Extension Set by Medcaptain Life Science Co., Ltd.

Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

Device Description

The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Extension Set." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and biocompatibility assessments, rather than presenting a performance study with acceptance criteria in the context of an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance with AI) are not applicable to this document.

However, I can extract information related to the device's performance based on the non-clinical tests performed to ensure its safety and effectiveness.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests)

The document lists numerous non-clinical tests performed to demonstrate that the device meets its design input requirements and applicable standards. The "reported device performance" in this context refers to the affirmation that the device met the requirements of these tests. Specific quantitative acceptance criteria are generally not explicitly stated in this summary but are implied by adherence to the referenced standards and guidance documents (e.g., ISO, ASTM, FDA guidance).

Acceptance Criteria Category (Implied by Test)	Reported Device Performance (as stated in the document)
Appearance	Met the requirements (per ISO 8536 series)
Dimensions	Met the requirements (per FDA guidance, similar devices, characteristics)
Particulate Contamination	Met the requirements (per ISO 8536 series and USP <788>)
Leakage	Met the requirements (per ISO 8536 series and FDA guidance)
Tensile Strength	Met the requirements (per ISO 8536 series and FDA guidance)
Flow Rate	Met the requirements (per FDA guidance)
Luer Connector Performance (Size, Fluid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding)	Met the requirements (per ISO 80369-7: 2021 and FDA guidance)
Check Valve Performance (Counter flow pressure resistance, Flow rate, Blocking performance, Opening pressure)	Met the requirements (per ISO 8536-12: 2021)
Anti-siphon Valve Performance (Counter flow pressure resistance, Flow rate, Blocking performance, Opening pressure)	Met the requirements (per ISO 8536-12: 2021)
Liquid Medicine Filter 0.2um (Bacterial interception)	Met the requirements (per ASTM F838-20)
Liquid Medicine Filter 1.2um (Retention of latex particles, Candida albicans interception)	Met the requirements (per ISO 8536-4: 2019)
Liquid Medicine Filter 5.0um (Retention of latex particles)	Met the requirements (per ISO 8536-4: 2019)
Needle Free Injection Port Performance (Flow rate, Test for exposure to IPA, Separation resistance, Backpressure, Fluid leakage, Air leakage, Activation duration and number)	Met the requirements (per ANSI/AAMI CN27:2021 and ISO 80369-7: 2021)
Storage Volume	Met the requirements (per ISO 8536-8: 2015 and FDA guidance)
Clamp and Flow Regulator Performance	Met the requirements (per ISO 8536-14: 2016)
Protective Cap Performance	Met the requirements (per ISO 8536-4: 2019)
Chemical Performance	Met the requirements (per ISO 8536-4: 2019)
Sterility	Met the requirements (per ISO 11135: 2014)
Bacterial Endotoxin	Met the requirements (per ANSI/AAMI ST72: 2019)
Package Performance (Shipping, Shelf Life)	Met the requirements (per ISTA 3A: 2018, ISO 11607-1: 2019, ISO 11607-2: 2019, ASTM F1980-21)
Biocompatibility (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Hemolysis)	All tests were performed, and it was "demonstrated that the materials used for the device is biocompatible" (per ISO 10993 series and FDA guidance)

Here's the relevant information based on your numbered questions, with explanations for why some information is not present:

A table of acceptance criteria and the reported device performance: See the table above. The acceptance criteria are implicitly defined by the referenced international standards (e.g., ISO 8536 series, ISO 80369-7, ASTM F838-20) and FDA guidance documents, which specify performance requirements (e.g., maximum leakage, tensile strength thresholds, bacterial retention rates). The "reported device performance" is a blanket statement that the device met the requirements of these standards for all tests performed.
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: Not explicitly stated in the summary document. For medical device bench testing, sample sizes are typically determined by statistical methods for quality control or standard requirements, but these details are not provided here.
- Data Provenance: The tests were conducted by MEDCAPTAIN LIFE SCIENCE CO., LTD. which is based in Shenzhen, Guangdong, China. The document does not specify if external labs were used or the specific origin of materials if different. Tests are non-clinical (bench tests).
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):
- Not applicable. This device is a physical medical device (Extension Set), not an AI diagnostic tool. Ground truth for its performance is established through adherence to engineering specifications and performance standards via bench testing, not through expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (often of images) where there can be disagreement, typically in AI/diagnostic studies. Bench testing of a physical device is a direct measurement against defined specifications, not subject to subjective adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI and human readers. This document concerns a physical "Extension Set" device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no algorithm or AI component in this medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is established by the specifications defined in international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges for physical, chemical, and biological properties (e.g., acceptable leakage rate, minimum tensile strength, non-cytotoxicity). The device's performance is measured directly against these pre-defined, objective criteria.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 1, 2023

Medcaptain Life Science Co., Ltd. Alan Tao Official Correspondent 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, Guangdong 518118 China

Re: K230528

Trade/Device Name: Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 31, 2023 Received: November 1, 2023

Dear Alan Tao:

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"

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(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).

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Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. 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

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Indications for Use

510(k) Number (if known) K230528

Device Name Extension Set

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)

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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable(@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

510(k) Summary- K230528

I. Submitter/510(k) Holder

Submission:	Traditional 510(k) Premarket Notification
Submitter:	MEDCAPTAIN LIFE SCIENCE CO., LTD.
Address:	601, Building C, Jinweiyuan Industrial Park, PingshanDistrict, Shenzhen, Guangdong, CN 518118.
Contact Person:	Alan Tao
Telephone:	+86-755-28380626
Telefax:	+86-755-84517910
Email:	alan.tao@medcaptain.com
Date prepared:	December 1, 2023

II. Device

Device Trade Name:	Extension Set
Device Common Name:	Intravascular Administration Set
Regulatory Name:	Intravascular Administration Set
Regulation Number:	21 CFR 880.5440
Product Code:	FPA
Product Code Name:	Set, Administration, Intravascular
Regulatory Class:	Class II
Review Panel:	General Hospital

III. Predicate Devices

The Extension Set is substantially equivalent to the following legally marketed predicate device: Extension Set (K153293, B.Braun Medical Inc.) cleared on April 6, 2016.

Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA

IV. Device Description

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Image /page/5/Picture/0 description: The image shows the word "Medcaptain" in a bold, sans-serif font. The "M" in "Medcaptain" is stylized with two purple triangles below it. The rest of the letters in the word are black. The word appears to be a logo or brand name.

MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen. Guangdong. CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

V. Indications for Use

Extension Sets are intended to be used with a vascular access device for direct injection, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

VI. Comparison of Technological Characteristics with the Predicate Device

The subject device, Extension Set, and the predicate device, Extension Sets (K153293), are substantially equivalent in that these devices have the same intended use and patient contact category/duration, similar indications for use, patient population and technological characteristics. They have the same characteristics including technology or design of PVC tube, luer lock connector, slide clamp, check valve, filters, pinch clamp and needle free injection port, etc. The differences between the subject device and the predicate device include the maximum pressure resistance, components of anti-siphon valve and protective cap, and materials. The maximum pressure of the subject device is less than that of the predicate device, which can be acceptable in clinical use to achieve the intended use. Performance testing has been conducted on the anti-siphon valve and protective cap components and have been demonstrated to meet the requirements. The materials of subject device are biocompatible based on biocompatibility tests. The differences between the subject and predicate device do not raise any new or different questions of safety and/or effectiveness.

Similarities and differences in technology characteristics are captured in the substantial equivalence comparison between the subject device and the predicate device, which are provided in Table 1.

Description	Extension Sets(Predicate device)	Extension Set(Subject device)	Comparison topredicate device
510(k) Number	K153293	K230528	N/A
Regulation Number	21 CFR 880.5440	21 CFR 880.5440	Identical
Regulatory Name	Intravascular Administration Set	Intravascular Administration Set	Identical
Product Code	FPA	FPA	Identical
Description	Extension Sets(Predicate device)	Extension Set(Subject device)	Comparison topredicate device
Regulatory Class	Class II	Class II	Identical
Intended Use	B.Braun Extension Sets areintended for direct injection,intermittent infusion,continuous infusion oraspiration.	Extension Sets are intended fordirect injection, intermittentinfusion, continuous infusion oraspiration.	Identical
Indications for use	B.Braun Extension Sets maybe used for direct injection,intermittent infusion,continuous infusion oraspiration of fluids,medications, blood andblood products. Select setsmay be used with powerinjector procedures to amaximum pressure of 400psi at a maximum flow rateof 15mL per second.B.Braun's optionalstabilization component onan extension set is intendedto provide stability to thepatient connector, which isattached to an intravascularcatheter. B.Braun ExtensionSets may be used for anypatient population.	Extension Sets are intended to beused with a vascular access devicefor direct injection, intermittentinfusion, continuous infusion oraspiration. The Extension Setsmay be used with power injectorprocedures to a maximumpressure of 200 kPa (2 bar).	DifferentDifference does notraise new or differentquestions of safety oreffectiveness.See Justification 1
Mode of FluidDelivery	Gravity, or power injectionto a maximum pressure of400 psi.	Gravity, or pressure injection to amaximum pressure of 200kPa.	DifferentDifference does notraise new or differentquestions of safety oreffectiveness.See Justification 2
Prescription/Over-the-Counter	Prescription	Prescription	Identical
Patient Population	Any patient population	Adults and pediatrics	Different
Description	Extension Sets(Predicate device)	Extension Set(Subject device)	Comparison topredicate device
			Difference does notraise new or differentquestions of safety oreffectiveness.See Justification 3
Patient Contactcategory/duration	Externally communicating,Blood path indirect,prolonged exposure	Externally communicating, Bloodpath indirect, prolonged exposure	Identical
Device Components	Configured: PVC tubing,Luer,Slide clamp, Stabilizationcomponent, Spin-lockconnector (patientconnector/male luer adapter).May be comprised of variousgeneric components:Stopcocks, Clamps (e.g.roller clamp, on-off clamp),Injection sites, Connectors,Manifolds, Filter (0.2um,1.2um, 5.0um), Check valve,Needleless connector.	PVC tube, Luer lock connector,Check valve, Anti-siphon valve,Filters (0.2um, 1.2um, 5.0um),Clamp (slide or pinch), Flowregulator, Needle free injectionport, Protective cap.	DifferentDifference does notraise new or differentquestions of safety oreffectiveness.See Justification 4
Summary of Non-clinical Tests	• Stabilization componentperformance• Visual• Catheter Angle• Flow Rate – No Catheter• Flow-rate – With Catheter• Tape Removal• Occlusion• Negative Pressure• Positive Pressure• Clamp and PositivePressure• Tensile Strength• Power Injection• Mechanical Hemolysis –Aspiration and injection	• Appearance• Dimension• Particulate Contamination• Leakage• Tensile Strength• Flow Rate• Luer Connector (Size, Fluidleakage, Sub-atmosphericpressure air leakage, Stresscracking, Resistance toseparation from axial load,Resistance to separation fromunscrewing, Resistance tooverriding)• Check Valve (Counter flowpressure resistance, Flow rate,	DifferentDifference does notraise new or differentquestions of safety oreffectiveness.See Justification 5
Description	Extension Sets(Predicate device)	Extension Set(Subject device)	Comparison topredicate device
	• Luer Connection• Gauging• Liquid and Air leakage• Separation Force• Stress Cracking• Collar Retention• Joint Qualification• Particulate Contamination	Blocking performance, Openingpressure)• Anti-siphon Valve (Counterflow pressure resistance, Flowrate, Blocking performance,Opening pressure)• Liquid Medicine Filter• Needle Free Injection Port(Flow rate, Test for exposure toIPA, Resistance to separationfrom axial load, Resistance toseparation from unscrewing,Resistance to overriding,Backpressure (un-activated),Positive pressure fluid leakage(activated), Sub-atmosphericpressure air leakage (un-activated), Sub-atmosphericpressure air leakage (activated),Duration of activation, Numberof activation)• Storage Volume• Clamp (Construction) and FlowRegulator (Construction, Flowrate)• Protective Cap• Chemical performance• Biological performance
Materials	PVC, LDPE, HDPE, PC, PP,ABS, Methylene Chloride(MC), Tetrahydrofuran(THF)	PVC (TOTM), PC, Silicone, PES,PTFE, MABS, PP, POM, ABS,HDPE, Styrene-ButadieneCopolymer (SBC).	DifferentDifference does notraise new or differentquestions of safety oreffectiveness.See Justification 6
Biocompatibility	ISO 10993	ISO 10993	Identical
Sterilization	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6	Identical
Sterile	Yes	Yes	Identical
Description	Extension Sets(Predicate device)	Extension Set(Subject device)	Comparison topredicate device
Single Use	Yes	Yes	Identical

Table 1 Substantial Equivalence Comparison

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MEDCAPTAIN LIFE SCIENCE CO., LTD.

601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

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MEDCAPTAIN LIFE SCIENCE CO., LTD.

601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: +86-755-28380626 Email: disposable@medcaptain.com

Fax.: +86-755-84517910

Website: www.medcaptain.com

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Justification 1: Indications for Use

The subject device, Extension Set, is intended to be used with a vascular access device for direct injection, intermittent infusion, continuous infusion or aspiration. The predicate device was described to be added to an intravascular catheter hub as a conduit for flow to and from the catheter as per K153293, and the subject device is same to it. Extension Sets may be used with pressure injection to a maximum pressure of 200kPa, and the differences do not raise new or different questions of safety or effectiveness according to Justification 2. The subject device does not contain a stabilization component which aims to fix the set, and the component has no influence to achieve the intended use. The patient population of the subject device is adults and pediatrics, the difference does not raise new or different questions of safety or effectiveness according to Justification 3. Based on the Justification 2 and 3, the differences in the "Indications for Use" of the subject device do not result in a new intended use. So the differences do not raise new or different questions of safety or effectiveness.

Justification 2: Mode of Fluid Delivery

The subject device is intended for gravity use or pressure injection. The gravity use is same to the predicate device. For pressure injection, the subject device is intended for pressure injection to a maximum pressure of 200kPa, while the predicate device for power injection to a maximum pressure of 400 psi. To achieve the maximum pressure of 200kPa, the subject device needs to connect with pressure infusion equipment. The pressure resistance testing of leakage is verified according to ISO 8536-9: 2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment and the connection part of the subject device is standard components meeting the requirements of ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications. So the pressure injection of 200kPa is acceptable to achieve the intended use. The difference does not raise new or different questions of safety or effectiveness.

Justification 3: Patient Population

The patient population of the subject device is "adults and pediatrics", while the patient population of the predicate device is "any patients". The subject device has demonstrated to perform to specification and is biocompatible, independent of the patient population. The difference does not raise new or different questions of safety or effectiveness.

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Image /page/10/Picture/0 description: The image shows the word "Medcaptain" in a bold, sans-serif font. The word is black, and there are two purple triangles below the "M" in "Medcaptain". The triangles are pointing to the right and are slightly offset from each other.

Justification 4: Device Components

The subject device and predicate device have the similar components, such as PVC tube, luer lock connector, slide clamp, check valve, filters, pinch clamp and needle free injection port. The pinch clamp of the subject device is similar to the on-off clamp of the predicate device. The subject device has the components of anti-siphon valve and protective cap, which are different from the predicate device. The anti-siphon valve is the same as the check-valve structure except the difference of opening pressure, and meets the performance requirements after testing according to ISO 8536-12:2021 Infusion equipment for medical use - Part 12: Check valves for single use. The protective cap is designed to protect the connectors and is secure and easily removable after testing. The differences of configurations between the subject device and predicate device do not raise different questions of safety and effectiveness. Both achieve the same intended use.

Justification 5: Summary of Non-Clinical Tests

The subject device has the components of PVC tube, luer lock connector, check valve, anti-siphon valve, filters (0.2um, 1.2um, 5.0um), clamp (slide or roller), flow regulator, needle free injection port, protective cap, no stabilization component. The different components compared with the predicate device include anti-siphon valve and protective cap. For all components, the verification testing was performed on the subject device and met the requirements of applicable parts of ISO 8536 series, ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications and FDA guidance. For example, the luer lock connector met the requirements of ISO 80369-7, check valve and anti-siphon valve met the requirements of ISO 8536-12: 2021 Infusion equipment for medical use - Part 12: Check valves for single use, filters met the requirements of ASTM F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration or ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed, clamp and flow regulator met the requirements of ISO 8536-14: 2016 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact, and needle free injection met the requirements of ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications, ANSI/AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications, and FDA guidance. In addition, chemical and biological performances, including Reducing matter, metal ions, titration acidity or alkalinity, residue on evaporation, UV absorption, EO residual, ECH residual, sterility and endotoxin were tested as well. Verification results confirm that the differences in the components do not raise new questions of safety and effectiveness.

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Justification 6: Materials

The liquid pathway of the subject device is PVC (TOTM) which is a DEHP-free PVC and similar to the material of the predicated device. And they have same PC, ABS, HDPE, PP materials. The materials used by the subject device are common medical materials with no significant clinical safety problems reported. In addition, a biological evaluation was conducted on the subject device according to ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, acute systemic toxicity, subacute toxicity and hemolysis. It has been demonstrated that the materials used for the device is biocompatible. Based on bench testing of Extension Set, the performance of the subject device meets the requirement of ISO 8536 series, ISO 80369-7, etc. The materials differences have no influence to the product performance. So the differences of materials do not raise new or different questions of safety or effectiveness.

VII. Performance Data

The subject device, Extension Set, was subjected to the following applicable testing to ensure reliable design and performance under the specified testing parameters:

Biocompatibility Testing:

Per ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.

In vitro cytotoxicity, per ISO 10993-5: 2009 Biological evaluation of ● medical devices - Part 5: Tests for in vitro cytotoxicity
Skin sensitization, per ISO 10993-10: 2021 Biological evaluation of . medical devices - Part 10: Tests for skin sensitization
Intracutaneous reactivity, per ISO 10993-23: 2021 Biological evaluation of . medical devices - Part 23: Tests for irritation
Pyrogenicity, per ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity and USP <151> Pyrogenicity Test
Acute systemic toxicity, per ISO 10993-11: 2017 Biological evaluation of ● medical devices - Part 11: Tests for systemic toxicity
Subacute toxicity, per ISO 10993-11: 2017 Biological evaluation of medical ● devices - Part 11: Tests for systemic toxicity
. Hemolysis, per ISO 10993-4: 2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood and ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials

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Bench Testing:

Per ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed, ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications, FDA guidance "Intravascular Administration Sets Premarket Submission Notifications (FDA; July 11, 2008)", etc., the following tests were performed to ensure performance/functionality of the subject device.

Appearance, per ISO 8536 series. .
Dimensions, per FDA guidance, similar devices and product characteristics. ●
Particulate contamination, per ISO 8536 series and USP <788> Particulate ● Matter in Injections
Leakage, per ISO 8536 series and FDA guidance. ●
. Tensile strength, per ISO 8536 series and FDA guidance.
Flow rate, per FDA guidance. ●
Luer connector: Size, Fluid leakage, Sub-atmospheric pressure air leakage, ● Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, per ISO 80369-7: 2021 and FDA guidance.
. Check valve: Counter flow pressure resistance, Flow rate, Blocking performance, Opening pressure, per ISO 8536-12: 2021 Infusion equipment for medical use - Part 12: Check valves for single use
Anti-siphon valve: Counter flow pressure resistance, Flow rate, Blocking ● performance, Opening pressure, per ISO 8536-12: 2021.
Liquid medicine filter 0.2um: Bacterial interception test, per ASTM F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
Liquid medicine filter 1.2um: Retention of latex particles, per ISO 8536-4: . 2019 and Candida albicans interception.
Liquid medicine filter 5.0um: Retention of latex particles, per ISO 8536-4: ● 2019.
Needle free injection port: Flow rate, Test for expose to IPA, Resistance to ● separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Backpressure (unactivated), Positive pressure fluid leakage (activated), Sub-atmospheric pressure air leakage (unactivated), Subatmospheric pressure air leakage (activated), Duration of activation, Number of activation, per ANSI/AAMI CN27:2021 and ISO 80369-7: 2021.
Storage volume, per ISO 8536-8: 2015 and FDA guidance. ●
Clamp, per ISO 8536-14: 2016 Infusion equipment for medical use Part 14: ● Clamps and flow regulators for transfusion and infusion equipment without fluid contact
Flow regulator, per ISO 8536-14: 2016. ●

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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen. Guangdong. CN 518118. Tel.: +86-755-28380626 Email: disposable(@medcaptain.com Fax.: +86-755-84517910 Website: www.medcaptain.com

Protective cap, per ISO 8536-4: 2019. ●
Chemical performance, per ISO 8536-4: 2019. ●
Sterility, per ISO 11135: 2014 Sterilization of health-care products Ethylene . oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Bacterial endotoxin, per ANSI/AAMI ST72: 2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
ISTA 3A: 2018, Packaged-Products for Parcel Delivery System Shipment ●
Package performance, per ISO 11607-1: 2019 Packaging for terminally . sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Shelf Life Validation, per ASTM F1980-21 Standard Guide for Accelerated . Aging of Sterile Barrier Systems and Medical Devices

Clinical Tests:

Clinical tests were not required to demonstrate performance of Extension Set. Product functionality has been adequately assessed by non-clinical tests.

Animal Tests:

Animal tests were not required to demonstrate performance of Extension Set. Product functionality has been adequately assessed by non-animal tests.

VIII. Conclusions

The results of these tests confirm that the Extension Set meets the design input requirements based on the intended use and support the conclusion that this device is as safe and effective as the legally marketed predicate device Extension Sets (K 153293, B.Braun Medical Inc.) and therefore, substantially equivalent.

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.