The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Device Description

Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x 2.75 inch needle designed for percutaneous access to introduce a guidewire. The PinpointTM GT Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with PinpointTM GT Technology. The PinpointTM GT Introducer Needle, when used with the PinpointTM GT System creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

AI/ML Overview

The provided text describes modifications to an introducer needle and asserts that the device meets acceptance criteria through various performance tests. However, it does not provide the detailed acceptance criteria and reported device performance in a table format, nor does it present a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement as requested.

The document is primarily a 510(k) summary for the Pinpoint™ GT Introducer Needle, arguing for its substantial equivalence to a predicate device (Pinpoint™ GT Safety Introducer Needle). It lists the types of tests conducted and the standards/guidance documents followed, but not the results against specific acceptance metrics.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract the information that is present and clearly state what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
However, the specific "predetermined acceptance criteria" and the "demonstrated performance" are not detailed in a table or any other format.

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

The document lists "Performance Testing - Bench" which implies physical bench tests of the device components.

Sample size for test set: Not specified.
Data provenance: Bench testing results, likely conducted internally by the manufacturer (C.R. Bard, Inc. / Bard Access Systems, Inc.). No information on country of origin of data, or if it was retrospective or prospective, as these are typically applicable to clinical studies, not bench tests like these.

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

This information is not applicable to the type of testing described (bench testing of a medical device's physical and functional properties). Ground truth and expert consensus are usually relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above (bench testing, not clinical evaluation requiring human reader adjudication).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC study. The device is an introducer needle, not an AI diagnostic tool. While it interacts with an "ultrasound system equipped with Pinpoint™ GT Technology" to display a virtual image of the needle, the focus of this 510(k) is the needle itself and its substantial equivalence in physical and functional characteristics to a predicate device. The information provided does not suggest AI assistance for human readers in a diagnostic context.

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

This is not applicable. The device is a physical introducer needle, not a standalone algorithm.

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

As this involves bench testing of physical device attributes (e.g., tensile strength, dimensions, stiffness, echogenicity), the "ground truth" would be established by engineering and material standards, measurement tools, and physical inspection techniques to verify that the device meets its design specifications and relevant industry standards (e.g., ISO standards listed).

8. The sample size for the training set

This is not applicable. The context is the evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary

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

November 4, 2016

C.R. Bard, Inc. Jamie Howell Associate Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K162769

Trade/Device Name: Pinpoint™ GT Introducer Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: September 29, 2016 Received: October 3, 2016

Dear Jamie Howell:

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.

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

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,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is a complex, looping design to the left of the name. The name is written in a simple, sans-serif font, with a dash following the last name. There is also a small letter "s" below the name.

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) K162769

Device Name

Pinpoint™ GT Introducer Needle

Indications for Use (Describe)

The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

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

21 CFR 807.92(a)

	Submitter Name:Address:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person:	Ms. Jamie HowellRegulatory Affairs Specialist
	Telephone Number:Fax Number:Date of Preparation:	801-522-5465801-522-542529 September 2016
SubjectDevice	Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:	PinpointTM GT Introducer NeedleIntroducer Needle21 CFR §870.1340Catheter IntroducerIIDYB
PredicateDevices	Premarket Notification:Trade Name:Common Name:Regulation NumberRegulation Name:Regulatory Class:Product Code:	K142445, date of clearance April 13, 2015PinpointTM GT Safety Introducer NeedleIntroducer Needle21 CFR §870.1340Catheter IntroducerIIDYB
DeviceDescription	Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x2.75 inch needle designed for percutaneous access to introduce a guidewire.The PinpointTM GT Introducer Needle contains a magnet which emits apassive magnetic field that can be detected by ultrasound systems equippedwith PinpointTM GT Technology. The PinpointTM GT Introducer Needle, whenused with the PinpointTM GT System creates a virtual image of the needle onthe ultrasound display, providing clinicians with a visual representation of theneedle throughout the insertion process.
Intended Use	The PinpointTM GT Introducer Needle is designed for percutaneous vascularaccess or procedures requiring the placement of a guidewire.
Indications ForUse	The PinpointTM GT Introducer Needle is intended for patients requiringpercutaneous access to place a guidewire for subsequent placement ofcatheters or other medical procedures requiring introducer needleaccess. The PinpointTM GT Introducer Needle may be used in anyappropriate patient population.

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Technological characteristics of the subject 18G Pinpoint™ GT Introducer Needle is substantially equivalent with respect to the basic design and function to those of the cited predicate device. Modifications made to the subject device when compared to the predicate device are as follows: . Dimensional specification modification from a 21G needle to an 18G needle; . Tip geometry, primary grind angle modification to the needle from 12° to 19° (required to accommodate the larger diameter of 18G needle shaft); . Removal of the active safety mechanism on the subject 18G Pinpoint™ GT Introducer Needle; . Modification to the hub design owing to the removal of the safety mechanism: . Use of a different, non-patient contacting, adhesive that is used to bond the needle to the magnet, in the subject 18G Pinpoint™ GT Introducer Needle; and Change to protective cover (packaging retainer) . . Change in the type of polyethylene used in the needle protective cover; and Technological ● Protective cover changed from clam shell to tube Characteristics over cannula. The following table provides a comparison between the technological characteristics of the subject and predicate device.

Subject and Predicate Device Comparison Table
Attribute	Subject:Pinpoint™ GT IntroducerNeedle	Predicate:Pinpoint™ GT SafetyIntroducer Needle
Owner	Bard Access Systems, Inc.	Bard Access Systems, Inc.
Classification	Same as predicate device.	DYB – 21 CFR §870.1340Catheter Introducer
510k Status	Subject of thisPremarket Notification	K142445 - date of clearanceApril 13, 2015
CommercialName	Pinpoint™ GT IntroducerNeedle	Pinpoint™ GT SafetyIntroducer Needle
Indications forUse	The Pinpoint™ GTIntroducer Needle isintended for patientsrequiring percutaneousaccess to place aguidewire for subsequentplacement of catheters orother medical procedures	The Pinpoint™ GT SafetyIntroducer Needle isintended for patientsrequiring percutaneousaccess to place a guidewirefor subsequent placement ofcatheters or other medicalprocedures requiring
		requiring introducer needleaccess. The Pinpoint™ GTGT Introducer Needle maybe used in any appropriatepatient population.	introducer needleaccess. The Pinpoint™ GTSafety Introducer Needlemay be used in anyappropriate patientpopulation.
		The primary intent of thesubject device, Pinpoint™GT Introducer Needle, isto assist withpercutaneous vasculatureaccess or proceduresrequiring the placement ofa guidewire.	The primary intent of thepredicate device, Pinpoint™GT Safety IntroducerNeedle, is to assist withpercutaneous vasculatureaccess or proceduresrequiring the placement of aguidewire.
TechnologicalCharacteristics(cont.)	ScientificTechnologyDescription	Additionally, the Pinpoint™GT Introducer Needlecontains, integral, withinthe needle hub a passivemagnet. The needle'sincorporated passivemagnet can be detectedby an ultrasound systemequipped with Pinpoint™GT Technology. ThePinpoint™ GT Technology(not the subject of thissubmission) consists of amagnet sensing probe andsoftware loaded onultrasound equipment,creating the Pinpoint™ GTSystem; this system iscapable of displaying avisual representation ofthe needle on anultrasound image. Thedetection of the needle'spassive magnet by thePinpoint™ GT technologyis an optional feature andtool/device offered toclinicians for visualrepresentation of a needlethroughout the insertionprocess; the presence ofthe passive magnet doesnot impact the ability of thedevice to perform as anintroducer needle.	Additionally, the Pinpoint™GT Safety Introducer Needlecontains, integral, within theneedle hub an active safetymechanism and a passivemagnet. The needle'sincorporated passivemagnet can be detected byan ultrasound systemequipped with Pinpoint™ GTTechnology. The Pinpoint™GT Technology (not thesubject of this submission)consists of a magnetsensing probe and softwareloaded on ultrasoundequipment, creating thePinpoint™ GT System; thissystem is capable ofdisplaying a visualrepresentation of the needleon an ultrasound image.The detection of theneedle's passive magnet bythe Pinpoint™ GTtechnology is an optionalfeature and tool/deviceoffered to clinicians forvisual representation of aneedle throughout theinsertion process; thepresence of the passivemagnet does not impact theability of the device toperform as an introducerneedle.
	NeedleComponents	Needle Shaft:Same as predicate device.Needle tip:Same as predicate device.A Bevel 19°Hub:Same as predicate device.	Needle Shaft:Silicone coatedNeedle tip:EchogenicA Bevel 12°HubOpen ended luer locking hubBevel IndicatorPassive Magnet
TechnologicalCharacteristics(cont.)	NeedleMaterials	Luer Hub:Same as predicate deviceNeedle Shaft:Same as predicate device.Magnet:Same as predicate device.Needle Protective Cover(packaging retainer):High Density Polyethylene(HDPE)No colorantSafety Mechanism:None	Luer Hub:Clear PolycarbonateNeedle shaft:Silicone Coated AlloyMagnet:Neodymium Iron Boron(NdFeB)Nickel (Ni) CoatedNeedle Protective Cover(packaging retainer):Clear AmorphousPolyethylene Terephtalate(APET)Safety Mechanism:Translucent GreenPolycarbonateSilicone O-ring301 Stainless SteelCap polycarbonate
	NeedleDimensions	Diameter:18 gaugeLength:Same as predicate	Diameter:21 gaugeLength:2.75" or 7cm
	NeedleLabeling	Gauge Size:No gauge size coloringdue to removal of thesafety mechanismBevel up Indicator:V in ribs of the hub	Gauge Size:Safety mechanism atranslucent green colorBevel up Indicator:Raised embossed arrow onthe hub
Sterility	Same as predicate device.	Provided SterileSAL 10⁻⁶Ethylene Oxide

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The differences between the subject and predicate device are not critical to the intended use of the device and do not raise any new or different questions regarding safety or effectiveness.

Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with inhouse protocols to determine appropriate methods for evaluating the performance of the device:

Performance Testing - Bench:

Needle Tip ●
. Needle Dimensions
Cannula Surface Finish
Needle-Hub Tensile Force ●
Needle Stiffness
Effective Needle Lenath
Needle Echogenicity
Needle Bevel Up Indicator
Needle Hub ●
Needle Fluid Path ●
Introducer Needle Interface with Guidewire
Needle Protective Cover ●
. Magnetic Axis Orientation
Needle Tip to Magnet Length ●

Safety & Performance Tests

The following guidance documents and standards in conjunction with in-house protocols were used to determine the appropriate methods for evaluating the performance of the device:

· ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment – Part 1: General Requirements
· ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
· ISO 9626: 2001. Stainless steel needle tubing for the manufacturer of medical devices
· ISO 7864: 1993, Sterile hypodermic needles for single use
Guidance Document; Medical Devices with Sharps Injury Prevention Features, August 9, 2005
Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles, April 1993
· Guidance Document; Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile

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	• ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7:Ethylene Oxide Sterilization Residuals• ISO 11135:2014 Annex B Sterilization Of Health Care Products-Ethylene Oxide—Requirements For Development, Validation AndRoutine Control Of A Sterilization Process For Medical Devices
	The subject device met all predetermined acceptance criteria derived from theabove listed references and demonstrated substantially equivalentperformance as compared to the cited predicate device.
Summary ofSubstantialEquivalence	Based on the intended use, technological characteristics, and performancetesting, the subject 18G Pinpoint™ GT Introducer Needle meets therequirements that are considered sufficient for its intended use anddemonstrates substantial equivalence to the cited predicate device.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).