ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE

{0}------------------------------------------------ K122690 510(k) Summary Page 1 of 6 29-Nov-12 . . ### DEC 2 1 2012 Arrow International Inc. 2400 Bernville Road . Reading, PA 19605 Official Contact: Paul Amudala Regulatory Affairs Specialist Tel: 610-378-0131 Fax: 610-478-3179 Proprietary or Trade Name: ARROW UltraQuik Peripheral Nerve Block Needle Common/Usual Name: Peripheral Nerve Block Classification Name: Product code - CAZ CFR 868-5140 - anesthetic conduction kit Class 2 Predicate Device: A VID-NIT (Arrow) - StimuQuik™ PNB Needle - K014246 ### Device Description: The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include: - Gauge . - 20 Ga (Touhy only) o - 21 to 24 Ga 0 - . Lengths - 35 mm to 150 mm 0 - Point style ● - Bevel tip o - Pencil point 0 - Touhy tip 0 - Cannula echogenicity - The cannula is naturally echogenic but the addition of grooves on the cannula 0 enhance the echogenicity The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location. ### Basic Components for Peripheral Nerve Block needle A typical basic Peripheral Nerve Block ("PNB") needle includes the following components. {1}------------------------------------------------ ### 510(k) Summary Page 2 of 6 29-Nov-12 - Cannula with sharp tip . - Hub - . Fluid extension line with female luer connector ### Indications for Use: The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of singleshot peripheral nerve block anesthesia or analgesia using medical imaging devices. ### Patient Population: Patients requiring peripheral nerve block procedures. ### Environment of Use: The environment of use is - hospital, sub-acute facilities, pain clinics, 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. ### Comparison to Predicates The UltraQuik PNB Needle for single shot non-stimulating nerve block procedures is viewed as substantially equivalent to the predicate device because: ### Indications - The intended uses are identical and the indications for use are identical except for the nonstimulating feature. Use of a non-stimulating PNB needle is common and not a new procedure. Equivalent to predicate - K014246 -- AVID-NIT StimuQuik PNB Needle. ### Technology - The components of the proposed UltraQuik PNB Needle are identical to the predicate K014246, A VID-NIT StimuQuik PNB Needle and there is no new technology or materials. ### Materials - The materials are identical to the predicate, K014246 - AVIV-NIT StimuQuik PNB Needle. ### Environment of Use - The proposed environments of use are identical to the predicate K014246 - AVID-NIT StimuQuik PNB Needle. They are - hospital, sub-acute facilities, pain clinics, and physician offices. {2}------------------------------------------------ ### 510(k) Summary Page 3 of 6 29-Nov-12 ### Patient Population - Patients requiring peripheral nerve block procedures. Identical to the predicate, K014246 -AVID-NIT StimuQuik PNB Needle. ### Non-clinical Testing Summary - The components of the proposed device are identical to the predicate K014246, except the addition of echogenic grooves. We have performed bench testing after 5 year accelerated shelflife. This testing included: - Tensile strength for regions of the needle not intended for insertion into the body ● - . Injection tubing to needle hub - Injection tubing to Luer Lock connector - Tensile strength for the needle cannula to needle hub . - . Needle sharpness - Injection tubing leakage - Resistance to leakage during aspiration or vacuum . - Corrosion resistance of metallic components . - Needle Stiffness - Luer Lock connector . ### Summary of Test Results | Description | Results | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Tensile Strength<br>For regions not<br>Inserted in body | Pass / fail criteria force to break is > 15 N<br>Injection Tubing to needle hub - mean 27 N<br>Injection Tubing to Luer Lock - mean 27 N | | Tensile Strength<br>Needle cannula to<br>Hub joint | Pass / fail criteria force to break > 40 N<br>All have a mean > 99 N | | Needle Sharpness | Pass / fail criteria - none<br>Penetration force - all have a mean >3.17 N | | Injection leakage | Pass / fail criteria - no leak at 50 psi for 30 sec<br>No leakage observed | | Resistance to<br>leakage | Pass / fail criteria - no internal leakage at - 25 mmHg for 120 sec<br>No leakage observed | | Corrosion<br>Resistance | Pass / fail - no visible sign of corrosion<br>No observed corrosion | {3}------------------------------------------------ ### 510(k) Summary Page 4 of 6 29-Nov-12 | Needle Stiffness | Pass / fail criteria - deflection < 0.5 mm ·<br>Deflection - all have a mean < 0.5 mm | |-------------------------|---------------------------------------------------------------------------------------| | Needle Markings | Pass / fail - permanent markings at 10 mm<br>Cannula are so marked | | Component<br>Capability | Pass / fail - usability testing<br>Results were favorable | ### Imaging and Echogenic property evaluation: Comparative ultrasound imagines were performed on the proposed design vs. the predicate. In addition a clinical preference survey was done with clinicians and all found the echogenic design to be easier to recognize. {4}------------------------------------------------ ## 510(k) Summary ## Predicate Comparative Table . | Features | Proposed<br>UltraQuik PNB Needle | Predicates<br>K014246 – AVID-NIT – StimuQuik PNB Needle | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification name | Anesthetic Conduction Kit | Anesthetic Conduction Kit | | Product Code | CAZ<br>868.5140 | CAZ<br>868.5140 | | Intended Use | Single Shot nerve block anesthetic administration | Single Shot nerve block anesthetic administration | | Indications for use | The Arrow UltraQuik® Peripheral Nerve Block Needle is<br>indicated for the delivery of single-shot peripheral nerve block<br>anesthesia or analgesia using medical imaging devices. | The AVID-NIT Nerve Stimulation Needles consist of an<br>insulated hollow needles intended for locating peripheral<br>nerves by electrical stimulation, and for the single shot<br>administration of a local anesthetic drug. These needles are<br>to be used with battery powered peripheral nerve locators<br>only. These needles' are specifically not intended for nerve<br>stimulation for purposes other than nerve location. These<br>needles are specifically not intended for neurolytic<br>ablation. | | Environment of Use | Hospital, sub-acute facilities, pain clinics, physician offices | Hospital, sub-acute facilities, pain clinics, physician offices | | Patient Population | Patients requiring peripheral nerve block procedures | Patients requiring peripheral nerve block procedures | | Contraindications | Pre-existing nerve injury, neuritis or plexitis are relative<br>contraindications for use of peripheral nerve blocks. These<br>conditions should be considered prior to needle insertion.<br>Skin sepsis in the area where the needle placement is<br>planned and systemic sepsis are relative contraindications.<br>Extreme care should be taken in patients with bleeding<br>tendencies or patients receiving anticoagulants. | Pre-existing nerve injury, neuritis or plexitis are relative<br>contraindications for use of peripheral nerve blocks. These<br>conditions should be considered prior to needle insertion.<br>Skin sepsis in the area where the needle placement is<br>planned and systemic sepsis are relative contraindications.<br>Extreme care should be taken in patients with bleeding<br>tendencies or patients receiving anticoagulants. | | Basic components | Non-insulated cannula with hub<br>Fluid extension tube with luer lock fitting | Insulated cannula with insulated coating and hub<br>Fluid extension tube with luer lock fitting<br>Lead wire for connection to a nerve stimulator | | Features | Proposed<br>UltraQuik PNB Needle<br>Component Design and Specifications | Predicates<br>K014246 - AVID-NIT - StimuQuik PNB Needle | | Cannula | | | | Gauges / dimensions | 20 Ga for Touhy<br>21 - 24 Ga | 21 - 24 Ga | | Cannula length | 35 - 150 mm | 35 - 150 mm | | Tip styles | Beveled<br>Pencil point<br>Touhy | Beveled<br>Pencil point | | Cannula | Smooth<br>Grooved | Smooth | | Cannula insulated | No, not required | Yes | | Cannula markings | Yes | Yes | | Fluid Extension Tube | with female luer lock fitting | with female luer lock fitting | | Lead wire | No, this is not a feature of the proposed device | Yes for connection to nerve stimulator | | Echogenic Properties | Yes | Yes | | Provided Sterile | Yes | Yes | | Shelf-life | 5 years | 5 years | Page 5 Page 5 K122690 Page 14 of 39 {5}------------------------------------------------ ## 510(k) Summary # Substantial Equivalence Conclusion The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predical have been found to substantially . {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### December 21, 2012 Mr. Paul Amudala Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road READING PA 19605 Re: K122690 Trade/Device Name: UltraQuik Peripheral Nerve Block Needle Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: November 29, 2012 Received: December 3, 2012 Dear Mr. Amudala: · · 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. {7}------------------------------------------------ ### Page 2 - Mr. Amudala 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 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Anthong La m Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Indications for Use Statement Page 1 of 1 510(k) Number: . K122690 Device Name: UltraQuik Peripheral Nerve Block Needle Indications for Use: The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices. Prescription Use XX (Part 21 CFR 801 Subpart D) or Over-the-counter use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ### Lester W. Schultheis Jr 2012.12.20 1,2:32:25 -05'00' (Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices 510(k) Number: k122690 K122690 Page 9 of 39