The Medcomp® Pro-Lock CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp Pro-Lock CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

Device Description

The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A nonremovable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged. The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pro-lock™ CT Safety Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility.

Therefore, many of the requested criteria, such as those related to AI algorithm performance studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission. This document describes a physical medical device, not an AI/ML software device.

However, I can extract information related to the device's acceptance criteria and studies to demonstrate its performance where applicable from the document.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the listed tests and the demonstration of substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for each test in a table, but rather lists the tests performed to ensure the device meets relevant standards and performs similarly to the predicate.

Test Performed	Test Method / Acceptance (Implicitly met if "results...effectively demonstrate" as stated)	Reported Device Performance (as compared to predicate)
Functional/Performance Tests
Priming Volume	Per Internal Test Method	Proposed Device: 0.20cc Predicate Device: 0.18cc (Difference noted, but implied acceptable due to substantial equivalence claim)
Gravity Flow	ISO 10555-1: 2013	Not explicitly detailed, but implied to be comparable to predicate.
Needle Insertion/Extraction Force	ISO 10555-6: 2015	Not explicitly detailed, but implied to be comparable to predicate.
Air Leakage	ISO 8536-8: 2004	Not explicitly detailed, but implied to be comparable to predicate.
Liquid Leakage	ISO 10555-1: 2013, Annex C	Not explicitly detailed, but implied to be comparable to predicate.
Luer Lock Fittings	ISO 594-2: 1998	Not explicitly detailed, but implied to be comparable to predicate.
Occlusion with Clamp	Per Internal Test Method	Device designed to restrict fluid flow when engaged.
Extension Tensile and % Elongation	ISO 10555-1: 2013	Not explicitly detailed, but implied to be comparable to predicate.
Power Injection Simulation	ISO 10555-1: 2013	Maximum Infusion Rate: 5 ml/sec at 11.8 cPs for 20 gauge. Maximum Flow Rate: 5ml/second at 325 psi max. (Matches predicate specifications).
Port Septum/Needle Evaluation for Coring	Per Internal Test Method	Device is "anti-coring Huber style needle."
Break Pull Test/Static Load Pull Test	ISO 10555-1: 2013	Not explicitly detailed, but implied to be comparable to predicate.
Needle to Extension Joint Pull	ISO 10555-1: 2013	Not explicitly detailed, but implied to be comparable to predicate.
Corrosion Resistance	ISO 11070: 2014	Not explicitly detailed, but implied to be acceptable.
Shelf Life (3 years)	ISO 11607-1: 2009+A1:2014, ASTM F1980-16, ISO 10555-1: 2013, ASTM F-1929-15, ASTM F-1140	Not explicitly detailed, but implied to be met.
Shipping Test	ISO 11607-1: 2009+A1:2014, ISTA-2A-2011, ASTM F-1929-15, ASTM F-1140	Not explicitly detailed, but implied to be met.
Simulated Use Study: Sharps Injury Prevention	FDA's Guidance: Medical Devices with Sharps Injury Prevention Features	Device has a "safety feature designed to aid in the prevention accidental needle sticks when manually activated during needle removal." Ergonomics of safety feature improved over predicate.
Living Hinge Fatigue	Per Internal Test Method	Not explicitly detailed, but implied to be acceptable.
Force at Break	Per Internal Test Method	Not explicitly detailed, but implied to be acceptable.
Evaluation of Magnetic Field Interactions, Heating, and Artifacts	ASTM F2052-15, ASTM F2119-07, F2182-11a, F2213-06, F 2503-13	Not explicitly detailed, but implied to be acceptable for MRI compatibility.
Biocompatibility Tests
Sensitization/Irritation	ISO 10993-10: 2010	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable).
Acute Systemic Toxicity	ISO 10993-11: 2006	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable).
Cytotoxicity	ISO 10993-5: 2009	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable).
Pyrogenicity	ISO 10993-11: 2006	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable).
Hemocompatibility	ISO 10993-4: 2002 Amended 2006	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable).
Material Characterization	ISO 10993-18: 2005	Biocompatibility performed per ISO 10993-1, endpoints tested successfully. (Implicitly acceptable), noting change in clamp material from acetal to polypropylene.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It only lists the tests performed and the relevant standards. These tests are laboratory-based, non-clinical tests.

Data Provenance: The tests are "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®, located in Harleysville, Pennsylvania, USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate the device's characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. The "ground truth" here is established by the accepted international and internal test methods and standards (e.g., ISO, ASTM), not by expert consensus in a clinical scenario. The tests are designed to objectively measure physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for imaging studies where subjective interpretation is involved. These are objective, quantitative, non-clinical laboratory tests where the results are measured against defined criteria within the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This is a physical medical device (an infusion set), not an AI/ML diagnostic or assistive device. No human-in-the-loop study with AI was performed.

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

This question is not applicable. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" or basis for evaluation is defined by:

Established Industry Standards: ISO and ASTM standards (e.g., ISO 10555-1, ISO 10993 series, ASTM F2052, etc.) that specify test methods and acceptable limits for medical devices of this type.
Internal Test Methods: Where no specific external standard exists, internal test methods are used, and their validity is implicitly accepted by the FDA's clearance.
Substantial Equivalence: The primary "ground truth" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device (K132880) through comparison of design, materials, indications for use, and performance testing.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a "training set" for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2017

Medcomp® Ms. Courtney Nix Regulatory Affairs Manager, North America and EU 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K162271

Trade/Device Name: Pro-lock™ CT Safety Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Single Lumen Hypodermic Needle Regulatory Class: Class II Product Code: PTI Dated: March 20, 2017 Received: March 21, 2017

Dear Ms. Nix:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162271

Device Name Pro-lock™ CT Safety Infusion 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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		510(k) SUMMARY	Traditional 510K
	K162271
1.	Submitter Information:
	Submitter:	Medcomp®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x 2285Fax: (215) 256-9191
	Registration Number:	2518902
	Contact:	Courtney NixCnix@Medcompnet.comRegulatory Affairs Manager: North America and
	EU
	Date Prepared:	04/26/2017
2.	Proposed or Subject Device Information:
	Trade Name:	Pro-Lock™ CT Safety Infusion Set
	Device:	Non-Coring (Huber) Needle
	Product Code:	PTI
	Regulation Name:	Single Lumen Hypodermic Needle
	C.F.R. Section:	21 CFR 880.5570
	Class:	II
	Regulation MedicalSpecialty and ReviewPanel:	General Hospital
3.	Predicate Device Information:
	510(k) Number:	K132880
	Trade Name:Needle	Medcomp® Power Injectable Safety Huber
	Device:	Non-Coring (Huber) Needle
	Product Code:	PTI
	C.F.R. Section:	21 CFR 880.5570
		Medcomp®: Pro-Lock™ CT Safety Infusion Set	Page 1 of 6

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Image /page/4/Picture/0 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in red, resembling an abstract letter or symbol. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black. A registered trademark symbol is present next to the word.

1499 Delo Drive

Harlevsville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Device Description:

The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

5. Indications for Use:

The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power iniection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 20 gauge non-corina Huber style needles.

Comparison to Predicate Devices: 6.

The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is substantially equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880), in terms of indications for use, intended use, fluid path materials, biocompatibility, basic design, performance, labeling, and manufacturing process.

The difference between the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880), and the 20G x 34" (19mm) Pro-Lock™ CT Safety Infusion Set are the changes to the clamp material from acetal to Polypropylene, and the ergonomics of the safety feature to allow better grip during safety feature activation.

The indications for use differ in regards to the name of the device. There are no other differences in the indications for use statements.

Table 6.1: 510(K) Summary: Design Comparison Matrix

Device	Proposed Device:	Predicate Device:
	20G x 3/4" (19mm) Pro-LockTM CT Safety InfusionSet	Medcomp® Power InjectableSafety Huber Needle(K132880)
Design	Anti-coring Huber style needle for port septum access having a safety feature which that will prevent accidental needle sticks. The needle is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.	Anti-coring Huber style needle for port septum access having a safety feature which that will prevent accidental needle sticks. The needle is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.
Dimensions or Lengths	$3/4$ "	$1/2$ ", $3/4$ " 1", 1- $1/2$ "
Indications for Use	The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 20 gauge non-coring Huber style needles.	The Medcomp® Power Injectable Safety Huber Needle is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Safety Huber Needle is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 20 gauge non-coring Huber style needles.
Gauge Sizes	20 GA	19, 20, 22 GA
Sterilization Method	EO	EO
Fluid Path Materials	Cannula: Stainless SteelFemale Luer: PVCExtension: Pellethane	Cannula: Stainless SteelFemale Luer: PVCExtension: Pellethane
Skin Contacting Materials	Clamp: PolypropyleneBase: PolypropyleneSleeve: PVC	Clamp: AcetalBase: PolypropyleneSleeve: PVC
Performance Testing	Maximum Infusion Rate:11.8 cPs is 5 ml/sec for 20 gaugePriming Volume: 0.20ccMaximum Flow Rate:5ml/second 325 psi max	Maximum Infusion Rate:11.8 cPs is 5 ml/sec for 20 gaugePriming Volume: 0.18ccMaximum Flow Rate:5ml/second 325 psi max
PatientErgonomics	Lift required to engagesafety lock, when lockedneedle is a blind hole, andcatch for extension tubing	Lift and squeeze required toengage safety lock, whenlocked needle is in an openhole, and no catch forextension tube

Medcomp®: Pro-Lock™ CT Safety Infusion Set

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Image /page/5/Picture/0 description: The image features the logo for medCOMP. The logo consists of a stylized, geometric shape in red, resembling a house or an abstract letter. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black.

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

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Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape above the word "medCOMP". The word "med" is in red, and the word "COMP" is in black.

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Bench / Performance Data / Non-Clinical Testing:

The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set, is equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880).

Test Performed	Test Method
Priming Volume	Per Internal Test Method
Gravity Flow	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements
NeedleInsertion/ExtractionForce	ISO 10555-6: 2015 – Intravascular catheters – Sterile andsingle-use catheters – Part 6: Subcutaneous implanted
Air Leakage	ISO 8536-8: 2004 – Infusion equipment for medical use –Part 8: Infusion equipment for use with pressure infusionapparatus
Test Performed	Test Method
Liquid Leakage	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements, Annex C
Luer Lock Fittings	ISO 594-2: 1998 – Conical fittings with 6 % (Luer) taper forsyringes, needles and certain other medical equipment
Occlusion withClamp	Per Internal Test Method
Extension Tensileand % Elongation	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements
Power InjectionSimulation	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements
Port Septum/NeedleEvaluation forCoring	Per Internal Test Method
Break Pull Test/Static Load PullTest	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements
Needle to ExtensionJoint Pull	ISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use cathetersPart 1: General Requirements
CorrosionResistance	ISO 11070: 2014 – Sterile single-use intravascularintroducers, dilators and guidewires
Shelf Life (3 years)	ISO 11607-1: 2009+A1:2014- Packaging for terminallysterilized medical devices - Part 1: Requirements formaterials sterile barrier systems and packagingASTM F1980-16, Standard guide for accelerated aging ofsterile barrier systems for medicalISO 10555-1: 2013 – Incorporating corrigendum April 2014– Intravascular catheters – Sterile and single-use catheters-Part 1: General RequirementsASTM F-1929-15-, Standard Test Method for DetectingSeal Leaks in Porous Medical Packaging by DyePenetrationASTM F-1140- Standard Test Methods for InternalPressurization Failure Resistance of UnrestrainedPackages
Shipping Test	ISO 11607-1: 2009+A1:2014- Packaging for terminallysterilized medical devices - Part 1: Requirements formaterials sterile barrier systems and packagingISTA-2A-2011 - Performance Tests for Packaged-ProductPackaged-Products 150lb (68 kg) or LessASTM F-1929-15-, Standard Test Method for DetectingSeal Leaks in Porous Medical Packaging by DyePenetrationASTM F-1140- Standard Test Methods for InternalPressurization Failure Resistance of UnrestrainedPackages
Simulated UseStudy: Sharps InjuryPrevention	FDA's Guidance: Medical Devices with Sharps InjuryPrevention Features
Living HingeFatigue	Per Internal Test Method
Force at Break	Per Internal Test Method
Evaluation ofMagnetic FieldInteractions,Heating, andArtifacts	ASTM F2052-15 – Standard Test Method for Measurementof Magnetically Induced Displacement Force on MedicalDevices in the Magnetic Resonance Environment
	ASTM F2119-07 – Standard Test Method for Evaluation ofMR Image Artifacts from Passive ImplantsF2182-11a- Standard Test Method for Measurement ofRadio Frequency Induced Heating On or Near PassiveImplants During Magnetic Resonance ImagingF2213-06– Standard test Method for Measurement ofMagnetically Induced Torque on Medical Devices in theMagnetic Resonance EnvironmentASTM F 2503-13 - Standard practice for Marking MedicalDevices and Other Items for Safety in the Magnetic

Medcomp®: Pro-Lock™ CT Safety Infusion Set

Page 4 of 6

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Medcomp®: Pro-Lock™ CT Safety Infusion Set

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Image /page/8/Picture/0 description: The image shows the MedComp logo. The logo consists of a red geometric shape that resembles a stylized letter "M" or a house outline. Below the shape, the word "medCOMP" is written, with "med" in red and "COMP" in black.

1499 Delo Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Biocompatibility:

Biocompatibility was performed on the final, finished 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set per ISO 10993-1 for an externally communicating device, with indirect blood path exposure for a prolonged duration with the body. The biological endpoints include:

Sensitization/Irritation: ISO 10993-10: 2010 Biological Evaluation of o Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
Acute Systemic Toxicity: ISO 10993-11: 2006 Biological Evaluation of o Medical Devices - Part 11: Tess for Systemic Toxicity
Cytotoxicity: ISO 10993-5: 2009 Biological Evaluation of Medical o Devices - Part 10: Tests for in vitro Cytotoxicity
Pvrogenicity: ISO 10993-11: 2006 Biological Evaluation of Medical o Devices - Part 11: Test for Systemic Toxicity
Hemocompatibility: ISO 10993-4: 2002 Amended 2006 Biological o Evaluation of Medical Devices - Part 4: Selection for tests for interactions with blood
Material Characterization: ISO 10993-18: 2005 Biological Evaluation of . Medical Devices - Part 18: Chemical Characterization of Materials

11. Summary of Substantial Equivalence:

In conclusion, the proposed device, 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set, is considered substantially equivalent to the predicate device, Medcomp® Power Injectable Safety Huber Needle (K132880) as demonstrated through non-clinical testing performed.

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).