Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Safety Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needle sticks.

Device Description

The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. It has two models, Intravenous Needle for Single Use and Safety Intravenous Needle for Single Use. For the Safety Intravenous Needle for Single Use, the safety sheath is designed to prevent accidental needlesticks. The proposed devices are provided sterile, single use.

The Intravenous Needle for Single Use consists of six components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap. The Safety Intravenous Needle for Single Use consists of seven components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap 7) Safety Sheath.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Intravenous Needles for Single Use and Safety Intravenous Needles for Single Use. This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way typically associated with AI/software devices.

Therefore, many of the questions regarding acceptance criteria, study design, and performance metrics for AI devices are not applicable to this submission. This document pertains to a traditional medical device (intravenous needles), where performance is generally assessed through non-clinical bench testing and adherence to recognized standards.

Here's an breakdown of the relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a single table of "acceptance criteria" and "reported device performance" in the context of an AI/software device. Instead, the performance is demonstrated through compliance with various international and ASTM standards for medical devices. The "acceptance criteria" are implied by these standards, and the "reported device performance" is a statement of compliance.

Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance (Statement of Compliance)
Mechanical properties (e.g., strength, flexibility of needle tubing)	Complied with ISO 7864, ISO 9626
Seal strength of flexible barrier materials	Complied with ASTM F88/F88M-15
Seal integrity in porous medical package (dye penetration)	Complied with ASTM F1929-15
Seal integrity for flexible packaging (visual inspection)	Complied with ASTM F1886/F1886M-16
Ethylene oxide sterilization residuals	Complied with ISO 10993-7:2008
Bacterial Endotoxins	Complied with USP <85>
Particular Matter in Injections	Complied with USP <788>
In vitro cytotoxicity	Complied with ISO 10993-5:2009 (No Cytotoxicity)
Interaction with blood (e.g., hemolysis, thromboresistance, complement activation)	Complied with ISO 10993-4:2017 (No Hemolysis, No thrombosis, No different from control group for Complement Activation)
Irritation and skin sensitization	Complied with ISO 10993-10:2010 (No intracutaneous reactivity, No skin sensitization)
Systemic toxicity (including subacute)	Complied with ISO 10993-11:2017 (No systemic toxicity, No Subacute Systemic Toxicity)
Hemolytic properties	Complied with ASTM F756-2017 (No Hemolysis)
Pyrogenicity	Complied with USP <151> (No Pyrogen)
Small-bore connectors for intravascular/hypodermic applications	Complied with ISO 80369-7:2016 and ISO 80369-20:2015
Labeling	Complied with 21 CFR part 801
Sterilization Assurance Level (SAL)	10^-6
Endotoxin Limit	20EU/device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for testing beyond the general statement of compliance with standards. These are non-clinical engineering and biocompatibility tests. Data provenance in terms of country of origin or retrospective/prospective does not apply here as it's not a clinical study. These tests would have been conducted by the manufacturer in China or by contracted laboratories.

3. 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)

This question is not applicable. The ground truth for device performance in this context is established by the specifications and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, USP). There are no "experts" in the sense of clinical specialists establishing a ground truth for a diagnostic outcome.

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

This question is not applicable. Adjudication methods are relevant for clinical studies with subjective interpretations, which is not the case for the non-clinical tests described.

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

This question is not applicable. This is not an AI-assisted device, nor is it a diagnostic device where human "readers" would be involved in interpreting results.

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

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

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

The "ground truth" for the non-clinical tests is defined by the objective measurement criteria and methodologies specified in the cited international regulatory standards (e.g., ISO, ASTM, USP) for the physical and biological properties of the device.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 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.

November 21, 2022

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

Re: K221078

Trade/Device Name: Intravenous Needles for Single Use, Safety Intravenous Needles for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 21, 2022 Received: October 21, 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

{1}------------------------------------------------

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,

Daniel Walloschek

David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. 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 Ouality Center for Devices and Radiological Health

Page 2

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221078

Device Name

Intravenous Needles for Single Use, Safety Intravenous Needles for Single Use

Indications for Use (Describe)

Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Type of Use (Select one or both, as applicable):

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K221078 - 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K221078

Date of Preparation: 11/21/2022 1.
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

{4}------------------------------------------------

4. Identification of Proposed Device

Trade Name: Intravenous Needles for Single Use, Safety Intravenous Needles for Single Use Common Name: Intravascular Administration Set

Regulatory Information Classification Name: Intravascular Administration Set Classification: II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;

Indications for Use Statement:

Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Device Description

Identification of Predicate Device న్.

510(k) Number: K152323

Product Name: Disposable Infusion Needle,

Safelock Disposable Infusion Needle

{5}------------------------------------------------

Substantially Equivalent (SE) Comparison 6.

ITEM	Proposed Device	Predicate DeviceK152323	Remark
Product	Intravenous Needle for Single UseSafety Intravenous Needle for SingleUse	Disposable Infusion Needle,Safelock Disposable Infusion Needle	/
Product Code	FPA	FPA	Same
Regulation Number	21 CFR 880.5440	21 CFR 880.5440	Same
Class	Class II	Class II	Same
Indication for Use	Intravenous Needle for Single Use isintended to administer fluid by usingan infusion set to a patient's vascularsystem through the needle inserted intothe vein.Safety Intravenous Needle for SingleUse is intended to administer fluid byusing an infusion set to a patient'svascular system through the needleinserted into the vein, and the safetysheath is designed to prevent accidentalneedle sticks.	Disposable Infusion Needle is intendedto administer fluid by using an infusionset to a patient's vascular systemthrough the needle inserted into thevein.Safelock Disposable Infusion Needle isintended to administer fluid by using aninfusion set to a patient's vascularsystem through the needle inserted intothe vein, and the safety sheath iddesigned to prevent accidental needlesticks	Same
Configuration	Needle Protect Cover	Needle Protect Cover	Same
	Infusion Needle	Infusion Needle	Same
	Needle Handle	Double Wing Needle Handle	Same
	Flexing Tube	Flexing Tube	Same
	Safety sheath	Safety sheath	Same
	Conical fitting	Conical fitting	Same
	Conical fitting protective cap	/	Different
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Safety Feature	The needle is locked in safety sheathby withdraw safety needlehandlebackward.	The needle is locked in safety sheath bywithdraw safety needlehandlebackward	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Performance	Complied withISO 7864,ISO 9626	Complied withISO 7864,ISO 9626	Same
Specification
Needle Gauge	18G, 19G, 20G, 21G, 22G, 23G, 24G,25G, 26G, 27G	18G, 21G, 23G, 25G	Different
Needle Length	16mm, 19mm, 25mm 28mm	3/4"	Different
Patient Contact Material
Needle	Stainless Steel (SUS304)	Stainless Steel (SUS316)	Different
Needle Handle	Poly Vinyl Chloride (PVC)	Acrylonitrile Butadiene Styrene (ABS)	Different
Flexible Tube	Poly Vinyl Chloride (PVC)	Polyvinyl Chloride (PVC)	Same
Conical fitting	Poly Vinyl Chloride (PVC)	Acrylonitrile Butadiene Styrene (ABS)	Different
Lubricants	Polydimethylsiloxane	Polydimethylsiloxane	Same
Adhesive	Epoxy adhesive	Epoxy adhesive	Same
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Similar
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
Pyrogen	No Pyrogen	No Pyrogen
Thromboresistance	No thrombosis	/
Complement Activation	No different from control group	/
Subacute Systemic Toxicity	No Subacute Systemic Toxicity	/
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU/device	20EU/device	Same

Table 1 Comparison of Technology Characteristics

{6}------------------------------------------------

Different-Configuration

Compared with predicate device, the proposed device has an additional component conical fitting protective cap, which is intended to protective the conical fitting, while this difference does not affect the intended use. Therefore, the difference does not raise new questions of safety and effectiveness for the proposed device.

Different – Needle Gauge

The subject device is available in ten specifications, the proposed specification 18G, 21G, 23G and 25G can be covered by the predicate device, while other gauges beyond the predicate device range. The different gauges will be selected by physician per patients' condition. In addition, the needle performance has been tested and results demonstrate that the needs the requirements of ISO 7864 and ISO 9626. Therefore, the difference does raise new questions of safety and effectiveness for

{7}------------------------------------------------

the proposed device.

Different – Needle Length

The needle length for the proposed device is different from the predicate device, however, the needle performance has been tested and results demonstrate that the needs the requirements of ISO 7864 and ISO 9626. Therefore, the difference does not raise new questions of safety and effectiveness for the proposed device.

Different - Patient Contact Material

The patient contact material for proposed device is different from predicate device. However, the biocompatibility test for proposed device was performed and the result show there is no adverse effect. Therefore, the difference does not raise new questions of safety and effectiveness for the proposed device.

Similar- Biocompatibility

The biocompatibility test was performed on the proposed device and three additional endpoints were evaluated compared to the predicate device, which are subacute toxicity, in vivo Thromboresistance and Complement Activation. The test results for these endpoints show there are no adverse effect on the material. Therefore, the provided biocompatibility testing supports substantial equivalence to the predicate device.

7. 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 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.
ISO 7864:2016, Sterile hypodermic needles for Single Use Requirements and test methods. A
ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ISO 10993-7:2008. Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.

{8}------------------------------------------------

USP <85> Bacterial Endotoxins Test.
USP <788> Particular Matter in Injections.
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity.
ISO 10993-4: 2017, Biological Evaluation of Medical Devices - Part 4: Selection of Test for Interaction with Blood.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
A ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ASTM F756-2017 Standard Practice for Assessment of Hemolytic Properties of Materials.
USP <151> Pyrogen Test.
1. 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 device is determined to be Substantially Equivalent (SE) to the predicate device with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.