The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.

Device Description

The StimuQuik peripheral nerve block needle is used to locate nerves or nerve plexuses and facilitate delivery of regional anesthesia to the desired location. The needles are constructed of a steel needle and insulated by a white, non-conductive siliconized polyester coating. A small area at the distal tip remains exposed to conduct the stimulating current to nerve tissue. The tip features a 30-degree bevel. and black centimeter markings are printed along the shaft of the needle. An electrical wire with a shrouded 2 mm female connector and an extension line with a Luer lock extend from the ergonomic plastic hub of the needle.

The StimuQuik ECHO peripheral nerve block needle is identical to the StimuQuik needle with the addition of 5 echogenic grooves on the needle tip. The five grooves are designed to help clinicians locate the tip of the StimuQuik ECHO needle under ultrasound.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the StimuQuik Peripheral Nerve Block Needle, and its substantial equivalence to a predicate device. However, it does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Therefore, I cannot extract information related to acceptance criteria or studies proving device performance in the context of an AI/ML device from this document.

The document details the following:

Device: StimuQuik Peripheral Nerve Block Needle
Purpose: To permit the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.
Approval type: 510(k) premarket notification, seeking substantial equivalence to a predicate device (AVID-NIT Nerve Stimulation Needles, K014246).
Testing: Biocompatibility testing (per ISO 10993-1) and Non-clinical performance testing (e.g., needle markings, ink adherence, continuity, current density, leakage, tensile strength, kink resistance, echogenicity).

The performance testing section shows a table with "Test," "Test Objective," "Acceptance Criteria," and "Results" (all pass). However, these are engineering and material performance tests for a physical medical device, not a diagnostic algorithm or AI/ML product. The "acceptance criteria" listed are for physical properties and safety parameters of the needle itself, not for the accuracy or effectiveness of a diagnostic output.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device's acceptance criteria and study design for proving its performance. The provided document is for a traditional physical medical device.

Summary

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April 25, 2018

Teleflex Medical Kristen Bisanz Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560

Re: K173321

Trade/Device Name: StimuOuik Peripheral Nerve Block Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: March 20, 2018 Received: March 22, 2018

Dear Kristen Bisanz:

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 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);

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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 mediation-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,

Geeta K. Pamidimukkala -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)	K173321
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Device Name

StimuQuik Peripheral Nerve Block Needle

Indications for Use (Describe)

The Arrow StimuQuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexus for single-shot nerve block anesthesia or analgesia techniques.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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PSC Publishing Sexvices (301) 443-6740

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510(k) SUMMARY StimuQuik® Peripheral Nerve Block Needle

Name, Address, Phone and Fax Number of Applicant

Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919.433.4932 Fax: 919.433.4996

Contact Person

Kristen Bisanz Senior Regulatory Affairs Specialist

Date Prepared

10 April 2018

Device Name

Trade Name:	StimuQuik Peripheral Nerve Block Needle
Classification Name:	Needle, Conduction, Anesthetic (W/Wo Introducer)
Product Code:	BSP
Regulation Number:	868.5150
Classification:	II
Classification Panel:	Anesthesiology

Predicate Device

This submission demonstrates substantial equivalence to the predicate devices A VID-NIT Nerve Stimulation Needles (StimuQuik) cleared in submission K014246.

Device Description

The StimuQuik Peripheral Nerve Block Needle product numbers and descriptions are below.

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Product Numbers	Product Description
AB-21090-SS	StimuQuik® 21G x 9cm (3.5") Peripheral Nerve Block
AB-21090-SSE	StimuQuik® Echo 21G x 9cm (3.5") Peripheral Nerve Block
AB-21150-SS	StimuQuik® 21G x 15cm (6") Peripheral Nerve Block
AB-21150-SSE	StimuQuik® Echo 21G x 15cm (6") Peripheral Nerve Block
AB-22025-SS	StimuQuik® 22G x 2.5cm (1") Peripheral Nerve Block
AB-22025-SSE	StimuQuik® Echo 22G x 2.5cm (1") Peripheral Nerve Block
AB-22050-SS	StimuQuik® 22G x 5cm (2") Peripheral Nerve Block Needle
AB-22050-SSE	StimuQuik® Echo 22G x 5cm (2") Peripheral Nerve Block

Principle of Action and mechanism of action of the subject device

The StimuQuik Peripheral Nerve Block Needles include a cannula, hub, and fluid extension line with a female luer connector. The needles are used to deliver singleshot anesthesia in peripheral nerve block procedures. An insulated needle with stimulating tip allows for confirmation of needle guidance and placement using stimulation (StimuQuik) and/or ultrasound (StimuQuik Echo). As the needle is advancing in the patient, stimulations are delivered via a nerve stimulator until appropriate muscle twitches occur which demonstrates correct placement. The StimuQuik Echo needles contain 5 rings at the distal end of the needle cannula to help with identification under ultrasound.

Indications for Use

The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.

Patient Population

The StimuQuik Peripheral Nerve Block Needles are intended for adult patients requiring peripheral nerve block procedures.

Environments of use

The environments of use are hospitals, sub-acute facilities, pain clinics, and physician offices.

Contraindications

Pre-existing nerve injury, neuritis or plexitis are relative contraindications for use of peripheral nerve blocks. These conditions should be considered prior to needle insertion. Skin sepsis in the area where the needle placement is planned and systemic sepsis are relative contraindications. Extreme care should be taken in patients with bleeding tendencies or patients receiving anticoagulants.

Substantial Equivalence

The proposed device is substantially equivalent to the predicate listed below.

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Predicate Device	510(k) Number	Date Cleared
AVID-NIT Nerve StimulationNeedles (StimuQuik)	K014246	July 16, 2002

Comparison to Predicate Device

The proposed device has the same operating principles, patient population, sterilization and general design as the predicate device. Biocompatibility testing (Section 020) and Performance testing (Section 023) have been performed on the proposed device to establish substantial equivalence to the predicate device. The proposed changes discussed above do not raise different questions of safety or effectiveness of the StimuQuik Peripheral Nerve Block Needle. The subject device is therefore substantially equivalent to the predicate device identified within this submission.

	PredicateK014246 StimuQuik PeripheralNerve Block Needle	Proposed StimuQuik®Peripheral Nerve Block Needle	Equivalence
ClassificationName	Anesthesia Conduction Kit	Needle, Conduction, Anesthetic,W/Wo Introducer	Equivalent
Product Code	73CAZ	73BSP	Equivalent
Classification	Class II	Class II	Identical
RegulationNumber	868.5140	868.5150	Equivalent
Intended Use	Single Shot nerve block anestheticadministration	Single Shot nerve block anestheticadministration	Identical
Indicationsfor Use	The AVID-NIT Nerve StimulationNeedle consist of an insulatedhollow needle intended for locatingperipheral nerves by electricalstimulation, and for the single shotadministration of a local anestheticdrug. These needles are to be usedwith battery powered peripheralnerve locators only. These needlesare specifically not intended fornerve stimulation for purposes otherthan nerve location. These needlesare specifically not intended forneurolytic ablation.	The Arrow StimuQuik InsulatedPeripheral Nerve Block Needlepermits the stimulation and locationof nerves and nerve plexuses forsingle-shot nerve block anesthesiaor analgesia techniques.	Equivalent
Environmentof Use	Hospitals, Sub-acute facilities,pain clinics, and physician office	Hospitals, Sub-acute facilities,pain clinics, and physician office	Identical
PatientPopulation	Patients requiring peripheralnerve block procedures	Patients requiring peripheralnerve block procedures	Identical
Contra-indications	Pre-existing nerve injury, neuritisor plexitis are relativecontraindications for use ofperipheral nerve blocks. Theseconditions should be consideredprior to needle insertion. Skinsepsis in the area where theneedle placement is planned andsystemic sepsis are relativecontraindications. Extreme careshould be taken in patients withbleeding tendencies or patientsreceiving anticoagulants.	Pre-existing nerve injury, neuritisor plexitis are relativecontraindications for use ofperipheral nerve blocks. Theseconditions should be consideredprior to needle insertion. Skinsepsis in the area where theneedle placement is planned andsystemic sepsis are relativecontraindications. Extreme careshould be taken in patients withbleeding tendencies or patientsreceiving anticoagulants.	Identical
Biocompat-ibility	Per ISO 10993-1	Per ISO 10993-1	Identical
BasicComponents	Insulated cannula with insulatedcoating and hub, fluid extensiontube with luer lock fitting, leadwire for connection to a nervestimulator	Insulated cannula with insulatedcoating and hub, fluid extensiontube with luer lock fitting, leadwire for connection to a nervestimulator	Equivalent
Gauges/Dimension	21-24 Ga	21 Ga	Identical
CannulaLength	35-150mm	35-150mm	Identical
Tip Styles	BeveledPencil Point	BeveledPencil Point	Identical
Cannula	Smooth	Smooth	Identical
CannulaInsulated	Yes	Yes	Identical
CannulaMarkings	Yes	Yes	Identical
FluidExtensiontube	Yes, with female luer lock fitting	Yes, with female luer lock fitting	Identical
Lead Wire	Yes, for connection to nervestimulator	Yes, for connection to nervestimulator	Identical
EchogenicProperties	Yes	Yes	Identical
Sterilization	Sterile	Sterile	Identical
Prescription	Yes	Yes	Identical
Shelf Life	5 years	2 years	Equivalent

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Discussion

Classification Name/Product Code/Regulation Number: The product code of the predicate device is CAZ (anesthesia conduction kit/868.5150) The design and intended use of the predicate and proposed devices is identical. The product code BSP (anesthesia conduction needle/868.5140) was chosen for the proposed device in this submission because it more accurately reflects the intended use of the StimuQuik Peripheral Nerve Block Needle. While product code CAZ can encompass several components in a kit, product code BSP is specific for a device used in the same manner as the StimuQuik Peripheral Nerve Block Needle.

Indication for Use: The Indications for Use of the proposed device are identical to the Indications for Use cleared in K122690 for the UltraQuik Peripheral Nerve Block Needle. The UltraQuik Peripheral Nerve Block Needle in K122690 was deemed substantially equivalent to K014246, the predicate for this submission. The UltraQuik and StimuQuik needles differ only in the presence and absence of the insulating material on the needle. This does not raise any additional questions of safety and effectiveness. Therefore, the Indications for Use of the predicate and proposed devices are equivalent.

Basic Components: The proposed StimuOuik Peripheral Nerve Block Needle contains a different insulator material on the needle as compared to the predicate. Comprehensive functional testing has been successfully completed on the StimuQuik Peripheral Nerve Block Needle. The functional testing proves the proposed device meets the standard requirements and also performs as well as the predicate devices. The testing included: needle markings, ink adherence, continuity, needle current density, current leakage, resistance to leakage, tensile strength, kink resistance, and echogenicity. As demonstrated by the functional testing, the change in insulator material on the needle has no impact on the function or performance of the StimuOuik Peripheral Nerve Block Needle. Biocompatibility testing has been performed on the final finished proposed device. The following testing has been done: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, and Hemolysis. The materials tested all met the ISO 10993 requirements. As demonstrated by the biocompatibility testing, the change in insulator material on the needle has no impact on the performance or intended use of the StimuQuik Peripheral Nerve Block Needle.

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Materials

All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.

Test	Acceptance Criteria	Results
Cytotoxicity -L929 MEM ElutionAssay	The test article will meet the requirements of thetest if it obtains a Grade of 0,1, or 2 (not morethan 50% of the cells are round, devoid ofintracytoplasmic granules, and no extensive celllysis)	Acceptable
Sensitization -KligmanMaximization Assay	The test article will be considered a non-irritantif the difference between the test article meanscore and the vehicle control mean score is 1.0 orless.	Acceptable
Irritation -IntracutaneousInjection Assay	The test article will meet the requirements of thetest if it receives a Grade of 1, 0 or less using theKligman scoring system.	Acceptable
Acute SystemicToxicity -Systemic Injection	The test article will meet the requirements of thetest if none of the animals injected with the testarticle show a significantly greater biologicalreaction than the animals treated with the controlarticle.	Acceptable
Pyrogenicity -Material MediatedRabbit Pyrogenicity	The test article will meet the requirements of thetest if no rabbit shows an individual rise intemperature of 0.5℃ or more above the baselinetemperature.	Acceptable
Hemolysis –Rabbit BloodHemolysis Complete	The test article will meet the requirements of thetest and is not considered to have hemolyticactivity potential, if the hemolytic index abovethe negative control article and negative controlarticle extract is <5%.	Acceptable

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Performance Data

Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs.

Test	Test Objective	Acceptance Criteria	Results
Needle Markings	To visuallyinspect theneedle markings	Needles shall be permanently marked withblack graduation at 10mm intervals startingfrom the tip of the needle. The visibleneedle markings shall be printed on theneedle cannula per the drawing.	Pass
Ink Adherence	To validate theadherence of inkto the needle	Samples with an initial rating of 4 or 5 shallhave an adherence score after the SCOTCH610 tape test of 3 or greater.Samples with an initial rating of 3 shallhave an adherence rating score after theSCOTCH 610 tape test of 3.	Pass
Continuity	To validate thecontinuity ofelectricalresistance	The electrical resistance of all measuredsamples shall be less than or equal to 10Ohms (Ω)	Pass
Needle CurrentDensity andCurrent Leakage	To validate theneedle currentdensity andcurrent leakage	There shall be no insulation breakdownduring the usage of the devices. Insulationbreakdown is considered to have occurredwhen the current which flows because ofthe application of the test voltage rapidlyincreased in an uncontrolled manner, i.e.insulation does not restrict the flow of thecurrent. Each needle will be required towithstand a voltage of 47V DC for 1 minutewith less than 0.001 mA leakage current.	Pass
Resistance toLeakage	To validate theresistance tointernal leakage	There shall be no internal leakage with aninternal negative pressure of 25mmHg for120 seconds (per EN1618:1997)	Pass
Tensile Strength -Needle Cannula toNeedle Hub	To validate thetensile strengthfrom needlecannula toneedle hub	The force at break for each UUT of 21Gasize needles between hub and needle tubeshall not exceed 44N (per ISO7864:1993)	Pass
Adherence ofInsulation to thebody of the needle	To determinethe adherence ofthe insulator tothe body of the	Each needle will be required to withstand avoltage of 47V DC for 1 minute less than0.001mA leakage current before and afterneedle is exposed to beef.	Pass
	needle
Kink Resistancefor FluidExtension Line	To establish thekink diameter ofthe fluidextension line	The kink diameter of the fluid extensionline will be determined.	Completed

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Conclusion

Based on the performance and comparative test results, the proposed StimuQuik Peripheral Nerve Block Needle is substantially equivalent to the predicate devices cleared to market in K014246. The modifications of the new insulator material do not introduce any different questions of safety and effectiveness.

Regulation Number and Section

§ 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).