Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.

Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.

Device Description

Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Needle Guide Kits. It outlines the device's intended use, technological characteristics, and safety and performance testing. However, the document does not contain information about an AI/algorithm-driven device, nor does it present "acceptance criteria" and "reported device performance" in the context of an AI study with human readers and ground truth established by experts.

The document primarily focuses on the physical and mechanical aspects of a sterile, single-use needle guide kit used with ultrasound systems, comparing it to a predicate device. The "tests" mentioned are for device validation and verification, such as "Needle Guide Depth Accuracy," "Force to Insert a Needle," and "Packaging Integrity." These are engineering and manufacturing tests, not clinical performance studies involving AI or human interpretation of diagnostic images.

Therefore, I cannot fulfill your request for the specific information regarding AI models, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

The document discusses:

Device: Pinpoint™ GT Needle Guide Kits
Intended Use: To be used with Site~Rite® Ultrasound Systems to guide a needle for placement of its tip in a specific structure, and probe covers to sheath the transducer and isolate the surgical site.
Predicate Device: Site~Rite® Needle Guide Kits and Probe Cover Kit.
Modifications from Predicate: New packaging, modified needle guides (including insertion funnel and stabilizing notches, and different colorant formulations but same base materials), additional probe cover offering (96" vs 48" length, dimensional changes and different material formulation), and labeling updates.
Testing: Verification and validation tests conducted per design controls, guidance documents, and internal protocols. These tests focus on the physical performance and safety of the needle guides and probe covers (e.g., loading, force to insert/remove needle, depth accuracy, material compatibility, damage, retention, packaging integrity, sterile barrier integrity, and biocompatibility/sterilization standards).

In summary, the provided document does not support a response to your prompt because it describes a physical medical device (needle guides), not a software or AI-driven diagnostic device that would necessitate the type of performance study criteria you've outlined.

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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

May 22, 2017

C.R. Bard, Inc. Bard Access Systems, Inc % Mr. Christopher Phillips Regulatory Affairs Associate Manager 650 North 5600 West SALT LAKE CITY UT 84116

Re: K171348

Trade/Device Name: Pinpoint™ GT Needle Guide Kits Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: May 5, 2017 Received: May 8, 2017

Dear Mr. Phillips:

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 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.

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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/Resourcesfor You/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 yours.

Michael D. D'Hara
For

Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171348

Device Name Pinpoint™ GT Needle Guide Kits

Indications for Use (Describe)

Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.

Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/2 description: The image shows the logo for BARD Access Systems. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary 21 CFR 807.92(a)

GeneralProvisions	Submitter Name:Address:Contact Person:Telephone Number:Fax Number:Date of Preparation:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116Christopher M. Phillips801.522.5000 ext 5965801.522.509105 May 2017
SubjectDevice Kits	Trade Name:Common Name:Regulation Name:Product Code:Regulation Number:Regulatory Class:Classification Panel:	Pinpoint™ GT Needle Guide KitsTransducer, Ultrasonic, DiagnosticDiagnostic Ultrasonic TransducerITX21 CFR 892.1570Class IIRadiology
PredicateDevice Kits	Trade Name:Common Name:Regulation Name:Premarket Notification:Product Code:Regulation Number:Regulatory Class:Manufacturer:Classification Panel:	Site~Rite® Needle Guide Kits and Probe Cover KitTransducer, Ultrasonic, DiagnosticDiagnostic Ultrasound TransducerK042445 (cleared Oct. 19, 2004)ITX21 CFR 892.1570Class IIBard Access Systems, Inc.Radiology

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A summary of the sterile, single-use ultrasound accessories included in subject device kits is included in the Table below.

	Summary of Sterile, Single-Use Ultrasound Accessories included inSubject Device Kits (Pinpoint™ GT Needle Guide Kits)
DeviceDescription	Shallow Pinpoint™ GTNeedle Guide Kit with a96" Site~Rite® ProbeCover	A set of shallow Pinpoint™ GT Needle Guides(0.5cm, 1.0cm, 1.5cm, and 2.0cm depths), Conductive gel, A 96" 1 mil Site~Rite® Probe Cover, and Elastic bands
	Deep Pinpoint™ GTNeedle Guide Kit with a96" Site~Rite® ProbeCover	A set of deep Pinpoint™ GT Needle Guides(2.5cm, 3.0cm, and 3.5cm depths), Conductive gel, A 96" 1 mil Site~Rite® Probe Cover, and Elastic bands
	Shallow Pinpoint™ GTNeedle Guide Kit with a48" Site~Rite® ProbeCover	A set of shallow Pinpoint™ GT Needle Guides(0.5cm, 1.0cm, 1.5cm, and 2.0cm depths)*, Conductive gel, A 48" 1 mil Site~Rite® Probe Cover, and Elastic bands
	Deep Pinpoint™ GTNeedle Guide Kit with a48" Site~Rite® ProbeCover	A set of deep Pinpoint™ GT Needle Guides(2.5cm, 3.0cm, and 3.5cm depths)*, Conductive gel, A 48" 1 mil Site~Rite® Probe Cover, and Elastic bands

*Indicates a change from the predicate device kits.

Intended Use	Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite®Ultrasound Systems.
Indications ForUse	Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite®Ultrasound Systems.
	Pinpoint™ GT Needle Guides provide guidance for a needle to intersect anultrasound beam at a fixed distance below the skin to assist the medicalpractitioner in placing the tip of a needle in a specific structure.
	Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgicalpenetration from microbial and other contamination.

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Technological Characteristics of the subject device kits. Pinpoint™ GT Needle Guide Kits, are substantially equivalent to the basic design and function to those of the cited predicate device kits. The differences do not alter the intended use of the subject device kits and do not raise new questions of equivalence.

Modifications made to the subject device kits when compared to the predicate device kits are as follows:

(1) New packaging configuration:
- New packaging configuration for the subject device kits (Pinpoint™ ● GT Needle Guide Kits).
(2) Modified needle quide offering:
- New subject Pinpoint™ GT Needle Guides will be offered in the ● subject device kits (Pinpoint™ GT Needle Guide Kits). The subject Pinpoint™ GT Needle Guides are modified from the predicate SiteRite® Needle Guides (which were included in predicate device kits), and include a needle insertion funnel and stabilizing notches. The subject Pinpoint™ GT Needle Guides also utilize different colorant formulations than the predicate SiteRite® Needle Guides, though they are comprised of the same base materials (Low-Density Polyethylene) and the same colorant additive base materials (Linear Low-Density Polyethylene) in the same blend.
(3) Additional probe cover offering:
- In addition to the predicate 48" 1 mil Site~~Rite® probe cover (which ● were included in predicate device kits), new subject 96" 1 mil Site~~Rite® Probe Cover will be offered in the subject device kits (Pinpoint™ GT Needle Guide Kits). The subject 96" 1 mil Site~~Rite® Probe Cover is modified from the predicate 48" long, 1 mill Site~~Rite® Probe Cover, and includes dimensional changes along with a different material formulation.
(4) Labeling updates:
- The Indications for Use statement for the subject device kit has been ● clarified from that of the predicate device kits to reflect Pinpoint™ GT and Site~Rite® branding, and
- An IFU and labels were generated for the subject device kits with ● content modified from the predicate device kits' IFU and labels, to provide clarity and to ensure safe and effective use of the subject device kit.

The differences identified above between the subject and predicate device kits do not alter the intended use of the subject device kits and do not raise any new questions of equivalence.

Technological Characteristics

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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 internal test protocols to determine appropriate methods for evaluating the performance of the device:

Validation of Pinpoint™ GT Needle Guide Use

Loading the Needle Guide ●
Force to Insert a Needle
Force to Remove a Needle

Verification Testing of the Pinpoint™ GT Needle Guide Kits and of the Ultrasound Accessories contained therein, including Pinpoint™ GT Needle Guides and 96" 1 mil Site~Rite® Probe Covers

Needle Guide Depth Accuracy ●
Needle Guide Depth Distinction and Material Compatibility
Needle Guide ID Dimension ●
Needle Guide Damage during Needle Insertion ●
Needle Guide Removal Force
Force to Remove a Needle from a Needle Guide ●
Needle Retention ●
Force to Insert a Needle ●
Packaging Integrity ●
Kit Component Integrity ●
Packaging Minimum Seal Width ●
Packaging Sterile Barrier Integrity ●

Safety & Performance Tests

The following guidance documents and standards were used to determine appropriate methods for evaluating the performance of the device:

AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of ● Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
AAMI / ANSI ST72:2011, Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
ASTM D4332-14, Standard Practice For Conditioning Containers, ● Packages, Or Packaging Components For Testing
. ASTM F1980-16, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices
ISO 10993-1: 2009, Biological Evaluation of Medical Devices; Part 1 -● Evaluation and Testing
ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: ● Ethylene Oxide Sterilization Residuals
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of ● Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-11 Second Edition 2006-08-15, Biological Evaluation Of ● Medical Devices - Part 11: Tests For Systemic Toxicity
ISO 10993-12 Fourth Edition 2012-07-01, Biological Evaluation Of Medical Devices - Part 12: Sample Preparation And Reference Materials
ISO 11135: 2014. Sterilization of healthcare products Ethylene Oxide ● - Requirements For Development, Validation And Routine Control Of A Sterilization

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Safety &PerformanceTests	ISO 11607-1 First Edition 2006-04-15, Packaging For TerminallySterilized Medical Devices - Part 1: Requirements For Materials,Sterile Barrier Systems And Packaging Systems [Including:Amendment 1 (2014)] ISO 11607-2 First Edition 2006-04-15, Packaging For TerminallySterilized Medical Devices - Part 2: Validation Requirements ForForming, Sealing And Assembly Processes [Including: Amendment 1(2014)] USP 39-NF34:2016, <85>, Bacterial Endotoxins Test USP 39-NF34:2016, <161>, Transfusion And Infusion AssembliesAnd Similar Medical Devices The subject device kits, Pinpoint™ GT Needle Guide Kits, met allpredetermined acceptance criteria derived from the above listed tests anddemonstrated substantially equivalent performance as compared to the citedpredicate device kits.Risk management, including failure mode and effects analysis (FMEA) of thesubject device kits (and the ultrasound accessories included therein) wasconducted in accordance with BS EN ISO 14971:2012, Medical Devices –Application of risk management to medical devices.
Summary ofSubstantialEquivalence	Based on the intended use, technological characteristics, and performancetesting, the subject device kits, Pinpoint™ GT Needle Guide Kits, meet therequirements that are considered sufficient for their intended use anddemonstrate substantial equivalence to the cited predicate device kits.

Safety &PerformanceTests

ISO 11607-1 First Edition 2006-04-15, Packaging For TerminallySterilized Medical Devices - Part 1: Requirements For Materials,Sterile Barrier Systems And Packaging Systems [Including:Amendment 1 (2014)] ISO 11607-2 First Edition 2006-04-15, Packaging For TerminallySterilized Medical Devices - Part 2: Validation Requirements ForForming, Sealing And Assembly Processes [Including: Amendment 1(2014)] USP 39-NF34:2016, <85>, Bacterial Endotoxins Test USP 39-NF34:2016, <161>, Transfusion And Infusion AssembliesAnd Similar Medical Devices The subject device kits, Pinpoint™ GT Needle Guide Kits, met allpredetermined acceptance criteria derived from the above listed tests anddemonstrated substantially equivalent performance as compared to the citedpredicate device kits.Risk management, including failure mode and effects analysis (FMEA) of thesubject device kits (and the ultrasound accessories included therein) wasconducted in accordance with BS EN ISO 14971:2012, Medical Devices –Application of risk management to medical devices.

Summary ofSubstantialEquivalence

Based on the intended use, technological characteristics, and performancetesting, the subject device kits, Pinpoint™ GT Needle Guide Kits, meet therequirements that are considered sufficient for their intended use anddemonstrate substantial equivalence to the cited predicate device kits.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.