iCE-SG Subcutaneous Electrode Arrays

K201678 · Ice Neurosystems, Inc. · GZL · Mar 8, 2021 · Neurology

Device Facts

• Record ID: K201678
• Device Name: iCE-SG Subcutaneous Electrode Arrays
• Applicant: Ice Neurosystems, Inc.
• Product Code: GZL · Neurology
• Decision Date: Mar 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

iCE-SG Subcutaneous Electrode Arrays are intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.

Device Story

iCE-SG Subcutaneous Electrode Arrays are sterile, single-patient-use depth electrodes designed for continuous EEG monitoring in the subcutaneous space. The system includes a preparation kit, insertion kit (trocar sheath, passage/exit assist tools, stoppers), and electrode arrays. Operated by healthcare professionals in hospital settings (including ICU), the device is tunneled subcutaneously to record electrical signals, which are then transmitted to external electrophysiology recording/monitoring equipment. The output allows clinicians to visualize EEG data for diagnostic or monitoring purposes. The device benefits patients by providing a minimally invasive method for subsurface brain signal acquisition without requiring intracranial penetration. The electrode is withdrawn at the bedside after the monitoring period.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing (ISO 10993-3, 5, 6, 10, 11) and bench performance testing (dimensions, bending force, adhesion, stopper endurance) and an animal study confirming durability for 14 days of continuous subcutaneous implantation.

Technological Characteristics

Platinum/iridium electrode array; 1.12 mm diameter; subcutaneous placement; ethylene oxide sterilization; single-patient use; disposable. Connectivity via standard electrophysiology systems. No active stimulation capability.

Indications for Use

Indicated for temporary (<14 days) recording and monitoring of electrical signals at the subsurface level of the brain in patients requiring EEG monitoring.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrode) (K163355)
• Epidural Peg Electrode (EP), Sphenoidal Electrode (EDS) and Foramen Ovale Depth Electrode (ED-FO) for Epilepsy Monitoring (K961942)

Submission Summary (Full Text)

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March 8, 2021

iCE Neurosystems, Inc. % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue Suite B-257 San Diego, California 92110

Re: K201678

Trade/Device Name: iCE-SG Subcutaneous Electrode Arrays Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: March 3, 2021 Received: March 4, 2021

Dear Allison Komiyama:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K201678

### Device Name

iCE-SG Subcutaneous Electrode Arrays

#### Indications for Use (Describe)

iCE-SG Subcutaneous Electrode Arrays are intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.

Type of Use (Select one or both, as applicable)

| <input checked="true" type="checkbox"/> | Prescription Use (Part 21 CFR 201 Subpart D) |
|-----------------------------------------|----------------------------------------------|
| <input type="checkbox"/> | Over-The-Counter Use (21 CFR 201 Subpart C) |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic on the left, with a red line extending from it to a red dot above the letter 'i' in 'iCE'. The letters 'iCE' are in a bold, blue font. Below 'iCE', the word 'NEUROSYSTEMS' is written in a smaller, gray font.

## 510(k) Summary K201678

#### DATE PREPARED

March 8, 2021

#### MANUFACTURER AND 510(k) OWNER

iCE Neurosystems, Inc. 1050 30th St NW Washington, DC 20007, USA Telephone: Official Contact: Allen Waziri, M.D., CEO

#### REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: [phone] Email: [e-mail]; [e-mail] Website: https://www.acknowledge-rs.com/

#### DEVICE INFORMATION

| Proprietary Name/Trade Name: | iCE-SG Subcutaneous Electrode Arrays |
|------------------------------|---------------------------------------------------------------------------|
| Common Name: | Depth electrode |
| Regulation Number: | 21 CFR 882.1330 |
| Class: | Class II |
| Product Code: | GZL |
| Review Panel: | Neurology |
| Premarket Review: | Neurosurgical, Neurointerventional<br>and Neurodiagnostic Devices (DHT5A) |

#### PREDICATE DEVICE IDENTIFICATION

The iCE-SG Subcutaneous Electrode Arrays is substantially equivalent to the following predicate and reference devices:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K163355 | Depth Electrodes (Depth Electrode, Foramen Ovale Depth<br>Electrodes, Macro Micro Depth Electrode, Spencer Probe<br>Depth Electrodes, Wyler Sphenoidal Depth Electrode) / Ad-<br>tech Medical Instrument Corporation | ✓ |
| K961942 | Epidural Peg Electrode (EP), Sphenoidal Electrode (EDS)<br>and Foramen Ovale Depth Electrode (ED-FO) for Epilepsy<br>Monitoring / Radionics Inc. | |

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Image /page/4/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic with red lines emanating from it, followed by the text "iCE" in blue, with a red dot above the "i". Below the text "iCE" is the word "NEUROSYSTEMS" in a smaller font size.

#### DEVICE DESCRIPTION

The iCE-SG Subcutaneous Electrode Arrays are intended for use with recording and monitoring equipment for the purpose of recording electroencephalograph (EEG) signals. The subject device allows for continuous EEG monitoring in the subcutaneous space. The iCE-SG Subcutaneous Electrode Arrays can connect to commonly used electrophysiology systems. The subject device is provided sterile and for single patient use in hospitals by healthcare professionals (HCPs).

A kit includes the following components:

- 1. Preparation box
- 2. Insertion kit box
- 3. Two iCE-SG electrode boxes

#### INDICATIONS FOR USE

iCE-SG Subcutaneous Electrode Arrays are intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

iCE Neurosystems believes that the iCE-SG Subcutaneous Electrode Arrays are substantially equivalent to the predicate device based on the information summarized here:

The subject device has the same intended use and similar technological characteristics as the devices cleared in K163355 and K961642. The electrode array used in the subject device is the same as the electrode array cleared in K163355. The insertion methodology is the same or similar to K163355 and K961942. Overall, the iCE-SG Subcutaneous Electrode Arrays have undergone testing to ensure that any difference in technological characteristics (i.e., inclusion of a preparation and insertion kit) do not affect safety and effectiveness when compared to the predicate device. A SE chart is included at the end of this summary.

#### SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the iCE SG-Subcutaneous Electrode Arrays. The following tests were performed to demonstrate safety based on current industry standards:

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Image /page/5/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic in red, with a red dot connecting it to the letters "iCE" in blue. Below the letters is the word "NEUROSYSTEMS" in a smaller, gray font.

Biocompatibility: Patient contacting material was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.

| Standard | Study Description | Results |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Insertion kit | | |
| ISO 10993-5 | Cytotoxicity study using L-929 cells; EMEM extract;<br>Evaluated using percent viability. | Non-cytotoxic |
| ISO 10993-10 | Intradermal injection and topical application in guinea pigs; sesame oil or 0.9%<br>normal saline extracts. | Non-sensitizing |
| ISO 10993-10 | Intracutaneous injection in New Zealand white rabbits; cottonseed oil or sodium<br>chloride extracts. | Non-irritating |
| ISO 10993-11 | Intraperitoneal injection of albino swiss mice with cottonseed oil or sodium chloride<br>extracts. | Non-toxic |
| ISO 10993-11 | Marginal ear vein injection of New Zealand white rabbits; 0.9% sodium chloride<br>extract. | Non-pyrogenic |
| iCE-SG Electrode Arrays | | |
| ISO 10993-5 | Cytotoxicity study using L-929 cells; EMEM extract;<br>Evaluated using morphological grading. | Non-cytotoxic |
| ISO 10993-10 | Intradermal injection and topical application in guinea pigs; cottonseed oil or 0.9%<br>sodium chloride extracts | Non-sensitizing |
| Standard | Study Description | Results |
| ISO 10993-10 | Intracutaneous injections in New Zealand white strain albino rabbits; cottonseed oil<br>or 0.9% sodium chloride extracts. | Non-irritating |
| ISO 10993-11 | Intraperitoneal injection in albino swiss mice with cottonseed oil extract<br>Intravenous injection in albino swiss mice with 0.9% sodium chloride extract | Non-toxic |
| ISO 10993-11 | Marginal ear vein injection of New Zealand white albino rabbits; 0.9% sodium<br>chloride extract. | Non-pyrogenic |
| ISO 10993-6<br>ISO 10993-11 | Implantation of two articles maintained for 28 and 29-days (males or females,<br>respectively). | Non-toxic |
| ISO 10993-6 | Implantation for four weeks into the left hemisphere in New Zealand White rabbits. | Non-bioreactive |
| ISO 10993-3 | Genotoxicity study with L5178Y cells; RPMIi and polyethylene glycol 400 (PEG)<br>extracts; Visual assessment of colonies. | Non-mutagenic |
| ISO 10993-3 | Top agar plating metabolically activated and incubated for 48 – 72 hours;<br>physiological saline and polyethylene glycol 400 (PEG) extracts | Non-mutagenic |

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Image /page/6/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic with red lines emanating from it, leading to the letters "iCE" in blue. Below the letters, the word "NEUROSYSTEMS" is written in a smaller, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic with red lines emanating from it, followed by the text "iCE" in blue, with a red dot above the "i". Below the "iCE" text is the word "NEUROSYSTEMS" in a smaller, gray font. The logo is clean and modern, suggesting a focus on neuroscience and technology.

The following tests were performed to demonstrate equivalence to the predicate device:

- Performance Testing (Bench) ●
- Examination of kit component dimensions O
- Examination of the packaging opening orientation O
- Examination of kit components colors, markings, and graphics O
- Examination for sharp edges o
- Examination of the opacity of the packaging O
- Examination of the trocar sheath tool's penetration tip bending force endurance O
- Examination of the bending force endurance of the exit assist device O
- Examination of the holding endurance of the posterior stopper O
- O Examination of the trocar sheath tool adhesion endurance
- Examination of the adhesion of the passage assist device O
- O Examination of the passage assist device bending resistance
- Examination of the anterior stopper endurance O
- о Cadaver study
- . Performance Testing (Animal)
- Durability of the subject device to record EEG after 14 days continuous implantation in o the subcutaneous space

The results of these tests indicate that the iCE-SG Subcutaneous Electrode Arrays are substantially equivalent to the predicate device.

#### CONCLUSION

Based on the testing performed, biocompatibility and performance testing (bench and animal), it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed iCE-SG Subcutaneous Electrode Arrays are assessed to be substantially equivalent to the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for iCE Neurosystems. The logo features a stylized brain graphic with red lines emanating from it, leading to the letters "iCE" in blue. Below the graphic and letters, the word "NEUROSYSTEMS" is written in a smaller, gray font.

| | Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | iCE Neurosystems, Inc. /<br>iCE-SG Subcutaneous Electrode<br>Arrays | Ad-Tech Medical Instrument<br>Corporation /<br>Depth Electrodes (Depth Electrode,<br>Foramen Ovale Depth Eletrodes,<br>Macro Micro Depth Electrode,<br>Spencer Probe Depth Electrodes,<br>Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /<br>Epidural Peg Electrode (EP), Sphenoidal<br>Electrode (EDS) and Foramen Ovale<br>Depth Electrode (ED-FO) for Epilepsy<br>Monitoring | |
| | K201678 | K163355 | K961942 | |
| Indications for Use | iCE-SG Subcutaneous Electrode<br>Arrays are intended for temporary<br>(<14 days) use with recording and<br>monitoring equipment for the<br>recording and monitoring of<br>electrical signals at the subsurface<br>level of the brain. | The Ad-Tech Depth Electrodes<br>(Depth Electrodes, Foramen Ovale<br>Depth Electrodes, Macro Micro<br>Depth Electrodes, Spencer Probe<br>Depth Electrodes, Wyler Sphenoidal<br>Depth Electrodes) are intended for<br>temporary (< 30 days) use with<br>recording, monitoring and<br>stimulation equipment for the<br>recording, monitoring and<br>stimulation of electrical signals at<br>the subsurface level of the brain. The<br>recording of electrical activity<br>supports definition of the location of<br>epileptogenic foci and brain<br>mapping. | Radionics Epidural Peg, Sphenoidal and<br>Foramen Ovale Depth Electrodes are<br>indicated for intraoperative recording<br>of electrical signals for epilepsy<br>monitoring at the surface and<br>subsurface levels of the brain. | Substantially equivalent to the<br>primary predicate device. The<br>subject device is intended for<br>use up to 14 days, is only for<br>recording/monitoring, and the<br>indications do not mention<br>epileptogenic foci and brain<br>mapping. This does not raise<br>new questions of safety and<br>effectiveness. |
| Product Codes /<br>Regulation Number | GZL / 21 CFR 882.1330 | GZL / 21 CFR 882.1330 | GZL / 21 CFR 882.1330<br>GYC / 21 CFR 882.1310 | Identical to the primary and<br>secondary predicate devices. |
| Regulation<br>Description | Depth electrode | Depth electrode | Depth electrode<br>Cortical electrode | Identical to the primary and<br>secondary predicate devices. |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence |
| | iCE Neurosystems, Inc. / | Ad-Tech Medical Instrument | Radionics, Inc. / | |
| | iCE-SG Subcutaneous Electrode | Corporation / | Epidural Peg Electrode (EP), Sphenoidal | |
| | Arrays | Depth Electrodes (Depth Electrode, | Electrode (EDS) and Foramen Ovale | |
| | | Foramen Ovale Depth Eletrodes, | Depth Electrode (ED-FO) for Epilepsy | |
| | | Macro Micro Depth Electrode, | Monitoring | |
| | | Spencer Probe Depth Electrodes, | | |
| | | Wyler Sphenoidal Depth Electrode) | | |
| | K201678 | K163355 | K961942 | |
| Use Environment | Hospitals including ICU | Intraoperative and neurological<br>monitoring locations within a<br>hospital setting | Unknown | Substantially equivalent to the<br>predicate device. The subject<br>device can be used in the same<br>and similar environments as<br>well as by the bedside due to<br>the convenience kits included in<br>the subject device. This does not<br>raise new questions of safety<br>and effectiveness. |
| Device Components | Surgical Ruler Marker pen Sterile drape Gauze pad Head drape Trocar sheath tool Passage assist tool Exist assist device Stoppers Body adhesive iCE-SG Electrode Array | Depth electrode array | Depth electrode arrays | Substantially equivalent to the<br>primary and secondary<br>predicate devices. The subject<br>device is provided with two<br>convenience kits (Preparation<br>Kit and Insertion Kit) to make<br>subject use easier for the user.<br>The nonclinical testing has<br>demonstrated that these kits do<br>not raise new questions of<br>safety and effectiveness. |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence |
| | iCE Neurosystems, Inc. /<br>iCE-SG Subcutaneous Electrode<br>Arrays | Ad-Tech Medical Instrument<br>Corporation /<br>Depth Electrodes (Depth Electrode,<br>Foramen Ovale Depth Eletrodes,<br>Macro Micro Depth Electrode,<br>Spencer Probe Depth Electrodes,<br>Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /<br>Epidural Peg Electrode (EP), Sphenoidal<br>Electrode (EDS) and Foramen Ovale<br>Depth Electrode (ED-FO) for Epilepsy<br>Monitoring | |
| | K201678 | K163355 | K961942 | |
| Insertion Kit<br>Components | ● Gauze pad<br>● Head drape<br>● Trocar sheath tool<br>● Passage assist tool<br>● Exist assist device<br>● Stoppers<br>● Body adhesive | (n/a) | (n/a) | The primary and secondary<br>predicate devices are tunneled<br>through the subcutaneous space<br>and out of the skin using a<br>trocar that is not included with<br>the cleared devices. The trocars<br>are sold separately by the<br>manufacturers. These<br>differences raise no new<br>questions of safety or<br>effectiveness. |
| Location of<br>Placement | Extracranially | Extracranially | Extracranially | Identical to the primary and<br>secondary predicate. |
| Duration of Use | <14 days | <30 | Unknown | Substantially equivalent to the<br>primary predicate device. The<br>subject device is intended to be<br>used for a shorter period of time<br>compared to the primary<br>predicate. Based on the results<br>of the nonclinical data, the<br>shorter time period does not<br>raise new questions of safety<br>and effectiveness. |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence |
| | iCE Neurosystems, Inc. /<br>iCE-SG Subcutaneous Electrode<br>Arrays | Ad-Tech Medical Instrument<br>Corporation /<br>Depth Electrodes (Depth Electrode,<br>Foramen Ovale Depth Electrodes,<br>Macro Micro Depth Electrode,<br>Spencer Probe Depth Electrodes,<br>Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /<br>Epidural Peg Electrode (EP), Sphenoidal<br>Electrode (EDS) and Foramen Ovale<br>Depth Electrode (ED-FO) for Epilepsy<br>Monitoring | |
| | K201678 | K163355 | K961942 | |
| Contraindications | These depth electrodes should not<br>be used on any patient who the<br>physician considers at risk for<br>infection or for whom the<br>insertion procedure cannot be<br>performed safely and effectively. | These depth electrodes should not<br>be used on any patient who the<br>physician/surgeon considers at risk<br>for infection or for whom the<br>surgical recording and stimulation<br>procedure cannot be performed<br>safely and effectively. | Unknown | Substantially equivalent to the<br>primary predicate. The subject<br>device does not stimulate.<br>Based on the results of the<br>nonclinical data, there are no<br>new questions of safety and<br>effectiveness. |
| Technological Characteristics | | | | |
| Electrode<br>configuration | Array | Array | Array | Identical to the primary and<br>secondary predicate devices.<br>There are no new questions of<br>safety and effectiveness. |
| Single Patient Use | Yes | Yes | Yes | Identical to the primary<br>predicate device. There are no<br>new questions of safety and<br>effectiveness. |
| Disposable | Yes | Yes | Yes | Identical to the primary<br>predicate device. There are no<br>new questions of safety and<br>effectiveness. |
| Electrode Material | Platinum<br>Iridium | Platinum<br>Iridium | Unknown | Identical to the primary<br>predicate device. There are no<br>new questions of safety and<br>effectiveness…