(198 days)
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.
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.
The provided document describes the hypodermic Pinpoint™ GT Needle and its journey through FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new performance claim or the efficacy of an AI algorithm. Therefore, many of the requested elements pertaining to AI model validation (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable to this document.
The document outlines acceptance criteria primarily through a list of performance tests designed to show the device meets engineering and safety standards, and is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study (verification and validation tests) as provided in the document:
Acceptance Criteria and Reported Device Performance
The document states: "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."
This implies that for each performance test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the provided text. Instead, the document lists the types of tests conducted and the standards utilized, indicating that the device passed these tests.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Needle Lumen Patency | Met standard requirements for clear lumen. | Passed. |
| Needle-Hub Tensile Force | Met ISO 7864:1993 requirements. | Passed (demonstrated substantial equivalence). |
| Effective Needle Length | Met specified dimensional requirements. | Passed. |
| Needle Tip Inspection | Met visual/dimensional requirements for tip quality. | Passed. |
| Cannula Surface Finish | Met ISO 9626:1991/Amd 1, 2001 and ISO 7864:1993 requirements. | Passed. |
| Needle OD and ID Dimensions | Met ISO 9626:1991/Amd 1, 2001 and ASTM A908-03:2013 requirements. | Passed. |
| Needle Stiffness | Met ISO 9626:1991/Amd 1, 2001 requirements. | Passed. |
| Corrosion | Met resistance to corrosion requirements. | Passed. |
| Needle Hub - Luer Connector | Met ISO 594-1:1986 and ISO 594-2:1998 requirements. | Passed. |
| Fluid Path Leakage | Met ISO 594-2:1998 requirements for no leakage. | Passed. |
| Needle Particulate | Met USP<788>:2011 limits for particulate matter. | Passed. |
| Needle Echogenicity | Met specified requirements for ultrasound visibility. | Passed. |
| Needle Bevel-Up Indicator | Functioned as designed to indicate bevel-up. | Passed. |
| Priming Volume | Met specified volume requirements. | Passed. |
| Magnetic Axis Orientation | Met specified requirements for magnetic field orientation. | Passed. |
| System Compatibility | Compatible with Pinpoint™ GT Needle Technology (per internal stds). | Passed. |
| Needle Tip to Magnet Length | Met specified dimensional requirements. | Passed. |
| Needle Chemical Properties | Met specified requirements for material composition. | Passed. |
| Needle Bevel Dimensions | Met specified dimensional requirements for bevel grind. | Passed. |
| Needle Insertion Force | Met specified force limits for insertion. | Passed. |
| Biocompatibility | Met ISO 10993 series requirements. | Passed (demonstrated biological compatibility). |
Study Proving Device Meets Acceptance Criteria:
The study design is described as "Verification and validation tests... designed and performed in accordance with Design Controls as per 21 CFR §820.30." The tests conducted are listed in the table above, referencing various ISO and ASTM standards, as well as USP standards and internal protocols.
Information Not Applicable or Not Provided in the Document:
Many of the requested details are specific to the validation of AI/ML algorithms and are not relevant to the approval of a physical medical device like this needle, which underwent a 510(k) submission based on substantial equivalence.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced standards (e.g., ISO, ASTM). The document lists four needle configurations (18G x 2.75", 19°; 21G x 3", 30°; 22G x 2", 30°; 24G x 1.5", 30°) which would have been tested.
- Data Provenance: Not specified, but generally, device performance testing is conducted by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, Utah) in controlled laboratory environments. This would be prospective testing on manufactured devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a needle is established through engineering and material science measurements against predefined specifications, not expert consensus on interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device testing. Test results are objective measurements against standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hypodermic needle, not an AI diagnostic tool. The "echogenic" feature simply means it's visible on ultrasound, and the optional "passive magnet" feature works with a separate "Pinpoint™ GT Needle Technology" system (which is explicitly stated as "not the subject of this submission"). The needle itself does not involve AI assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involved engineering specifications, material properties, and performance standards (e.g., tensile strength, dimensional accuracy, biocompatibility, leakage).
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The sample size for the training set: Not applicable. There is no AI model being trained as part of this submission.
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How the ground truth for the training set was established: Not applicable. There is no AI model being trained as part of this submission.
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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 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
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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
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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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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 WestSalt Lake City, UT 84116 | |
|---|---|---|
| GeneralProvisions | Contact Person:Telephone Number:Fax Number:Date of Preparation: | Jamie (Howell) DukeAssociate Regulatory Affairs Specialist(801) 522-5465(801) 522-496923 June 2017 |
| SubjectDevice | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Manufacturer:Classification Panel: | hypodermic Pinpoint™ GT NeedleHypodermic Needle21 CFR §880.5570Needle, Hypodermic, Single LumenIIPVZBard Access Systems, Inc.General Hospital |
| PrimaryPredicateDevice | Premarket Notification:Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Manufacturer:Classification Panel: | K021475; date of clearance, July 19, 2002BD Single Lumen NeedleHypodermic Needle21 CFR §880.5570Needle, Hypodermic, Single LumenIIFMIBecton Dickinson & CompanyGeneral Hospital |
| ReferenceDevice | Premarket Notification:Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Manufacturer:Classification Panel: | K142445, date of clearance, April 13, 2015Pinpoint™ GT Safety Introducer NeedleSafety Introducer Needle21 CFR §870.1340Catheter IntroducerIIDYBBard Access Systems, Inc.Cardiovascular |
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| DeviceDescription | Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles aredesigned to inject medication or aspirate fluid. The hypodermic Pinpoint™GT Needles contain a magnet which emits a passive magnetic field that canbe detected by ultrasound systems equipped with Pinpoint™ GT NeedleTechnology. The hypodermic Pinpoint™ GT Needles, when used with anultrasound system equipped with Pinpoint™ GT Needle Technology, createsa virtual image of the needle on the ultrasound display, providing clinicianswith a visual representation of the needle throughout the insertion,medication administration and aspiration process.There are four (4) hypodermic Pinpoint™ GT Needle configurations includedin 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 ofmedication into or the withdrawal of body fluids from parts of the body belowthe surface of the skin. The needle is to be used with syringes for generalpurpose fluid injection/aspiration. | |
| Indications ForUse | The hypodermic Pinpoint™ GT Needle is intended for the injection ofmedication into or the withdrawal of body fluids from parts of the body belowthe surface of the skin. The needle is to be used with syringes for generalpurpose fluid injection/aspiration. The needle tip is echogenic and may beused with ultrasound to provide a visual representation of the needle tipthroughout the insertion, medication administration and aspiration process. | |
| TechnologicalCharacteristics | The technological characteristics of the subject hypodermic Pinpoint™ GTNeedles are substantially equivalent with respect to the basic design andfunction to those of the cited predicate device. The differences between thesubject and predicate device (e.g. the addition of the passive magnet) are notcritical to the intended use of the device and do not raise any new or differentquestions regarding equivalence.The subject and predicate devices share equivalent intended use and patientpopulation. The subject device differs from its primary predicate in terms of intypes of materials used, dimensions (gauges, lengths), needle tipconfigurations and the addition of a passive magnet on the subject device.The difference in materials, dimensions (gauges, lengths), and needle tipconfigurations do not alter the indications for use or intended use of theneedles, nor do they raise different questions of equivalence between thesubject device and the primary predicate device. A reference device isintroduced to support the material and dimensional features of the subjectdevice. Nonclinical testing further demonstrates the equivalence of thesubject device to its predicates. |
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| Attribute | Subject:hypodermicPinpoint™ GTNeedles | Primary Predicate:BD Single LumenNeedle | Reference:Pinpoint™ GTSafety IntroducerNeedle | |
|---|---|---|---|---|
| Owner | Bard Access Systems,Inc. | Becton Dickinson &Company | Bard Access Systems,Inc. | |
| Classification | 21 CFR §880.5570Hypodermic Needle | FMI21 CFR §880.5570Hypodermic Needle | DYB21 CFR §870.1340Catheter Introducer | |
| 510k Status | Subject of thisPremarket Notification | K021475 - date ofclearance July 19, 2002 | K142445 – date ofclearance April 13,2015 | |
| CommercialName | hypodermic Pinpoint™GT Needles | BD Single LumenNeedle | Pinpoint™ GT SafetyIntroducer Needle | |
| TechnologicalCharacteristicsContinued | Indications forUse | The hypodermicPinpoint™ GT Needleis intended for theinjection of medicationinto or the withdrawalof body fluids fromparts of the bodybelow the surface ofthe skin. The needle isto be used withsyringes for generalpurpose fluidinjection/aspiration.The needle tip isechogenic and may beused with ultrasoundto provide a visualrepresentation of theneedle tip throughoutthe insertion,medicationadministration andaspiration process. | These needles areintended for generalpurpose fluidinjection/aspiration,infusion, venipunctureto obtain bloodcollection and insulininjection. | The Pinpoint™ GTSafety IntroducerNeedle is intended forpatients requiringpercutaneous accessto place a guidewirefor subsequentplacement ofcatheters or othermedical proceduresrequiring introducerneedle access.The Pinpoint™ GTSafety IntroducerNeedle may be usedin any appropriatepatient population. |
| Intended Use | The hypodermicPinpoint™ GTNeedles are intendedfor the injection ofmedication into or thewithdrawal of bodyfluids from parts of thebody below thesurface of the skin.The needle is to beused with syringes forgeneral purpose fluidinjection/aspiration. | These needles areintended for generalpurpose fluidinjection/aspiration,infusion, venipunctureto obtain bloodcollection and insulininjection. | The Pinpoint™ GTSafety IntroducerNeedle is designed forpercutaneousvascular access orprocedures requiringthe placement of aguidewire. | |
| ScientificTechnologyDescription | The primary intent ofthe subject device,hypodermic Pinpoint™GT Needles, are toinject medication oraspirate fluid fromparts of the bodybelow the surface ofthe skin. | Not publically available. | The primary intent ofthe reference device,Pinpoint™ GT SafetyIntroducer Needle, isto assist withpercutaneousvasculature access orprocedures requiringthe placement of aguidewire. | |
| Subject and Primary Predicate Device Comparison Table | ||||
| Attribute | Subject:hypodermic Pinpoint™GT Needles | Primary Predicate:BD Single LumenNeedle | Reference:Pinpoint™ GTSafety IntroducerNeedle | |
| TechnologicalCharacteristicsContinued | ScientificTechnologyDescriptionContinued | Additionally, thehypodermic Pinpoint™GT Needles contain,integral, within theneedle hub a passivemagnet. The needle'sincorporated passivemagnet can be detectedby an ultrasound systemequipped withPinpoint™ GT NeedleTechnology (not thesubject of thissubmission). ThePinpoint™ GT NeedleTechnology consists ofa magnet sensing probeand software loaded onultrasound equipment,creating the Pinpoint™GT System; this systemis capable of displayinga visual representationof the needle on anultrasound image. Thedetection of the needle'spassive magnet by thePinpoint™ GT NeedleTechnology is anoptional feature andtool/device offered toclinicians for visualrepresentation of aneedle. The presence ofthe passive magnetdoes not impact theability of the device toperform as ahypodermic needle. | Not publicallyavailable. | Additionally, thePinpoint™ GT SafetyIntroducer Needlecontains, integral,within the needlehub an active safetymechanism and apassive magnet. Theneedle'sincorporated passivemagnet can bedetected by anultrasound systemequipped withPinpoint™ GTTechnology. ThePinpoint™ GTTechnology (not thesubject of thissubmission)consists of a magnetsensing probe andsoftware loaded onultrasoundequipment, creatingthe Pinpoint™ GTSystem; this systemis capable ofdisplaying a visualrepresentation of theneedle on anultrasound image.The detection of theneedle's passivemagnet by thePinpoint™ GTtechnology is anoptional feature andtool/device offered toclinicians for visualrepresentation of aneedle throughoutthe insertionprocess; thepresence of thepassive magnetdoes not impact theability of the deviceto perform as anintroducer needle. |
| Subject and Primary Predicate Device Comparison Table | ||||
| Attribute | Subject:hypodermicPinpoint™ GTNeedles | Primary Predicate:BD Single LumenNeedle | Reference:Pinpoint™ GTSafety IntroducerNeedle | |
| NeedleComponents | Needle Shaft:Silicone coatedNeedle tip:EchogenicA-Bevel 19° or Short30°Hub:Open ended luerlocking hubBevel IndicatorPassive MagnetSafety Mechanism:None | Needle Shaft:Silicone coatedNeedle tip:Regular, Short,Intradermal BevelHub:Open ended luer lockinghubSafety Mechanism:None | Needle Shaft:Silicone coatedNeedle tip:EchogenicA-Bevel 12°Hub:Open ended luerlocking hubBevel IndicatorPassive MagnetSafety Mechanism:Incorporated activesafety mechanism | |
| TechnologicalCharacteristicsContinued | Needle Materials | Luer Hub:Makrolon®2458PolycarbonateClearNeedle Shaft:Silicone Coated alloyMagnet:Neodymium IronBoron (NdFeB)Nickel (Ni) CoatedNeedle ProtectiveCover (packagingretainer):High DensityPolyethylene (HDPE)No colorantSafety Mechanism:None | Luer Hub:PolypropyleneNeedle shaft:Stainless SteelSilicone CoatedMagnet:NoneNeedle Protective Cover(packaging retainer):Protective Plastic sheathDetails not publicallyavailableSafety Mechanism:None | Luer Hub:Makrolon®2458PolycarbonateClearNeedle Shaft:Silicone Coated alloyMagnet:Neodymium IronBoron (NdFeB)Nickel (Ni) CoatedNeedle ProtectiveCover (packagingretainer):Clear AmorphousPolyethyleneTerephtalate (APET)Safety Mechanism:Translucent GreenPolycarbonateSilicone O-ring301 Stainless SteelCap polycarbonate |
| NeedleDimensions | There are four (4)total subject deviceconfigurationsconsisting of thefollowing gauge sizesand lengths:Diameter:18, 21, 22, 24 gaugeLength:1.50", 2.00", 2.75",3.00" | Diameter:16 to 30 gaugeLength:3/8" to 2" | Diameter:21 gaugeLength:2.75" | |
| Subject and Primary Predicate Device Comparison Table | ||||
| TechnologicalCharacteristicsContinued | Attribute | Subject:hypodermicPinpoint™ GTNeedles | Primary Predicate:BD Single LumenNeedle | Reference:Pinpoint™ GTSafety IntroducerNeedle |
| Needle Labeling | Gauge Size:No gauge sizecoloring**Note: Needle hubs forthe different needlegauge sizes are notcolored to ensurevisualization of bloodflashback. Colors used inthe subject devicelabeling are based onneedle length and areconsistent with theneedle color coding usedwith the Pinpoint™ GTNeedle Technology. | Gauge Size:Translucent, color-codedhubs: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 isa translucent greencolor | |
| Bevel-Up Indicator:V in ribs of the hub(extra ribs on the hubform a V-shape onthe hub that indicatesbevel-up). | Bevel-Up Indicator:None | Bevel-Up Indicator:Raised embossedarrow on the hub | ||
| Sterility | Provided SterileSAL 10-6Ethylene Oxide | Provided SterileSAL 10-6Gamma irradiation orEthylene Oxide | Provided SterileSAL 10-6Ethylene Oxide |
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Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following 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 needlesfor 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 IDDimensions | • 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 - LuerConnector 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<788>: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 | ||
| PerformanceTestsContinued | Biocompatibility | ISO 10993-1:2009, Biological Evaluation ofMedical Devices – Part 1: Evaluation andTesting Within a Risk Management Process ISO 10993-5:2009, Biological Evaluation ofMedical Devices – Part 5: Tests for in vitrocytotoxicity ISO 10993-10:2010, Biological Evaluation ofMedical Devices – Part 10: Tests for irritationand skin sensitization ISO 10993-11:2006, Biological Evaluation ofMedical Devices – Part 11: Tests for systemictoxicity ISO 10993-12:2012, Biological Evaluation ofMedical Devices – Part 12: Samplepreparation and reference materials |
Performance Tests
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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.
§ 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).