PressOn Electrode Headset

K190801 · Rhythmlink International, LLC · GXZ · Jul 10, 2019 · Neurology

Device Facts

• Record ID: K190801
• Device Name: PressOn Electrode Headset
• Applicant: Rhythmlink International, LLC
• Product Code: GXZ · Neurology
• Decision Date: Jul 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

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.

Device Story

PressOn Electrode Headset facilitates rapid EEG electrode application in hospital settings where specialized staff availability is limited. Device consists of 2 to 48 Nitinol electrodes loaded into individual button applicators, interconnected by elastic netting. Headset is secured to patient head via nasion marker and chinstrap. Electrodes are inserted into epidermis layer. Proximal end features multipin connector interfacing with color-coded extension cables, terminating in single pin connectors for monitoring equipment. Designed for quick application by non-neurological medical personnel. Provides signal quality equivalent to predicate. Minimally invasive; does not contact neural tissues. Benefits include reduced setup time and standardized electrode placement.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is supported by bench testing, including electrical continuity, deployment force, pull force, visual insertion uniformity, and dimensional assessment on head phantoms.

Technological Characteristics

Nitinol electrodes; ABS, Polycarbonate, Silicone, and Stainless Steel applicators. Multi-conductor ribbon cable (PVC-jacketed copper). 1.5mm touchproof DIN 42-802 and multipin connectors. EtO sterilization. Headset form factor with elastic netting. Complies with IEC 60601-1 (1988) sub clause 56.3(c).

Indications for Use

Indicated for patients requiring EEG or EP monitoring; intended for use in hospital environments for recording electroencephalogram, evoked potential, or as a ground/reference electrode.

Regulatory Classification

Identification

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

Predicate Devices

• MR Conditional PressOn Electrode (K130220)

Reference Devices

• Rhythmlink device (K172503)

Submission Summary (Full Text)

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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. 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

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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 mediation-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 ([e-mail]) or phone [phone] 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

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## 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.

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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 [phone]

EF

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# 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: [phone]<br>FDA Registration #: 1067162 | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Official<br>Correspondent | Gabriel Orsinger, PhD<br>Director of Engineering<br>Email: [e-mail]<br>Phone: [phone] | |
| 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 | |

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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 |

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| 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