(198 days)
No
The description focuses on a passive magnetic field and virtual image creation based on detection by an ultrasound system, with no mention of AI or ML algorithms for image processing, analysis, or decision support.
No
The device is a needle used for injection or fluid withdrawal, it does not directly provide therapy.
No
Explanation: The device is a needle intended for injection or aspiration of fluids. While it can be visualized with ultrasound, its primary function is not to diagnose medical conditions but to facilitate procedures that may be part of a diagnostic or treatment process.
No
The device description clearly states that the device is a hypodermic needle containing a magnet, which is a physical hardware component. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection and withdrawal of body fluids from parts of the body below the surface of the skin. This is a direct interaction with the patient's body for therapeutic or diagnostic sampling purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is a needle designed for injection and aspiration, and it uses a magnetic field to enhance visualization during ultrasound-guided procedures. This is a surgical/procedural tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
The device is clearly intended for use in vivo (within the living body) to facilitate procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.
Product codes (comma separated list FDA assigned to the subject device)
PVZ
Device Description
Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are designed to inject medication or aspirate fluid. The hypodermic Pinpoint™ GT Needles contain a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The hypodermic Pinpoint™ GT Needles, 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, medication administration and aspiration process.
There are four (4) hypodermic Pinpoint™ GT Needle configurations included in this submission, as shown in the table below.
Needle configurations
18G x 2.75", 19°
21G x 3", 30°
22G x 2", 30°
24G x 1.5", 30°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
parts of the body below the surface of the skin
Indicated Patient Age Range
Not Found
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 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:
Needle Lumen Patency
Needle-Hub Tensile Force - ISO 7864:1993, Sterile hypodermic needles for single use
Effective Needle Length
Needle Tip Inspection
Cannula Surface Finish - ISO 9626:1991/Amd 1, 2001, Stainless steel needle tubing for the manufacturer of medical devices, ISO 7864:1993, Sterile hypodermic needles for single use
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
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
Magnetic Axis Orientation
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
Key Results: 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.
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.
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.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a stream.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
C. R. Bard, Inc. Jamie Howell Associate Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K163437
Trade/Device Name: hypodermic Pinpoint™ GT Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PVZ Dated: June 19, 2017 Received: June 20, 2017
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.
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,
Lori A. Wiggins -S6
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
2
Indications for Use
510(k) Number (if known) K163437
Device Name
hypodermic Pinpoint™ GT Needle
Indications for Use (Describe)
The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.
| 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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3
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 the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font.
K163437
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:
Telephone Number:
Fax Number:
Date of Preparation: | Jamie (Howell) Duke
Associate Regulatory Affairs Specialist
(801) 522-5465
(801) 522-4969
23 June 2017 |
| Subject
Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Manufacturer:
Classification Panel: | hypodermic Pinpoint™ GT Needle
Hypodermic Needle
21 CFR §880.5570
Needle, Hypodermic, Single Lumen
II
PVZ
Bard Access Systems, Inc.
General Hospital |
| Primary
Predicate
Device | Premarket Notification:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Manufacturer:
Classification Panel: | K021475; date of clearance, July 19, 2002
BD Single Lumen Needle
Hypodermic Needle
21 CFR §880.5570
Needle, Hypodermic, Single Lumen
II
FMI
Becton Dickinson & Company
General Hospital |
| Reference
Device | Premarket Notification:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Manufacturer:
Classification Panel: | K142445, date of clearance, April 13, 2015
Pinpoint™ GT Safety Introducer Needle
Safety Introducer Needle
21 CFR §870.1340
Catheter Introducer
II
DYB
Bard Access Systems, Inc.
Cardiovascular |
4
| Device
Description | Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are
designed to inject medication or aspirate fluid. The hypodermic Pinpoint™
GT Needles contain a magnet which emits a passive magnetic field that can
be detected by ultrasound systems equipped with Pinpoint™ GT Needle
Technology. The hypodermic Pinpoint™ GT Needles, 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,
medication administration and aspiration process.
There are four (4) hypodermic Pinpoint™ GT Needle configurations included
in this submission, as shown in the table below. | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | hypodermic Pinpoint™
GT Needles | Needle configurations |
| | | 18G x 2.75", 19° |
| | | 21G x 3", 30° |
| | | 22G x 2", 30° |
| | | 24G x 1.5", 30° |
| Intended Use | The hypodermic Pinpoint™ GT Needles are intended for the injection of
medication into or the withdrawal of body fluids from parts of the body below
the surface of the skin. The needle is to be used with syringes for general
purpose fluid injection/aspiration. | |
| Indications For
Use | The hypodermic Pinpoint™ GT Needle is intended for the injection of
medication into or the withdrawal of body fluids from parts of the body below
the surface of the skin. The needle is to be used with syringes for general
purpose fluid injection/aspiration. The needle tip is echogenic and may be
used with ultrasound to provide a visual representation of the needle tip
throughout the insertion, medication administration and aspiration process. | |
| Technological
Characteristics | The technological characteristics of the subject hypodermic 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 any new or different
questions regarding equivalence.
The subject and predicate devices share equivalent intended use and patient
population. The subject device differs from its primary predicate in terms of in
types of materials used, dimensions (gauges, lengths), needle tip
configurations and the addition of a passive magnet on the subject device.
The difference in materials, dimensions (gauges, lengths), and needle tip
configurations do not alter the indications for use or intended use of the
needles, nor do they raise different questions of equivalence between the
subject device and the primary predicate device. A reference device is
introduced to support the material and dimensional features of the subject
device. Nonclinical testing further demonstrates the equivalence of the
subject device to its predicates. | |
5
| | Attribute | Subject:
hypodermic
Pinpoint™ GT
Needles | Primary Predicate:
BD Single Lumen
Needle | Reference:
Pinpoint™ GT
Safety Introducer
Needle |
|-----------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Owner | Bard Access Systems,
Inc. | Becton Dickinson &
Company | Bard Access Systems,
Inc. |
| | Classification | 21 CFR §880.5570
Hypodermic Needle | FMI
21 CFR §880.5570
Hypodermic Needle | DYB
21 CFR §870.1340
Catheter Introducer |
| | 510k Status | Subject of this
Premarket Notification | K021475 - date of
clearance July 19, 2002 | K142445 – date of
clearance April 13,
2015 |
| | Commercial
Name | hypodermic Pinpoint™
GT Needles | BD Single Lumen
Needle | Pinpoint™ GT Safety
Introducer Needle |
| Technological
Characteristics
Continued | Indications for
Use | The hypodermic
Pinpoint™ GT Needle
is intended for the
injection of medication
into or the withdrawal
of body fluids from
parts of the body
below the surface of
the skin. The needle is
to be used with
syringes for general
purpose fluid
injection/aspiration.
The needle tip is
echogenic and may be
used with ultrasound
to provide a visual
representation of the
needle tip throughout
the insertion,
medication
administration and
aspiration process. | These needles are
intended for general
purpose fluid
injection/aspiration,
infusion, venipuncture
to obtain blood
collection and insulin
injection. | 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. |
| | Intended Use | The hypodermic
Pinpoint™ GT
Needles are intended
for the injection of
medication into or the
withdrawal of body
fluids from parts of the
body below the
surface of the skin.
The needle is to be
used with syringes for
general purpose fluid
injection/aspiration. | These needles are
intended for general
purpose fluid
injection/aspiration,
infusion, venipuncture
to obtain blood
collection and insulin
injection. | The Pinpoint™ GT
Safety Introducer
Needle is designed for
percutaneous
vascular access or
procedures requiring
the placement of a
guidewire. |
| | Scientific
Technology
Description | The primary intent of
the subject device,
hypodermic Pinpoint™
GT Needles, are to
inject medication or
aspirate fluid from
parts of the body
below the surface of
the skin. | Not publically available. | The primary intent of
the reference device,
Pinpoint™ GT Safety
Introducer Needle, is
to assist with
percutaneous
vasculature access or
procedures requiring
the placement of a
guidewire. |
| | Subject and Primary Predicate Device Comparison Table | | | |
| | Attribute | Subject:
hypodermic Pinpoint™
GT Needles | Primary Predicate:
BD Single Lumen
Needle | Reference:
Pinpoint™ GT
Safety Introducer
Needle |
| Technological
Characteristics
Continued | Scientific
Technology
Description
Continued | Additionally, the
hypodermic 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 (not the
subject of this
submission). The
Pinpoint™ GT Needle
Technology 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. The presence of
the passive magnet
does not impact the
ability of the device to
perform as a
hypodermic needle. | Not publically
available. | 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. |
| | Subject and Primary Predicate Device Comparison Table | | | |
| | Attribute | Subject:
hypodermic
Pinpoint™ GT
Needles | Primary Predicate:
BD Single Lumen
Needle | Reference:
Pinpoint™ GT
Safety Introducer
Needle |
| | Needle
Components | Needle Shaft:
Silicone coated
Needle tip:
Echogenic
A-Bevel 19° or Short
30°
Hub:
Open ended luer
locking hub
Bevel Indicator
Passive Magnet
Safety Mechanism:
None | Needle Shaft:
Silicone coated
Needle tip:
Regular, Short,
Intradermal Bevel
Hub:
Open ended luer locking
hub
Safety Mechanism:
None | Needle Shaft:
Silicone coated
Needle tip:
Echogenic
A-Bevel 12°
Hub:
Open ended luer
locking hub
Bevel Indicator
Passive Magnet
Safety Mechanism:
Incorporated active
safety mechanism |
| Technological
Characteristics
Continued | Needle Materials | Luer Hub:
Makrolon®2458
Polycarbonate
Clear
Needle Shaft:
Silicone Coated alloy
Magnet:
Neodymium Iron
Boron (NdFeB)
Nickel (Ni) Coated
Needle Protective
Cover (packaging
retainer):
High Density
Polyethylene (HDPE)
No colorant
Safety Mechanism:
None | Luer Hub:
Polypropylene
Needle shaft:
Stainless Steel
Silicone Coated
Magnet:
None
Needle Protective Cover
(packaging retainer):
Protective Plastic sheath
Details not publically
available
Safety Mechanism:
None | Luer Hub:
Makrolon®2458
Polycarbonate
Clear
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 | There are four (4)
total subject device
configurations
consisting of the
following gauge sizes
and lengths:
Diameter:
18, 21, 22, 24 gauge
Length:
1.50", 2.00", 2.75",
3.00" | Diameter:
16 to 30 gauge
Length:
3/8" to 2" | Diameter:
21 gauge
Length:
2.75" |
| | Subject and Primary Predicate Device Comparison Table | | | |
| Technological
Characteristics
Continued | Attribute | Subject:
hypodermic
Pinpoint™ GT
Needles | Primary Predicate:
BD Single Lumen
Needle | Reference:
Pinpoint™ GT
Safety Introducer
Needle |
| | Needle Labeling | Gauge Size:
No gauge size
coloring*
*Note: Needle hubs for
the different needle
gauge sizes are not
colored to ensure
visualization of blood
flashback. Colors used in
the subject device
labeling are based on
needle length and are
consistent with the
needle color coding used
with the Pinpoint™ GT
Needle Technology. | Gauge Size:
Translucent, color-coded
hubs:
Gray (27-gauge), Tan
(26), Blue (25),
Turquoise (23), Black
(22), Green (21), Yellow
(20), Brown (19), Pink
(18), and Purple (16) | Gauge Size:
Safety mechanism is
a translucent green
color |
| | | Bevel-Up Indicator:
V in ribs of the hub
(extra ribs on the hub
form a V-shape on
the hub that indicates
bevel-up). | Bevel-Up Indicator:
None | Bevel-Up Indicator:
Raised embossed
arrow on the hub |
| | Sterility | Provided Sterile
SAL 10-6
Ethylene Oxide | Provided Sterile
SAL 10-6
Gamma irradiation or
Ethylene Oxide | Provided Sterile
SAL 10-6
Ethylene Oxide |
6
7
8
9
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 | |
|---|---|---|
| Needle Lumen Patency | ||
| Needle-Hub Tensile Force | • ISO 7864:1993, Sterile hypodermic needles | |
| for single use | ||
| Effective Needle Length | ||
| Needle Tip Inspection | ||
| Cannula Surface Finish | • ISO 9626:1991/Amd 1, 2001, Stainless steel needle tubing for the manufacturer of medical devices | |
| • ISO 7864:1993, Sterile hypodermic needles for single use | ||
| 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 | ||
| 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 | ||
| Magnetic Axis Orientation | ||
| System Compatibility | • Bard internal standards and procedures | |
| Needle Tip to Magnet Length | ||
| Needle Chemical Properties | ||
| Needle Bevel Dimensions | ||
| (Primary Grind) | ||
| Needle Insertion Force | ||
| Performance | ||
| Tests | ||
| Continued | 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
10
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.
Summary of Substantial Equivalence
Based on the intended use, technological characteristics, and performance testing, the subject hypodermic Pinpoint™ GT Needles met the requirements that are considered sufficient for its intended use and demonstrate that the subject devices are substantial equivalent to the cited predicate device.