Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on a passive magnetic field and virtual image creation based on that field, with no mention of AI or ML algorithms for image processing, analysis, or decision support.

Therapeutic

No
The device is used to inject anesthetics and facilitate catheter placement, which are procedural steps, rather than directly treating a condition or disease.

Diagnostic

No.
The device is described as a needle intended for injecting local anesthetics and/or analgesics, which is a therapeutic function, not a diagnostic one. While it can be used with ultrasound for guidance, the device itself does not perform any diagnostic function to detect or identify a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Pinpoint™ GT Needle" which is a physical needle containing a magnet. It is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to inject local anesthetics and/or analgesics into a patient for regional anesthesia and/or catheter placement. This is a therapeutic and procedural use, not a diagnostic one.
Device Description: The device is a needle designed for injection and includes a magnetic component for visualization during ultrasound-guided procedures. This describes a medical device used for a procedure, not for testing samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.
The peripheral nerve block Pinpoint™ GT Needle may be used in any appropriate patient population.

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

BSP

Device Description

Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The Pinpoint™ GT Needle, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The subject device can be used with or without ultrasound assisted procedures and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.

The subject peripheral nerve block Pinpoint™ GT Needles included in this submission will be offered in varying configuration types, as summarized in the table below:

Pinpoint™ GT Needles	Needle configurations
18G x 2.75", 19°
21G x 3", 30°
22G x 2", 30°
24G x 1.5", 30°
18G x 3", Tuohy (containing a preloaded stylet)

Mentions image processing

Not Found

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

Not Found

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 Performance Tests listed were conducted per standards in conjunction with in-house protocols to determine appropriate methods for evaluating the performance of the device. The subject device configurations met all predetermined acceptance criteria derived from the verification tests 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.

K113207

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.

K142445

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

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).

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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

June 27, 2017

C.R. Bard, Inc. % Silvia De La Barra Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116

Re: K163216

Trade/Device Name: Pinpoint™ GT Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 25, 2017 Received: May 30, 2017

Dear Silvia De La Barra:

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

1

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,

James P. Bertram -S

for

CDR Lori A. Wiggins, MPT, CLT 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)

K163216

Device Name

Pinpoint™ GT Needles

Indications for Use (Describe)

The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.

The peripheral nerve block Pinpoint™ GT 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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Image /page/3/Picture/1 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in a bold, sans-serif font, with the "A" stylized as an inverted "V". 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)

| General
Provisions | Submitter Name:
Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Silvia De La Barra
(801) 522-5909
(801) 522-4969
27 June 2017 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Subject Trade Name:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | Pinpoint™ GT Needles
Anesthesia Needle
Anesthesia Conduction Needle
BSP
21 CFR §868.5150
II
Anesthesiology |
| Predicate
Device | Predicate Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | SonoTAP Needle
K113207 (cleared February 29, 2012)
Pajunk Medical System
Anesthesia Needle
Anesthesia Conduction Needle
BSP
21 CFR §868.5150
II
Anesthesiology |
| Reference
Device | Reference Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | Pinpoint™ GT Safety Introducer Needle
K142445 (cleared April 13, 2015)
Bard Access Systems, Inc.
Safety Introducer Needle
Catheter Introducer
DYB
21 CFR §870.1340
II
Cardiovascular |
| Device
Description | Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject
anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a
magnet which emits a passive magnetic field that can be detected by
ultrasound systems equipped with Pinpoint™ GT Needle Technology. The
Pinpoint™ GT Needle, when used with an ultrasound system equipped with
Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the
ultrasound display, providing clinicians with a visual representation of the | |

4

needle throughout the insertion process.

The subject device can be used with or without ultrasound assisted procedures
and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.

The subject peripheral nerve block Pinpoint™ GT Needles included in this submission will be offered in varying configuration types, as summarized in the table below:

Pinpoint™ GT Needles	Needle configurations
	18G x 2.75", 19°
	21G x 3", 30°
	22G x 2", 30°
	24G x 1.5", 30°
	18G x 3", Tuohy (containing a preloaded stylet)

| Intended Use | The peripheral nerve block Pinpoint™ GT Needles are intended to inject
anesthetic and/or analgesics to provide regional anesthesia and/or to facilitate
the placement of a catheter. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The peripheral nerve block Pinpoint™ GT Needle is intended for use in
injecting local anesthetics and/or analgesics into a patient to provide regional
anesthesia and/or analgesia and/or facilitate the placement of a catheter.
The peripheral nerve block Pinpoint™ GT Needle may be used in any
appropriate patient population. |
| | The technological characteristics of the subject peripheral nerve block
Pinpoint™ GT Needles are substantially equivalent with respect to the basic
design and function to those of the cited predicate device. The differences
between the subject and predicate device (e.g. the addition of the passive
magnet) are not critical to the intended use of the device and do not raise new
or different questions regarding equivalence. |
| | The following table provides a comparison between the technological
characteristics of the subject and predicate device. |
| Technological
Characteristics | The indications for use of the subject device are different compared to the
predicate device. The differences provide additional specificity on the use of
the subject device. These differences in the indications for use are not critical
to the intended therapeutic, diagnostic, or surgical use of the subject device
(i.e., to administer anesthetics and/or analgesics to provide regional
anesthesia). Additionally, the minor differences do not affect the safety and
effectiveness of the device when used as labeled. |
| | The primary technological differences between the subject and predicate
devices include material differences, needle tip design, and the addition of a
passive magnet on the subject device. These technological differences do not
impact substantial equivalence because they do not alter the general purpose
or function of the device, or change the patient population, therapeutic or
diagnostic use of the subject device compared to the predicate device. The
technological differences were evaluated using appropriate test methods and |

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requirements, as defined in the Risk Assessment, to ensure they perform according to their intended use and do not raise different questions of safety and efficacy. The needle tip designs include common industry configurations, and all materials were determined to be biocompatible in accordance with the intended use of the subject device. Additionally, the risks associated with the use of the subject device with Pinpoint™ GT Needle Technology have been further mitigated, and the benefits have been determined to outweigh the risks of using the subject Pinpoint™ GT Needle with the Pinpoint™ GT Needle Technology (not the subject of this submission).

Therefore, the differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

Subject and Predicate Device Comparison Table				Needle Shaft
Attribute	Subject:
Pinpoint™ GT Needle	Primary Predicate:
SonoTAP Needle	Needle
Components	Needle tip:
Echogenic
Curve Tip (Tuohy)
A Bevel 19°
Short Bevel 30°	Needle tip:
Echogenic
Curve Tip (Tuohy)
Quincke tip
Crawford tip
Chiba tip
Owner	Bard Access Systems, Inc.	PAJUNK MEDICAL
SYSTEMS		Hub:
Same as Predicate Device	Hub:
Open ended Luer locking hub
Bevel Indicator
Classification	Same as predicate	BSP - 21 CFR 868.5150
Anesthesia Conduction
Needle		Luer Hub:
Makrolon®2458
Polycarbonate
Clear	Luer Hub:
Information is not publically
available
510k Status	Subject of this
Premarket Notification	K113207 - Concurrence date
February 29, 2012		Needle Shaft:
Silicone Coated alloy	Needle shaft:
Information is not publically
available
Commercial
Name	Pinpoint™ GT Needle	SonoTAP Needle		Magnet:
Neodymium Iron Boron
(NdFeB)
Nickel (Ni) Coated	Magnet:
None
Intended Use	The peripheral nerve block
Pinpoint™ GT Needles
are intended for use in
injecting local anesthetics
and/or analgesics into a
patient to provide regional
anesthesia and/or
analgesia and/or to
facilitate the placement of
a catheter.	The cannulas/needles for
anesthesia and analgesia
enhanced for ultrasound
visibility- Tuohy Sono, Sono
TAP, Quincke Sono, Chiba
Sono, Sono and Crawford
Sono - are intended for the
transient delivery of
anesthetics to provide
regional anesthesia and
analgesia or to facilitate
placement of a catheter.	Needle
Materials	Cap:
Polypropylene
*Available only on the Tuohy
Needle; the other needles do
not include a cap.	Cap:
Information is not available
Indications for
Use	The peripheral nerve block
Pinpoint™ GT Needle is
intended for use in
injecting local anesthetics
and/or analgesics into a
patient to provide regional
anesthesia and/or
analgesia and/or to
facilitate the placement of
a catheter.
The peripheral nerve block
Pinpoint™ GT Needle may	The cannulas/needles for
anesthesia and analgesia
enhanced for ultrasound
visibility- Tuohy Sono, Sono
TAP, Quincke Sono, Chiba
Sono, Sono and Crawford
Sono - are intended for the
transient delivery of
anesthetics to provide
regional anesthesia and
analgesia or to facilitate
placement of a catheter.		Stylet:
Polypropylene
*Available only on the Tuohy
Needle; the other needles do
not include a stylet.	Stylet:
Information is not available
	be used in any appropriate
patient population.			Needle Protective Cover
(packaging retainer):
High Density Polyethylene
(HDPE)
No colorant	Needle Protective Cover
(packaging retainer):
Information is not available
Scientific
Technology
Description	The primary intent of the
subject device, peripheral
nerve block Pinpoint™ GT
Needles, are to inject
anesthetic for regional
anesthesia and/or to
facilitate the placement of
a catheter.
Additionally, the peripheral
nerve block Pinpoint™ GT
Needles contain, 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 Needle
Technology. The
Pinpoint™ GT Needle
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 Needle
Technology is an optional
feature and tool/device
offered to clinicians for
visual representation of a
needle throughout the
anesthetic process; the
presence of the passive
magnet does not impact
the ability of the device to
perform as an anesthetic
needle.	The SonoTAP cannula has
been designed especially to
meet the requirements for
single shot TAP and rectus
sheath blocks.
Equipped with the patented
"Cornerstone" reflectors, it
ensures that the ultrasonic
waves are maximally
reflected at both steep and
shallow puncture angles. This
is an essential prerequisite
for the precise placement of
the cannula in the appropriate
neurovascular plane.		Diameter:
18G, 21G, 22G and 24G	Diameter:
16G - 26G
Needle
Dimensions	Length:
38.1mm, 50.8mm,
69.85mm, 76.2mm	Length:
20mm - 180mm

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7

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| Needle
Labeling | Gauge Size:
Tuohy needle – 18G
indicated by hub color (i.e.,
pink)

Other needles - Gauge
size not identified | Gauge Size:
Information is not publically
available |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Bevel up Indicator:
V in ribs of the hub | Bevel up Indicator:
Raised feature on the Cap |
| Catheter
Compatibility | 20G catheter

Compatible only with the 18G
Needles | Needles are compatible with
catheters per Instructions for
use, however catheter sizes
are not publicly available |
| Sterility | Same as Predicate Device | Provided Sterile
SAL $10^{-6}$
Ethylene Oxide |

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

	Performance Tests	Test Description / Standard Utilized
Performance
Tests	Needle Lumen Patency	ISO 7864:1993, Sterile hypodermic
needles for single use
	Needle-Hub Tensile	ISO 7864:1993, Sterile hypodermic
needles for single use
	Effective Needle Length	ISO 7864:1993, Sterile hypodermic
needles for single use
	Needle Tip Inspection	ISO 7864:1993, Sterile hypodermic
needles for single use
Cannula Surface Finish	ISO 9626:1991/Amd 1, 2001, Stainless
steel needle tubing for the manufacturer
of medical devices
Needle OD and ID
Dimensions	ISO 9626:1991/Amd 1, 2001, Stainless
steel needle tubing for the manufacturer
of medical devices
ASTM A908-03 (2013): Standard
Specification for Stainless Steel Needle
Tubing
Needle Stiffness	ISO 9626:1991/Amd 1, 2001, Stainless
steel needle tubing for the manufacturer
of medical devices
Corrosion	ISO 9626:1991/Amd 1, 2001, Stainless
steel needle tubing for the manufacturer
of medical devices
Performance
Tests
Cont.	Needle Hub - Luer
Connector Testing	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
	Fluid Path Leakage	ISO 594-2:1998, Conical fittings with
6% luer taper for syringes, needles and
certain other medical equipment - Part
2: Lock Fittings
	Needle Particulate	USP (2011): Particulate Matter in
Injections
	Needle Echogenicity
	Needle Bevel Up
Indicator
	Priming Volume
	Needle Interface With
Catheter
	Magnetic Axis orientation	Bard internal standards and procedures
	System Compatibility	Bard internal standards and procedures
	Needle Tip to Magnet
Length
	Needle Chemical
Properties
	Needle Bevel Dimensions
(Primary Grind)
	Needle Insertion Force
	Biocompatibility	• ISO 10993-1:2009, Biological Evaluation
of Medical Devices – Part 1: Evaluation
and Testing Within a Risk Management
Process
• ISO 10993-5:2009, Biological Evaluation
of Medical Devices - Part 5: Tests for in
vitro cytotoxicity
• ISO 10993-10:2010, Biological
Evaluation of Medical Devices – Part 10:
Tests for irritation and skin sensitization
• ISO 10993-11:2006, Biological
Evaluation of Medical Devices - Part 11:
Tests for systemic toxicity
• ISO 10993-12:2012, Biological
Evaluation of Medical Devices - Part 12:
Sample preparation and reference
materials
Performance
Tests
Cont.	Sterilization	ISO 10993-7:2008, Biological Evaluation
of Medical Devices – Part 7: Ethylene
Oxide Sterilization Residuals.
ANSI/AAMI/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 configurations met all predetermined acceptance criteria
derived from the above listed verification tests and demonstrated substantially
equivalent performance as compared to the cited predicate device.
Based on the intended use, technological characteristics, and performance
testing, the subject peripheral nerve block Pinpoint™ GT Needles met the
Summary of
requirements that are considered sufficient for its intended use and
Substantial
demonstrates that the subject devices are substantially equivalent to the
Equivalence
predicate device cited.

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