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

Device Description

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by Ultrasound Systems equipped with Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ 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 a 510(k) premarket notification for the Pinpoint™ GT Safety Introducer Needle, arguing for its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The document relates to a physical medical device (introducer needle) and the performance tests described are for the physical properties and safety of this device, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance for an AI/algorithm.
Sample size used for the test set and data provenance for AI.
Number of experts and their qualifications for establishing ground truth for AI.
Adjudication method for AI.
MRMC comparative effectiveness study results for AI.
Standalone performance for an algorithm.
Type of ground truth used for AI.
Sample size for the training set for AI.
How ground truth for the training set was established for AI.

The Pinpoint™ GT Safety Introducer Needle is a physical device, not an AI-powered diagnostic/predictive tool. The "Pinpoint™ GT Technology" mentioned is described as a passive magnet that interacts with an Ultrasound System to create a "virtual image of the needle on the Ultrasound display." This indicates a hardware-software integration for visualization, not an AI algorithm performing diagnostic interpretation or prediction.

What the document does provide regarding acceptance criteria and performance:

The document states that a series of verification and validation tests were performed "in accordance with Design Controls as per 21 CFR §820.30" and various ISO standards and guidance documents.
"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."

Summary of Performance Tests (Bench, Biocompatibility):

Bench Tests:

Dimensional Analysis
Assembly Leak
Hub to Cannula Bond Strength
Needle Stiffness
ISO Luer Compliance
Guidewire Compatibility
Safety Mechanism Override
Visual Inspection
Corrosion
Usability and Simulated Use
Blood Flash
Echogenicity
Magnet Testing
Particulate testing (USP <788>)

Biocompatibility Testing:

Cytotoxicity
Sensitization
Intracutaneous
Acute Systemic Toxicity
Pyrogenicity
Rabbit Blood Hemolysis
Unactivated partial Thromboplastin Time Assay
Dog Thrombogenicity

The document asserts that the device met the acceptance criteria for these tests (which would be defined by the referenced standards and internal protocols), thereby demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or detailed results of these tests are not provided in this summary document. It only states that the criteria were met.

Summary

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

April 13, 2015

Bard Access Systems, Inc. M.s Amy McManus Regulatory Affairs Specialist II 605 North 5600 West Salt Lake City, UT 84116

Re: K142445

Trade/Device Name: Pinpoint™ GT Safety Introducer Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: March 12, 2015 Received: March 13, 2015

Dear Ms. McManus:

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 (reporting of medical device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours.

Tina
Kiang-S

for Erin I. Keith, M.S. 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):

K142445

Device Name:

Pinpoint™ GT Safety Introducer Needle

Indications for Use:

Prescription Use (Part 21 CFR §801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below that, in a smaller, sans-serif font, are the words "ACCESS SYSTEMS."

510(k) Summary 21 CFR 807.92(a)

	Submitter Name:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person:	Amy McManusRegulatory Affairs Specialist II
	Telephone Number:	(801) 522-5724
	Fax Number:	(801) 522-5425
	Date of Preparation:	April 10, 2015
	Trade Name:	Pinpoint™ GT Safety Introducer Needle
SubjectDevice	Common Name:	Safety Introducer Needle
	Classification Name:	Catheter Introducer
	Product Code/Regulation:	DYB/21 CFR §870.1340
	Predicate Trade Name:	SecureLoc™ Safety Introducer Needle
Predicate Device	Classification Name:	Catheter Introducer
	Premarket Notification:	K050023
	Manufacturer:	Bard Access System, Inc.
	Reference Device Trade Name:	Soma Access Systems ExactTrack™ IProcedure Kit
ReferenceDevice	Classification Name:	Ultrasonic Pulsed Echo ImagingSystem
	Premarket Notification:	K113680
	Manufacturer:	Soma Access Systems LLC

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive Device magnetic field that can be detected by Ultrasound Systems equipped with Description Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ 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.

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Intended Use	The Pinpoint™ GT Safety Introducer Needle is designed for percutaneousvasculature access or procedures requiring the placement of a guidewire.
Indications ForUse	The Pinpoint™ GT Safety Introducer Needle is intended for patients requiringpercutaneous access to place a guidewire for subsequent placement ofcatheters or other medical procedures requiring introducer needle access.The Pinpoint™ GT Safety Introducer Needle may be used in any appropriatepatient population.
TechnologicalCharacteristics	Technological characteristics of the subject Pinpoint™ GT Safety IntroducerNeedle are substantially equivalent with respect to basic design and functionto those of the predicate, Bard Access Systems, Inc.'s SecureLoc™ SafetyIntroducer Needle. The differences are not critical to the intended use of thedevice and do not raise any new questions regarding safety or effectiveness.

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Table1– Subject Device Attribute and Technology Comparison Table
Device Attribute	Subject:PinpointTM GT Safety Introducer Needle	Primary Predicate:Introducer NeedleSecureLocTM	Reference Device:Magnet Tracking System(Needle TechnologyExactTrackTM Procedure Kit(AKA AxoTrackTM))
Owner	Bard Access Systems, Inc.	Bard Access Systems, Inc.	Soma Access Systems LLC.
NeedleComponents	Needle tip:-Echogenic-A Bevel	Needle tip:-Available as Echogenic andnon-echogenic-Modified B Bevel	Needle tip:-Bevel type is not publicallyavailable
	Open ended luer locking hubBevel IndicatorIncorporated active safety mechanismPassive Magnet	Open ended luer locking hubBevel IndicatorIncorporated active safetymechanism	HubBevel IndicatorDoes not contain a safety mechanismPassive Magnet
Needle Dimensions	• Length: 7 cm• Diameter: 21 gauge	• Length: 5.08 -8.89 cm• Diameter: 18, 19 and 21 gauge	• Length: Information not publicallyavailable• Diameter: 18 gauge
Needle-shield(SafetyMechanism)feature description	The PinpointTM GT Safety IntroducerNeedle includes an active safety guardmechanism. The safety guard is manuallyactivated by the user sliding the	Needle includes an active safetyguard mechanism. The safety guardis manually activated by the user.The user sliding the mechanism	Device does not contain a safetymechanism.
Table1- Subject Device Attribute and Technology Comparison Table
Device Attribute	Subject:PinpointTM GT Safety Introducer Needle	Primary Predicate:Introducer NeedleSecureLocTM	Reference Device:Magnet Tracking System(Needle TechnologyExactTrackTM I Procedure Kit(AKA AxoTrackTM))
	mechanism down the needle cannula andover the needle tip. As the safetymechanism passes over the needle tipthe safety locks into place, securing andcovering the tip.	down the needle cannulation andover the needle tip; as themechanism passes over the needletip the safety locks into place,securing and covering the tip.	The data was gathered from publiclyavailable resources. See Attachment4 for all resources used.
GuidewireCompatibility	21 Ga NeedleSame as Primary PredicateGW OD ≤ 0.018"	21 Ga NeedleGW OD ≤ 0.018"	18 Ga NeedleGW OD ≤ 0.035" (0.89 mm)

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

ISO 11070: 1998, Sterile, single use intravascular catheter introducer
· 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
BSI BS EN ISO 23908: 2013, Sharps injury protection
· 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: Applving Human Factors and Usabilitv 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
ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
ISO 11135:2007, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
· ISO 6009: 1992, Hypodermic Needles for Single Use- Colour Coding for Identification

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.

Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2012, Medical Devices – Risk Management for Medical Devices.

Performance Tests

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Performance Testing- Bench:

Dimensional Analysis
Assembly Leak
Hub to Cannula Bond Strength
Needle Stiffness
ISO Luer Compliance
Guidewire Compatibility
Safety Mechanism Override
Visual Inspection
Corrosion
Usability and Simulated Use
Blood Flash

Performance

Tests
Echogenicity
Magnet Testing
Particulate testing (USP <788>)

Biocompatibility Testing:

· Cytotoxicity
Sensitization
Intracutaneous
Acute Systemic Toxicity
· Pyrogenicity
Rabbit Blood Hemolysis
Unactivated partial Thromboplastin Time Assay
· Dog Thrombogenicity

Summary of Substantial Equivalence

Based on the intended use, technological characteristics, and safety and performance testing, the subject Pinpoint™ GT Safety Introducer Needle met the requirements that are considered sufficient for its intended use and is as safe and as effective as predicate device cited.

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).