Pinpoint GT Needles

K163216 · C.R. Bard, Inc. · BSP · Jun 27, 2017 · Anesthesiology

Device Facts

• Record ID: K163216
• Device Name: Pinpoint GT Needles
• Applicant: C.R. Bard, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jun 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Pinpoint™ GT Needles are anesthesia conduction needles used to inject anesthetics/analgesics or place catheters. Needles contain an integral passive Neodymium Iron Boron (NdFeB) magnet in the hub. When used with ultrasound systems equipped with Pinpoint™ GT Needle Technology, the magnet emits a field detected by the system to create a virtual needle image on the display. This provides clinicians with real-time visual representation of the needle during insertion. The feature is optional; the device functions as a standard anesthetic needle regardless of magnet use. Used in clinical settings by healthcare providers. Benefits include improved needle visualization during regional anesthesia procedures, potentially increasing precision and safety.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included needle lumen patency, tensile strength, tip inspection, surface finish, dimensions, stiffness, corrosion resistance, luer connector testing, fluid path leakage, particulate matter, echogenicity, priming volume, catheter interface, magnetic axis orientation, and system compatibility. Biocompatibility testing followed ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity). Sterilization validated per ISO 11135.

Technological Characteristics

Needle configurations: 18G-24G, various lengths. Materials: Silicone-coated alloy shaft, Makrolon® 2458 polycarbonate hub, NdFeB magnet with Nickel coating. Features: Passive magnetic field emission for ultrasound tracking, echogenic tips (Tuohy, bevel, short bevel). Standards: ISO 7864 (needles), ISO 9626 (tubing), ASTM A908-03 (tubing), ISO 594-1/2 (luer fittings), ISO 10993 (biocompatibility), ISO 11135 (EO sterilization).

Indications for Use

Indicated for injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or analgesia and/or facilitate the placement of a catheter. May be used in any appropriate patient population.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• SonoTAP Needle (K113207)

Reference Devices

• Pinpoint™ GT Safety Introducer Needle (K142445)

Submission Summary (Full Text)

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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

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

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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<br>anesthetic and/or analgesics to provide regional anesthesia and/or to facilitate<br>the placement of a catheter. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | The peripheral nerve block Pinpoint™ GT Needle is intended for use in<br>injecting local anesthetics and/or analgesics into a patient to provide regional<br>anesthesia and/or analgesia and/or facilitate the placement of a catheter.<br>The peripheral nerve block Pinpoint™ GT Needle may be used in any<br>appropriate patient population. |
| | The technological characteristics of the subject peripheral nerve block<br>Pinpoint™ GT Needles are substantially equivalent with respect to the basic<br>design and function to those of the cited predicate device. The differences<br>between the subject and predicate device (e.g. the addition of the passive<br>magnet) are not critical to the intended use of the device and do not raise new<br>or different questions regarding equivalence. |
| | The following table provides a comparison between the technological<br>characteristics of the subject and predicate device. |
| Technological<br>Characteristics | The indications for use of the subject device are different compared to the<br>predicate device. The differences provide additional specificity on the use of<br>the subject device. These differences in the indications for use are not critical<br>to the intended therapeutic, diagnostic, or surgical use of the subject device<br>(i.e., to administer anesthetics and/or analgesics to provide regional<br>anesthesia). Additionally, the minor differences do not affect the safety and<br>effectiveness of the device when used as labeled. |
| | The primary technological differences between the subject and predicate<br>devices include material differences, needle tip design, and the addition of a<br>passive magnet on the subject device. These technological differences do not<br>impact substantial equivalence because they do not alter the general purpose<br>or function of the device, or change the patient population, therapeutic or<br>diagnostic use of the subject device compared to the predicate device. The<br>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 | Needle Shaft |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Attribute | Subject:<br>Pinpoint™ GT Needle | Primary Predicate:<br>SonoTAP Needle | Needle<br>Components | Needle tip:<br>Echogenic<br>Curve Tip (Tuohy)<br>A Bevel 19°<br>Short Bevel 30° | Needle tip:<br>Echogenic<br>Curve Tip (Tuohy)<br>Quincke tip<br>Crawford tip<br>Chiba tip |
| Owner | Bard Access Systems, Inc. | PAJUNK MEDICAL<br>SYSTEMS | | Hub:<br>Same as Predicate Device | Hub:<br>Open ended Luer locking hub<br>Bevel Indicator |
| Classification | Same as predicate | BSP - 21 CFR 868.5150<br>Anesthesia Conduction<br>Needle | | Luer Hub:<br>Makrolon®2458<br>Polycarbonate<br>Clear | Luer Hub:<br>Information is not publically<br>available |
| 510k Status | Subject of this<br>Premarket Notification | K113207 - Concurrence date<br>February 29, 2012 | | Needle Shaft:<br>Silicone Coated alloy | Needle shaft:<br>Information is not publically<br>available |
| Commercial<br>Name | Pinpoint™ GT Needle | SonoTAP Needle | | Magnet:<br>Neodymium Iron Boron<br>(NdFeB)<br>Nickel (Ni) Coated | Magnet:<br>None |
| Intended Use | The peripheral nerve block<br>Pinpoint™ GT Needles<br>are intended for use in<br>injecting local anesthetics<br>and/or analgesics into a<br>patient to provide regional<br>anesthesia and/or<br>analgesia and/or to<br>facilitate the placement of<br>a catheter. | The cannulas/needles for<br>anesthesia and analgesia<br>enhanced for ultrasound<br>visibility- Tuohy Sono, Sono<br>TAP, Quincke Sono, Chiba<br>Sono, Sono and Crawford<br>Sono - are intended for the<br>transient delivery of<br>anesthetics to provide<br>regional anesthesia and<br>analgesia or to facilitate<br>placement of a catheter. | Needle<br>Materials | Cap:<br>Polypropylene<br>*Available only on the Tuohy<br>Needle; the other needles do<br>not include a cap. | Cap:<br>Information is not available |
| Indications for<br>Use | The peripheral nerve block<br>Pinpoint™ GT Needle is<br>intended for use in<br>injecting local anesthetics<br>and/or analgesics into a<br>patient to provide regional<br>anesthesia and/or<br>analgesia and/or to<br>facilitate the placement of<br>a catheter.<br>The peripheral nerve block<br>Pinpoint™ GT Needle may | The cannulas/needles for<br>anesthesia and analgesia<br>enhanced for ultrasound<br>visibility- Tuohy Sono, Sono<br>TAP, Quincke Sono, Chiba<br>Sono, Sono and Crawford<br>Sono - are intended for the<br>transient delivery of<br>anesthetics to provide<br>regional anesthesia and<br>analgesia or to facilitate<br>placement of a catheter. | | Stylet:<br>Polypropylene<br>*Available only on the Tuohy<br>Needle; the other needles do<br>not include a stylet. | Stylet:<br>Information is not available |
| | be used in any appropriate<br>patient population. | | | Needle Protective Cover<br>(packaging retainer):<br>High Density Polyethylene<br>(HDPE)<br>No colorant | Needle Protective Cover<br>(packaging retainer):<br>Information is not available |
| Scientific<br>Technology<br>Description | The primary intent of the<br>subject device, peripheral<br>nerve block Pinpoint™ GT<br>Needles, are to inject<br>anesthetic for regional<br>anesthesia and/or to<br>facilitate the placement of<br>a catheter.<br>Additionally, the peripheral<br>nerve block Pinpoint™ GT<br>Needles contain, integral<br>within the needle hub, a<br>passive magnet. The<br>needle's incorporated<br>passive magnet can be<br>detected by an ultrasound<br>system equipped with<br>Pinpoint™ GT Needle<br>Technology. The<br>Pinpoint™ GT Needle<br>Technology (not the<br>subject of this submission)<br>consists of a magnet<br>sensing probe and<br>software loaded on<br>ultrasound equipment,<br>creating the Pinpoint™ GT<br>System; this system is<br>capable of displaying a<br>visual representation of<br>the needle on an<br>ultrasound image. The<br>detection of the needle's<br>passive magnet by the<br>Pinpoint™ GT Needle<br>Technology is an optional<br>feature and tool/device<br>offered to clinicians for<br>visual representation of a<br>needle throughout the<br>anesthetic process; the<br>presence of the passive<br>magnet does not impact<br>the ability of the device to<br>perform as an anesthetic<br>needle. | The SonoTAP cannula has<br>been designed especially to<br>meet the requirements for<br>single shot TAP and rectus<br>sheath blocks.<br>Equipped with the patented<br>"Cornerstone" reflectors, it<br>ensures that the ultrasonic<br>waves are maximally<br>reflected at both steep and<br>shallow puncture angles. This<br>is an essential prerequisite<br>for the precise placement of<br>the cannula in the appropriate<br>neurovascular plane. | | Diameter:<br>18G, 21G, 22G and 24G | Diameter:<br>16G - 26G |
| Needle<br>Dimensions | Length:<br>38.1mm, 50.8mm,<br>69.85mm, 76.2mm | Length:<br>20mm - 180mm | | | |

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| Needle<br>Labeling | Gauge Size:<br>Tuohy needle – 18G<br>indicated by hub color (i.e.,<br>pink)<br><br>Other needles - Gauge<br>size not identified | Gauge Size:<br>Information is not publically<br>available |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Bevel up Indicator:<br>V in ribs of the hub | Bevel up Indicator:<br>Raised feature on the Cap |
| Catheter<br>Compatibility | 20G catheter<br><br>Compatible only with the 18G<br>Needles | Needles are compatible with<br>catheters per Instructions for<br>use, however catheter sizes<br>are not publicly available |
| Sterility | Same as Predicate Device | Provided Sterile<br>SAL $10^{-6}$<br>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<br>Tests | Needle Lumen Patency | ISO 7864:1993, Sterile hypodermic<br>needles for single use | |
| | Needle-Hub Tensile | ISO 7864:1993, Sterile hypodermic<br>needles for single use | |
| | Effective Needle Length | ISO 7864:1993, Sterile hypodermic<br>needles for single use | |
| | Needle Tip Inspection | ISO 7864:1993, Sterile hypodermic<br>needles for single use | |
| Cannula Surface Finish | ISO 9626:1991/Amd 1, 2001, Stainless<br>steel needle tubing for the manufacturer<br>of medical devices | | |
| Needle OD and ID<br>Dimensions | ISO 9626:1991/Amd 1, 2001, Stainless<br>steel needle tubing for the manufacturer<br>of medical devices<br>ASTM A908-03 (2013): Standard<br>Specification for Stainless Steel Needle<br>Tubing | | |
| Needle Stiffness | ISO 9626:1991/Amd 1, 2001, Stainless<br>steel needle tubing for the manufacturer<br>of medical devices | | |
| Corrosion | ISO 9626:1991/Amd 1, 2001, Stainless<br>steel needle tubing for the manufacturer<br>of medical devices | | |
| Performance<br>Tests<br>Cont. | Needle Hub - Luer<br>Connector Testing | ISO 594-1:1986, Conical fittings with<br>6% luer taper for syringes, needles and<br>certain other medical equipment – Part<br>1: General Requirements | |
| | | ISO 594-2:1998, Conical fittings with<br>6% luer taper for syringes, needles and<br>certain other medical equipment - Part<br>2: Lock Fittings | |
| | Fluid Path Leakage | ISO 594-2:1998, Conical fittings with<br>6% luer taper for syringes, needles and<br>certain other medical equipment - Part<br>2: Lock Fittings | |
| | Needle Particulate | USP<788> (2011): Particulate Matter in<br>Injections | |
| | Needle Echogenicity | | |
| | Needle Bevel Up<br>Indicator | | |
| | Priming Volume | | |
| | Needle Interface With<br>Catheter | | |
| | Magnetic Axis orientation | Bard internal standards and procedures | |
| | System Compatibility | Bard internal standards and procedures | |
| | Needle Tip to Magnet<br>Length | | |
| | Needle Chemical<br>Properties | | |
| | Needle Bevel Dimensions<br>(Primary Grind) | | |
| | Needle Insertion Force | | |
| | Biocompatibility | • ISO 10993-1:2009, Biological Evaluation<br>of Medical Devices – Part 1: Evaluation<br>and Testing Within a Risk Management<br>Process<br>• ISO 10993-5:2009, Biological Evaluation<br>of Medical Devices - Part 5: Tests for in<br>vitro cytotoxicity<br>• ISO 10993-10:2010, Biological<br>Evaluation of Medical Devices – Part 10:<br>Tests for irritation and skin sensitization<br>• ISO 10993-11:2006, Biological<br>Evaluation of Medical Devices - Part 11:<br>Tests for systemic toxicity<br>• ISO 10993-12:2012, Biological<br>Evaluation of Medical Devices - Part 12:<br>Sample preparation and reference<br>materials | |
| Performance<br>Tests<br>Cont. | Sterilization | ISO 10993-7:2008, Biological Evaluation<br>of Medical Devices – Part 7: Ethylene<br>Oxide Sterilization Residuals.<br>ANSI/AAMI/ISO 11135:2014, Annex B<br>Sterilization of Health Care Products -<br>Ethylene Oxide - Requirements for<br>Development, Validation and Routine<br>Control of A Sterilization Process for<br>Medical Devices | |
| | The subject device configurations met all predetermined acceptance criteria<br>derived from the above listed verification tests and demonstrated substantially<br>equivalent performance as compared to the cited predicate device. | | |
| Based on the intended use, technological characteristics, and performance<br>testing, the subject peripheral nerve block Pinpoint™ GT Needles met the<br>Summary of<br>requirements that are considered sufficient for its intended use and<br>Substantial<br>demonstrates that the subject devices are substantially equivalent to the<br>Equivalence<br>predicate device cited. | | | |

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