Huber Needle Infusion Set: The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Safety Huber Needle Infusion Set: The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Device Description

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s). The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Huber Needle Infusion Set and Safety Huber Needle Infusion Set. This document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

The provided text does not contain information about an AI/ML powered medical device. Therefore, the specific details requested regarding acceptance criteria and study proving an AI/ML device meets acceptance criteria (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not present in this document.

The document focuses on the physical and functional equivalence of the Huber Needle Infusion Set to its predicate device through a series of non-clinical tests (performance testing and biocompatibility testing).

Here's what can be extracted, interpreted based on the provided document, and why the other AI/ML related questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance (Focus: Non-AI/ML Physical Device)

The document primarily outlines performance tests and biocompatibility tests to prove substantial equivalence of a physical medical device (Huber needle). It doesn't explicitly list "acceptance criteria" in a table format with "reported device performance" in the way one might for an AI/ML algorithm's effectiveness metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted to verify that the proposed device met all design specifications and test results demonstrated compliance with related standards requirements.

However, we can infer some "acceptance criteria" based on the tests performed:

Acceptance Criterion (Inferred from Tests)	Reported Device Performance (Summary from document)
Wing Flexibility: Withstand bending without cracking	Verified as able to withstand bending without cracking.
Penetration Force	Demonstrated compliance with ISO 10555-6:2015.
Coring Testing	Demonstrated compliance with ASTM F3212-16.
Occlusion Testing	Verified to withstand 45 psi pressure; liquid path free from leakage.
Leakage, Joint Integrity, Tubing Testing, Tensile Strength	Demonstrated compliance with ISO 8536-4:2010.
Safety Mechanism Activation and Function	Demonstrated compliance with ISO 23908:2011 and FDA Guidance "Medical Devices with Sharps Injury Prevention Features". Test results showed safety mechanism protects needle tip from exposure and provides audible click.
Ability to withstand power injection pressures	Watertight and resistant up to 330 psi.
Power Injection Flow rate	Confirmed maximum flow rates with a power injector.
Needle performance	Demonstrated compliance with ISO 7864:2016 and ISO 9626:2016.
Luer Connector performance	Demonstrated compliance with ISO 80369-7:2016 and ISO 80369-20:2015.
MRI Compatibility	Demonstrated compliance with ASTM F2182-09, ASTM F2052-06, ASTM 2119-07, ASTM 2213-06 R11.
Particulates	Demonstrated compliance with USP <788>.
Sterilization	Demonstrated compliance with ISO 10993-7:2008, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15.
Biocompatibility (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemolytic Property, Partial Thromboplastin, Complement Activation, Bacterial Endotoxin Limit)	Tested according to ISO 10993-1:2018 and specific sub-parts/related standards; results indicate compliance.

Regarding AI/ML specific questions:

2. Sample size used for the test set and data provenance:

Not applicable for AI/ML. This document describes testing of a physical medical device. The "test set" here refers to physical samples of the device and test media (e.g., liquids for flow rate, materials for penetration/coring). No medical imaging or patient data is involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for AI/ML. Ground truth for a physical device is established through verified measurement techniques and standardized testing protocols, not expert consensus on medical images.

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

Not applicable for AI/ML. Adjudication relates to resolving disagreements among experts for ground truth labeling in AI/ML studies. For physical device performance, tests are objective and measurable against established standards.

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:

No. This device is a physical infusion set, not an AI/ML algorithm intended to assist human readers (e.g., radiologists). Therefore, no MRMC study was performed.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable for AI/ML diagnostic/interpretive purposes. For this physical device, "ground truth" is defined by the established physical, chemical, and biological properties of the materials and function of the device as measured by validated laboratory methods and adherence to international standards (e.g., ISO, ASTM, USP).

8. The sample size for the training set:

Not applicable for AI/ML. This refers to a physical medical device, not an AI model requiring a training set.

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

Not applicable for AI/ML. See point 8.

In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (Huber Needle Infusion Set). The "acceptance criteria" discussed are performance and material standards for the physical device, and the "study" consists of a comprehensive suite of non-clinical, laboratory-based tests to demonstrate compliance with these standards and substantial equivalence to a predicate device. None of the questions specifically pertaining to AI/ML device validation are addressed because the device is not an AI/ML product.

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). The logo consists of two parts: the Department of Health & Human Services USA seal on the left and the FDA acronym followed by 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 agency name in a rectangular shape.

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

Re: K200463

Trade/Device Name: Huber Needle Infusion Set. Safety Huber Needle Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: February 1, 2021 Received: March 8, 2021

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 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

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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 (QS) 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-devices/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.

James M. Simpson Jr -S7

for Paval Patel Acting 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

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Indications for Use

510(k) Number (if known) K200463

Device Name

Huber Needle Infusion Set Safety Huber Needle Infusion Set

Indications for Use (Describe)

Huber Needle Infusion Set

The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port.

The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Safety Huber Needle Infusion Set

The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: K200463

1. Date of Preparation: 3/31/2021
1. Sponsor Identification Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town, Jiangyin city, Jiangsu, 214415, China. Establishment Registration Number: 3005670221 Contact Person: Jianwei Pan Position: Management Representative Tel: +86-510-8686 6666-8027 Fax: +86-510-8686 6666-8009 Email: jianwei.pan@cainamed.com
1. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person) Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-228-15850, Fax: +1-360-925-3199 Email: info@mid-link.net
1. Identification of Proposed Device

Trade Name: Huber Needle Infusion Set, Safety Huber Needle Infusion Set Common Name: Intravascular Administration Set Regulatory Information Classification Name: Hypodermic Single Lumen Needle Classification: II Product Code: PTI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;

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1. Identification of Predicate Device 510(k) Number: K170897 Product Name: Surecan Safety II
  Indication for Use:

Huber Needle Infusion Set

Safety Huber Needle Infusion Set

Device Description:

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Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s).

The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

1. Summary of Technological Characteristics

Item	Proposed DeviceHuber NeedleInfusion Set	Proposed DeviceSafety Huber NeedleInfusion Set	Predicate DeviceK170897	Remake
Product Code	PTI	PTI	PTI	Same
Regulation No.	880.557	880.557	880.557	Same
Class	II	II	II	Same
Indication forUse	The Huber NeedleInfusion Set is adevice with anon-coring rightangle needle intendedfor insertion into theseptum of asubcutaneouslyimplanted port andfor the infusion offluids and drugs, aswell as bloodsampling into theport.	The Safety Huber NeedleInfusion Set is a devicewith a non-coring rightangle needle intended forinsertion into the septumof a subcutaneouslyimplanted port and for theinfusion of fluids anddrugs, as well as bloodsampling into the port.The safety feature ismanually activated duringneedle removal, and isdesigned to aid in theprevention of accidentalneedle sticks.	The Surecan Safety IIpower-injectable safetynon-coring needle is adevice intended forinsertion into theseptum of asubcutaneouslyimplanted port for theinfusion of fluids anddrugs, as well as bloodsampling through theport.The Surecan Safety IIsafety feature ismanually activatedduring needle removal,and is designed to aid inthe prevention ofaccidentalneedle-sticks. Whenused with ports that are	Similar 1
	The 19G-22G needlesof device are alsosuitable for powerinjection of contrastmedia to a maximumpressure of 325psi.When used with ports	The 19G-22G needles ofdevice are also suitablefor power injection ofcontrast media to amaximum pressure of
Item	Proposed DeviceHuber NeedleInfusion Set	Proposed DeviceSafety Huber NeedleInfusion Set	Predicate DeviceK170897	Remake
	indicated for powerinjection, themaximumrecommendedinfusion rate isapproximately 5ml/sfor 19G and 20G,2ml/s for 22G.	325psi. For powerinjection of contrastmedia, the maximumrecommended infusionrate is approximately5ml/s for 19G and 20G,2ml/s for 22G.	indicated for powerinjection of contrastmedia into the centralvenous system, theSurecan Safety IIneedle is also indicatedfor power injection ofcontrast media.For power injection ofcontrast media, themaximum flow rates at325 psi are 5mL/s for19 gauge and 20 gaugeneedles and 2mL/s forthe 22 gauge needles.
	Non-coring needle	Non-coring needle	Non-coring needle
	NA	Safety mechanism-hub	Safety mechanism-hub
	PVC tube	PVC tube	PVC tube
	Clamps	Clamps	Clamps
Configuration	Female luer fitting	Female luer fitting	Female luer fitting	Similar 2
	Male luer cap	Male luer cap	Male luer cap
	Needleless connector	Needleless connector	Needleless connector
	Y needleless adapters	Y needleless adapters	Y needleless adapters
	Y needle adapters	Y needle adapters	Y needle adapters
	NA	Safety Mechanism	Safety Mechanism
Label/Labeling	Complied with 21CFR part 801	Complied with 21 CFRpart 801	Complied with 21CFR part 801
Needle gauge	19G, 20G, 22G, 24G,25G	19G, 20G, 22G, 24G,25G	19G, 20G, 22G	Different 3
Needle length	0.5 ", 0.75 ", 1 ",1.25 ", 1.5 "	0.5 ", 0.75 ", 1 ",1.25 ", 1.5 "	0.5 ", 0.6 ", 0.8 "1 ", 1.3 ", 1.5 "	Different 4
Item	Proposed DeviceHuber NeedleInfusion Set	Proposed DeviceSafety Huber NeedleInfusion Set	Predicate DeviceK170897	Remake
Available for usewith contrastmedia	19G, 20G, 22G	19G, 20G, 22G	19G, 20G, 22G	Same
Infusion ratewith contrastmedia	5ml/s for 19G and20G2ml/s for 22G	5ml/s for 19G and 20G2ml/s for 22G	5ml/s for 19G and 20G2ml/s for 22G	Same
Needle beveldesign	Non-coring needle	Non-coring needle	Non-coring needle	Same
Priming volume	S-1: 0.4mLS-2: 0.5mLY-1: 0.7mLY-2: 0.7mLD-2: not applicable	S-1s: 0.4mLS-2s: 0.5mLY-1s: 0.7mLY-2s: 0.7mL	19ga (withoutCaresite)- 0.32mL20ga (withoutCaresite)- 0.24mL22ga (withoutCaresite)- 0.18mL19ga (with Caresite)-0.62mL20ga (with Caresite)-0.53mL22ga (with Caresite)-0.46mL	Different 5
SafetyMechanismDesign	NA	The activation of thesafety device is manual.After the infusion iscompleted, hold the baseof the safetymechanism-plate with onehand, hold the doublewing with the other handand pull the needle out.When the needle iscompletely pulled outuntil the click sound isheard, the tip of theneedle is locked in thesafety mechanism-plate.	Manually activatedsafety mechanism uponremoval of the needlefrom the implantedvascular port. Safetymechanism locksneedle into place whena firm stop is felt.A green dot appears onthe clear bottom platewhen safety mechanismis fully engaged.	Different 6
Item	Proposed DeviceHuber NeedleInfusion Set	Proposed DeviceSafety Huber NeedleInfusion Set	Predicate DeviceK170897	Remake
Does the devicehave wings?	NA	Yes	Yes	Same
Is theengagement ofthe safetymechanismvisible to theuser?	NA	Yes	Yes	Same
Hub	Methyl methacrylateacrylonitrilebutadiene styreneplastics (MABS)	NA
Joint pipe	Polyvinyl chloride(PVC)	NA
PVC tube	Polyvinyl chloride(PVC)	Polyvinyl chloride (PVC)		Non-clinicaltestingperformed.Does notraise newquestion ofsafety andeffectiveness.
Female Luerfitting	Methyl methacrylateacrylonitrilebutadiene styreneplastics (MABS);Polypropylene (PP)White Color	Methyl methacrylateacrylonitrile butadienestyrene plastics (MABS);White Color	Unknown
Needlelessconnector	Polycarbonate(PC)+Silicone rubber	Polycarbonate (PC)+Silicone rubber
Y needlelessadapters	Polycarbonate (PC) +Silicone rubber	Polycarbonate (PC) +Silicone rubber
PVC extend tube	Polyvinyl chloride(PVC)	Polyvinyl chloride (PVC)
Y needleadapters-connector	Methyl methacrylateacrylonitrilebutadiene styreneplastics (MABS)	Methyl methacrylateacrylonitrile butadienestyrene plastics (MABS)
Y needleadapters-injection site	Silicone rubber	Silicone rubber
Lubricant	Polydimethylsiloxane	Polydimethylsiloxane
Item	Proposed DeviceHuber NeedleInfusion Set	Proposed DeviceSafety Huber NeedleInfusion Set	Predicate DeviceK170897	Remake
Safetymechanism-hub	NA	Polycarbonate (PC)
Protective pad	NA	Polyethylene (PE)
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Per ISO 10993-1	same
Sterilization	EO sterilization	EO sterilization	EO sterilization	Same
SAL	10-6	10-6	10-6	Same
Single use	Single use	Single use	Single use	Same
Endotoxin Limit	20 EU per device	20 EU per device	20 EU per device	Same

Table 1 Comparison of Technological Characteristics with the Predicate Device

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Similar 1- Indications for Use

Both the predicate and Huber Needle Infusion Set and Safety Huber Needle Infusion Set are intended for use with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as into the port. Although the Huber Needle Infusion Set has no safety mechanism, the predicate and proposed device have similar Indications for Use, and the same intended use.

Similar 2- Configuration

The Safety Huber Needle Infusion Set and Huber Needle Infusion Set have the similar configuration with the predicate device. Although the Huber Needle infusion Set does not have the safety mechanism, the difference will not affect the safety and effectiveness of the proposed device. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.

Different 3- Needle gauge

The needle gauge of proposed device is different from the predicate device. However, the performance of needle has been evaluated and test results demonstrated compliance with related needle performance standards requirements. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.

Different 4- Needle length

The needle length of proposed device is different form the predicate device. However, the needle length of the Safety Huber Needle Infusion Set and Huber Needle Infusion Set is within the needle length of the predicate device. Additionally, the performance of the needle has evaluated per ISO 7864 and test results meet related standards requirements. Therefore, the difference does not raise new questions on safety and effectiveness of the

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proposed device.

Different 5 - Priming volume

The priming volume of the proposed device is different from the predicate device. The priming volume for each configuration of proposed device is included in the user manual. Therefore, the slight difference on priming volume does not raise new questions on safety and effectiveness of the proposed device.

Different 6 - Safety Mechanism Design

The proposed Huber Needle Infusion Set does not have a safety mechanism. The safety mechanism design of proposed Safety Huber Needle Infusion Set is different from predicate device. However, both the proposed device and predicate device were tested in simulated clinical use study. The test results showed the safety mechanism can protect the needle tip from exposure. And there's a click sound for the user to know when the needle is locked. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Performance Testing

Functional performance testing was completed to demonstrate that the proposed device performs as intended after ethylene oxide (EO) sterilization. The following performance tests were evaluated in support of the substantial equivalence determination:

Wing Flexibility	Verify whether wings are able to withstand bending without cracking
Penetration Force	ISO 10555-6:2015 Intravascular catheters – Sterile and single-usecatheters Part 6: Subcutaneous implanted ports
Coring Testing	ASTM F3212-16: Standard test method for coring testing of Huberneedles
Occlusion Testing	Verify that the device can understand 45 psi pressure, and the liquid pathis freedom from leakage
Leakage, Joint integrity,tubing testing, tensilestrength	ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusionsets for single use, gravity feed
Safety Mechanism	ISO 23908:2011 Sharps injury protection - Requirements and test
Activation and Function	methods – Sharps protection features for single-use hypodermicneedles, introducers for catheters and needles used for bloodSampling;FDA Guidance Medical Devices with Sharps InjuryPrevention Features, Issued August 9, 2005
Ability to withstand powerinjection pressures	Watertight and resistant up to a high pressure of 330 psi
Power Injection Flow rate	Confirm Maximum flow rates with a power injector
Needle performance	ISO 7864:2016 Sterile Hypodemic Needles for Single Use- RequirementsAnd Test Methods;ISO 9626:2016 Stainless Steel Needle Tubing For The Manufacture ofMedical Devices- Requirements and Test Methods
Luer Connector performance	ISO 80369-7:2016 Small-bore connectors for liquids and gases inhealthcare applications-Part 7: Connectors for intravascular orhypodermic applications;ISO 80369-20:2015 Small-bore connectors for liquids and gases inhealthcare applications-Part 20: Common test methods
MRI Compatibility	ASTM F2182-09 Standard test method for measurement of radiofrequency induced heating on or near passive implants duringmagnetic resonance imaging;ASTM F2052-06 Standard test method for measurement ofmagnetically induced displacement force on medical devices in themagnetic resonance environment;ASTM 2119-07 Standard test method for evaluation of MR imageartifacts from passive implants;ASTM 2213-06 R11 Standard test method for measurement ofmagnetically induced torque on medical devices in the magneticresonance environment
Simulated Use Study	FDA Guidance Medical Devices with Sharps Injury PreventionFeatures, Issued August 9, 2005
Particulates	USP <788>
Sterilization	ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7:Ethylene Oxide Sterilization ResidualsASTM F1886 / F1886M-16, Standard Test Method for DeterminingIntegrity of Seals for Flexible Packaging by Visual InspectionASTM F88/F88M-15, Standard Test Method For Seal Strength OfFlexible Barrier Materials. (Sterility)ASTM F1929-15 Standard Test Method for Detecting Seal Leaks inPorous Medical Package by Dye Penetration

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Biocompatibilty testing

The materials of construction of a fully assembled Huber Needle Infusion Set and Safety Huber Needle Infusion Set were tested according to ISO 10993-1:2018. The following biocompatibility testing was performed with the reference standard:

Biocompatibility Testing	Standard
Cytotoxicity	ISO 10993-5
Skin Sensitization	ISO 10993-10
Intracutaneous Reactivity	ISO 10993-10
Acute Systemic Toxicity	ISO 10993-11
Pyrogen	ISO 10993-11, USP 42 NF 37 <151>
Hemolytic Property	ASTM F756
Partial Thromboplastin	ASTM F2382
Complement Activation	ISO 10993-4
Bacterial Endotoxin Limit	USP <85>

8. Clinical Test Conclusion

No clinical study is included in this testing.

9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device, K200463, the Huber Needle Infusion Set and the Safety Huber Needle Infusion Set are as safe and effective for its intended use and substantially equivalent to the predicate device, K170897.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).