RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE

{0}------------------------------------------------ ﺮ f . . # APR | 1 2014 # 5.0 Traditional 510(k) Summary Disposable Concentric Stimulation Probe The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR § 807.92(a). | 807.92(a)(1)<br>Submitter Information: | Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209<br><br>Phone: 803-252-1222<br>FDA Registration #: 1067162<br>Owner Operator #: 9052354 | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Daniel McCoy<br>Director of Engineering and Regulatory Affairs<br>Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209<br>Phone: 803-252-1222 ext. 102<br>Email: dmccoy@rhythmlink.com | | Summary Date: | March 6, 2014 | | 807.92(a)(2)<br>Device Identification: | Proprietary Device Name:<br>Disposable Concentric Stimulating Probe (Trade name has not been finalized at this time)<br><br>Generic Device Name:<br>Surgical Nerve Stimulator/Locator<br><br>Regulatory Class:<br>Class II<br><br>Classification Name:<br>21 CFR §874.1820, Surgical Nerve Stimulator/Locator<br><br>Product Code: ETN | | 807.92(a)(3)<br>Predicate Device(s): | K103128 Cadwell Disposable Stimulator Probes | | | | | Device Description | target nerves and to locally stimulate them in order to provide a measurable<br>response. The stimulus will have a very small current spread to reduce the<br>innervation of the surrounding nerves. | | | The concentric design has two main parts, an inner stainless steel wire and<br>an outer cannula also insulated from reading un-intended signals. | | | The Inner wire is isolated from the outer stainless steel cannula using a<br>biocompatible heat shrink tubing. This Inner Wire acts as the stimulator and<br>is surrounded by the outer cannula. The Outer Cannula is isolated with a<br>biocompatible heat shrink which isolates the outer cannula allowing contact<br>in a localized area of the intended nerves of interest. | | | The inner wire, the cathode, is stimulated using EMG/EP<br>electroneurodiagnostic equipment cleared for the stimulation of nerve<br>tissue and recording muscle activity during surgical procedures (not part of<br>this 510(k) submission) The outer cannula acts as the anode or reference. | | | The Inner wire and outer cannula are isolated from each other using a<br>dielectric heat shrink and are connected to a color coded pair of leadwires<br>which are terminated by two DIN 42 802 touch proof connectors. The<br>concentric stimulators are terminated on the distal end inside of a plastic<br>handle and are independently connected to the leadwires. | | 807.92(a)(5)<br>Intended Use(s) | The Rhythmlink Disposable Concentric Stimulating Probe is used to perform<br>localized stimulation of neural tissue and to locate, identify and monitor<br>cranial motor nerves, peripheral nerve and spinal nerve roots during<br>surgery. | | | The Rhythmlink Disposable Concentric Stimulating Probe is a single patient<br>use device. | {1}------------------------------------------------ . -' . ・・ . {2}------------------------------------------------ . . r ・・ | 807.92(a)(6)<br>Technological<br>Characteristics | An evaluation of the technological characteristics of the Rhythmlink Disposable Concentric Stimulating Probe where compared to the predicate device, Cadwell Probes. | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | | Rhythmlink<br>Concentric Probe | Predicate Device<br>Cadwell | | | | 510(k) Number | K132138 | K103128 | | | Shaft Length | 80 – 330mm | 80 - 340mm | | | Handle Length | 100mm | 110mm | | | Leadwire Length | 1.0m – 3.0m | 2.0m | | | Tip Diameter/Exposure | $Ø$ 1.6mm x 0.0 – 0.3mm | $Ø$ 1.3mm x 0-0.3mm | | | Shaft Material | SST 316 and SST 304 | SST 316 | | | Shaft Insulation | PET | PTFE | | | Handle Material | Medical Grade ABS | Medical Grade ABS | | | Lead Wire Material | Tin Plated Copper | Tin Plated Copper | | | Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | | 807.92(b)(1)<br>Summary of Non-Clinical<br>Tests | Non-clinical bench testing was comprised of dimensional measurements and performance tests. Dimensional testing was conducted of the Probe diameter and Probe lengths. Performance testing was conducted and analyzed for a continuity of .5 Ohms, Hi Pot testing of insulator breakdown, stimulation delivery, Pull-off strength and leadwire (patient cables) strength. The device was sterilized under the current, validated EO Sterilization Cycle 93007, and testing for residual EtO and ECH levels determined that the residuals are at the lowest possible limits. | | | | | Biocompatibility per ISO-10993-1: 1997, Part I "Biological Evaluation of Medical Devices, Evaluation and Testing" was confirmed by analyzing biocompatibility tests on the device (exclusive of the handle and lead wire). The biocompatibility testing is summarized in the table below: | | | | | Test | Results | Conclusion | | | ISO BET Get<br>Clot Testing | The system did not interfere with the lysate reaction, and no inhibition or enhancement or enhancement was present. The test articles did not clot at the neat concentration. The geometric mean endpoint concentration of each test article was <0.06 EU/mL and each contained <0.9 EU/Device of bacterial endotoxin. The results are acceptable. | The device is non-pyrogenic. | | USP Inhibition<br>and<br>Enhancement<br>Testing, Gel<br>Clot Method | The test Concentric<br>Stimulation Probe does not<br>inhibit or enhance the<br>Bacterial Endotoxin Test<br>according to the USP<br>guidelines. | The device is non-<br>pyrogenic. | | | ISO MEM<br>Elution Test | There was no biological<br>reactivity (Grade 0) of the<br>cells exposed to the test<br>article extract. The response<br>obtained from the positive<br>and negative control article<br>extracts confirmed the<br>suitability of the test system. | The device is non-<br>cytotoxic. | | | ISO<br>Intracutaneous<br>Reactivity Test | The test article sites did not<br>show a significantly greater<br>biological reaction than the<br>sites injected with the<br>control article. | The device is non-irritant. | | | Once the verification testing was completed it was confirmed that the<br>proposed Rhythmlink Concentric Stimulation Probes are as safe and<br>effective as the predicate device. | | | | | 807.92(b)(2)<br>Clinical Tests | There was no clinical testing performed on the proposed device. | | | | 807.92(b)(3)<br>Clinical Summary | | | | {3}------------------------------------------------ ? ና. 、 、 . {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . We 166 Silver Spring, MD 2005-0002 Image /page/4/Picture/12 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text that appears to be part of the logo, though the specific words are not clear due to the image quality. The overall design is simple and symbolic, likely representing an organization or entity associated with aviation, freedom, or a similar concept. # April 11, 2014 Rhythmlink International. L.C. Mr. Daniel E. McCoy Director of Engineering and Regulatory Affairs 1140 First Sireet South Columbia. South Carolina 29209 Re: K132138 > Trade/Device Name: Rhythmlink disposable concentric stimulating probe Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class H Product Code: PDQ. ETN Dated: March 1. 2014 Received: March 14, 2014 Dear Mr. McCoy: We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent ffor 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. Ifsting 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 (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in {5}------------------------------------------------ Page 2 - Mr. Daniel E. McCoy 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours, # Felipe Aguel -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K132138 Device Name Disposable Concentric Stimulating Probe #### Indications for Use (Describe) The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery. The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device. 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) # 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) # 11 - - - Date: 2014.04.11 1 --- 13:51:09 -04'00' 13:51:09 -04'00' FORM FDA 3881 (1/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {7}------------------------------------------------ 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. 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