Remington Medical Inc. Tuohy Epidural Needles

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 4, 2015 Remington Medical, Inc. Caitlin Senter, M.S., RAC Regulatory Affairs Manager 6830 Meadowridge Court Alpharetta, GA 30005 Re: K150266 Trade/Device Name: Remington Medical Inc. Tuohy Epidural Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 1, 2015 Received: May 4, 2015 Dear Ms. Senter: 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 {1}------------------------------------------------ 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 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) K150266 Device Name Remington Medical, Inc. Tuohy Epidural Needle Indications for Use (Describe) Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Drug 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger, bolder font than the word "MEDICAL", which is stacked below it. #### Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle | Preparation Date | June 2, 2015 | |------------------------------|-------------------------------------------------------------------------------------------------------------| | Applicant | Remington Medical, Inc.<br>6830 Meadowridge Court,<br>Alpharetta, GA, USA 30005 | | | Registration Number: 1056553<br>Owner/Operator Number: 9006473 | | Contact Person | Caitlin Senter, MS, RAC<br>Regulatory Affairs Manager<br>770-888-8520, extension 207<br>caitlins@remmed.com | | Trade Proprietary<br>Name(s) | Remington Medical, Inc. Tuohy Epidural Needle | | Common Name (s) | Needle, Conduction, Anesthetic (W/Wo Introducer) | | Classification Name | 21 CFR 868.5150 (Anesthesia conduction needle);<br>Product Code: BSP | | Device Class: | Class II | ## Section 5 - 510(k) Summary ### Legally Marketed Devices to Which Substantial Equivalence is Claimed: Myco Medical Supplies, Inc. Dr. Japan's Phoenix Epidural & Spinal Needles, (K990519) B. Braun Medical, Inc. Perican™ Ultra Needle, (K133632) ### Description of the Device: The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics. Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath. Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits). #### Intended Use/Indications for Use Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" in blue on the right. The word "Remington" is in a larger font than the word "MEDICAL", which is directly below it. #### Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle ### Technological Characteristics: The technological characteristics (design, specifications, and performance) of the subject device and the predicate devices are substantially equivalent. Remington Medical Inc. Tuohy Epidural Needles meet performance standards where applicable for: Hub to Needle Bond Strength: ISO 7864 Color: ISO 6009 | | Subject Device:<br>Remington Medical Inc. Tuohy<br>Epidural Needles | Predicate Device:<br>Myco Medical Supplies, Inc.<br>Dr. Japan's Phoenix Epidural &<br>Spinal Needles (K990519) | Predicate Device:<br>B. Braun Medical, Inc.<br>Perican™ Ultra Needle,<br>(K133632) | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Class | Class II | Class II | Class II | | FDA Product<br>Code | BSP | BSP | BSP | | Regulation | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 | | Indications for<br>Use Statement | Remington Medical, Inc. Tuohy<br>Epidural Needles are to be used to<br>inject local anesthetics into a<br>patient to provide regional<br>anesthesia or to facilitate the<br>placement of an epidural catheter. | Spinal and Epidural needles are to<br>be used to inject local anesthetics<br>into a patient to provide regional<br>anesthesia. | The B. Braun Perican Ultra<br>needle is intended for use in<br>injecting local anesthetics<br>and/or analgesics into a patient<br>to provide regional anesthesia<br>and/or to facilitate the<br>placement of a catheter. | | Cannula<br>Material | Metal, Stainless Steel | Metal, Stainless Steel | Metal, Stainless Steel | | Cannula Depth<br>Marking | 10 mm, Wide Band | Wide Band | Wide Band | | Cannula Hub<br>Material | Plastic (Polycarbonate), Stainless<br>Steel Bushing and UV Cured<br>Medical Grade Adhesive | Plastic, Metal Bushing, and<br>Adhesive | Plastic, Spacer (Bushing) and<br>Adhesive | | Stylet Material | Metal, Stainless Steel | Metal, Stainless Steel | Metal, Stainless Steel | | Stylet Hub<br>Material | Color-coded Plastic<br>(Polycarbonate) and UV Cured<br>Medical Grade Adhesive | Color-coded Plastic and Adhesive | | | Gauge/Length<br>(inches)/Color<br>Depiction | 17 GA 3.5", 5.0" Violet | 16 GA 3.5" White | | | | 18 GA 3.5", 5.0" Pink | 17 GA 3.5", 6.0" Violet | | | | 19 GA 2.0" Cream | 18 GA 2.5", 3.5", 6.0" Pink | | | | 20 GA 3.5", 5.0", 6.0" Yellow | 20 GA 3.5", 4.5", 6.0" Yellow | | | | 22 GA 3.5" Black | 22 GA 2.5", 3.5" Black | | | Final Needle<br>Assembly<br>Protection | Sheath | Sheath | Sheath | | Sterilization<br>Method | ETO | ETO | ETO | {5}------------------------------------------------ ### Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle ### Performance Data: Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles including verification/validation testing to internal functional specifications (e.g. catheter placement, and bond strength between cannula, hub, and stylet) including comparison data (e.g., needle flow) to the K990519 predicate device. These tests demonstrated that the Remington Medical Inc. Tuohy Epidural Needles are substantially equivalent to the predicate device. Visual inspection of the test catheter under magnification confirmed no negative impact to the catheter post-placement. Testing confirmed that the Remington Medical Inc. Tuohy Epidural Needles comply with relevant standards, specifically ISO standards 7864 and 6009. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility (ISO 10993-1) and sterilization. Biocompatibility testing performed includes cytotoxicity, sensitization, irritation or intracutaneous reactivity, and acute systemic toxicity. Pyrogenicity was also tested. ## Clinical testing: Clinical testing was not required. ## Conclusion: The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. Tuohy Epidural Needles, is substantially equivalent to the predicate devices, Myco Medical Supplies, Inc. Dr. Japan's Phoenix Epidural & Spinal Needles and B. Braun Medical, Inc. Perican™ Ultra Needle, (K133632) with respect to intended use, materials, design, and technological characteristics.