SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 5, 2016 Spectra Medical Devices, Inc. % Tanya O'Brien Clinical Affairs Specialist AJW Technology Consultants, Inc. 445 Apollo Beach Blvd Apollo Beach, Florida 33572 Re: K151069 Trade/Device Name: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: November 23, 2015 Received: December 8, 2015 Dear Ms. O'Brien: 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 {1}------------------------------------------------ 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 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 yours. **Tejashri Purohit-Sheth, M.D.** Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K151069 Device Name SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle ## Indications for Use (Describe) The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain the echnogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or extension set. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY (as required by 807.92) #### -SUBMITTER Spectra Medical Devices, Inc. 260 F/H Fordham Road Wilmington, MA 01887 Phone: 757-220-8917 Fax: 757-220-8919 Contact Person: Scott Henderson Date Prepared: March 26, 2015 ## REGULATORY CORRESPONDENT AJW Technology Consultants, Inc. 445 Apollo Beach, Blvd. Apollo Beach, FL 33572 Contact Person: Tanya O'Brien Email: tmobrien@ajwtech.com Phone: 813-645-2855 x102 Fax: 813-645-2856 #### 11. DEVICE Name of Device: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle Common or Usual Name: Conduction Needle Classification Name: Needle, Anesthesia Conduction Device Panel: Anesthesiology Regulatory Class: 2 Product Code: BSP Contact Type: Limited Exposure Device #### lll. PREDICATE DEVICE ● Havel's Inc. - K063380 ECHOSTIM FACIT TIP These predicates have not been subject to a design-related recall. No reference devices were used in this submission. {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle consists of a stainless steel needle and a clear or colored (translucent) standard female Luer lock square or round Hub locking connector for rapid (flashback) visualization. The stainless steel needles are available with and without an echogenic feature (i.e. mechanical dimpling treatment to the needle point surface), and with or without lubrication. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need (16 to 30 gauges). ### V. INIDCATIONS FOR USE The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or an extension set. ## VI. COMPMARISOIN OF TECHNOLIGICAL CHARACTERISTICS IWHT THE PREDICATE DEVICE To inject fluids (drug solutions), or withdraw fluids from parts of the body below the surface of the skin is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter. At a high level, the subject and predicate devices are based on the following same technological characteristics: - . Design - . Materials of the needle - Sterility - . No thermal source - Indications for use ● The following technological differences exist between the subject and predicate devices: - . Additional or different sizes of needles are offered - Some additional/different materials are used for the Spectra hub designs - Physical dimensions - VII. DEVICE COMPARISON CHART See Appendix A {5}------------------------------------------------ #### VIII. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination. Mechanical Testing - Bond strength of hub and cannula - ISO 594-1 - ISO 7864:11 ● - Luer compatibility ● - Hub and Needle Strength #### BIOCOMPATIBILITY TESTING וא. The product contact materials utilized in the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles have been well characterized chemically and physically. The following table indicates the individual biocompatibility tests performed on the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles. | Test | Description | |--------------|------------------------------------------------------------| | ISO 10993-5 | Cytotoxicity Study Using the ISO Elution Method | | ISO 10993-4 | In Vitro Hemolysis Study (Modified ASTM-Extraction Method) | | ISO 10993-11 | USP and ISO Systemic Toxicity Study - Extracted | | ISO 10993-10 | ISO Intracutaneous Study - Extract | | ISO 10993-10 | ISO Maximization Sensitization Study - Extract | #### X. CONCLUSIONS The testing completed demonstrates that the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles have exhibited comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable. Based on these characteristics, the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles, ARE substantially equivalent to the predicate device in addition to being intended for the same uses. {6}------------------------------------------------ # APPENDIX A {7}------------------------------------------------ | SPECTRA DEVICE | HAVEL'S | SIMILARITIES | DIFFERENCES | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pending<br>21 CFR 868.5150<br>BSP | K063380<br>21 CFR 868.5150<br>BSP | N/A | N/A | | II | II | Same | None | | The SPECTRA Disposable<br>Single Lumen Echogenic<br>Injection Anesthesia<br>Conduction Needle is<br>intended for use in injecting a<br>single dose of local anesthetic<br>or analgesic into a patient for<br>regional anesthesia or pain<br>therapy with the echogenic<br>reflective pattern providing<br>visualization of the needle tip<br>using Ultrasound Imaging.<br>The needles are intended to<br>mate with the male<br>connector of a Luer Lock or<br>Luer Slip Syringe or an<br>extension set. | Havel's Electrically insulated<br>anesthesia conduction<br>needles are used to puncture<br>the tissue in order to gain<br>entry and locally inject<br>anesthetics to induce regional<br>anesthesia. An electrical<br>stimulus may be applied to<br>the needle via a cable and<br>connector to assist the<br>physician to pinpoint the area<br>of application. | Same<br>The Indications for Use are<br>basically the same, in that<br>they are both conduction<br>needles intended to<br>administer regional<br>anesthesia, and both are used<br>as a non-insulated needle. | None for Non-Insulated<br>Havel's Needle Configuration | | Adult and Pediatric<br>Single Use Disposable Device<br>Echogenic Injection<br>Anesthesia Conduction<br>Needle with Standard Round<br>Luer Style Hub or Square<br>Hubs and a Stainless Steel<br>Needle. The needle protector<br>is an extracted tube or a<br>molded protector. The<br>square clear hub has a<br>colored printed bevel<br>indicator and the round luer<br>hub is colored with no bevel<br>indicator. | Adult and Pediatric<br>Single Use Disposable Device<br>Echogenic Injection<br>Anesthesia Conduction<br>Needle with a molded Square<br>Hub and a Stainless Steel<br>Needle. The needle protector<br>is an extruded tube. The Sq.<br>needle hub has a colored<br>molded insert as a bevel<br>indicator. | Same<br>The molded Hub for both<br>products is functionally<br>equivalent, as are the<br>stainless steel needle and<br>needle protector. | None<br>The Havel's Hub Assembly has<br>a metal Bushing and is Glued;<br>the Spectra Sq. Hub Assembly<br>is over molded and the Round<br>Luer Hub Assembly is glued.<br>The Havel's Hub has a molded<br>bevel indicator; the Spectra<br>hub has a printed bevel<br>indicator. The Havel's needle<br>has depth marks on the<br>needle and the Spectra<br>needles do not. | | B = 17° & C = 30°<br>21G to 25G; 2.0" to 6.0" | B = 17° & C= 30°<br>21G to 22G; 2.0" to 6.00" | Same<br>Similar Gauge Range | None<br>Spectra has a 25G Needle | {8}------------------------------------------------ | Design - Echogenic Treatment of Needle Tip | Echogenic Treatment [dimpling] of Needle Tip for Ultrasound Visualization | Echogenic Treatment [4 x 4 Corner Cube indentations] of Needle Tip for Ultrasound Visualization | Similar; both are functional | Echogenic Treatment methods are different and shape of reflective surface is different. | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------| | Materials | Cannula = 304 Stainless Steel<br>Round Hub = Polypropylene<br>Square Hub = K-Resin<br>Protector = LDPE / Polypropylene (Molded)<br>Lubrication = Silicone | Cannula = 304 Stainless Steel<br>Square Hub = N/A (PP)<br>Protector = N/A | Equivalent Materials of Construction | None | | Performance | Hub/Cannula Tensile Strength<br>Penetration Force<br>Luer Taper | Hub/Cannula Tensile Strength<br>Luer Taper<br>Separation from Luer | Same | None | | Sterility | Separation from Luer | Supplied Packaged Sterile | Same | None | | Sterilization Method(s) | Supplied Packaged Sterile | EO (Ethylene Oxide) | Same | None | | Chemical safety | EO (Ethylene Oxide) | Assumed; Device does not pose a chemical hazard and is compatible with chemicals commonly used in the areas designated for use. | Same | None | | Anatomical Sites | Device does not pose a chemical hazard and is compatible with chemicals commonly used in the areas designated for use. | Various, including: Arm, Hand, Neck, Shoulder, Groin, Buttock, Leg, Knee, Foot, etc. | Same | None | | Energy used and /or delivered | Various, including: Arm, Hand, Neck, Shoulder, Groin, Buttock, Leg, Knee, Foot, etc. | No Energy used or delivered by the Device | Same | None | | Compatibility with environment and other devices | No Energy used or delivered by the Device | Assumed; Device does not contain any materials considered to be dangerous to the environment. | Same | None | | Where used: hospital, home, ambulance, etc. | Device does not contain any materials considered to be dangerous to the environment. | Device is designed to connect to a piston syringe (L/S and L/L) or extension set with a male luer connector. | Same | None | | Thermal safety | Device is designed to connect to a piston syringe (L/S and L/L) or extension set with a male luer connector. | Used in Hospital, Clinics, Research Centers, Ambulance, and others<br>Device does not contain a thermal source | Same | None | {9}------------------------------------------------ | Radiation safety | Device does not admit any<br>form of radiation | Device does not admit any<br>form of radiation | Same | None | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------|------| | Performance testing | Hub/Cannula Tensile Strength<br>Penetration Force | Hub/Cannula Tensile Strength | Same | None | | Electrical safety | Device does not contain an<br>electrical source or connect to<br>an electrical source | Device does not contain an<br>electrical source or connect to<br>an electrical source | Same | None | | Biocompatibility | Biocompatibility Testing has<br>been conducted for each<br>product configuration with<br>test results confirming<br>compliance with ISO 10993<br>requirements. | Assumed; Biocompatibility<br>Testing has been conducted<br>and included with 510(K)<br>Submission to FDA. | Same | None | | Mechanical safety | Device does not include a<br>separate safety feature and<br>does not claim it is a safety<br>device. | Device does not include a<br>separate safety feature and<br>does not claim it is a safety<br>device. | Same | None |