(90 days)
NDA020832, K140330
No
The summary describes a subcutaneous electrode kit for recording electrical signals. There is no mention of AI, ML, or any data processing beyond basic signal recording and impedance testing.
No
The device is described as an electrode kit intended for recording and monitoring electrical signals, specifically for continuous electroencephalograph (EEG) monitoring. It is not mentioned to provide any therapeutic effect.
No
The device is used for recording and monitoring electrical signals (EEG), which aids in diagnosis but is not a diagnostic device itself. It captures data for interpretation by healthcare professionals.
No
The device description explicitly states it is a "Subcutaneous Electrode Kit" and describes physical components like electrodes and needles, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The iCE-SG2 Subcutaneous Electrode Kit is used to record electrical signals directly from within the body (subcutaneously at the subsurface level of the brain). It is an in vivo device, not an in vitro device.
- Intended Use: The intended use is for "recording and monitoring of electrical signals at the subsurface level of the brain," which is a physiological measurement taken directly from the patient.
Therefore, based on the provided information, the iCE-SG2 Subcutaneous Electrode Kit is a device for in vivo physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
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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 ( 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."
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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 |
| 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 / | |
| iCE Neurosystems, Inc. | ✓ |
DEVICE DESCRIPTION
The iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (