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

• K Number: K221078
• Device Name: Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
• Manufacturer: Sichuan Prius Biotechnology Co., Ltd.
• Date Cleared: 2022-11-21 ( 223 days)
• Product Code: FPA
• Regulation Number: 880.5440

Intended Use

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.

Predicate Devices

K152323

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and standard testing of an intravenous needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is used for administering fluid, which is a supportive rather than a therapeutic function. It facilitates the delivery of treatment but does not inherently treat a condition itself.

Diagnostic

No

The device is an intravenous needle used to administer fluid, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like needles, handles, tubes, and protective covers, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to "administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein." This describes a device used for direct patient treatment (administering fluids intravenously), not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
• Device Description: The description focuses on the physical components and function of a needle and tubing for intravenous fluid administration. It does not mention any components or processes related to analyzing biological samples.
• Performance Studies: The performance studies listed are related to the physical and biological safety of the needle and its components (e.g., standards for connectors, sterility, biocompatibility, particulate matter), not the analytical performance of a diagnostic test.

IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide diagnostic information. This device is a tool for delivering substances into the body, which is a therapeutic or supportive function, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system (vein)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.
• 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.
• 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.
• USP Bacterial Endotoxins Test.
• USP 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.
• 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 Pyrogen Test.

Key Metrics

Not Found

Predicate Device(s)

K152323

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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). 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

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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 ([e-mail]) or phone [phone] 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

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Enclosure

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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.

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.

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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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.
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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.

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.

Identification of Predicate Device న్.

510(k) Number: K152323

Product Name: Disposable Infusion Needle,

Safelock Disposable Infusion Needle

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Substantially Equivalent (SE) Comparison 6.

| ITEM | Proposed Device | Predicate Device
K152323 | Remark |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Intravenous Needle for Single Use
Safety Intravenous Needle for Single
Use | 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 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. | Disposable Infusion Needle is intended
to administer fluid by using an infusion
set to a patient's vascular system
through the needle inserted into the
vein.
Safelock Disposable Infusion Needle 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 id
designed to prevent accidental needle
sticks | 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 sheath
by withdraw safety needle
handle
backward. | The needle is locked in safety sheath by
withdraw safety needle
handle
backward | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Performance | Complied with
ISO 7864,
ISO 9626 | Complied with
ISO 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

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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

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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.

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• USP Bacterial Endotoxins Test.

• USP 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 Pyrogen Test.

• 8. Clinical Test Conclusion

No clinical study is included in this submission.

• 9. 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.