iCE-SG2 Subcutaneous Electrode Kit
Device Facts
| Record ID | K222706 |
|---|---|
| Device Name | iCE-SG2 Subcutaneous Electrode Kit |
| Applicant | Ice Neurosystems, Inc. |
| Product Code | GZL · Neurology |
| Decision Date | Dec 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1330 |
| Device Class | Class 2 |
Indications for Use
iCE-SG2 Subcutaneous Electrode Kit is 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-SG2 Subcutaneous Electrode Kit consists of 8-contact platinum electrode arrays; 14-gauge Touhy needles; and ancillary components (drapes, dressings, disinfectant). Used by healthcare professionals in hospitals/ICUs for temporary (<14 days) subcutaneous EEG monitoring. Electrodes are inserted via needle into subcutaneous space to detect subsurface brain electrical signals. Signals are transmitted to external electrophysiology recording/monitoring equipment. Output allows clinicians to monitor brain electrical activity; aids in clinical assessment of neurological status. Benefits include minimally invasive access to subsurface EEG signals for short-term monitoring.
Clinical Evidence
Bench testing only. Cadaver study (n=10) demonstrated reproducibility of electrode insertion, stability, and removal. Pre- and post-removal impedance testing confirmed successful performance per prespecified criteria.
Technological Characteristics
Depth electrode array; 8 platinum contacts; TPU (Tecoflex) body; 1.12 mm diameter; 380 mm length. Insertion via 14-gauge stainless steel Touhy needle. Sterile; single-patient use. Ethylene oxide sterilization. Standalone device for connection to external electrophysiology systems.
Indications for Use
Indicated for temporary (<14 days) recording and monitoring of electrical signals at the subsurface level of the brain in hospital settings, including ICUs.
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
- iCE-SG Subcutaneous Electrode Arrays (K201678)
Reference Devices
- Skin disinfectant device (NDA020832)
- Sterile table drape (K140330)
Submission Summary (Full Text)
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December 6, 2022
iCE Neurosystems, Inc. % Allison Komiyama Principal Consultant ROM+ 2251 San Diego Avenue Suite B-257 San Diego, California 92110
Re: K222706
Trade/Device Name: iCE-SG2 Subcutaneous Electrode Kit Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: September 6, 2022 Received: September 7, 2022
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.
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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 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.
# Patrick Antkowiak -S
# 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
Submission Number (if known)
Device Name
iCE-SG2 Subcutaneous Electrode Kit
Indications for Use (Describe)
iCE-SG2 Subcutaneous Electrode Kit is 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)
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, composed of vertical lines in shades of blue and gray. To the right of the brain graphic is the word "ice" in a simple, sans-serif font, with the "i" having a circular dot. Below the word "ice" is the word "neurosystems" in a smaller, sans-serif font.
DATE PREPARED
November 8, 2022
#### MANUFACTURER AND 510(k) OWNER
iCE Neurosystems, Inc. 1010 Wisconsin Avenue NW, Suite 307 Washington, DC 20007, USA Telephone: Official Contact: Emir Kapetanovic, Chief Operating Officer
#### REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., RAC Erin A. Gontang, Ph.D. RQM+ Telephone: (412) 816-8253 Email: akomiyama@rqmplus.com; egontang@rqmplus.com Website: https://www.rgmplus.com/
## DEVICE INFORMATION
| Proprietary Name/Trade Name: | iCE-SG2 Subcutaneous Electrode Kit |
|------------------------------|---------------------------------------------------------------------------|
| Common Name: | Electrode, Depth |
| 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-SG2 Subcutaneous Electrode Kit is substantially equivalent to the following primary predicate device:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---------------|------------------------------------------------------------------|-------------------|
| K201678 | iCE-SG Subcutaneous Electrode Arrays /<br>iCE Neurosystems, Inc. | ✓ |
#### DEVICE DESCRIPTION
The iCE-SG2 Subcutaneous Electrode Kit is 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. The subject device allows for continuous
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Image /page/4/Picture/0 description: The image shows the logo for "ice neurosystems". The logo features a stylized waveform graphic to the left of the word "ice", with "neurosystems" written in a smaller font directly below. The waveform graphic consists of vertical bars of varying heights, alternating between blue and gray. The word "ice" is written in a bold, sans-serif font, and the word "neurosystems" is written in a thinner, sans-serif font.
electroencephalograph (EEG) monitoring in the subcutaneous space. The iCE-SG2 Subcutaneous Electrode Kit can connect to commonly used electrophysiology systems. The subject device is provided sterile and for single patient use in hospitals by healthcare professionals (HCPs).
| Item | Quantity | Kit Component | 510(k) Status |
|------|----------|-----------------------------------|-------------------|
| 1 | 2 | iCE-SG2 Subcutaneous Electrode | Pending Clearance |
| 2 | 2 | 14-gauge Touhy needle with stylet | Pending Clearance |
| 3 | 1 | Surgical marking pen and ruler | 510(k) Exempt |
| 4 | 2 | Skin disinfectant device | NDA020832 |
| 5 | 1 | Sterile table drape | K140330 |
| 6 | 2 | Sterile gauze pad | 510(k) Exempt |
| 7 | 2 | Electrode securement dressing | 510(k) Exempt |
| 8 | 2 | Cable securement dressing | 510(k) Exempt |
The iCE-SG2 Subcutaneous Electrode Kit includes the following components:
#### INDICATIONS FOR USE
iCE-SG2 Subcutaneous Electrode Kit is 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-SG2 Subcutaneous Electrode Kit is substantially equivalent to the primary predicate device based on the information summarized below.
The electrodes of the subject device have the identical intended use and similar technological characteristics as the device cleared in K201678. Both the subject device and primary predicate device include depth electrode arrays that are placed in the subcutaneous space to detect electrical signals at the subsurface level of the brain. The electrodes of both the subject device and the primary predicate device are intended for temporary use (<14 days) in hospitals, including intensive care units (ICUs). While the electrodes of the subject device have eight contacts, whereas the predicate device has ten, the decreased number of contacts (and thereby decreased recording length and overall depth length) does not affect the recording performance of the subject device.
The insertion methodology of the subject device is similar to K201678. Overall, the iCE-SG2 Subcutaneous Electrode Kit has undergone testing to ensure that any difference in technological characteristics (i.e., insertion procedure) do not affect safety and effectiveness when compared to the predicate device.
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Image /page/5/Picture/0 description: The image contains the logo for "ice neurosystems". The logo features a stylized graphic to the left, resembling sound waves or brain activity, with alternating blue and gray vertical lines. To the right of the graphic, the word "ice" is written in a modern, sans-serif font, with the "i" in lowercase and the "c" and "e" connected. Below the graphic, the word "neurosystems" is written in a smaller, sans-serif font, aligned with the left edge of the "ice" text above.
As detailed in the device description, components of the iCE-SG2 Subcutaneous Electrode Kit have either been determined to be substantially equivalent to the predicate device, 510(k) exempt, or previously cleared or approved by FDA. While the electrodes and insertion needles associated with the kit have been determined to be substantially equivalent as part of the current 510(k), the skin disinfectant device was previously approved and the sterile table drape previously cleared by FDA. The remaining kit components, including the surgical marking pen and ruler, sterile gauze pads, and securement dressings are all 510(k) exempt medical devices that are provided in their final finished form, consistent with their legal marketing authorization. An SE chart is included at the end of this summary.
# SUMMARY OF NON-CLINICAL TESTING
The results of these tests indicate that the iCE-SG2 Subcutaneous Electrode Kit is substantially equivalent to the predicate device.
- BIOCOMPATIBILITY
The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This evaluation of the device included relevant data sources related to biological safety of finished device testing of the previously cleared product (K201678) and kit components with history of safe biological use. This biocompatibility evaluation establishes the biological safety for the iCE-SG2 Subcutaneous Electrode Kit.
- . PERFORMANCE TESTING (BENCH)
A cadaver study was conducted using ten electrodes to demonstrate reproducibility in the following phases: insertion of the electrode array through the needle within the subcutaneous space, stability of the electrode array position, and removal of electrode arrays from the subcutaneous space. Pre-insertion and post-removal impedance testing of the electrodes was also performed. Based on the prespecified criteria, all 10 out of 10 electrode arrays performed successfully. Functions associated with electrode array insertion, stability, and removal were shown to perform as expected.
# CONCLUSION
Based on the testing performed (i.e., biocompatibility and performance testing (bench)), it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The identical indications for use, similar technological characteristics, and similar performance characteristics for the proposed iCE-SG2 Subcutaneous Electrode Kit are assessed to be substantially equivalent to the predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for "ice neurosystems". The logo features a series of vertical lines of varying heights, with the left half of each line colored blue and the right half colored gray. To the right of the lines is the word "ice" in a simple, sans-serif font, with a dot above the "i". Below the word "ice" is the word "neurosystems" in a smaller, sans-serif font.
| | Subject Device | Predicate Device | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | iCE Neurosystems, Inc. | iCE Neurosystems, Inc. | |
| | | | |
| | iCE-SG2 Subcutaneous Electrode Kit<br>K222706 | iCE-SG Subcutaneous Electrode Arrays<br>K201678 | |
| Indications for Use | iCE-SG2 Subcutaneous Electrode Kit is<br>intended for temporary (<14 days) use with<br>recording and monitoring equipment for the<br>recording and monitoring of electrical signals<br>at the subsurface level of the brain. | iCE-SG Subcutaneous Electrode Arrays are<br>intended for temporary (<14 days) use with<br>recording and monitoring equipment for the<br>recording and monitoring of electrical signals<br>at the subsurface level of the brain. | |
| Product Codes /<br>Regulation Number | GZL / 21 CFR 882.1330 | GZL / 21 CFR 882.1330 | |
| Regulation Description | Depth electrode | Depth electrode | |
| Use Environment | Hospitals including ICU | Hospitals including ICU | |
| Device Components | Surgical Ruler Pen Sterile Drape Disinfectant Devices Gauze Pads Electrode Securement Dressings Cable Securement Dressings Insertion Needles iCE-SG2 Electrode Arrays | Surgical Ruler Pen Sterile Drape Head Drape Gauze Pads Electrode Securement Dressings Trocar sheath tools Passage assist tools Exist assist devices Stoppers iCE-SG Electrode Arrays | |
| Location of Placement | Subcutaneous space | Subcutaneous space | |
| Method of Placement | Placed using needle | Placed using trocar/sheath | |
| Gauge of Insertion<br>Instrument | 14 gauge | 11 gauge | |
| Insertion Instrument<br>Material | Stainless steel | Stainless steel | |
| Electrode<br>Configuration | Array | Array | |
| Electrode Material | TPU (Tecoflex) | TPU (Tecoflex) | |
| Contact Number | 8 | 10 | |
| Contact Length/Size | 2.41 mm | 2.41 mm | |
| Contact Spacing | 5 mm/10 mm | 5 mm/10 mm | |
| Contact Material | Platinum | Platinum | |
| Recording Field Length | 66 mm | 88 mm | |
| Single Patient Use | Yes | Yes | |
| Disposable | Yes | Yes | |
| Electrode Diameter | 1.12 mm | 1.12 mm | |
| Overall Depth Length | 380 mm | 390 mm | |
| | Subject Device | Predicate Device | |
| | iCE Neurosystems, Inc. | iCE Neurosystems, Inc. | |
| | iCE-SG2 Subcutaneous Electrode Kit<br>K222706 | iCE-SG Subcutaneous Electrode Arrays<br>K201678 | |
| Biocompatibility | Per 10993-1 | Per 10993-1 | |
| Performance Testing | Cadaver study | Visual tests Functional tests Cadaver study Animal study | |
| | Electrode Sterilization | Ethylene oxide | Ethylene oxide |
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Image /page/7/Picture/1 description: The image shows the logo for "ICE neurosystems". The logo features a stylized brain graphic on the left, composed of vertical lines in shades of blue and gray. To the right of the brain graphic is the word "ICE" in a bold, sans-serif font, with the "I" and "C" in black. Below "ICE" is the word "neurosystems" in a smaller, lighter font, also in black.
