The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.

Device Description

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use. The proposed devices include 32 models.

AI/ML Overview

This document describes a 510(k) premarket notification for "Infusion Sets for Single Use." This is a medical device application that demonstrates "Substantial Equivalence" to a predicate device. This type of submission relies on non-clinical testing to support its claims, rather than clinical studies with human participants. Therefore, several of the requested categories are not applicable (N/A) to this document.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it refers to conformity with established international and US standards for medical devices. The "reported device performance" is implicitly that the device conforms to these standards, making it "substantially equivalent" to the predicate device and safe for its intended use.

Acceptance Criterion (Standard)	Reported Device Performance
ISO 8536-4:2010 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed)	Conforms
ISO 8536-14:2016 (Clamps and flow regulators)	Conforms
ISO 80369-7:2016 (Small-bore connectors for intravascular or hypodermic applications)	Conforms
ISO 80369-20:2015 (Small-bore connectors - Common test methods)	Conforms
ISO 7864:2016 (Sterile hypodermic needles for single use)	Conforms
ISO 9626:2016 (Stainless steel needle tubing)	Conforms
ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Conforms (No Cytotoxicity, No Skin Sensitization, No Intracutaneous reactivity, No Acute Systematic Toxicity, No Pyrogen, No Hemolysis reported)
USP <85> (Bacterial Endotoxins Test)	Conforms (Endotoxin Limit: 20 EU per device)
USP <788> (Particular Matter in Injections)	Conforms
ISO 10993-5:2009 (Test for in vitro cytotoxicity)	Conforms (No Cytotoxicity)
ISO 10993-4:2017 (Selection of Test for Interaction with Blood)	Conforms (No Thromboresistance, No Complement Activation, No Hemolysis)
ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Conforms (No Skin Sensitization, No Intracutaneous reactivity)
ISO 10993-11:2017 (Tests for systemic toxicity)	Conforms (No Acute Systematic Toxicity)
ASTM F756-2017 (Assessment of Hemolytic Properties of Materials)	Conforms (No Hemolysis)
USP <151> (Pyrogen Test)	Conforms (No Pyrogen)
ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials)	Conforms
ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration)	Conforms
ASTM D4169-16 (Performance Testing of Shipping Containers and Systems)	Conforms
Sterilization Assurance Level (SAL)	10-6

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual non-clinical performance and biocompatibility test. It simply states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests, typical sample sizes are relatively small and determined by the specific ISO/ASTM standard.
Data Provenance: The testing was conducted as part of the submission by Jiangsu Suyun Medical Materials Co., Ltd. from China. The types of tests (Performance Testing, Biocompatibility Testing, Sterility, Shipping and Shelf-life) are generally performed prospectively in a lab setting rather than being retrospective analyses of existing data. The specific country of origin for the data acquisition (i.e., where the labs are located) is not explicitly stated beyond the sponsor's location.

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 is N/A. For non-clinical device testing, "ground truth" is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, USP). The "experts" are the qualified laboratory personnel performing the standardized tests, and their qualifications are in conducting these specific test methods, not in clinical interpretation.

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

This is N/A. Adjudication methods are typically relevant for clinical studies or studies involving subjective human assessment (like image interpretation). Non-clinical performance and biocompatibility tests are objective measurements against predefined criteria in standards, not subject to individual interpretation requiring adjudication.

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 is N/A. This submission is for a physical medical device (infusion sets), not an AI/software device that involves human readers or image interpretation. No MRMC study was performed.

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

This is N/A. This submission is for a physical medical device, not an algorithm or AI device.

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

The "ground truth" for this device's performance and safety is based on established international and national standards and test methods. For example, the ISO 8536 series for infusion equipment, ISO 10993 series for biocompatibility, and various USP and ASTM standards define the accepted methods and criteria for assessing device attributes like flow rate, mechanical integrity, material safety, and sterility.

8. The sample size for the training set

This is N/A. This is a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set.

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

This is N/A. As mentioned above, there is no training set for a physical medical device.

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: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

March 25, 2022

Jiangsu Suyun Medical Materials Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K202437

Trade/Device Name: Infusion Sets for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 22, 2022 Received: February 24, 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,

Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K202437

Device Name Infusion Sets for Single Use

Indications for Use (Describe)

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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

K202437 510(k) Summary

1. Date of Preparation: 3/22/2022
1. Sponsor Identification

Jiangsu Suyun Medical Materials Co., Ltd.

No.18, Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone Lianyungang, Jiangsu, 222002, China

Establishment Registration Number: 3003717263

Contact Person: Guangning Xu Position: Management Representative Tel: +86-518-85608151 Fax: +86-518-85608151 Email: quality(@suyunmedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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}------------------------------------------------

1. Identification of Proposed Device
  Trade Name: Infusion Sets for Single Use Common Name: Disposable Infusion Set

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

Identification of Predicate Device 5.
510(k) Number: K163160 Product Name: Sterile Single-use Infusion Set
1. Indication for Use Statement:
  The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.

7. Device Description

The proposed devices include 32 models. The differences between models are described below:

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

		Table 1 the differences in components for each model
Model		D3	D3-2	D4	D5	D6	D7	D8	D9
Component		D1-3	D1-3-2	D1-4	D1-5	D1-6	D1-7	D1-8	D1-9
		D2-3	D2-3-2	D2-4	D2-5	D2-6	D2-7	D2-8	D2-9
		D3-3	D3-3-2	D3-4	D3-5	D3-6	D3-7	D3-8	D3-9
Air Filter		X	N.A.	X	N.A.	X	N.A.	X	X
Protective Cap of Spike		X	X	N.A.	X	N.A.	X	N.A.	X
Protective Cap of Spike(Steel Needle)		N.A.	N.A.	X	N.A.	X	N.A.	X	N.A.
Spike	Spike with Air Filter	N.A.	X	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.
	Spike with Drip Tube and Air Filter	N.A.	N.A.	N.A.	X	N.A.	X	N.A.	N.A.
	Spike (Plastic)	X	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	X
	Spike (Steel Needle)	N.A.	N.A.	X	N.A.	X	N.A.	X	N.A.
Tee		N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	X	X
Pinch Clamp		X	X	X	N.A.	X	N.A.	X	X
Drip Tube		X	X	X	N.A.	X	N.A.	X	X
Drip Chamber		X	X	X	X	X	X	X	X
Flexible Tube		X	X	X	X	X	X	X	X
Roller Clamp		X	X	X	X	X	X	X	X
Injection Site		X	X	X	X	X	X	X	X
Fluid Filter		D3: 5um	D3-2: 5um	D4: 5um	D5: 5um	D6: 5um	D7: 5um	D8: 5um	D9: 5um
		D1-3: 3um	D1-3-2: 3um	D1-4: 3um	D1-5: 3um	D1-6: 3um	D1-7: 3um	D1-8: 3um	D1-9: 3um
		D2-3: 2um	D2-3-2: 2um	D2-4: 2um	D2-5: 2um	D2-6: 2um	D2-7: 2um	D2-8: 2um	D2-9: 2um
		D3-3: 15um	D3-3-2: 15um	D3-4: 15um	D3-5: 15um	D3-6: 15um	D3-7: 15um	D3-8: 15um	D3-9: 15um
External Cone LockConnector	X	X	X	X	X	X	X	X
Protector Cap of LockConnector	X	X	X	X	X	X	X	X
Intravenous Infusion Needle	X	X	X	X	X	X	X	X

Table 1 the differences in components for each model

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

Note: X= the proposed device has this component; N.A. = the proposed device does not have this component

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

8. Summary of Technological characteristics

ITEM	Proposed Device	Predicate DeviceK163160	Remark
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Product Code	FPA	FPA	Same
Class	II	II	Same
Indications for Use	The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.	The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.	DifferentAnalysis 1
Configuration	Protective Cap of SpikeSpike (one plastic spike / one metal spike/ two metal spikes)Multiple air filters, including:Air filter with tubing integrate with plastic spike (model: D3/D1-3/D2-3/D3-3 and D9/D1-9/D2-9/D3-9);Air filter without tubing integrate with plastic spike (model: D3-2/D1-3-2/D2-3-2/D3-3-2 and D5/D1-5/D2-5/D3-5 and D7/D1-7/D2-7/D3-7)Stand-alone Air filter unit (model: D4/D1-4/D2-4/D3-4 and D6/D1-6/D2-6/D3-6 and D8/D1-8/D2-8/D3-8)Fluid Filter near the patient accessDrip Chamber integrate with the spike OR,Drip Chamber is several inches below the Spike	Protective Cap of SpikeSpike (plastic spike)Air filter without tubing integrate with plastic spikeFluid Filter integrate with the Drip ChamberDrip Chamber integrate with the spike	SameDifferentAnalysis 2
Flexible Tube			Same

Table 2 General Comparison

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

	Roller Clamp		Same
	Drip Tube		Same
	Injection Site		Same
	Luer Lock Connector		Same
	Protector Cap of Lock Connector		Same
Operation Mode	Manual	Manual	Same
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same

SE Analysis 1-Indications for Use

The proposed device and the predicate device has the same intended use, they are both intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The intended duration of use is included in the indications for use of proposed device, and it provides safety information for the end user. Therefore, the difference on indications for use does not raise new question on safety and effectiveness of the proposed device.

SE Analysis 2-Configuraiton

The proposed device and predicate device have the similar configurations (protector cap, spike, air filter, fluid filter, drip chamber, flexible tube, roller clamp, drip tube, injection site and luer lock connector) to achieve the intended use. The differences are mainly in some components structure (spike, air filter, fluid filter and drip chamber) which look different than the predicate device. The detail analysis on components are listed as following:

Spike:

The proposed device has one plastic spike / one metal spikes, while the predicate device only have one plastic spike. The metal spike of the proposed device is also used to pierce and penetrate the closure of a fluid container, and it facilitates piercing and penetrate because it has lower penetration resistance than the plastic spike. The two metal spikes are applicable to the simultaneous transfusion of two liquid container. In addition, the metal spikes meet the dimensions requirements of closure-piercing device specified in ISO 8536-3.

Air filter:

The proposed device has Multiple air filters, including: Air filter with tubing integrate with plastic spike; Air filter without tubing integrate with plastic spike and Stand-alone Air filter unit. The predicate device only has Air filter without tubing integrate with plastic spike. The air filter with tubing integrate with plastic spike and Stand-alone Air filter unit play the same role as Air filter without tubing integrate with plastic spike; they are all used to make the air entering the fluid bottle during infusion to maintains a balance of pressure inside of the rigid container. In addition, all of the air filters of the proposed device don't affect the flow rate of proposed device when air entering the rigid container passes through the air filter.

The spike of Stand-alone Air filter unit of proposed device is capable of piercing and penetrating the closure of a fluid container without pre-piercing, which is also meet the requirement of ISO 8536-4.

{9}------------------------------------------------

Fluid Filter

The fluid filter of predicate device is within in the drip chamber. The fluid filter of proposed device is near the patient access, this position is acceptable based on ISO 8536-9. The proposed device has four type of fluid filter (2, 3, 5, and 15um filter size) and they are capable of more than 80% latex particle retention. The fluid filters of proposed device meet the fluid filter requirement specified in ISO 8536-3.

Drip Chamber

The proposed device has drip chamber integrates with the spike OR Drip Chamber being several inches below the Spike. The predicate device's drip chamber only integrates with the spike. The Drip Chamber being several inches below the Spike facilitates the observation of the fall of drops when the liquid container is hung high. In addition, the drip chamber of the proposed device meet the requirement of drip chamber specified in ISO 8536-3.

Based on above analysis, the proposed device and predicate device have the similar configurations to achieve the intended use. The differences that mainly in some components structure (spike, air filter, fluid filter and drip chamber) which look different than the predicate device don't raise new problem on safety and effectiveness of proposed device.

{10}------------------------------------------------

Item	Proposed Device	Predicate Device K163160	Remark
Infusion Set Performance	Conform with ISO 8536-4:2010	Conform with ISO 8536-4:2010	Same
Needle performance	Conform with ISO 7864: 2016ISO 9626: 2016	Conform with ISO 7864: 2016ISO 9626: 2016	Same
Needle guage	21G	21G	Same
Capacity (ml)	20, 21, 22, 23, 25	19, 21, 23	DifferentAnalysis 3
PatientcontactMaterial	Spike	Acrylonitrile ButadineStyrene (ABS)Polyethylene (PE)Stainless Steel 304 (SUS304)	SpikeHDPE
	Tee	Polyvinyl Chloride (PVC)	TeeUnknown
	Drip Tube	Acrylonitrile ButadineStyrene (ABS)	Drip tubeUnknown
	Drip Chamber	Polyvinyl Chloride (PVC)	Drip ChamberPVC
	Flexible Tube	Polyvinyl Chloride (PVC)	Flexible TubePVC
	Fluid Filter	Methyl Metha Acrylate ABS(MABS)Polypropylene (PP)	Fluid FilterABS
	External Cone Lock Connector	Acrylonitrile ButadineStyrene (ABS)	External Cone Lock ConnectorUnknown
	Injection Site	Polyisoprene	Injection SiteABS
	Intravenous Infusion Needle	Polyvinyl Chloride (PVC)Acrylonitrile Butadine Styrene (ABS)Stainless Steel 304 ( SUS304)	Intravenous Infusion NeedleUnknown


BiocompatibilitydD
Cytotoxicity	No Cytotoxicity		No Cytotoxicity
Skin Sensitization	No Skin Sensitization		No Skin SensitizationDifferentAnalysis 4
Intracutaneous reactivity	No Intracutaneous reactivity		No Intracutaneous reactivity

Table 3 Safety and Effectiveness Comparison for Infusion Set for Single Use

{11}------------------------------------------------

AcuteSystematicToxicity	No Acute Systematic Toxicity	No Acute SystematicToxicity
Pyrogen	No Pyrogen	No Pyrogen
VivoThromboresistance	No Thromboresistance /	/
ComplementActivation	No Complement Activation /	/
Hemolysis	No Hemolysis	No Hemolysis
Sterilization
Method	EO sterilized	EO sterilized
SAL	10-6	10-6Same
EndotoxinLimit	20 EU per device	20 EU per device

SE Analysis 3 - Capacity

The proposed device has different total length and difference configuration, so it has different capacity. The slight difference on the capacity between the proposed device and predicate device capacity cannot affect the devices' intended use. Therefore, the difference on capacity will not raise any safety and effectiveness of proposed device.

SE Analysis 4 - Patient contact Material and Biocompatibility

The patient contact materials for proposed device are different from predicate device. However, the biocompatibility test for proposed device was performed on the proposed device and there are two more biological compatibility test items than those of predicate device, Vivo Thromboresistance and Complement Activation. And the test results show there is no adverse effect on the material. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

1. Non-Clinical Testing
  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:

Performance Testing

A ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed.
ISO 8536-14:2016 Infusion equipment for medical use-Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact.
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications.

{12}------------------------------------------------

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.

BiocompatibilityTesting

This device is classified as: Externally communicating, Blood path Indirect, Limited contact ≤ 24 hours.

A ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
USP <85> Bacterial Endotoxins Test.
USP <788> Particular Matter in Injections.
A 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 Interation 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 <151> Pyrogen Test. >

Sterility, Shipping and Shelf-life:

ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
A ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

No clinical study is included in this submission.

9. Conclusion

The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Infusion Sets for Single Use are substantially equivalent to the Sterile Single Use Infusion Sets K163160 with respect to indications for use, 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.