Who is the manufacturer of hypodermic Pinpoint GT Needle?

C.R. Bard, Inc. filed the 510(k) submission for hypodermic Pinpoint GT Needle (K163437).

What is the FDA product code for hypodermic Pinpoint GT Needle?

PVZ. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for hypodermic Pinpoint GT Needle?

510(k) clearance (submission type: Traditional).

What are the predicate devices for hypodermic Pinpoint GT Needle?

BD Single Lumen Needle (K021475).

Who can help prepare an FDA 510(k) submission like hypodermic Pinpoint GT Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

hypodermic Pinpoint GT Needle

K163437 · C.R. Bard, Inc. · PVZ · Jun 23, 2017 · General Hospital

Device Facts

Record ID	K163437
Device Name	hypodermic Pinpoint GT Needle
Applicant	C.R. Bard, Inc.
Product Code	PVZ · General Hospital
Decision Date	Jun 23, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Hypodermic needle for fluid injection/aspiration; features integral passive neodymium iron boron (NdFeB) magnet in hub. Used with ultrasound systems equipped with Pinpoint™ GT Needle Technology (magnet sensing probe and software). Magnet allows ultrasound system to generate virtual image of needle tip on display during insertion, medication administration, and aspiration. Operated by clinicians in clinical settings. Visual output assists needle guidance; improves accuracy of needle placement; reduces potential for multiple insertion attempts. Does not impact basic needle function.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 7864, ISO 9626, ISO 594-1/2, and USP <788>. Biocompatibility testing performed per ISO 10993-1, -5, -10, -11, and -12. Testing confirmed lumen patency, tensile force, tip inspection, surface finish, dimensions, stiffness, corrosion resistance, leakage, particulate matter, echogenicity, and magnetic axis orientation.

Technological Characteristics

Hypodermic needle with echogenic tip and passive NdFeB magnet (nickel-coated) in hub. Hub: Makrolon® 2458 polycarbonate. Shaft: silicone-coated alloy. Dimensions: 18G-24G, 1.5"-3.0". Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: passive magnetic field detection via external ultrasound system.

Indications for Use

Indicated for patients requiring injection of medication or withdrawal of body fluids from below the skin surface using syringes.

Regulatory Classification

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.

Predicate Devices

BD Single Lumen Needle (K021475)

Reference Devices

Pinpoint™ GT Safety Introducer Needle (K142445)

Related Devices

K163216 — Pinpoint GT Needles · C.R. Bard, Inc. · Jun 27, 2017
K162769 — Pinpoint GT Introducer Needle · C.R. Bard, Inc. · Nov 4, 2016
K142445 — PINPOINT GT SAFETY INTRODUCER NEEDLE · C.R. Bard, Inc. · Apr 13, 2015
K963794 — PUNCTURENEEDLE · Ferguson Medical · Mar 19, 1998
K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle · Spectra Medical Devices, Inc. · Feb 5, 2016

Submission Summary (Full Text)

{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) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display: inline-block; vertical-align: middle;"> <svg height="16px" width="16px"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M2,14 L14,2" stroke="black" stroke-width="2"></path> </svg> </div> Prescription Use (Part 21 CFR 801 Subpart D) | | <div style="display: inline-block; vertical-align: middle;"> <svg height="16px" width="16px"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> </div> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 | |…