(262 days)
Not Found
No
The summary describes a passive electrode array for recording EEG signals and does not mention any AI/ML processing or analysis of these signals.
No
The device is used for recording and monitoring electrical signals, specifically EEG signals, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is used for "recording and monitoring of electrical signals" and "recording electroencephalograph (EEG) signals," which are used by healthcare professionals to diagnose conditions related to brain activity.
No
The device description explicitly states it is a "Subcutaneous Electrode Array" and lists physical components like a preparation box, insertion kit box, and electrode boxes. It also details performance testing involving physical properties and animal studies, indicating it is a hardware device.
Based on the provided information, the iCE-SG Subcutaneous Electrode Arrays are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- iCE-SG Function: The iCE-SG Subcutaneous Electrode Arrays are designed to be implanted subcutaneously to record electrical signals directly from the subsurface level of the brain. This is an in vivo (within the living body) measurement, not an in vitro (outside the living body) examination of a specimen.
- Intended Use: The intended use is for "recording and monitoring of electrical signals at the subsurface level of the brain," which is a direct physiological measurement, not an analysis of a bodily fluid or tissue sample.
Therefore, the iCE-SG Subcutaneous Electrode Arrays fall under the category of implantable medical devices used for physiological monitoring, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
iCE-SG Subcutaneous Electrode Arrays are 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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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( | Prescription Use (Part 21 CFR 201 Subpart D) |
|---|---|
| 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: (619) 458-9547 Email: akomiyama@acknowledge-rs.com; mrubin@acknowledge-rs.com 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 |
| 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 | |
| Electrodes, Macro Micro Depth Electrode, Spencer Probe | ||
| Depth Electrodes, Wyler Sphenoidal Depth Electrode) / Ad- | ||
| tech Medical Instrument Corporation | ✓ | |
| K961942 | Epidural Peg Electrode (EP), Sphenoidal Electrode (EDS) | |
| and Foramen Ovale Depth Electrode (ED-FO) for Epilepsy | ||
| 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:
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- Preparation box
-
- Insertion kit box
-
- Two iCE-SG electrode boxes
INDICATIONS FOR USE
iCE-SG Subcutaneous Electrode Arrays are intended for temporary (