Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a standard syringe, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a syringe, which is used for injecting or withdrawing fluids (diagnostic or therapeutic substances), but it does not inherently provide a therapeutic effect itself.

Diagnostic

No

The intended use of the device is to inject or withdraw fluids, which is a therapeutic or procedural action, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (barrel, plunger, Piston, Needle tube, Needle hub, Needle cap) and mentions physical, mechanical, and biocompatibility testing, indicating it is a hardware 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 inject fluids into or withdraw fluids from the body." This describes a direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
Device Description: The description details a syringe, which is a tool for administering or collecting substances from the body, not for performing diagnostic tests on those substances.
Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic devices.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This syringe's function is to move substances into or out of the body, which is a different category of medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.

Product codes (comma separated list FDA assigned to the subject device)

FMF, FMI

Device Description

Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.

All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume. The syringe size, needle gauges and lengths are provided in following table.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical professionals and trained care givers
Hospitals and clinics

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical 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
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)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package A 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 6009:2016 Hypodermic needles for single use – Colour coding for identification
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Physical, Mechanical, Chemical testing performed on the proposed device:

Cleanliness
Limits for acidity or alkalinity
Limits for extractable metals
Size designation
Color coding
Needle hub
Sheath
Needle tube
Needle point
Bond between hub and needle tube
Patency of lumen
Surface finish
Cleanliness
Limits for acidity and alkalinity
Size designation
Dimensions
Stiffness
Resistance to breakage
Resistance to corrosion
Extraneous matter
Lubricant
Tolerance on graduated capacity
Graduated scale
Barrel
Piston/ plunger assembly
Nozzle
Performance

Sterile barrier packaging testing performed:

visual inspection (ASTM F1886/F1886M-16)
seal strength (ASTM F88/F88-15)
dye penetration test (ASTM F1929-15)

Sterilization and shelf-life testing performed:

EO residue (ISO 11737-2:2019)
Shelf-Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples)

Biocompatibility testing performed:

Cytotoxicity
Skin Sensitization
Intracutaneous Reactivity (Irritation)
Acute Systemic Toxicity
Material-Mediated Pyrogens
Hemolysis

Key results: The test results demonstrated that the proposed device complies with the listed standards and that the device meets the requirements of related standards. The device package can maintain its integrity. EO residue did not exceed the limit of ISO 11737-2:2019. Endotoxin limit did not exceed 20EU/device. Shelf-life test result showed that the device can maintain its performance during the claimed shelf life. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K163161

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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.

October 6, 2023

Weihai Shengjie Medical Technology Co., Ltd Huihui Wang Manager No.58. Chuhe South Road High-Tech Industrial District, Weihai Weihai. Shandong 264210 China

Re: K221777

Trade/Device Name: Disposable Sterile Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: August 28, 2023 Received: August 29, 2023

Dear Huihui Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,

2

General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K221777

Device Name Disposable Sterile Syringe

Indications for Use (Describe)

Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.

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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4

Tab #5 510(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: K221777

1. Date of Preparation: 03/20/2022
1. Sponsor Identification

Weihai Shengjie Medical Technology Co., Ltd.

No.58, Chuhe South Road, High-Tech Industrial District, Weihai, Shandong, China

Establishment Registration Number:3014632157

Contact Person: Huihui Wang Position: Manager Tel: +86-631-5679637 Fax: +86-631-5623812 Email: 383291896@qq.com

3.Identification of Proposed Device

Trade Name: Disposable Sterile Syringe Common Name: Piston Syringe Common Name: Hypodermic Single Lumen Needle

Regulatory Information: Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

Regulatory Information:

5

Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital

Indications for use:

Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.

Device Description:

Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle сар.

All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume. The syringe size, needle gauges and lengths are provided in following table.

Syringe Size	Needle Gauge	Needle Length
0.5 ML	27G,28G,29G,30G	1/2",3/8",5/8"
1 ML	26G	1/2",5/8",3/8",1"
	25G,24G	5/8",3/8",3/4",1"
	23G	3/4",1"
2 ML,2.5 ML,
3 ML,5 ML	26G	1/2",5/8",3/8",1"
	25G,24G	5/8",3/8",3/4",1"
	23G	3/4",1"
	22G	1",1 1/4",1 1/5"
10 ML,20 ML,30 ML,
50 ML,60 ML	18G,19G,20G,21G,22G	1",1 1/4",1 1/2",1 1/5"
100 ML	16G,18G,19G,20G,21G	1 1/4",1 1/2",1 1/5"

4.Predicate Device Identification

510(k) Number: K163161

Product Name: Sterile Single-use Syringe with Needle Manufacturer: JiangXi HongDa Medical Equipment Group Ltd.

Comparison of technological characteristics with the predicate devices

6

Item	Proposed Device	Predicate Device (K163161)	Remark
	Disposable Sterile Syringe	Sterile Single-use Syringe with
		Needle
Product Code	FMF, FMI	FMF, FMI	SAME
Regulation	21 CFR 880.5860	21 CFR 880.5860	SAME
Number	21 CRF 880.5570	21 CRF 880.5570	SAME
Class	II	II	SAME
Indications
for Use	Disposable Sterile Syringe is
intended to inject fluids into or
withdraw fluids from the body.	Sterile Single-use Syringe with
Needle is intended to inject fluids
into or withdraw fluids from the
body.	SAME
Operation
Mod	For manual use only	For manual use only	SAME
Principle
of
operation	The syringe is composed of a
syringe with a small hole at the
front end and a matching piston
core rod. It uses the "hydraulic"
principle to transport liquid.
Through the action of force, when
the core rod is pushed in, the liquid
is pushed from the place with high
pressure to the place where the
pressure is high. Low pressure
place. Inject a small amount of
fluid
into
a
muscle,
subcutaneously, or into a vein. Or
when the mandrel is pulled out, the
liquid or gas is sucked from the
small hole at the front end of the
syringe.	The syringe is composed of a
syringe with a small hole at the
front end and a matching piston
core rod. It uses the "hydraulic"
principle to transport liquid.
Through the action of force, when
the core rod is pushed in, the liquid
is pushed from the place with high
pressure to the place where the
pressure is high. Low pressure
place. Inject a small amount of
fluid into a muscle,
subcutaneously, or into a vein. Or
when the mandrel is pulled out, the
liquid or gas is sucked from the
small hole at the front end of the
syringe.	SAME
Intended user	Medical professionals and trained
care givers	Medical professionals and trained
care givers	SAME
Environment
of use	Hospitals and clinics	Hospitals and clinics	SAME
Item	Proposed Device	Predicate Device (K163161)	Remark
	Disposable Sterile Syringe	Sterile Single-use Syringe with
		Needle
Syringe
Volume	0.5,1,2,2.5,3,5,10,20,30,50,60,
100ml	1ml, 3ml, 5ml, 10ml, 20ml, 60ml	Different
Comment
#1
Nozzle type	Luer Slip and Luer Lock	Luer Slip and Luer Lock	SAME
Lubricant	Silicone oil	Silicone oil	SAME
Barrel
transparency	Clear as required by ISO 7886-1	Clear as required by ISO 7886-1	SAME
Gradations
legibility	Clear as required by ISO 7886-1	Clear as required by ISO 7886-1	SAME
Needle
Length	1/2",5/8",3/8",1",1 1/4",1 1/2"	1/2", 5/8", 1", 1 1/4", 1 1/2"	Different
Comment
#2
Needle
Gauge	16G, 18G, 19G, 20G, 21G, 22G,
23G, 24G, 25G, 26G, 27G,28G,
29G, 30G	18G, 20G, 21G, 22G, 23G, 25G,
26G, 27G,28G, 29G, 30G	Different
Comment
#3
Configuration
of the tip	Short bevel, long bevel.	Short bevel, long bevel.	SAME
Needle hub	Colorless according to ISO 7864	Colorless according to ISO 7864	SAME
Single Use	Yes	Yes	SAME
Performance	Complies with ISO 7864, ISO	Complies with ISO 7864, ISO	SAME
specifications	7886-1, ISO 7886-4	7886-1, ISO 7886-4
Sterilization	EO Sterilization	EO Sterilization	SAME
SAL	10-6	10-6	SAME

Table 1 General Comparison

7

Table 2 Performance Comparison

Comment #1

Differences in specifications and models can provide users with more flexible choices in terms of injection volume and injection accuracy, and have no impact on clinical applications.

Comment #2

The subject device is available in gauges 16G-30G and the predicate device is available in 18G-30G. Performance testing was done per ISO 9626 and ISO 7864 done to demonstrate that the differences in needle gauges do not affect the clinical safety or effectiveness of the devices.

Comment #3

Differences in specifications and models can provide users with more flexible choices in terms of injection volume and injection accuracy, and have no impact on clinical applications.

8

| Item | Proposed Device
Disposable Sterile Syringe | | Predicate Device (K163161)
Sterile Single-use Syringe with
Needle | | Remark |
|-------------------------------|-----------------------------------------------|----------------------------|-------------------------------------------------------------------------|----------------------------|--------|
| Configuration
and material | Barrel | Polypropylene
(PP) | Barrel | Polypropylene
(PP) | |
| | Plunger | Polypropylene
(PP) | Plunger | Polypropylene
(PP) | |
| | Piston | Polyisoprene | Piston | Polyisoprene | |
| | Needle tube | Stainless Steel,
SUS304 | Needle tube | Stainless Steel,
SUS304 | SAME |
| | Needle hub | Polypropylene
(PP) | Needle hub | Polypropylene
(PP) | |
| | Needle cap | Polypropylene
(PP) | Needle cap | Polypropylene
(PP) | |
| 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 |
| Labeling | Complied with 21 CFR part 80
1 | | Complied with 21 CFR part 801 | | SAME |

6.Performance data

Nonclinical 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:

A ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
A ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Test for irritation and skin sensitization.
A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
A ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for

9

Flexible Packaging by Visual Inspection

A ASTM F88/F88M-15 , Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package A by Dye Penetration
A 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 6009:2016 Hypodermic needles for single use – Colour coding for identification
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part > 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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
Color coding	Clause 4.7 of ISO 7864:2016
Needle hub	Clause 4.8 of ISO 7864:2016
Sheath	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	Clause 5.1 of ISO 9626:2016
Cleanliness	Clause 5.3 of ISO 9626:2016

10

Premarket Notification 510(k) Submission

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 5.7 of ISO 9626:2016
Resistance to breakage	Clause 5.8 of ISO 9626:2016
Resistance to corrosion	Clause 5.9 of ISO 9626:2016

Item	Standard
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

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 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 de vice. EO residue did not exceed the limit of ISO 11737-2:2019. Endotoxin limit did not exceed 20EU/device. Shelf-life test result showed that the device can maintain its performance during the claimed shelf life.

Item	Standard
EO residue	ISO 11737-2:2019
Shelf-Life Evaluation	Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device

Biocompatibility testing

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (