(223 days)
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.
Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The Pinpoint™ GT Needle, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.
The subject device can be used with or without ultrasound assisted procedures and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.
The document describes the Pinpoint™ GT Needles, which are peripheral nerve block needles intended for injecting local anesthetics and/or analgesics for regional anesthesia or catheter placement. The device contains a passive magnet that can be detected by compatible ultrasound systems to provide a virtual image of the needle.
All the information provided in the input is related to the Pinpoint™ GT Needles and its comparison against a predicate device (SonoTAP Needle) and a reference device (Pinpoint™ GT Safety Introducer Needle).
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the subject device configurations met all predetermined acceptance criteria derived from the listed verification tests, demonstrating substantially equivalent performance as compared to the predicate device. However, specific numerical acceptance criteria and their corresponding reported performance values are not explicitly provided in a direct table format with thresholds. Instead, a list of performance tests conducted and the standards utilized is given, implying that meeting these standards constitutes the acceptance criteria.
| Performance Test / Standard Utilized | Device Performance (as stated in document) |
|---|---|
| Needle Lumen Patency (ISO 7864:1993, Sterile hypodermic needles for single use) | Met all predetermined acceptance criteria. |
| Needle-Hub Tensile (ISO 7864:1993, Sterile hypodermic needles for single use) | Met all predetermined acceptance criteria. |
| Effective Needle Length (ISO 7864:1993, Sterile hypodermic needles for single use) | Met all predetermined acceptance criteria. |
| Needle Tip Inspection (ISO 7864:1993, Sterile hypodermic needles for single use) | Met all predetermined acceptance criteria. |
| Cannula Surface Finish (ISO 9626:1991/Amd 1, 2001, Stainless steel needle tubing for the manufacturer of medical devices) | Met all predetermined acceptance criteria. |
| Needle OD and ID Dimensions (ISO 9626:1991/Amd 1, 2001 & ASTM A908-03 (2013)) | Met all predetermined acceptance criteria. |
| Needle Stiffness (ISO 9626:1991/Amd 1, 2001) | Met all predetermined acceptance criteria. |
| Corrosion (ISO 9626:1991/Amd 1, 2001) | Met all predetermined acceptance criteria. |
| Needle Hub - Luer Connector Testing (ISO 594-1:1986, ISO 594-2:1998) | Met all predetermined acceptance criteria. |
| Fluid Path Leakage (ISO 594-2:1998) | Met all predetermined acceptance criteria. |
| Needle Particulate (USP <788> (2011)) | Met all predetermined acceptance criteria. |
| Needle Echogenicity | Met all predetermined acceptance criteria. |
| Needle Bevel Up Indicator | Met all predetermined acceptance criteria. |
| Priming Volume | Met all predetermined acceptance criteria. |
| Needle Interface With Catheter | Met all predetermined acceptance criteria. |
| Magnetic Axis orientation (Bard internal standards and procedures) | Met all predetermined acceptance criteria. 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. |
| System Compatibility (Bard internal standards and procedures) | Met all predetermined acceptance criteria. 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. |
| Needle Tip to Magnet Length | Met all predetermined acceptance criteria. |
| Needle Chemical Properties | Met all predetermined acceptance criteria. |
| Needle Bevel Dimensions (Primary Grind) | Met all predetermined acceptance criteria. |
| Needle Insertion Force | Met all predetermined acceptance criteria. |
| Biocompatibility (ISO 10993-1, 10993-5, 10993-10, 10993-11, 10993-12) | Met all predetermined acceptance criteria. All materials were determined to be biocompatible. |
| Sterilization (ISO 10993-7, ANSI/AAMI/ISO 11135:2014) | Met all predetermined acceptance criteria. Provided Sterile. SAL $10^{-6}$, Ethylene Oxide. |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes used for each individual test or the overall "test set." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing methods are primarily focused on device performance tests against recognized standards (e.g., ISO, ASTM, USP) and internal protocols, rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is primarily focused on engineering performance and material compatibility, not clinical ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation or assessment, which is not the primary focus of the performance tests described here.
5. 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
There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The Pinpoint™ GT Needle incorporates a "passive magnet" feature that works with an "ultrasound system equipped with Pinpoint™ GT Needle Technology" to create a "virtual image of the needle." This describes a technology for enhanced visualization during a procedure, not an AI-assisted diagnostic or interpretive system that human readers would interact with in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. The Pinpoint™ GT Needle is a physical medical device (a needle) that assists in a medical procedure, not a standalone algorithm. Its magnetic feature is designed to be used in conjunction with an ultrasound system and the clinician, so there is always a human in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests described is rooted in established international standards (ISO, ASTM, USP) and internal Bard protocols for medical device quality, safety, and functionality. These standards define physical, chemical, and mechanical properties that the device must meet, effectively serving as the ground truth for engineering and material performance. For example, "Needle Lumen Patency" is tested against requirements specified in ISO 7864:1993. Biocompatibility is tested against ISO 10993 series.
8. The sample size for the training set
This information is not provided and is not applicable. The Pinpoint™ GT Needle is a physical device, and the described evaluation involves functional and safety testing, not machine learning model training.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no mention of a "training set" or machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2017
C.R. Bard, Inc. % Silvia De La Barra Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116
Re: K163216
Trade/Device Name: Pinpoint™ GT Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 25, 2017 Received: May 30, 2017
Dear Silvia De La Barra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
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)
Device Name
Pinpoint™ GT Needles
Indications for Use (Describe)
The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.
The peripheral nerve block Pinpoint™ GT Needle may be used in any appropriate patient population.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
21 CFR 807.92(a)
| GeneralProvisions | Submitter Name:Address:Contact Person:Telephone Number:Fax Number:Date of Preparation: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116Silvia De La Barra(801) 522-5909(801) 522-496927 June 2017 |
|---|---|---|
| SubjectDevice | Subject Trade Name:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | Pinpoint™ GT NeedlesAnesthesia NeedleAnesthesia Conduction NeedleBSP21 CFR §868.5150IIAnesthesiology |
| PredicateDevice | Predicate Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | SonoTAP NeedleK113207 (cleared February 29, 2012)Pajunk Medical SystemAnesthesia NeedleAnesthesia Conduction NeedleBSP21 CFR §868.5150IIAnesthesiology |
| ReferenceDevice | Reference Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | Pinpoint™ GT Safety Introducer NeedleK142445 (cleared April 13, 2015)Bard Access Systems, Inc.Safety Introducer NeedleCatheter IntroducerDYB21 CFR §870.1340IICardiovascular |
| DeviceDescription | Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to injectanesthetic for regional anesthesia. The Pinpoint™ GT Needle contains amagnet which emits a passive magnetic field that can be detected byultrasound systems equipped with Pinpoint™ GT Needle Technology. ThePinpoint™ GT Needle, when used with an ultrasound system equipped withPinpoint™ GT Needle Technology, creates a virtual image of the needle on theultrasound 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 injectanesthetic and/or analgesics to provide regional anesthesia and/or to facilitatethe placement of a catheter. |
|---|---|
| Indications ForUse | The peripheral nerve block Pinpoint™ GT Needle is intended for use ininjecting local anesthetics and/or analgesics into a patient to provide regionalanesthesia and/or analgesia and/or facilitate the placement of a catheter.The peripheral nerve block Pinpoint™ GT Needle may be used in anyappropriate patient population. |
| The technological characteristics of the subject peripheral nerve blockPinpoint™ GT Needles are substantially equivalent with respect to the basicdesign and function to those of the cited predicate device. The differencesbetween the subject and predicate device (e.g. the addition of the passivemagnet) are not critical to the intended use of the device and do not raise newor different questions regarding equivalence. | |
| The following table provides a comparison between the technologicalcharacteristics of the subject and predicate device. | |
| TechnologicalCharacteristics | The indications for use of the subject device are different compared to thepredicate device. The differences provide additional specificity on the use ofthe subject device. These differences in the indications for use are not criticalto the intended therapeutic, diagnostic, or surgical use of the subject device(i.e., to administer anesthetics and/or analgesics to provide regionalanesthesia). Additionally, the minor differences do not affect the safety andeffectiveness of the device when used as labeled. |
| The primary technological differences between the subject and predicatedevices include material differences, needle tip design, and the addition of apassive magnet on the subject device. These technological differences do notimpact substantial equivalence because they do not alter the general purposeor function of the device, or change the patient population, therapeutic ordiagnostic use of the subject device compared to the predicate device. Thetechnological 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:Pinpoint™ GT Needle | Primary Predicate:SonoTAP Needle | NeedleComponents | Needle tip:EchogenicCurve Tip (Tuohy)A Bevel 19°Short Bevel 30° | Needle tip:EchogenicCurve Tip (Tuohy)Quincke tipCrawford tipChiba tip |
| Owner | Bard Access Systems, Inc. | PAJUNK MEDICALSYSTEMS | Hub:Same as Predicate Device | Hub:Open ended Luer locking hubBevel Indicator | |
| Classification | Same as predicate | BSP - 21 CFR 868.5150Anesthesia ConductionNeedle | Luer Hub:Makrolon®2458PolycarbonateClear | Luer Hub:Information is not publicallyavailable | |
| 510k Status | Subject of thisPremarket Notification | K113207 - Concurrence dateFebruary 29, 2012 | Needle Shaft:Silicone Coated alloy | Needle shaft:Information is not publicallyavailable | |
| CommercialName | Pinpoint™ GT Needle | SonoTAP Needle | Magnet:Neodymium Iron Boron(NdFeB)Nickel (Ni) Coated | Magnet:None | |
| Intended Use | The peripheral nerve blockPinpoint™ GT Needlesare intended for use ininjecting local anestheticsand/or analgesics into apatient to provide regionalanesthesia and/oranalgesia and/or tofacilitate the placement ofa catheter. | The cannulas/needles foranesthesia and analgesiaenhanced for ultrasoundvisibility- Tuohy Sono, SonoTAP, Quincke Sono, ChibaSono, Sono and CrawfordSono - are intended for thetransient delivery ofanesthetics to provideregional anesthesia andanalgesia or to facilitateplacement of a catheter. | NeedleMaterials | Cap:Polypropylene*Available only on the TuohyNeedle; the other needles donot include a cap. | Cap:Information is not available |
| Indications forUse | The peripheral nerve blockPinpoint™ GT Needle isintended for use ininjecting local anestheticsand/or analgesics into apatient to provide regionalanesthesia and/oranalgesia and/or tofacilitate the placement ofa catheter.The peripheral nerve blockPinpoint™ GT Needle may | The cannulas/needles foranesthesia and analgesiaenhanced for ultrasoundvisibility- Tuohy Sono, SonoTAP, Quincke Sono, ChibaSono, Sono and CrawfordSono - are intended for thetransient delivery ofanesthetics to provideregional anesthesia andanalgesia or to facilitateplacement of a catheter. | Stylet:Polypropylene*Available only on the TuohyNeedle; the other needles donot include a stylet. | Stylet:Information is not available | |
| be used in any appropriatepatient population. | Needle Protective Cover(packaging retainer):High Density Polyethylene(HDPE)No colorant | Needle Protective Cover(packaging retainer):Information is not available | |||
| ScientificTechnologyDescription | The primary intent of thesubject device, peripheralnerve block Pinpoint™ GTNeedles, are to injectanesthetic for regionalanesthesia and/or tofacilitate the placement ofa catheter.Additionally, the peripheralnerve block Pinpoint™ GTNeedles contain, integralwithin the needle hub, apassive magnet. Theneedle's incorporatedpassive magnet can bedetected by an ultrasoundsystem equipped withPinpoint™ GT NeedleTechnology. ThePinpoint™ GT NeedleTechnology (not thesubject of this submission)consists of a magnetsensing probe andsoftware loaded onultrasound equipment,creating the Pinpoint™ GTSystem; this system iscapable of displaying avisual representation ofthe needle on anultrasound image. Thedetection of the needle'spassive magnet by thePinpoint™ GT NeedleTechnology is an optionalfeature and tool/deviceoffered to clinicians forvisual representation of aneedle throughout theanesthetic process; thepresence of the passivemagnet does not impactthe ability of the device toperform as an anestheticneedle. | The SonoTAP cannula hasbeen designed especially tomeet the requirements forsingle shot TAP and rectussheath blocks.Equipped with the patented"Cornerstone" reflectors, itensures that the ultrasonicwaves are maximallyreflected at both steep andshallow puncture angles. Thisis an essential prerequisitefor the precise placement ofthe cannula in the appropriateneurovascular plane. | Diameter:18G, 21G, 22G and 24G | Diameter:16G - 26G | |
| NeedleDimensions | Length:38.1mm, 50.8mm,69.85mm, 76.2mm | Length:20mm - 180mm |
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| NeedleLabeling | Gauge Size:Tuohy needle – 18Gindicated by hub color (i.e.,pink)Other needles - Gaugesize not identified | Gauge Size:Information is not publicallyavailable |
|---|---|---|
| Bevel up Indicator:V in ribs of the hub | Bevel up Indicator:Raised feature on the Cap | |
| CatheterCompatibility | 20G catheterCompatible only with the 18GNeedles | Needles are compatible withcatheters per Instructions foruse, however catheter sizesare not publicly available |
| Sterility | Same as Predicate Device | Provided SterileSAL $10^{-6}$Ethylene Oxide |
Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following table identifies the performance tests conducted per standards in conjunction with in-house protocols to determine appropriate methods for evaluating the performance of the device.
| Performance Tests | Test Description / Standard Utilized | ||
|---|---|---|---|
| PerformanceTests | Needle Lumen Patency | ISO 7864:1993, Sterile hypodermicneedles for single use | |
| Needle-Hub Tensile | ISO 7864:1993, Sterile hypodermicneedles for single use | ||
| Effective Needle Length | ISO 7864:1993, Sterile hypodermicneedles for single use | ||
| Needle Tip Inspection | ISO 7864:1993, Sterile hypodermicneedles for single use | ||
| Cannula Surface Finish | ISO 9626:1991/Amd 1, 2001, Stainlesssteel needle tubing for the manufacturerof medical devices | ||
| Needle OD and IDDimensions | ISO 9626:1991/Amd 1, 2001, Stainlesssteel needle tubing for the manufacturerof medical devicesASTM A908-03 (2013): StandardSpecification for Stainless Steel NeedleTubing | ||
| Needle Stiffness | ISO 9626:1991/Amd 1, 2001, Stainlesssteel needle tubing for the manufacturerof medical devices | ||
| Corrosion | ISO 9626:1991/Amd 1, 2001, Stainlesssteel needle tubing for the manufacturerof medical devices | ||
| PerformanceTestsCont. | Needle Hub - LuerConnector Testing | ISO 594-1:1986, Conical fittings with6% luer taper for syringes, needles andcertain other medical equipment – Part1: General Requirements | |
| ISO 594-2:1998, Conical fittings with6% luer taper for syringes, needles andcertain other medical equipment - Part2: Lock Fittings | |||
| Fluid Path Leakage | ISO 594-2:1998, Conical fittings with6% luer taper for syringes, needles andcertain other medical equipment - Part2: Lock Fittings | ||
| Needle Particulate | USP<788> (2011): Particulate Matter inInjections | ||
| Needle Echogenicity | |||
| Needle Bevel UpIndicator | |||
| Priming Volume | |||
| Needle Interface WithCatheter | |||
| Magnetic Axis orientation | Bard internal standards and procedures | ||
| System Compatibility | Bard internal standards and procedures | ||
| Needle Tip to MagnetLength | |||
| Needle ChemicalProperties | |||
| Needle Bevel Dimensions(Primary Grind) | |||
| Needle Insertion Force | |||
| Biocompatibility | • ISO 10993-1:2009, Biological Evaluationof Medical Devices – Part 1: Evaluationand Testing Within a Risk ManagementProcess• ISO 10993-5:2009, Biological Evaluationof Medical Devices - Part 5: Tests for invitro cytotoxicity• ISO 10993-10:2010, BiologicalEvaluation of Medical Devices – Part 10:Tests for irritation and skin sensitization• ISO 10993-11:2006, BiologicalEvaluation of Medical Devices - Part 11:Tests for systemic toxicity• ISO 10993-12:2012, BiologicalEvaluation of Medical Devices - Part 12:Sample preparation and referencematerials | ||
| PerformanceTestsCont. | Sterilization | ISO 10993-7:2008, Biological Evaluationof Medical Devices – Part 7: EthyleneOxide Sterilization Residuals.ANSI/AAMI/ISO 11135:2014, Annex BSterilization of Health Care Products -Ethylene Oxide - Requirements forDevelopment, Validation and RoutineControl of A Sterilization Process forMedical Devices | |
| The subject device configurations met all predetermined acceptance criteriaderived from the above listed verification tests and demonstrated substantiallyequivalent performance as compared to the cited predicate device. | |||
| Based on the intended use, technological characteristics, and performancetesting, the subject peripheral nerve block Pinpoint™ GT Needles met theSummary ofrequirements that are considered sufficient for its intended use andSubstantialdemonstrates that the subject devices are substantially equivalent to theEquivalencepredicate device cited. |
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§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).