Guardian Needle Electrode

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May 27, 2020 Rhythmlink International, LLC Gabriel Orsinger Vice President of Engineering and R&D 1140 First Street South Columbia, South Carolina 29209 Re: K200984 Trade/Device Name: Guardian Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: April 9, 2020 Received: April 14, 2020 Dear Gabriel Orsinger: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name Guardian Needle™ Electrode #### Indications for Use (Describe) Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use. Type of Use (*Select one or both, as applicable*) | <span> <span style="text-decoration:overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Guardian Needle™ Electrode Rhythmlink International, LLC {3}------------------------------------------------ # 510(k) Summary – K200984 | 807.92(a)(1)<br>Submitter<br>Information | Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209<br>Phone: 803-252-1222<br>FDA Registration #: 1067162 | | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official<br>Correspondent | Gabriel Orsinger, PhD<br>Vice President of Engineering and R&D<br>Email: gorsinger@rhythmlink.com<br>Phone: 803-365-9664 | | | Summary Date | May 27, 2020 | | | 807.92(a)(2)<br>Device<br>Identification | Device Trade Name:<br>Classification Name:<br>Product Code:<br>Classification:<br>Classification Panel: | Guardian Needle™ Electrode<br>Needle Electrode<br>GXZ<br>21 CFR 882.1350 Class II<br>Neurology | | 807.92(a)(3)<br>Predicate Device | Device Trade Name:<br>Classification Name:<br>510(k) Number:<br>Product Code:<br>Classification:<br>Classification Panel:<br>Manufacturer: | Subdermal Needle Electrodes<br>Needle Electrode<br>K022914<br>GXZ<br>21 CFR 882.1350 Class II<br>Neurology<br>Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209 | | 807.92(a)(4)<br>Device Description | Guardian Needle™ Electrodes are a sterile, single-use device. The<br>electrodes are applied during the study of biopotentials such as<br>electromyography (EMG), electroencephalography (EEG), nerve conduction<br>and stimulation/response. The electrodes are invasive as they are placed<br>subcutaneously or in contact with nerve or muscle tissue. The needle is<br>housed inside a sheath until application and secured to the patient during use<br>with adhesive tape. | | | 807.92(a)(5)<br>Intended Use | Rhythmlink International Guardian Needle™ Electrodes are intended<br>for use with recording, monitoring and stimulation equipment for the<br>purpose of recording of biopotential signals. Examples include:<br>Electromyography (EMG), Electroencephalography (EEG) and Nerve<br>potential signals. The electrodes are sterile and for single patient use<br>only | | | 807.92(a)(6)<br>Technological<br>Characteristics | The technological characteristics of Guardian Needle™ Electrodes are<br>identical to the predicate device (K022914), with the addition of a needle<br>sheath and adhesive tape, both of which have been assessed to not change the<br>fundamental scientific technology, intended use, performance, or safety and<br>effectiveness of the predicate device (reference Substantial Equivalence of | | {4}------------------------------------------------ | Technological Characteristics table, below). The test methods were identical<br>to those used to assess the predicate device. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>807.92(b)(1)<br/>Summary of Non-<br/>Clinical Tests</b> | | Guardian Needle™ Electrodes are substantially equivalent in technology,<br>safety, and effectiveness as the predicate device (K022914), as demonstrated<br>by the test results. | | The Guardian Needle™ Electrode was assessed by applying the TIR 28:2009<br>Guidance, from which it was determined that the subject device does not<br>challenge the Submitter's Master Challenge Device and can thus fall under<br>the previously validated EtO sterilization cycle. Reevaluation of the EtO<br>residuals was performed to confirm low levels of EtO and Ethylene<br>Chlorohydrin (ECH) after a 24-hour aeration time below the maximum limits<br>described in ANSI/AAMI/ISO 10993-7:2008/(R) 2012. | | The biocompatibility evaluation was conducted within the risk management<br>framework and in compliance with ISO 10993 standards. This<br>biocompatibility evaluation establishes the biological safety for the Guardian<br>Needle™ Electrode with intact skin contact for a limited (≤24 hours)<br>duration | | Functional performance equivalency was determined by electrical and<br>adhesive benchtop testing, as follows: | | Electrical Continuity Adhesion Testing | | Benchtop performance testing passed predetermined acceptance criteria,<br>demonstrating Guardian Needle™ Electrodes are equivalent to the predicate<br>device in functionality, safety, and effectiveness. | | <b>807.92(b)(2)<br/>Clinical Tests</b> | | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). | | <b>807.92(b)(3)<br/>Clinical Summary</b> | | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). | {5}------------------------------------------------ ### Substantial Equivalence Table | Characteristic | Subject Device:<br>Guardian Needle™<br>Electrodes | Predicate Device:<br>Subdermal Needle<br>Electrodes | Substantial<br>Equivalence<br>(SE)1 | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | K200984 | K022914 Subdermal Needle<br>Electrodes | | | Manufacturer | Rhythmlink International,<br>LLC | Rhythmlink International,<br>LLC | SE | | Device Class | Class II | Class II | SE | | Product Code | GXZ | GXZ | SE | | Regulatory<br>Name | Subdermal Needle | Subdermal Needle | SE | | Device Type | Subdermal Needle Electrodes | Subdermal Needle Electrodes | SE | | Regulation # | 21 CFR 882.1350 | 21 CFR 882.1350 | SE | | Intended Use | Rhythmlink International<br>Subdermal Needle Electrodes<br>are intended for use with<br>recording, monitoring and<br>stimulation equipment for the<br>purpose of recording of<br>biopotential signals.<br>Examples include:<br>Electromyography (EMG),<br>Electroencephalography<br>(EEG), and Nerve potential<br>signals. The electrodes are<br>sterile and for single patient<br>use. | Rhythmlink International<br>Subdermal Needle Electrodes<br>are intended for use with<br>recording, monitoring and<br>stimulation equipment for the<br>purpose of recording of<br>biopotential signals.<br>Examples include:<br>Electromyography (EMG),<br>Electroencephalography<br>(EEG), and Nerve potential<br>signals. The electrodes are<br>sterile and for single patient<br>use. | SE | | Anatomical<br>Site(s) | Subdermal muscle or nerve<br>tissue | Subdermal muscle or nerve<br>tissue | SE | | Environment<br>usage | Hospital | Hospital | SE | | Electrode<br>Material | Medical Grade 304VM<br>(vacuum melt) Stainless Steel | Medical Grade 304VM<br>(vacuum melt) Stainless Steel | SE | | Electrode<br>Length | 7mm to 22 mm | 7mm to 22 mm | SE | | Electrode<br>Diameter | 0.4mm | 0.4mm | SE | | Leadwire<br>Material | PVC-coated Electrical Wire | PVC-coated Electrical Wire | SE | | Leadwire<br>Length | 1.0m to 3.0m | 1.0m to 3.0m | SE | | Connector | 1.5mm DIN 42 802 pin touch<br>proof connector | 1.5mm DIN 42 802 pin touch<br>proof connector | SE | | Characteristic | Subject Device:<br>Guardian Needle™<br>Electrodes | Predicate Device:<br>Subdermal Needle<br>Electrodes | Substantial<br>Equivalence | | 510(k)<br>Number | K200984 | K022914 Subdermal Needle<br>Electrodes | (SE)1 | | Use of<br>Adhesive Tape | YES | NO | SE; Material<br>change has<br>been validated<br>by testing and<br>does not<br>adversely<br>impact safety<br>Or<br>effectiveness | | Needle Cover | Thermoplastic polyester<br>elastomer sheath | PVC tube | SE; Material<br>and<br>dimensional<br>change has<br>been validated<br>by testing and<br>does not<br>adversely<br>impact safety<br>Or<br>effectiveness | | Operation of<br>Applying the<br>Device | Applied subcutaneously to the<br>skin | Applied subcutaneously to the<br>skin | SE | | Prescription<br>Use | YES - Inserted by a licensed<br>physician or practitioner | YES - Inserted by a licensed<br>physician or practitioner | SE | | Targeted<br>Procedures | IONM, EMG, EP, EEG | IONM, EMG, EP, EEG | SE | | Compatibility<br>with other<br>devices | Neurophysiology Monitors<br>with a 1.5mm DIN 42 802 pin<br>touch proof connector | Neurophysiology Monitors<br>with a 1.5mm DIN 42 802 pin<br>touch proof connector | SE | | Packaging | 24 electrodes sealed in a<br>Tyvek pouch and placed<br>inside a sealed, labeled box | 24 electrodes sealed in a<br>Tyvek pouch and placed<br>inside a sealed, labeled box | SE | | Sterilization<br>Method | Supplied EtO Sterile | Supplied EtO Sterile | SE | | Single Patient<br>Use | YES - disposable | YES - disposable | SE | | Electrical<br>Safety | Connectors comply with IEC<br>60601-1 (1988) sub clause<br>56.3(c) per CFR 898.12 | Connectors comply with IEC<br>60601-1 (1988) sub clause<br>56.3(c) per CFR 898.12 | SE | | Characteristic | Subject Device:<br>Guardian Needle™<br>Electrodes | Predicate Device:<br>Subdermal Needle<br>Electrodes | Substantial<br>Equivalence<br>(SE)1 | | 510(k)<br>Number | K200984 | K022914 Subdermal Needle<br>Electrodes | | | Mechanical<br>Safety | Leadwires are soldered to<br>electrode using Tin/Silver<br>solder and covered with heat<br>shrink | Leadwires are soldered to<br>electrode using Tin/Silver<br>solder and covered with heat<br>shrink | SE | | Duration of<br>use | ≤24 hours | ≤24 hours | SE | | Standards | • IEC 60601-1-1: 1988/a1:<br>1991/A2 :1995 § 56.3(c)<br>per CFR 898.12<br>• DIN 42802<br>• ISO 14971<br>• ISO 15223-1 | • IEC 60601-1-1: 1988/a1:<br>1991/A2 : 1995 § 56.3(c)<br>per CFR 898.12<br>• DIN 42802<br>• ISO 14971<br>• ISO 15223-1 | SE | | Biocompatible | Yes | Yes | SE | {6}------------------------------------------------ {7}------------------------------------------------ ¹Only differences are indicated in this column.