical test. It states that tests were "conducted" and "met" or "complied" with standards.
Data Provenance: The document does not explicitly state the country of origin for the data (beyond the manufacturer being in China), nor whether it was retrospective or prospective. Given it's a 510(k) submission, the testing would generally be prospective to demonstrate compliance with standards.

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

This is not applicable as this is not a study involving ground truth established by human experts for interpretive tasks. The evaluation is based on objective measurements against engineering and biological standards.

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

Not applicable for non-clinical engineering and biological tests.

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 is not an AI device or an MRMC study.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's evaluation consists of the acceptance limits and methodologies defined by recognized international and national standards (e.g., ISO, USP, ASTM). The device's performance is measured against these objective criteria.

8. The sample size for the training set:

Not applicable. This is not a machine learning model; therefore, there is no "training set."

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

Not applicable, as there is no training set.

Summary

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

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: K221066

Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: August 26, 2022 Received: September 8, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221066

Device Name

Sterile Hypodermic Needles for Single Use

Indications for Use (Describe)

The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K221066 -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. 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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Identification of Proposed Device 4.

Trade Name: Sterile Hypodermic Needles for Single Use Common Name: Syringe Needle

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

న. Predicate
K180417, Sterile Hypodermis Needles for Single Use

6. Device Description

Needle Sizes
Needle Length	Needle gauge	Wall
32mm	16G	TW
38mm	16G	TW
32mm	18G	TW
38mm	18G	TW
32mm	19G	TW
38mm	19G	TW
32mm	20G	TW
38mm	20G	TW
32mm	21G	TW
38mm	21G	TW
32mm	22G	TW
38mm	22G	TW
19mm	23G	TW
25mm	23G	TW
32mm	23G	TW

Needle specification:

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19mm	24G	RW
25mm	24G	RW
32mm	24G	RW
16mm	25G	RW
19mm	25G	RW
25mm	25G	RW
13mm	26G	RW
16mm	26G	RW
19mm	26G	RW
13mm	27G	RW
16mm	27G	RW
19mm	27G	RW
13mm	28G	RW
16mm	28G	RW
13mm	29G	RW
16mm	29G	RW
13mm	30G	RW
16mm	30G	RW

7. Indication for Use

Characterization	Proposed device	Predicate Device
	Sterile Hypodermic Needles forSingle UseK221066	Sterile Hypodermic Needles forSingle UseK180417
	Indication for Use	The Sterile Hypodermic Needlesfor Single Use are intended to beused with a luer slip or luer locksyringe for general purpose fluidinjection/ aspiration.	The Sterile Hypodermic Needles forSingle Use are intended to be usedwith a luer slip or luer lock syringefor general purpose fluid injection/aspiration.
		Prescription or OTC (overthe counter)	Prescription use	Prescription use
		TechnologicalCharacteristic	Proposed Device	Predicate Device
		Sterile Hypodermic Needles forSingle Use	Sterile Hypodermic Needles forSingle use
	K221066	K180417
Configuration	Needle hubProtective capNeedle	Needle hubProtective capNeedle	Same
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	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	14G, 15G, 16G, 17G, 18G,19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G,29G, 30G	DifferentSee comment #1
Needle Length	13mm, 16mm, 19mm, 25mm,32mm, 38mm	6mm, 9mm, 12mm, 13mm,16mm, 20mm, 25mm, 38mm,50mm, 60mm	DifferentSee comment #2
Wall type	TW: 16G, 18G, 19G, 20G, 21G,22G, 23GRW: 24G, 25G, 26G, 27G, 28G,29G, 30G	TW: 14G, 15G, 16G, 17G, 18G,19G, 20G, 21G, 22G, 23G,29G, 30GRW: 14G, 15G, 16G, 18G, 19G,20G, 21G, 22G, 24G, 25G,26G, 27G, 29G, 30G	DifferentSee comment #3
Needle	Stainless Steel SUS304	Stainless Steel SUS304	Same
Needle hub	Polypropylene (PP)	Polypropylene (PP)	Same
Needle cap	Polypropylene (PP)	Polypropylene (PP)	Same
Lubricants	Polydimethylsiloxane	Polydimethylsiloxane	Same
Adhesive	Epoxy adhesive	HTU-3312 Glue	DifferentSee comment #4

8. Technological Characteristic

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

Table 1 Comparison of Technology Characteristics

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Discussions of differences in technological characteristics

Comment # 1 – Needle Gauge

The proposed device has the less gauges compared to the predicate device and the proposed gauge can be covered by the range of needle gauge available in the predicate device. In addition, the needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

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Comment # 2 – Needle Length

The proposed device has less needle lengths compared to the proposed needle length specifications can be covered by the range of available needle lengths for the 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 # 3 – Wall Type

The proposed device is available in thin wall and normal wall. The predicate device also has thin wall and normal wall. The performance data results demonstrate that the needs the requirements of ISO 7864 and ISO 9626.

Comment # 4 – Material of Adhesive

The proposed device has different adhesive compared to the predicate device. This difference does not impact intended use and does not raise new questions of safety and effectiveness. However, biocompatibility test has been conducted on the proposed device and the test result does not show anv adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.

9. Non- Clinical Testing

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

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 liguids and gases in healthcare applications-Part 20: Common test methods
ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.
ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices

Biocompatibility

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

Cytotoxicity
A Irritation
A Skin Sensitization
Acute Systemic Toxicity
Pyrogenicity
Hemolvsis A
A Material Mediated Toxicity

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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 106. 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 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.

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. 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 Needles for Single Use is as safe, as effective, and performs as well as the legally marketed predicative device cleared under K180417.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).