Who is the manufacturer of Guardian Needle Electrode?

Rhythmlink International, LLC filed the 510(k) submission for Guardian Needle Electrode (K200984).

What is the FDA product code for Guardian Needle Electrode?

GXZ. It is classified under 21 CFR 882.1350 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Guardian Needle Electrode?

510(k) clearance (submission type: Special).

What are the predicate devices for Guardian Needle Electrode?

Subdermal Needle Electrodes (K022914).

Who can help prepare an FDA 510(k) submission like Guardian Needle Electrode?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Guardian Needle Electrode

K200984 · Rhythmlink International, LLC · GXZ · May 27, 2020 · Neurology

Device Facts

Record ID	K200984
Device Name	Guardian Needle Electrode
Applicant	Rhythmlink International, LLC
Product Code	GXZ · Neurology
Decision Date	May 27, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.1350
Device Class	Class 2

Indications for Use

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.

Device Story

Guardian Needle Electrodes are sterile, single-use subdermal needle electrodes used for recording biopotential signals (EMG, EEG, nerve potentials) and stimulation. The device consists of a 304VM stainless steel needle, PVC-coated leadwire, and a 1.5mm DIN 42802 touch-proof connector. The subject device includes a thermoplastic polyester elastomer needle sheath and adhesive tape for securing the electrode to the patient, features not present in the predicate. Used in hospital settings, the device is inserted subcutaneously by a physician or practitioner. The electrodes interface with neurophysiology monitoring equipment to capture electrical signals from muscle or nerve tissue. The output is displayed on the monitoring equipment, assisting clinicians in diagnostic or intraoperative monitoring. Benefits include reliable signal acquisition for neurophysiological assessment.

Clinical Evidence

No clinical data. Bench testing only, including electrical continuity, adhesion testing, and biocompatibility evaluation per ISO 10993.

Technological Characteristics

Needle: 304VM stainless steel (0.4mm diameter, 7-22mm length). Leadwire: PVC-coated. Connector: 1.5mm DIN 42802. Sheath: Thermoplastic polyester elastomer. Sterilization: EtO. Standards: IEC 60601-1, DIN 42802, ISO 14971, ISO 15223-1, ISO 10993.

Indications for Use

Indicated for patients requiring biopotential signal recording, monitoring, or stimulation during procedures such as EMG, EEG, and nerve potential studies. For use by licensed physicians or practitioners.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

Subdermal Needle Electrodes (K022914)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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*) | ☑ 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." Guardian Needle™ Electrode Rhythmlink International, LLC {3}------------------------------------------------ # 510(k) Summary – K200984 | 807.92(a)(1) Submitter Information | Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 Phone: 803-252-1222 FDA Registration #: 1067162 | | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent | Gabriel Orsinger, PhD Vice President of Engineering and R&D Email: gorsinger@rhythmlink.com Phone: 803-365-9664 | | | Summary Date | May 27, 2020 | | | 807.92(a)(2) Device Identification | Device Trade Name: Classification Name: Product Code: Classification: Classification Panel: | Guardian Needle™ Electrode Needle Electrode GXZ 21 CFR 882.1350 Class II Neurology | | 807.92(a)(3) Predicate Device | Device Trade Name: Classification Name: 510(k) Number: Product Code: Classification: Classification Panel: Manufacturer: | Subdermal Needle Electrodes Needle Electrode K022914 GXZ 21 CFR 882.1350 Class II Neurology Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 | | 807.92(a)(4) Device Description | Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape. | | | 807.92(a)(5) Intended Use | Rhythmlink International Guardian 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 only | | | 807.92(a)(6) Technological Characteristics | The technological characteristics of Guardian Needle™ Electrodes are identical to the predicate device (K022914), with the addition of a needle sheath and adhesive tape, both of which have been assessed to not change the fundamental scientific technology, intended use, performance, or safety and effectiveness of the predicate device (reference Substantial Equivalence of | | {4}------------------------------------------------ | Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 807.92(b)(1) Summary of Non- Clinical Tests | | Guardian Needle™ Electrodes are substantially equivalent in technology, safety, and effectiveness as the predicate device (K022914), as demonstrated by the test results. | | The Guardian Needle™ Electrode was assessed by applying the TIR 28:2009 Guidance, from which it was determined that the subject device does not challenge the Submitter's Master Challenge Device and can thus fall under the previously validated EtO sterilization cycle. Reevaluation of the EtO residuals was performed to confirm low levels of EtO and Ethylene Chlorohydrin (ECH) after a 24-hour aeration time below the maximum limits described in ANSI/AAMI/ISO 10993-7:2008/(R) 2012. | | The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This biocompatibility evaluation establishes the biological safety for the Guardian Needle™ Electrode with intact skin contact for a limited (≤24 hours) duration | | Functional performance equivalency was determined by electrical and adhesive benchtop testing, as follows: | | Electrical Continuity Adhesion Testing | | Benchtop performance testing passed predetermined acceptance criteria, demonstrating Guardian Needle™ Electrodes are equivalent to the predicate device in functionality, safety, and effectiveness. | | 807.92(b)(2) Clinical Tests | | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). | | 807.92(b)(3) Clinical Summary | | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). | {5}------------------------------------------------ ### Substantial Equivalence Table | Characteristic | Subject Device: Guardian Needle™ Electrodes | Predicate Device: Subdermal Needle Electrodes | Substantial Equivalence (SE)1 | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K200984 | K022914 Subdermal Needle Electrodes | | | Manufacturer | Rhythmlink International, LLC | Rhythmlink International, LLC | SE | | Device Class | Class II | Class II | SE | | Product Code | GXZ | GXZ | SE | | Regulatory 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 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. | 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. | SE | | Anatomical Site(s) | Subdermal muscle or nerve tissue | Subdermal muscle or nerve tissue | SE | | Environment usage | Hospital | Hospital | SE | | Electrode Material | Medical Grade 304VM (vacuum melt) Stainless Steel | Medical Grade 304VM (vacuum melt) Stainless Steel | SE | | Electrode Length | 7mm to 22 mm | 7mm to 22 mm | SE | | Electrode Diameter | 0.4mm | 0.4mm | SE | | Leadwire Material | PVC-coated Electrical Wire | PVC-coated Electrical Wire | SE | | Leadwire Length | 1.0m to 3.0m | 1.0m to 3.0m | SE | | Connector | 1.5mm DIN 42 802 pin touch proof connector | 1.5mm DIN 42 802 pin touch proof connector | SE | | Characteristic | Subject Device: Guardian Needle™ Electrodes | Predicate Device: Subdermal Needle Electrodes | Substantial Equivalence | | 510(k) Number | K200984 | K022914 Subdermal Needle Electrodes | (SE)1 | | Use of Adhesive Tape | YES | NO | SE; Material change has been validated by testing and does not adversely impact safety Or effectiveness | | Needle Cover | Thermoplastic polyester elastomer sheath | PVC tube | SE; Material and dimensional change has been validated by testing and does not adversely impact safety Or effectiveness | | Operation of Applying the Device | Applied subcutaneously to the skin | Applied subcutaneously to the skin | SE | | Prescription Use | YES - Inserted by a licensed physician or practitioner | YES - Inserted by a licensed physician or practitioner | SE | | Targeted Procedures | IONM, EMG, EP, EEG | IONM, EMG, EP, EEG | SE | | Compatibility with other devices | Neurophysiology Monitors with a 1.5mm DIN 42 802 pin touch proof connector | Neurophysiology Monitors with a 1.5mm DIN 42 802 pin touch proof connector | SE | | Packaging | 24 electrodes sealed in a Tyvek pouch and placed inside a sealed, labeled box | 24 electrodes sealed in a Tyvek pouch and placed inside a sealed, labeled box | SE | | Sterilization Method | Supplied EtO Sterile | Supplied EtO Sterile | SE | | Single Patient Use | YES - disposable | YES - disposable | SE | | Electrical Safety | Connectors comply with IEC 60601-1 (1988) sub clause 56.3(c) per CFR 898.12 | Connectors comply with IEC 60601-1 (1988) sub clause 56.3(c) per CFR 898.12 | SE | | Characteristic | Subject Device: Guardian Needle™ Electrodes | Predicate Device: Subdermal Needle Electrodes | Substantial Equivalence (SE)1 | | 510(k) Number | K200984 | K022914 Subdermal Needle Electrodes | | | Mechanical Safety | Leadwires are soldered to electrode using Tin/Silver solder and covered with heat shrink | Leadwires are soldered to electrode using Tin/Silver solder and covered with heat shrink | SE | | Duration of use | ≤24 hours | ≤24 hours | SE | | Standards | • IEC 60601-1-1: 1988/a1: 1991/A2 :1995 § 56.3(c) per CFR 898.12 • DIN 42802 • ISO 14971 • ISO 15223-1 | • IEC 60601-1-1: 1988/a1: 1991/A2 : 1995 § 56.3(c) per CFR 898.12 • DIN 42802 • ISO 14971 • ISO 15223-1 | SE | | Biocompatible | Yes | Yes | SE | {6}------------------------------------------------ {7}------------------------------------------------ ¹Only differences are indicated in this column.

Guardian Needle Electrode

Device Facts

Indications for Use

Device Story

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Predicate Devices

Submission Summary (Full Text)

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