The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

Specifically,

the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.

Device Description

The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use.

The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use.

The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:

One (1) 22g non-coring (Huber) Refill Needle
One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, clamp, and female luer
One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty syringe barrel

The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.

AI/ML Overview

The provided text is a 510(k) summary for the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special Bolus Needles, and OR Prep Kit. It describes the device, its intended use, and a comparison to a predicate device, along with summary of testing conducted to demonstrate substantial equivalence.

However, the request asks for specific information related to acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered device. The submitted document pertains to a medical device that is a set of needles and an OR Prep Kit, not an AI/ML-powered medical device.

Therefore, the requested information elements (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and are not present in the provided document.

The document focuses on bench performance tests, sterilization validation, biocompatibility, and shelf-life validation to demonstrate substantial equivalence to a predicate device, which is typical for non-AI medical devices.

Here's the table of acceptance criteria and reported device performance from the document, which are performance criteria for the physical device components, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

Test Standard	Tests Conducted	Test Acceptance Criteria	Reported Device Performance (Implied "Met" or "Exceeded")
ISO 7864:2016 Sterile Hypodermic Needles for Single Use - Requirements and Test Methods	Visual inspections	Outside surface of the tubing shall be smooth and free from defects. Needle tube shall appear straight and of regular roundness. Surfaces of the tubing shall be free from metal soil and processing agents.	Met
	Needle length tolerance verification	Needle length shall be within +1.5 mm/-2.5 mm of the nominal length.	Met
	Tensile Testing of needle/hub connections	Cannula/Hub connection shall withstand a 15 lbf tensile load.	Met
	Patency of Flow Testing	Stainless steel stylet of 0.30 mm shall pass through the needle to the non-coring feature.	Met
	Drag/Penetration force testing	Maximum Drag/Penetration force of 5 lbf.	Met
	Acidity / Alkalinity testing	Extract PH shall be within one unit of pH of that of the control fluid.	Met
	Extractables testing	Limit of 5 mg/L of lead, tin, zinc, and iron. Limit of 0.1 mg/L of cadmium.	Met
ISO 9626:2016 Stainless Steel Needle Tubing for The Manufacture of Medical Devices - Requirements and Test Methods	Stiffness testing	Maximum deflection of 0.42 mm.	Met
	Resistance to breakage testing	No visible breakage.	Met
	Corrosion testing	No visible sign of corrosion.	Met
ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles	Non-Coring Testing	Absence of core in the needle cannula.	Met
ISO 8536-9:2015 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment	Leak Testing	Cannula/Hub connection shall maintain leak integrity when a pressure of 45 psi.	Met
	Tensile testing of tubing luer connections	Each joint in the device shall withstand a tensile force of 5 lbs.	Met
	Leak testing of tubing luer connections	Flow path shall withstand a minimum of 50 psig of air.	Met
ISO 594-1:1986 and ISO 594-2:1998 Conical Fittings With 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements and Part 2: Lock Fittings	Luer performance testing	The connectors fit within the limits of the gauge. No observed leakage sufficient to form a falling drop of water. Connectors remained attached under 35 N load. Connectors remained attached under 0.020 N·m unscrewing torque. Connectors successful connected to the reference fitting/male luer. Connector did not override threads under load. No signs of stress cracking observed.	Met
USP <788> Particulate Matter in Injections	Particulate testing	Average number of particles present does not exceed 6000 per device equal to or greater than 10 µm and does not exceed 600 per device equal to or greater than 25 µm.	Met
Internal Intera Protocols	Clamp Flow Stoppage and Release Testing	Clamp shall prevent water at 45 psig from flowing once clamped for 2 minutes. Upon release of the clamp, water at 5 psig must flow through the clamped section.	Met
Internal Intera Protocols	Leak Testing (Syringe Barrel Lid)	No leakage when inverted with 18 mL of water present.	Met

As the device is not an AI/ML device, the following points are not applicable and cannot be answered from the provided document:

Sample size used for the test set and the data provenance: Not applicable (no AI test set). For the physical device, testing was conducted on "samples" that were real-time aged, but specific sample sizes for each test are not detailed in this summary.
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 (no AI ground truth).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no AI test set requiring 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 (not an AI device).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (no AI ground truth).
The sample size for the training set: Not applicable (no AI training set).
How the ground truth for the training set was established: Not applicable (no AI training set).

Summary

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Image /page/0/Picture/0 description: The image contains 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.

October 14, 2021

Intera Oncology, Inc. % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K211121

Trade/Device Name: Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: September 14, 2021 Received: September 15, 2021

Dear Sheila Hemeon-Heyer:

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.

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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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

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

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Indications for Use

510(k) Number (if known) K211121

Device Name

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

Indications for Use (Describe)

The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

Specifically,

the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K211121 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.

A. Submitter:	Intera Oncology, Inc.
	65 Williams St, Suite 200
	Wellesley, MA 02481
	Contact: Michael Gaisford
	Title:	Chief Executive Officer
	Tel #:	781-489-5724
	Email:	mgaisford@interaoncology.com

B. Date Prepared: October 14, 2021

D. Device Name and Classification Information:

Trade Name:	Intera Non-coring (Huber) Refill Needles
	Intera Non-coring (Huber) Special Bolus Needles
	OR Prep Kit
Common Name:	Non-Coring (Huber) Needle
Classification Name:	Hypodermic Single Lumen Needle
Classification:	21 CFR 880.5570
Product Code:	PTI
Review Panel:	General Hospital
Class:	II

E. Predicate Devices: K200463 Huber Needle Infusion Set

F. Summary Device Description:

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The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:

One (1) 22g non-coring (Huber) Refill Needle
One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, ● clamp, and female luer
One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty ● syringe barrel

G. Indications for Use Statement:

The Intera Non-coring (Huber) Needles (Refill Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

Specifically,

the Refill Needles are indicated for emptying and refilling the reservoir of an Intera ● 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump
. the Special Bolus Needles are indicated for delivering bolus injections or infusions through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump
the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or . CODMAN® 3000 Series Pump prior to implantation.

H. Technical Comparison with Predicate Devices

The table below provides technological comparisons between the proposed and predicate devices. A discussion of the differences is provided following the table.

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Comparison Item	Proposed DeviceK211121	Predicate DeviceK200463	Assessment ofSubstantialEquivalence
Devices	Intera Non-coring (Huber) RefillNeedleIntera Non-coring (Huber)Special Bolus NeedleIntera OR Prep Kit	Huber Needle Infusion Set	N/A
Manufacturer	Intera Oncology, Inc.	Jiangsu Caina Medical Co.,Ltd	N/A
FDA ProductCode	PTI	PTI	Same
Class	II	II	Same
Indication for Use	The Intera Non-coring (Huber)Needles (Refill Needles andSpecial Bolus Needles) and ORPrep Kit are indicated for usewith the Intera implantedinfusion pumps to administerinfusate solutions. Specifically,• the Refill Needles areindicated for emptying andrefilling the reservoir of anIntera 3000 Hepatic ArteryInfusion Pump orCODMAN® 3000 SeriesPump• the Special Bolus Needlesare indicated for deliveringbolus injections or infusionsthrough an Intera 3000Hepatic Artery InfusionPump or CODMAN® 3000Series Pump• the OR Prep Kit is used toprepare the Intera 3000Hepatic Artery InfusionPump or CODMAN® 3000Series Pump prior toimplantation	The Huber Needle Infusion Setis a device with a non-coringright angle needle intended forinsertion into the septum of asubcutaneously implanted portand for the infusion of fluidsand drugs, as well as bloodsampling into the port.The 19G-22G needles ofdevice are also suitable forpower injection of contrastmedia to a maximum pressureof 325psi. When used withports indicated for powerinjection, the maximumrecommended infusion rate isapproximately 5ml/s for 19Gand 20G, 2ml/s for 22G	See SE discussion
Comparison Item	Proposed DeviceK211121	Predicate DeviceK200463	Assessment ofSubstantialEquivalence
Use environment	Hospital or clinic setting	Hospital or clinic setting	Same
Intended users	Healthcare providers licensedto use Huber needles andinfusion sets	Healthcare providers licensedto use Huber needles andinfusion sets	Same
Components andmaterials ofconstruction	Huber needles - 304 stainlesssteelPVC tubeClampsMale and female LuersEmpty syringe barrel (no piston)	Huber needles - stainlesssteelPVC tubeClampsMale and female LuersNeedle-less connectorY-needleless adapterY-needle adapter	Different, see SEdiscussion in Section Iand discussion of testingin Section J.
Hub/needle bondstrength	≥ 15 lbf (66 N)	Unknown	Different. Interaneedle/hub bondstrength exceedsrequirement of ISO7864:2016. See SectionJ.
Needle tipconfiguration	Non-coring (Huber) tip, straight	Non-coring (Huber) tip, bent,90° angle	Different, see SEdiscussion
Dimensions	Needle gauges: 20G, 22GNeedle lengths: 1", 1 3/8", 1.5",2"Tubing set length: 33 cm	Needle gauges: 19G, 20G,22G, 24G, 25GNeedle lengths: 0.5", 0.75",1", 1.25", 1.5"Tubing set: Unknown	Different, See SEdiscussion
Safety andPerformance tests	Coring testPenetration forceOcclusion testingJoint integrity/tensile testingLeak testingNeedle performanceLuer connector performanceParticulatesBiocompatibilitySterilization validationTransportation testingShelf life testing	Coring testPenetration forceOcclusion testingJoint integrity/tensile testingLeak testingNeedle performanceLuer connector performanceWing flexibilityParticulatesBiocompatibilitySterilization validationTransportation testingShelf life testing	Same except wingflexibility is not requiredfor proposed device as itdoes not contain anywings.See Section J fordiscussion of Interasafety and performancetests.
Material safety	Complies with ISO 10993	Complies with ISO 10993	Same
Sterile	Yes, EtO, SAL 10-6	Yes, EtO, SAL 10-6	Same
Non-Pyrogenic	Yes	Yes	Same
Single Use	Yes	Yes	Same
Shelf life	24 months	Unknown	Different

Table 1. Comparison of the Intera Huber Needle Set to the Predicate Huber Needle Set

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-Discussion of Differences

Indications for Use

Both the proposed and predicate devices are intended for insertion through the septum of subcutaneously implanted receptacles for infusion of fluids and drugs. The proposed device is used for infusion of an implanted infusion pump, while the predicate device is used for infusion of an implanted port. The predicate device is also used for blood sampling from the implanted port and for power injection, neither of which can be done with the proposed device. These differences do not raise new questions of safety or effectiveness because the indications for use of the proposed device are within those of the predicate device.

Infusion Set Components

Both the proposed and predicate devices include non-coring (Huber) needles, tubing, luers, and clamps. Some of the accessories in the two infusion sets differ, i.e., the predicate infusion set also includes connectors, wings, and Y-adapters, that are needed for its intended uses related to an implanted port, while the proposed infusion set includes an empty syringe barrel, which is needed for its intended uses related to an implanted infusion pump. The empty syringe barrel is provided as a convenience to the user and serves as a passive waste receptacle for bacteriostatic water that is removed from the pump prior to implantation. The empty syringe barrel is not a piston syringe and contains no piston is not needed to draw out the fluid. There is no patient contact with the empty syringe barrel, and both the barrel and removed fluid are discarded after use. The end of the empty syringe barrel is covered by a Tyvek seal, and leak testing conducted to an internal protocol (see Section J) confirmed the integrity of this seal. Even if the Tyvek seal were to leak, there would be no risk to the patient or user as: 1) this process occurs during pump preparation before pump implantation: 2) the operator will be wearing sterile gloves; and 3) the removed fluid is bacteriostatic water. Therefore, this additional infusion set accessory does not raise any new questions of safety or effectiveness.

Hub/Needle Bond Strength

The hub/needle bond strength for the predicate device is unknown. However, the hub/needle bond strength for the Intera needles was tested to and demonstrated to comply with the requirements of ISO 7864:2016 (See Section J). Therefore, any differences between the proposed and predicate devices do not raise any new questions of safety or effectiveness.

Huber Needle Tip Configuration

The Huber needles in the proposed device have a straight tip, while the Huber needles in the predicate device have a bent (90 degrees) tip. The straight tip of the Intera Huber needles is appropriate for accessing the Intera 3000 and Codman 3000 infusion pumps, which are implanted subcutaneously in the lower abdomen. A bent needle is not necessary for pump access. The Intera needles were tested to and shown to comply with the applicable requirements of ISO 7864:2016, ISO 9626:2016, and ASTM F3212-16 for stainless steel needles (see Section J). Therefore, this difference does not raise any new questions of safety or effectiveness for the Intera Huber needles.

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Needle Gauge and Length

The needle gauges of the Intera Huber needles are within the range offered by the predicate device. The Intera Huber needle lengths are also within the range offered by the predicate device except that the largest Intera Huber needle is 2" as compared to 1.5" for the predicate. This longer length is only needed in the case of a larger patient where there may be a greater distance to reach the pump receptacle. All needle lengths function the same. The Intera needles were tested to and shown to comply with the applicable requirements of ISO 7864:2016, ISO 9626:2016, and ASTM F3212-16 for stainless steel needles (see Section J). Therefore, this difference does not raise new questions of safety or effectiveness.

Shelf Life

The shelf life for the predicate device is unknown. However, the 24-month shelf life for the Intera Non-coring (Huber) Needles and OR Prep Kit was established by testing samples that had been real-time aged under warehouse conditions in conformance with ASTM F1929-15 and ASTM F88M/F88-15 for package integrity and applicable requirements of ISO 7864:2016 and ISO 8536-9:2015 for device integrity (see Section J). Therefore, any differences between the proposed and predicate devices do not raise any new questions of safety or effectiveness.

J. Testing to Support Substantial Equivalence

Performance Testing

The table below presents all of the bench performance tests conducted to support this 510(k). All tests met or exceeded the acceptance criteria of the applicable standards. No animal or clinical testing was conducted.

Test Standard	Tests Conducted	Test Acceptance Criteria
ISO 7864:2016 SterileHypodermic Needles forSingle Use -Requirements and TestMethods	Visual inspections	Outside surface of the tubing shallbe smooth and free from defects.Needle tube shall appear straightand of regular roundness.Surfaces of the tubing shall be freefrom metal soil and processingagents.
	Needle length toleranceverification	Needle length shall be within +1.5mm/-2.5 mm of the nominal length.
	Tensile Testing ofneedle/hub connections	Cannula/Hub connection shallwithstand a 15 lbf tensile load
	Patency of Flow Testing	Stainless steel stylet of 0.30 mmshall pass through the needle tothe non-coring feature.
	Drag/Penetration forcetesting	Maximum Drag/Penetration force of5 lbf.
Test Standard	Tests Conducted	Test Acceptance Criteria
	Acidity / Alkalinity testing	Extract PH shall be within one unitof pH of that of the control fluid.
	Extractables testing	Limit of 5 mg/L of lead, tin, zinc,and iron. Limit of 0.1 mg/L ofcadmium.
ISO 9626:2016 StainlessSteel Needle Tubing forThe Manufacture ofMedical Devices -Requirements and TestMethods	Stiffness testing	Maximum deflection of 0.42 mm.
	Resistance to breakagetesting	No visible breakage.
	Corrosion testing	No visible sign of corrosion.
ASTM F3212-16Standard Test Method forCoring Testing of HuberNeedles	Non-Coring Testing	Absence of core in the needlecannula
ISO 8536-9:2015Infusion Equipment forMedical Use - Part 9:Fluid Lines for SingleUse with PressureInfusion Equipment	Leak Testing	Cannula/Hub connection shallmaintain leak integrity when apressure of 45 psi
	Tensile testing of tubingluer connections	Each joint in the device shallwithstand a tensile for of 5 lbs
	Leak testing of tubing luerconnections	Flow path shall withstand aminimum of 50 psig of air
ISO 594-1:1986 and ISO594-2:1998Conical Fittings With 6 %(Luer) Taper forSyringes, Needles andCertain Other MedicalEquipment - Part 1:General Requirementsand Part 2: Lock Fittings	Luer performance testing	The connectors fit within the limitsof the gauge.No observed leakage sufficient toform a falling drop of water.Connectors remained attachedunder 35 N load.Connectors remained attachedunder 0.020 N·m unscrewingtorque.Connectors successful connectedto the reference fitting/male luer.Connector did not override threadsunder load.No signs of stress crackingobserved
Test Standard	Tests Conducted	Test Acceptance Criteria
USP <788> ParticulateMatter in Injections	Particulate testing	Average number of particlespresent does not exceed 6000 perdevice equal to or greater than 10µm and does not exceed 600 perdevice equal to or greater than 25µm.
Internal Intera Protocols	Clamp Flow Stoppage andRelease Testing	Clamp shall prevent water at 45psig from flowing once clamped for2 minutes.Upon release of the clamp, water at5 psig must flow through theclamped section.
Internal Intera Protocols	Leak Testing (SyringeBarrel Lid)	No leakage when inverted with 18mL of water present

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Sterilization Validation

Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 10° using the half-cycle, overkill method per ISO 11135:2014, 2m edition, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. Bacterial endotoxin testing conducted using the LAL Test per USP 40-NF35:2017 <85> Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard (<20.0 EU/Device), Sterilization residuals were evaluated according to ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals and were found to be below the maximum allowed levels of the standard after aeration.

Biocompatibility

The following biocompatibility tests were conducted to support this 510(k):

Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. Sensitization and Irritation per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. Acute systemic toxicity per ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Material-mediated pyrogenicity per USP 40-NF35:2017 <151> Pyrogen Test (USP Rabbit Test)
Hemocompatibility per ISO 10993-4:2017 Biological evaluation of medical devices-● Part 4: Selection of tests for interactions with blood, including hemolysis per ASTM

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F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials (indirect), and hemocompatibility

Shelf-Life Validation Testing

The following package validation and shelf life testing was completed on final, finished EtO sterilized samples that had been real-time aged for at least 25 months.

Transportation testing according to ISTA 3A for Packaged-Products for Parcel Delivery System Shipments 70kg (150 lb) or Less (standard, small, flat or elongated)
Package integrity testing, including the dye penetration test per ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and the seal strength test per ASTM F88M/F88-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
Device integrity testing, including tensile strength and leak testing .

K. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The information and testing presented in this 510(k) demonstrate that the Intera Non-coring (Huber) Refill and Special Bolus Needles and OR Prep Kit with Tubing Set are substantially equivalent to the Huber Needle Infusion Set cleared under K200463 with respect to the indications for use and technological characteristics.

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).