(209 days)
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block (PNB) Needle consist of a polycarbonate luer hub, stainless steel cannula and a polyethylene sheath. The needle cannula will be supplied with a bevel tip or a Tuohy tip. The EchoGlo™ PNB Needle will be used for peripheral nerve block under ultrasound guidance. The distal end of the cannula has been engraved with two bands to increase ultrasound visibility by optimally reflecting ultrasound waves. These needles are provided as sterile, nonpyrogenic, single-use disposable devices. The needles may be used for single shot peripheral nerve block or for continuous infusion nerve block. The EchoGlo™ PNB Needle used for a single shot procedure will be supplied in a pouch along with a 24 inch extension set. The extension set will consist of polyvinyl chloride (PVC) tubing and have a Female luer at one end of the tubing and a Male luer at the opposite end of the tubing.
The provided text describes specific medical devices and their non-clinical testing for regulatory approval. It does not contain information about studies involving human readers or comparative effectiveness studies with AI assistance. Hence, acceptance criteria and study details related to human performance, AI, or clinical outcomes are not available in this document.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Non-Clinical Performance Testing" in Table 5-2 that the device was evaluated against. The reported performance for all these tests was that they "met pre-established specifications," demonstrating the device performs as intended. Specific numerical acceptance criteria or performance values are not provided in this summary.
| Category | Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Met pre-established specifications |
| Sensitization | Met pre-established specifications | |
| Acute systemic toxicity | Met pre-established specifications | |
| Material-Mediated Pyrogenicity | Met pre-established specifications | |
| Particulate Matter in Injections | Met pre-established specifications | |
| Exaggerated Leachables | Met pre-established specifications | |
| Hemocompatibility | Met pre-established specifications | |
| Packaging | Packaging integrity (based on ASTM D4169, ASTM F1886, ASTM F2825, ASTM F88, ASTM F2096, ISO 11607-1) | Met pre-established specifications |
| Device Performance | Gauging (T=0, T=6 months accelerated aging (AA)) | Met pre-established specifications |
| Leakage, Air (T=0, T=6 months AA) | Met pre-established specifications | |
| Leakage, Liquid (T=0, T=6 months AA) | Met pre-established specifications | |
| Ease of Assembly (T=0, T=6 months AA) | Met pre-established specifications | |
| Separation Force (T=0, T=6 months AA) | Met pre-established specifications | |
| Resistance to Overriding (T=0, T=6 months AA) | Met pre-established specifications | |
| Unscrewing Torque (T=0, T=6 months AA) | Met pre-established specifications | |
| Stress Cracking (T=0, T=6 months AA) | Met pre-established specifications | |
| Needle Inspections: Bond - Needle and hub (T=0, T=6 months AA), Limits of Acidity/Alkalinity, Patency of Lumen, Limits for Extractable materials | Met pre-established specifications | |
| Needle Stiffness, Resistance to Breakage, Resistance to Corrosion | Met pre-established specifications | |
| Bond Pull - Extension set (T=0, T=6 months AA) | Met pre-established specifications | |
| Demonstration Penetration Force | Met pre-established specifications | |
| Ultrasound Visibility | Ensured equivalence to predicate (qualitative assessment implied by "Summary of Technology Characteristics" on page 4) | |
| Human Factors | Evaluate user interface (based on FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff (3 February 2016)) | Met pre-established specifications |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each non-clinical test. The testing is described as "non-clinical performance testing," which implies laboratory or bench testing rather than studies involving human subjects or real-world clinical data. Therefore, data provenance such as country of origin or retrospective/prospective nature is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes non-clinical performance and engineering tests, not studies that require expert-established ground truth for medical imaging or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical performance and engineering tests, not studies requiring expert adjudication of results.
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
No, an MRMC comparative effectiveness study involving human readers or AI is not discussed in this document. The device is a physical medical needle, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, this question pertains to AI/algorithm performance. The device is a physical medical needle.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference standard would be the established specifications and requirements outlined in the various ISO, ASTM, and USP standards referenced (e.g., ISO 10993 for biocompatibility, ISO 594 for conical fittings, ISO 7864 for hypodermic needles, ASTM D4169 for packaging). The device was tested against these predefined engineering and safety specifications.
8. The Sample Size for the Training Set
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
January 25, 2018
Smiths Medical ASD, Inc. Michael Johnson Sr. Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K171968
Trade/Device Name: EchoGlo Periphreal Nerve Block Needle: Single Shot and EchoGlo Periphreal Nerve Block Needle: Continuous Catheter Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 20, 2017 Received: December 22, 2017
Dear Michael Johnson:
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
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tina Kiang, Ph.D. 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) K171968
Device Name
EchoGloTM Peripheral Nerve Block Needle: Single Shot EchoGlo™ Peripheral Nerve Block Needle: Continuous
Indications for Use (Describe)
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous This device is intended for use in the administration of regional anesthetic blocks.
Intended population is adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Confidential
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1. ADMINISTRATIVE INFORMATION
| 510(k) | K171968 |
|---|---|
| Applicant's Nameand Address | Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442 USA |
| Contact Person | Michael R. JohnsonSr. Regulatory Affairs SpecialistPhone: 763-383-3341Fax: 763-383-3679Email: mike.johnson@smiths-medical.com |
| Date | December 14, 2017 |
| Regulation No. | 21 CFR § 868.5150 |
| Regulation Name | Anesthesia conduction needle |
| Primary ProductCode | BSP |
| Trade Name | EchoGlo™ Peripheral Nerve Block Needle: Single ShotEchoGlo™ Peripheral Nerve Block Needle: Continuous |
2. DEVICE INFORMATION
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | SONO TapTuohy Sono | EchoGlo™ Peripheral Nerve BlockNeedle: Single ShotEchoGlo™ Peripheral Nerve BlockNeedle: Continuous |
| Regulation No. | 21 CFR § 868.5150 | 21 CFR § 868.5150 |
| Regulation Name | Anesthesia conduction needle | Anesthesia conduction needle |
| Regulatory Class | II | II |
| Product Code | BSP | BSP |
| 510(k) | K113207 | K171968 |
3. DEVICE DESCRIPTION
The EchoGlo™ Peripheral Nerve Block (PNB) Needle consist of a polycarbonate luer hub, stainless steel cannula and a polyethylene sheath. The needle cannula will be supplied with a bevel tip or a Tuohy tip. The EchoGlo™ PNB Needle will be used for peripheral nerve block under ultrasound guidance. The distal end of the cannula has been engraved with two bands to increase ultrasound visibility by optimally reflecting ultrasound waves. These needles are provided as sterile, nonpyrogenic, single-use disposable devices. The needles may be used for single shot peripheral nerve block or for continuous infusion nerve block. The EchoGlo™ PNB Needle used for a single shot procedure will be supplied in a pouch along with a 24 inch extension set. The extension set will consist of polyvinyl chloride (PVC) tubing and have a Female luer at one end of the tubing and a Male luer at the opposite end of the tubing.
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4. INDICATIONS FOR USE
The EchoGlo™ Peripheral Nerve Block Needle: Single Shot
This device is intended for use in the administration of regional anesthetic blocks.
The EchoGlo™ Peripheral Nerve Block Needle: Continuous
This device is intended for use in the administration of regional anesthetic blocks.
Intended population is adults.
5. SUBSTANTIAL EQUIVALENCE DISCUSSION
Indications for Use
The Echoglo indications for use is similar to the predicate devices include enhanced for ultrasound visibility, similar transient delivery and the option to facilitate placement of a catheter.
A. Both the subject and predicate devices are enhanced for ultrasound visibility. The EchoGlo™ needles are enhanced for ultrasound visibility via grooved echogenic feature. The EchoGlo™ needles also have visible bands which identify the needle length and needle insertion depth in 1cm increments after echogenic feature, visible to the eye without ultrasound imaging.
B. Both the subject and predicate devices offer similar transient use.
C. Both the subject and predicate devices offer the option to facilitate placement of a catheter. Testing demonstrating equivalency for placement.
Summary of Technology Characteristics
The Smiths Medical EchoGlo Peripheral Nerve Block Needles and predicate devices are both designed for enhanced ultrasound visibility, delivery of regional anesthesia, and to facilitate placement of a catheter. The Smiths Medical EchoGlo™ Peripheral Nerve Block Needles has similar technological characteristics as the predicate device. Both subject and predicate device incorporate 1cm incremented visible depth markings to monitor insertion depth through ultrasound imaging. The subject device and predicate devices are prescribe by physician only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user.
The difference between the predicate is the Smiths EchoGlo has echogenic visible bands with helical markers while the SonoTAP and Tuohy Sono include diamond shape markers. Additionally, the Echoglo offers a Bevel tip in 20G-22G, and a Tuohy tip in 18G.
| Table 5-1 | |||
|---|---|---|---|
| Characteristic | Predicate DeviceK113207 | Subject DeviceK171968 | Discussion |
| Company | Pajunk GMBH | Smiths Medical | NA |
| FDA Product Code& CFE | BSP21 CFR 868.5150. | BSP21 CFR 868.5150. | Same |
| Trade Name | SONO TapTuohy Sono | EchoGlo™ PeripheralNerve Block Needle: | NA |
| Characteristic | Predicate DeviceK113207 | Subject DeviceK171968 | Discussion |
| Single Shot | |||
| EchoGlo™ PeripheralNerve Block Needle:Continuous | |||
| Product | Needle, Conduction,Anesthetic (w/wointroducer) | Single Shot andContinuous Nerve BlockNeedle | NA |
| Common /ClassificationName | Anesthesia conductionneedle | Anesthesia conductionneedle | Same |
| Indications for Use | The cannulas/ needlesfor anesthesia andanalgesia enhanced forultrasound visibility -Tuohy Sono, SonoTAP, Quincke Sono,Chiba Sono, Sono andCrawford Sono - areintended for thetransient delivery ofanesthetics to provideregional anesthesiaand analgesia or tofacilitate placement ofa catheter | The EchoGlo™ PeripheralNerve Block Needle:Single ShotThis device is intended foruse in the administrationof regional anestheticblocks.The EchoGlo™ PeripheralNerve Block Needle:ContinuousThis device is intended foruse in the administrationof regional anestheticblocks. | Similar. Both areenhanced forultrasoundvisibility. Also,both are intendedfor the delivery ofregionalanesthesia, or tofacilitateplacement of acatheter. |
| Hospital LocationUse | ICU/OR | ICU/OR | Same |
| Visibility feature | Etched cannula/needleto enhance ultrasoundvisibility. The needlecannula is equippedwith a specificdiamond shapedreflector pattern that isdesigned to reflectultrasound waves. | Etched cannula/needle toenhance ultrasoundvisibility. A specialhelical-shaped groovedesign is cut into theneedle cannula. Thegrooves are designed tooptimally reflectultrasound waves to makethe needle more visibleunder ultrasound. | Similar. Both areetched needles thatare designed toenhance visibilityunder ultrasound.Difference is theetched pattern. |
| Proximal EndConnection | Luer, Per ISO 594-1,and ISO 594-2 | Luer, Per ISO 594-1, andISO 594-2 | Same |
| Single Use | Yes | Yes | Same |
| SterilizationMethod | EtO | EtO | Same |
| Tip Design | Tuohy, Bevel | Tuohy, Bevel | Same |
| Needle Gauge | Tuohy SONO : 16G -26G | Bevel : 20G-22GTuohy: 18G | Similar. Subjectdiameter is |
| Characteristic | Predicate DeviceK113207 | Subject DeviceK171968 | Discussion |
| Quincke SONO: 16G -26GSono TAP, ChibaSONO: 16G - 26GCrawford SONO: 16G- 26G | betweenpredicate's gaugerange | ||
| Needle Length | Tuohy SONO: 20mm-180mmSono TAP, QuinckeSONO: 20mm-180mmChiba SONO: 20mm-180mmCrawford SONO:20mm-180mm | Single Shot: 35-150mmContinuous: 50-150mm | Similar. Subjectlength is withinpredicate's lengthrange |
| Cannula Material | Stainless steel | Stainless steel | Same |
| Needle HubMaterial | Polycarbonate | Polycarbonate | Same |
| Sheath Material | Polyethylene | Polyethylene | Same |
| Extension SetTubing Material | Polyvinylchloride (PVC) | Polyvinylchloride (PVC) | Same |
| Extension Set MaleLuer Material | Polyacrylic | PVC | Similar |
| Extension SetFemale LuerMaterial | PVC | PVC | Same |
A comparative analysis of the technological characteristics is provided in Table 5-1.
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bringing technology to life
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bringing technology to life
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6. SUMMARY OF NON-CLINICAL TESTING
The Smiths Medical EchoGlo™ Peripheral Nerve Block Needle was evaluated via non-clinical performance testing to demonstrate the devices are substantially equivalent the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the EchoGlo™ Peripheral Nerve Block Needle performed as intended. A summary of the Non-Clinical performance testing is in Table 5-2. Biological and Bench testing was conducted to the Standards in Table 5-3.
| Category | Evaluation | Standards |
|---|---|---|
| Biocompatibility | Cytotoxicity | ISO 10993-7:2009: Biologicalevaluation of medical devices—Part 5: Tests for in vitrocytotoxicity |
| Sensitization | ISO 10993-10:2010: Biologicalevaluation of medical devices—Part 10: Tests for irritation and skinsensitization | |
| Acute systemic toxicity | ISO 10993-11:2006: Biologicalevaluation of medical devices—Part 11: Tests for systemic toxicity | |
| Material-Mediated Pyrogenicity | USP<151>Pyrogen Test | |
| Particulate Matter in Injections | USP<788>:2012 Particulate Matterin Injections | |
| Exaggerated Leachables | ISO 10993-17:2002: Biologicalevaluation of medical devices—Part 17: Establishment of allowablelimits for leachable substances | |
| Hemocompatibility | ISO 10993-4:2002/(R)2013 &A1:2006/(R)2013: Biologicalevaluation of medical devices - Part4: Selection of tests for interactionwith blood | |
| Packaging | Existing packaging material for currentlymarketed devices will be used for thepackaging of the EchoGlo™ PeripheralNerve Block Needle. Packaging integritytest were performed to ensure packagingmeet specifications. For details referenceSection 14.3 | ASTM D4169:2016: Standardpractice for performance testing ofshipping containers and systems. |
| ASTM F1886:2013: Determiningintegrity of seals for flexiblepackaging by visual inspection. | ||
| ASTM F2825:2015: Standardpractice of climatic stressing ofpackaging systems for single parceldelivery. | ||
| Category | Evaluation | Standards |
| test method for seal strength offlexible barrier materials. | ||
| ASTM F2096:2011: Standard testmethod for detecting gross leaks inmedical packaging by internalpressurization. | ||
| ISO 11607-1:2006/(R):2010:Packaging for terminally sterilizedmedical devices Part 1:Requirements for materials, sterilebarrier systems, and packagingsystems. | ||
| Device Performance | Gauging (T=0, T=6 months acceleratedaging (AA))Leakage, Air (T=0, T=6 months AA)Leakage, Liquid (T=0, T=6 months AA)Ease of Assembly (T=0, T=6 months AA)Separation Force (T=0, T=6 months AA)Resistance to Overriding (T=0, T=6 monthsAA)Unscrewing Torque (T=0, T=6 months AA)Stress Cracking (T=0, T=6 months AA) | ISO 594-1: Conical fittings with a6% (luer) taper for syringes,needles, and certain other medicalequipment - Part 1: GeneralRequirementsISO 594-2 second ed. 1998-09-01:Conical Fittings with a 6% taper(luer) for syringes, needles, andcertain other medical equipment -Part 2: Lock fittings |
| Needle InspectionsBond - Needle and hub (T=0, T=6 monthsAA)Limits of Acidity/AlkalinityPatency of LumenLimits for Extractable materials | ISO 7864 Fourth Edition: 2016-08-01: Sterile hypodermic needles forsingle use - Requirements and testmethods | |
| Needle InspectionsNeedle StiffnessResistance to BreakageResistance to Corrosion | ISO 9626 Second Edition 2016-08-01: Stainless steel needle tubing forthe manufacture of medical devices- Requirements and test methods | |
| Bond Pull - Extension set (T=0, T=6months AA)DemonstrationPenetration ForceUltrasound Visibility | N/A | |
| Human Factors | Evaluate user interface | FDA guidance, Applying HumanFactors and Usability Engineeringto Medical Devices: Guidance forIndustry and Food and DrugAdministration Staff (3 February2016) |
Table 5-2 - Non-Clinical Performance Testing
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| RecognitionNumber | Standard Number | Assessment |
|---|---|---|
| 14-452 | ISO 11135 2nd Edition 2014 | Sterilization Of Health-Care Products -Ethylene Oxide - Requirements For TheDevelopment, Validation And Routine |
| RecognitionNumber | Standard Number | Assessment |
| 2-156 | ISO 10993-1:2009 R 2013 | Control Of A Sterilization Process ForMedical Devices. (Sterility) |
| 6-11 | ISO 594-1 | Biological Evaluation Of MedicalDevices - Part 1: Evaluation And TestingWithin A Risk Management Process |
| 6-129 | ISO 594-2 Second Ed. 1998-09-01 | Conical Fittings With A 6% (Luer)Taper For Syringes, Needles AndCertain Other Medical Equipment - Part1: General Requirements |
| 14-457 | 11607-1:2006/(R)2010 | Conical Fittings With A 6% (Luer)Taper For Syringes, Needles AndCertain Other Medical Equipment - Part2: Lock Fittings |
| 2-234 | ISO 10993-4:2002/(R)2013 &A1:2006/(R)2013 | Packaging For Terminally SterilizedMedical Devices - Part 1: RequirementsFor Materials, Sterile Barrier SystemsAnd Packaging Systems [Including:Amendment 1 (2014)] |
| 14-278 | 10993-7:2008(R)2012 | Biological evaluation of medical devices- Part 4: Selection of tests for interactionwith blood |
| 2-118 | AAMI ANSI ISO 10993-11:2006/(R)2010 | Biological Evaluation Of MedicalDevices - Part 7: Ethylene OxideSterilization Residuals |
| 14-227 | AAMI ANSI ISO 11737-1:2006(R)2011 | Biological evaluation of medical devicesPart 11: Tests for systemic toxicity |
| 14-360 | ANSI/AAMI ST72:2011 | Sterilization Of Health Care Products -Microbiological Methods - Part 1:Determination Of The Population OfMicroorganisms On Product |
| 6-379 | ISO 7864 Fourth Edition 2016-08-01 | Bacterial Endotoxins - Test Methods,Routine Monitoring, And AlternativesTo Batch Testing |
| 6-380 | ISO 9626 Second Edition 2016-08-01 | Sterile Hypodermic Needles For SingleUse - Requirements And Test Methods |
| 5-108 | ASTMD 4169-16 2014 | Stainless Steel Needle Tubing For TheManufacture Of Medical Devices -Requirements And Test Methods |
| N/A | USP<151> | Standard Practice for PerformanceTesting of Shipping Containers andSystems |
| N/A | USP<788>:2012 | Pyrogen Test |
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7. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Smiths Medical EchoGlo™ Peripheral Nerve Block Needle is substantially equivalent to the
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Image /page/10/Picture/1 description: The image shows the logo for Smiths Medical. The logo consists of the words "smiths medical" in blue font. Below the logo is the tagline "bringing technology to life" in a smaller, lighter blue font.
predicate device based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the subject devices for its intended uses. The results of biocompatibility testing and performance confirmed the substantial equivalence of the EchoGlo™ Peripheral Nerve Block Needle. The test results do not raise different safety or performance questions, and confirmed that the EchoGlo™ Peripheral Nerve Block Needle is substantially equivalent to the predicate devices.
§ 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).