(90 days)
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 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 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).
The document describes the iCE-SG2 Subcutaneous Electrode Kit and its substantial equivalence to a predicate device (iCE-SG Subcutaneous Electrode Arrays, K201678). The acceptance criteria and the study that proves the device meets them are primarily focused on biocompatibility and performance (bench), as this is a medical device for recording electrical signals from the brain.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 standards and establish biological safety. | Biocompatibility evaluation conducted within risk management framework and in compliance with ISO 10993 standards. Evaluation included relevant data sources related to biological safety of finished device testing of previously cleared product (K201678) and kit components with a history of safe biological use. Conclusion: Biological safety established. |
| Performance Testing (Bench): Demonstrate reproducibility in electrode insertion, stability of electrode array position, and removal from subcutaneous space. Also, pre-insertion and post-removal impedance testing should be performed. | A cadaver study was conducted using ten electrodes. Functions associated with electrode array insertion, stability, and removal were shown to perform as expected. Pre-insertion and post-removal impedance testing was performed. Conclusion: All 10 out of 10 electrode arrays performed successfully based on prespecified criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 10 electrodes were used in the cadaver study for performance testing.
- Data Provenance: The document does not explicitly state the country of origin. The study was a "cadaver study," implying human cadavers, and is presented as part of a U.S. FDA 510(k) submission, suggesting it was conducted to U.S. regulatory standards. It is a prospective evaluation of the new device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. The performance criteria (reproducibility of insertion, stability, removal, and impedance measurements) are objective and measured directly, not subject to expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as a traditional ground truth based on expert consensus was not established for the performance testing. The assessment of successful performance was based on pre-specified objective criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an electrode kit for recording electrical signals, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance study was based on objective, pre-specified criteria and measurements from the cadaver study (e.g., successful insertion, stability, removal, and impedance values). For biocompatibility, it was based on compliance with ISO 10993 standards and a history of safe biological use for components.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
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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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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, Neurointerventionaland 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 (<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 KitK222706 | iCE-SG Subcutaneous Electrode ArraysK201678 | ||
| Indications for Use | iCE-SG2 Subcutaneous Electrode Kit isintended for temporary (<14 days) use withrecording and monitoring equipment for therecording and monitoring of electrical signalsat the subsurface level of the brain. | iCE-SG Subcutaneous Electrode Arrays areintended for temporary (<14 days) use withrecording and monitoring equipment for therecording and monitoring of electrical signalsat the subsurface level of the brain. | |
| Product Codes /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 InsertionInstrument | 14 gauge | 11 gauge | |
| Insertion InstrumentMaterial | Stainless steel | Stainless steel | |
| ElectrodeConfiguration | 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 KitK222706 | iCE-SG Subcutaneous Electrode ArraysK201678 | ||
| 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.
§ 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).