PressOn Electrode Headset

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July 10, 2019 Rhythmlink International, LLC Gabriel Orsinger Manager, Product Development 1140 First Street South Columbia, South Carolina 29209 Re: K190801 Trade/Device Name: PressOn Electrode Headset Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: June 7, 2019 Received: June 10, 2019 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. 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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) K190801 Device Name PressOn™ Electrode Headset #### Indications for Use (Describe) The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only. > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) PressOn™ Electrode Headset Rhythmlink International, LLC Type of Use (Select one or both, as applicable) PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(k) Summary | 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>Director of Engineering<br>Email: gorsinger@rhythmlink.com<br>Phone: 803-365-9664 | | | Summary Date | July 9, 2019 | | | 807.92(a)(2)<br>Device<br>Identification | Device Trade Name:<br>Common/Classification Name:<br>Product Code:<br>Classification:<br>Classification Panel: | PressOn™ Electrode Headset<br>Needle Electrode<br>GXZ<br>21 CFR 882.1350 Class II<br>Neurology | | 807.92(a)(3)<br>Predicate<br>Device | K130220 - MR Conditional PressOn Electrode | | | 807.92(a)(4)<br>Device<br>Description | The PressOn™ Electrode Headset is intended to be used in medical environments<br>where quick EEG electrode application is required. The device provides a<br>workflow solution where the availability of technologists or other specialty-trained<br>EEG staff is limited for applying EEG electrodes.<br><br>The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into<br>individual button applicators, which are positioned in predetermined locations and<br>interconnected by elastic netting, altogether forming the headset. The<br>predetermined electrode positions are arranged by generally referencing the 10-20<br>Positioning System, but with flexibility to account for various head shapes and<br>sizes and to avoid interference with intracranial pressure monitoring, ventricular<br>drainage, and other separate devices. Like the predicate, the subject device is<br>minimally invasive and does not directly contact neural tissues. | | | | The PressOn™ Electrode Headset is placed on the patient's head and is oriented<br>and secured using a nasion marker and chinstrap. The distal end of the device<br>contains the array of PressOn™ electrodes in predetermined locations that are<br>placed on the scalp by minimal insertion of the micro needles into the epidermis<br>layer of the skin for use during monitoring procedures. The PressOn™ electrodes<br>in the subject device are inserted in an identical fashion as the predicate device<br>(K130220). Minor material and dimensional changes have been made to the<br>original applicator to allow for multiple applicators to be connected to form the<br>headset. | | | | At the proximal end of the subject device is a multipin connector where the<br>electrode leadwires terminate. The multipin connector interfaces with color-coded<br>extension cables (identical to those used in another previously cleared Rhythmlink | | {4}------------------------------------------------ device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment. The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220]. The PressOn™ Electrode Headset is intended for use in the recording of 807.92(a)(5) electroencephalogram (EEG), evoked potential (EP), or as a ground and reference Intended Use in an EEG or EP recording. The device is provided sterile for single patient use only. ### 807.92(a)(6) Technological Characteristics The technological characteristics of the PressOn™ Electrode Headset are identical to the predicate device (K130220), with several minor dimensional and material modifications which have been assessed to be substantially equivalent to the predicate and therefore do not affect the safety or effectiveness of the device (reference Technological Characteristics table, below). All test methods were identical to those used to assess the predicate device. | Characteristic | Subject Device:<br>PressOn™ Electrode Headset | Predicate Device:<br>MR PressOn™ Electrodes | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | PressOn™ Electrode Headset | MR PressOn™ Electrodes | | 510(k) Number | K190801 | K130220 | | Manufacturer | Rhythmlink International, LLC | Rhythmlink International, LLC | | Device Class | Class II | Class II | | Product Code | GXZ | GXZ | | Regulatory Name | Subdermal Needle | Subdermal Needle | | Device Type | PressOn™ Electrodes | PressOn™ Electrodes | | Regulation # | 21 CFR 882.1350 | 21 CFR 882.1350 | | Intended Use | The PressOn Electrode Headset is<br>intended for use in the recording<br>of Electroencephalogram (EEG),<br>evoked potential (EP), or as a<br>ground and reference in an EEG<br>or EP recording. This device is<br>provided sterile for Single Patient<br>Use Only. | The MR PressOn Electrode is<br>intended for use in the recording<br>of the Electroencephalogram<br>(EEG), the evoked potential (EP),<br>or as a ground and reference in an<br>EEG or EP recording. This device<br>is provided sterile for Single<br>Patient Use Only. | | Single Patient<br>Use | YES - disposable | YES - disposable | | Sterilization<br>Method | Supplied EtO Sterile | Supplied EtO Sterile | | Anatomical<br>Site(s) | Head and Muscular sites | Head and Muscular sites | | Environment<br>usage | Hospital | Hospital | | Targeted<br>Procedures | EEG, EP | EEG, EP | | Electrode<br>Material | Nitinol | Nitinol | | Size of Electrode | ≈ 7 mm | ≈ 7 mm | | Number of<br>Electrodes per<br>Device | 2 to 48 | 1 | | Electrode<br>Applicator<br>Dimensions | 1.5cm x 2.1cm x 2.1cm | 4.5cm x 3.0cm x 1.6cm | | Electrode<br>Applicator<br>Materials | ABS, Polycarbonate, Silicone,<br>Stainless Steel | ABS, Polycarbonate | {5}------------------------------------------------ | Use of Headset | Yes | No | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Electrode<br>Application | Apply positioning headset, then<br>then insert electrodes into the<br>dermis layer with applicators | Insert electrodes into the dermis<br>layer with an applicator | | Leadwire | Multi-conductor ribbon cable,<br>PVC-jacketed copper | Single conductor cable, PVC-<br>jacketed copper | | Electrode Cable<br>Length | Multiple cables 50 to 500 mm | 240mm | | Extension Cable<br>Length | Multiple cables 1.0 to 3.0 m,<br>sheathed | Single cable 1.0 to 3.0 m | | Connector | 1.5mm touchproof DIN 42-802<br>and multipin touchproof<br>connectors | 1.5mm touchproof DIN 42-802<br>connector | | Compatibility<br>with Other<br>Devices | Interfaces with a 1.5mm DIN 42-<br>802 touchproof connector | Interfaces with a 1.5mm DIN 42-<br>802 touchproof connector | | MR Safety | MR Unsafe | MR Conditional | | Electrical Safety | Connectors comply with IEC<br>60601-1 (1988) sub clause<br>56.3(c) per CFR 898.12 (Both the<br>Electrode Cable and the<br>Extension Cable) | Connectors comply with IEC<br>60601-1 (1988) sub clause 56.3(c)<br>per CFR 898.12 (Both the<br>Electrode Cable and the Extension<br>Cable) | | Duration of Use | Electrode: For the length of the<br>procedure, but not more than 30<br>days. Positioning Headset: used<br>to apply electrodes and then<br>removed. | Electrode: For the length of the<br>procedure, but not more than 30<br>days | | Biocompatible | Yes | Yes | ### 807.92(b)(1) Summary of Non-Clinical Tests The PressOn™ Electrode Headset is substantially equivalent in technology, safety, and effectiveness as the predicate device (K130220), as demonstrated by the test results. Functional performance equivalency was determined by dimensional characterization, mechanical, and electrical benchtop testing, as follows: - Electrical Continuity testing of the completed assembly - . Deployment force to eject electrode from applicator and apply to synthetic skin - Pull force required to remove the electrode from synthetic skin - Visual assessment of electrode insertion uniformity into synthetic skin ● - Dimensional assessment of electrode placement on head phantom . All benchtop performance testing passed predetermined acceptance criteria, demonstrating the PressOn™ Electrode Headset is equivalent to the predicate device in functionality, safety, and effectiveness. No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). 807.92(b)(2) Clinical Tests 807.92(b)(3) No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). Clinical Summary