Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a passive magnetic field and a virtual image created by the ultrasound system, not on AI/ML processing of the ultrasound data.

Therapeutic

No.
The device is an introducer needle used for percutaneous access and guidewire placement, which is a procedural tool rather than a device designed to treat a medical condition or disease.

Diagnostic

No

The device is an introducer needle used for percutaneous access and guidewire placement, which is a procedural tool. While it aids in visualization during the procedure, it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical needle with a magnet, which is a hardware component. The software component (PinpointTM GT Technology) is part of a larger system that interacts with this hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Pinpoint™ GT Introducer Needle is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
Device Description: The description details a needle designed for percutaneous access and its features for use with an ultrasound system. It does not mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information based on sample analysis

The device is a surgical/procedural tool used to facilitate other medical procedures, not a diagnostic test performed in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DYB

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.

Mentions image processing

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.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

any appropriate patient population

Intended User / Care Setting

clinicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 in-house 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 Length
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:

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
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 And Routine Control Of A Sterilization Process For Medical Devices

Key results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142445

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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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.

1

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,

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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

2

Indications for Use

510(k) Number (if known) K162769

Device Name

Pinpoint™ GT Introducer Needle

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

21 CFR 807.92(a)

| | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Contact Person: | Ms. Jamie Howell
Regulatory Affairs Specialist |
| | Telephone Number:
Fax Number:
Date of Preparation: | 801-522-5465
801-522-5425
29 September 2016 |
| Subject
Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code: | PinpointTM GT Introducer Needle
Introducer Needle
21 CFR §870.1340
Catheter Introducer
II
DYB |
| Predicate
Devices | Premarket Notification:
Trade Name:
Common Name:
Regulation Number
Regulation Name:
Regulatory Class:
Product Code: | K142445, date of clearance April 13, 2015
PinpointTM GT Safety Introducer Needle
Introducer Needle
21 CFR §870.1340
Catheter Introducer
II
DYB |
| 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. | |
| Intended Use | The PinpointTM GT Introducer Needle is designed for percutaneous vascular
access or procedures requiring the placement of a guidewire. | |
| Indications For
Use | The PinpointTM 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 PinpointTM GT Introducer Needle may be used in any
appropriate patient population. | |

4

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 Introducer
Needle	Predicate:
Pinpoint™ GT Safety
Introducer Needle
Owner	Bard Access Systems, Inc.	Bard Access Systems, Inc.
Classification	Same as predicate device.	DYB – 21 CFR §870.1340
Catheter Introducer
510k Status	Subject of this
Premarket Notification	K142445 - date of clearance
April 13, 2015
Commercial
Name	Pinpoint™ GT Introducer
Needle	Pinpoint™ GT Safety
Introducer Needle
Indications for
Use	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	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
		requiring introducer needle
access. The Pinpoint™ GT
GT Introducer Needle may
be used in any appropriate
patient population.	introducer needle
access. The Pinpoint™ GT
Safety Introducer Needle
may be used in any
appropriate patient
population.
		The primary intent of the
subject device, Pinpoint™
GT Introducer Needle, is
to assist with
percutaneous vasculature
access or procedures
requiring the placement of
a guidewire.	The primary intent of the
predicate device, Pinpoint™
GT Safety Introducer
Needle, is to assist with
percutaneous vasculature
access or procedures
requiring the placement of a
guidewire.
Technological
Characteristics
(cont.)	Scientific
Technology
Description	Additionally, the Pinpoint™
GT Introducer Needle
contains, integral, within
the needle hub a passive
magnet. The needle's
incorporated passive
magnet can be detected
by an ultrasound system
equipped with Pinpoint™
GT Technology. The
Pinpoint™ GT Technology
(not the subject of this
submission) consists of a
magnet sensing probe and
software loaded on
ultrasound equipment,
creating the Pinpoint™ GT
System; this system is
capable of displaying a
visual representation of
the needle on an
ultrasound image. The
detection of the needle's
passive magnet by the
Pinpoint™ GT technology
is an optional feature and
tool/device offered to
clinicians for visual
representation of a needle
throughout the insertion
process; the presence of
the passive magnet does
not impact the ability of the
device to perform as an
introducer needle.	Additionally, the Pinpoint™
GT Safety Introducer Needle
contains, integral, within the
needle hub an active safety
mechanism and a passive
magnet. The needle's
incorporated passive
magnet can be detected by
an ultrasound system
equipped with Pinpoint™ GT
Technology. The Pinpoint™
GT Technology (not the
subject of this submission)
consists of a magnet
sensing probe and software
loaded on ultrasound
equipment, creating the
Pinpoint™ GT System; this
system is capable of
displaying a visual
representation of the needle
on an ultrasound image.
The detection of the
needle's passive magnet by
the Pinpoint™ GT
technology is an optional
feature and tool/device
offered to clinicians for
visual representation of a
needle throughout the
insertion process; the
presence of the passive
magnet does not impact the
ability of the device to
perform as an introducer
needle.
	Needle
Components	Needle Shaft:
Same as predicate device.
Needle tip:
Same as predicate device.
A Bevel 19°
Hub:
Same as predicate device.	Needle Shaft:
Silicone coated
Needle tip:
Echogenic
A Bevel 12°
Hub
Open ended luer locking hub
Bevel Indicator
Passive Magnet
Technological
Characteristics
(cont.)	Needle
Materials	Luer Hub:
Same as predicate device
Needle Shaft:
Same as predicate device.
Magnet:
Same as predicate device.
Needle Protective Cover
(packaging retainer):
High Density Polyethylene
(HDPE)
No colorant
Safety Mechanism:
None	Luer Hub:
Clear Polycarbonate
Needle shaft:
Silicone Coated Alloy
Magnet:
Neodymium Iron Boron
(NdFeB)
Nickel (Ni) Coated
Needle Protective Cover
(packaging retainer):
Clear Amorphous
Polyethylene Terephtalate
(APET)
Safety Mechanism:
Translucent Green
Polycarbonate
Silicone O-ring
301 Stainless Steel
Cap polycarbonate
	Needle
Dimensions	Diameter:
18 gauge
Length:
Same as predicate	Diameter:
21 gauge
Length:
2.75" or 7cm
	Needle
Labeling	Gauge Size:
No gauge size coloring
due to removal of the
safety mechanism
Bevel up Indicator:
V in ribs of the hub	Gauge Size:
Safety mechanism a
translucent green color
Bevel up Indicator:
Raised embossed arrow on
the hub
Sterility	Same as predicate device.	Provided Sterile
SAL 10⁻⁶
Ethylene Oxide

5

6

7

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

8

| | • 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 And
Routine Control Of A Sterilization Process For Medical Devices |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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
Substantial
Equivalence | Based on the intended use, technological characteristics, and performance
testing, the subject 18G Pinpoint™ GT Introducer Needle meets the
requirements that are considered sufficient for its intended use and
demonstrates substantial equivalence to the cited predicate device. |