(262 days)
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.
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:
- Preparation box
- Insertion kit box
- Two iCE-SG electrode boxes
Here's an analysis of the acceptance criteria and supporting study for the iCE-SG Subcutaneous Electrode Arrays, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it details various tests to demonstrate safety and equivalence to a predicate device. The "results" column below reflects the outcomes reported for these tests, which were deemed sufficient for demonstrating substantial equivalence.
| Category | Specific Test / Criterion | Reported Device Performance / Result |
|---|---|---|
| Biocompatibility | Cytotoxicity (L-929 cells; EMEM extract; % viability / morphological grading) | Non-cytotoxic |
| Sensitization (Intradermal injection and topical application in guinea pigs; sesame oil/0.9% saline / cottonseed oil/0.9% sodium chloride extracts) | Non-sensitizing | |
| Irritation (Intracutaneous injection in New Zealand white rabbits; cottonseed oil/sodium chloride extracts) | Non-irritating | |
| Acute Systemic Toxicity (Intraperitoneal injection of albino swiss mice with cottonseed oil/sodium chloride extracts / Intravenous injection of albino swiss mice with 0.9% sodium chloride extract) | Non-toxic | |
| Pyrogenicity (Marginal ear vein injection of New Zealand white rabbits; 0.9% sodium chloride extract) | Non-pyrogenic | |
| Material-Mediated Pyrogenicity / Implantation (Implantation of two articles for 28/29 days) | Non-toxic | |
| Implantation (Four weeks, left hemisphere in New Zealand White rabbits) | Non-bioreactive | |
| Genotoxicity (L5178Y cells; RPMIi and PEG extracts; Visual assessment; Top agar plating) | Non-mutagenic | |
| Performance Testing (Bench) | Kit component dimensions examination | Demonstrated equivalence |
| Packaging opening orientation examination | Demonstrated equivalence | |
| Kit components colors, markings, and graphics examination | Demonstrated equivalence | |
| Sharp edges examination | Demonstrated equivalence | |
| Opacity of the packaging examination | Demonstrated equivalence | |
| Trocar sheath tool's penetration tip bending force endurance | Demonstrated equivalence | |
| Bending force endurance of the exit assist device | Demonstrated equivalence | |
| Holding endurance of the posterior stopper | Demonstrated equivalence | |
| Trocar sheath tool adhesion endurance | Demonstrated equivalence | |
| Adhesion of the passage assist device | Demonstrated equivalence | |
| Passage assist device bending resistance | Demonstrated equivalence | |
| Anterior stopper endurance | Demonstrated equivalence | |
| Cadaver study | Demonstrated equivalence | |
| Performance Testing (Animal) | Durability to record EEG after 14 days continuous implantation in the subcutaneous space | Demonstrated durability |
| Technological Characteristics Comparison | Indications for Use (<14 days use, recording/monitoring only, no stimulation) | Substantially equivalent to predicate (shorter duration, no stimulation in subject device; deemed not to raise new safety/effectiveness questions) |
| Product Codes / Regulation Number | Identical to primary/secondary predicates | |
| Regulation Description | Identical to primary/secondary predicates | |
| Use Environment (Hospitals including ICU) | Substantially equivalent (same/similar environments; convenience kits expand use but no new safety questions) | |
| Device Components (Includes prep/insertion kits) | Substantially equivalent (kits make use easier; nonclinical testing showed no new safety/effectiveness questions) | |
| Insertion Kit Components | Substantially equivalent (trocars sold separately by predicates; no new safety/effectiveness questions) | |
| Location of Placement (Extracranially) | Identical to primary/secondary predicates | |
| Duration of Use (<14 days) | Substantially equivalent (shorter than predicate, but nonclinical data show no new safety/effectiveness questions) | |
| Contraindications (Risk for infection, unsafe/ineffective procedure) | Substantially equivalent (predicate includes stimulation, subject device does not; no new safety/effectiveness questions) | |
| Electrode configuration (Array) | Identical to primary/secondary predicates | |
| Single Patient Use (Yes) | Identical to primary predicate | |
| Disposable (Yes) | Identical to primary predicate | |
| Electrode Material (Platinum Iridium) | Identical to primary predicate | |
| Electrode Diameter (1.12 mm) | Falls within predicate range (0.86-1.96 mm); no new safety/effectiveness questions | |
| Maximum Stimulation Charge Density (< 30 µC/cm²) (Not applicable for subject device as it doesn't stimulate) | Identical to primary predicate (not applicable to subject device but meets criteria if it were) | |
| Insertion Procedure (Tunneled subcutaneously, stoppers, <14 days monitoring, bedside withdrawal) | Substantially equivalent (shorter duration than predicate; no new safety/effectiveness questions) | |
| Use of Stylet (Removed prior to passage) | Identical to primary predicate | |
| Impedance Cutoff for Each Electrode Contact Prior to Product Release (kΩ) (0.25) | Identical to primary predicate | |
| Sterilization (Ethylene oxide) | Identical to primary predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for most of the tests, only the types of animals used (e.g., L-929 cells, guinea pigs, New Zealand white rabbits, albino swiss mice).
- Biocompatibility: Involves various cell lines and animal models as listed in the table above. Specific numbers of animals per test are not provided.
- Performance Testing (Bench): Refers to "Examination" of various physical characteristics and "endurance" tests. No numerical sample sizes are given.
- Performance Testing (Animal): Mentions "14 days continuous implantation" for durability in the subcutaneous space. No specific number of animals is stated for this.
- Cadaver Study: Mentioned under Performance Testing (Bench), but no specifics on the number of cadavers or the details of the study are provided.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated. These are likely prospective studies conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention human experts used to establish "ground truth" for the test set in the context of diagnostic accuracy, as this device (iCE-SG Subcutaneous Electrode Arrays) is a recording electrode and not an AI-powered diagnostic tool. The "ground truth" for the electrode's performance is based on objective laboratory and animal testing results (e.g., non-cytotoxic, non-irritating, successful EEG recording durability).
4. Adjudication Method for the Test Set
This information is not applicable as the device is not an AI diagnostic tool requiring expert adjudication of outputs. The tests performed are objective, measurable outcomes in a laboratory or animal setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for AI-assisted diagnostic devices where human reader performance (with and without AI) is evaluated. The iCE-SG Subcutaneous Electrode Arrays are recording electrodes, not a diagnostic system for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study of an algorithm is not applicable because the device is a hardware electrode designed for recording electrical signals, not an algorithm for data processing or diagnosis. The performance studies focus on the physical and biological compatibility of the electrode itself.
7. Type of Ground Truth Used
The "ground truth" for evaluating this device's safety and effectiveness is primarily based on:
- Objective laboratory measurements: (e.g., cytotoxicity, irritation, pyrogenicity, specified physical properties like bending force, impedance cutoff).
- Biological responses: Observed in animal models (e.g., non-sensitizing, non-bioreactive, successful EEG recording).
- Comparison to predicate device characteristics: Demonstrating that the subject device's characteristics (e.g., dimensions, materials, use duration) are either identical, within acceptable ranges, or that any differences do not raise new questions of safety or effectiveness when compared to previously cleared devices.
8. Sample Size for the Training Set
This is not applicable. The device is an electrode array, not a software algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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 (<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 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, Neurointerventionaland 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 DepthElectrodes, Macro Micro Depth Electrode, Spencer ProbeDepth 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 EpilepsyMonitoring / 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:
-
- Preparation box
-
- Insertion kit box
-
- 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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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;Evaluated using percent viability. | Non-cytotoxic |
| ISO 10993-10 | Intradermal injection and topical application in guinea pigs; sesame oil or 0.9%normal saline extracts. | Non-sensitizing |
| ISO 10993-10 | Intracutaneous injection in New Zealand white rabbits; cottonseed oil or sodiumchloride extracts. | Non-irritating |
| ISO 10993-11 | Intraperitoneal injection of albino swiss mice with cottonseed oil or sodium chlorideextracts. | Non-toxic |
| ISO 10993-11 | Marginal ear vein injection of New Zealand white rabbits; 0.9% sodium chlorideextract. | Non-pyrogenic |
| iCE-SG Electrode Arrays | ||
| ISO 10993-5 | Cytotoxicity study using L-929 cells; EMEM extract;Evaluated using morphological grading. | Non-cytotoxic |
| ISO 10993-10 | Intradermal injection and topical application in guinea pigs; cottonseed oil or 0.9%sodium chloride extracts | Non-sensitizing |
| Standard | Study Description | Results |
| ISO 10993-10 | Intracutaneous injections in New Zealand white strain albino rabbits; cottonseed oilor 0.9% sodium chloride extracts. | Non-irritating |
| ISO 10993-11 | Intraperitoneal injection in albino swiss mice with cottonseed oil extractIntravenous 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% sodiumchloride extract. | Non-pyrogenic |
| ISO 10993-6ISO 10993-11 | Implantation of two articles maintained for 28 and 29-days (males or females,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)extracts; Visual assessment of colonies. | Non-mutagenic |
| ISO 10993-3 | Top agar plating metabolically activated and incubated for 48 – 72 hours;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. /iCE-SG Subcutaneous ElectrodeArrays | Ad-Tech Medical InstrumentCorporation /Depth Electrodes (Depth Electrode,Foramen Ovale Depth Eletrodes,Macro Micro Depth Electrode,Spencer Probe Depth Electrodes,Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /Epidural Peg Electrode (EP), SphenoidalElectrode (EDS) and Foramen OvaleDepth Electrode (ED-FO) for EpilepsyMonitoring | ||
| K201678 | K163355 | K961942 | ||
| Indications for Use | iCE-SG Subcutaneous ElectrodeArrays are intended for temporary(<14 days) use with recording andmonitoring equipment for therecording and monitoring ofelectrical signals at the subsurfacelevel of the brain. | The Ad-Tech Depth Electrodes(Depth Electrodes, Foramen OvaleDepth Electrodes, Macro MicroDepth Electrodes, Spencer ProbeDepth Electrodes, Wyler SphenoidalDepth Electrodes) are intended fortemporary (< 30 days) use withrecording, monitoring andstimulation equipment for therecording, monitoring andstimulation of electrical signals atthe subsurface level of the brain. Therecording of electrical activitysupports definition of the location ofepileptogenic foci and brainmapping. | Radionics Epidural Peg, Sphenoidal andForamen Ovale Depth Electrodes areindicated for intraoperative recordingof electrical signals for epilepsymonitoring at the surface andsubsurface levels of the brain. | Substantially equivalent to theprimary predicate device. Thesubject device is intended foruse up to 14 days, is only forrecording/monitoring, and theindications do not mentionepileptogenic foci and brainmapping. This does not raisenew questions of safety andeffectiveness. |
| Product Codes /Regulation Number | GZL / 21 CFR 882.1330 | GZL / 21 CFR 882.1330 | GZL / 21 CFR 882.1330GYC / 21 CFR 882.1310 | Identical to the primary andsecondary predicate devices. |
| RegulationDescription | Depth electrode | Depth electrode | Depth electrodeCortical electrode | Identical to the primary andsecondary 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 neurologicalmonitoring locations within ahospital setting | Unknown | Substantially equivalent to thepredicate device. The subjectdevice can be used in the sameand similar environments aswell as by the bedside due tothe convenience kits included inthe subject device. This does notraise new questions of safetyand 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 theprimary and secondarypredicate devices. The subjectdevice is provided with twoconvenience kits (PreparationKit and Insertion Kit) to makesubject use easier for the user.The nonclinical testing hasdemonstrated that these kits donot raise new questions ofsafety and effectiveness. |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence | |
| iCE Neurosystems, Inc. /iCE-SG Subcutaneous ElectrodeArrays | Ad-Tech Medical InstrumentCorporation /Depth Electrodes (Depth Electrode,Foramen Ovale Depth Eletrodes,Macro Micro Depth Electrode,Spencer Probe Depth Electrodes,Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /Epidural Peg Electrode (EP), SphenoidalElectrode (EDS) and Foramen OvaleDepth Electrode (ED-FO) for EpilepsyMonitoring | ||
| K201678 | K163355 | K961942 | ||
| Insertion KitComponents | ● Gauze pad● Head drape● Trocar sheath tool● Passage assist tool● Exist assist device● Stoppers● Body adhesive | (n/a) | (n/a) | The primary and secondarypredicate devices are tunneledthrough the subcutaneous spaceand out of the skin using atrocar that is not included withthe cleared devices. The trocarsare sold separately by themanufacturers. Thesedifferences raise no newquestions of safety oreffectiveness. |
| Location ofPlacement | Extracranially | Extracranially | Extracranially | Identical to the primary andsecondary predicate. |
| Duration of Use | <14 days | <30 | Unknown | Substantially equivalent to theprimary predicate device. Thesubject device is intended to beused for a shorter period of timecompared to the primarypredicate. Based on the resultsof the nonclinical data, theshorter time period does notraise new questions of safetyand effectiveness. |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence | |
| iCE Neurosystems, Inc. /iCE-SG Subcutaneous ElectrodeArrays | Ad-Tech Medical InstrumentCorporation /Depth Electrodes (Depth Electrode,Foramen Ovale Depth Electrodes,Macro Micro Depth Electrode,Spencer Probe Depth Electrodes,Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /Epidural Peg Electrode (EP), SphenoidalElectrode (EDS) and Foramen OvaleDepth Electrode (ED-FO) for EpilepsyMonitoring | ||
| K201678 | K163355 | K961942 | ||
| Contraindications | These depth electrodes should notbe used on any patient who thephysician considers at risk forinfection or for whom theinsertion procedure cannot beperformed safely and effectively. | These depth electrodes should notbe used on any patient who thephysician/surgeon considers at riskfor infection or for whom thesurgical recording and stimulationprocedure cannot be performedsafely and effectively. | Unknown | Substantially equivalent to theprimary predicate. The subjectdevice does not stimulate.Based on the results of thenonclinical data, there are nonew questions of safety andeffectiveness. |
| Technological Characteristics | ||||
| Electrodeconfiguration | Array | Array | Array | Identical to the primary andsecondary predicate devices.There are no new questions ofsafety and effectiveness. |
| Single Patient Use | Yes | Yes | Yes | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. |
| Disposable | Yes | Yes | Yes | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. |
| Electrode Material | PlatinumIridium | PlatinumIridium | Unknown | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence | |
| iCE Neurosystems, Inc. /iCE-SG Subcutaneous ElectrodeArrays | Ad-Tech Medical InstrumentCorporation /Depth Electrodes (Depth Electrode,Foramen Ovale Depth Eletrodes,Macro Micro Depth Electrode,Spencer Probe Depth Electrodes,Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /Epidural Peg Electrode (EP), SphenoidalElectrode (EDS) and Foramen OvaleDepth Electrode (ED-FO) for EpilepsyMonitoring | ||
| K201678 | K163355 | K961942 | ||
| Electrode Diameter | $1.12 mm$ | $0.86 – 1.96 mm$ | Unknown | Identical to the primarypredicate. The diameter of thesubject device falls within thecleared range for the primarypredicate device, thereforethere are no new questions ofsafety or effectiveness raised. |
| MaximumStimulation ChargeDensity | $< 30 µC/cm²$ | $< 30 µC/cm²$ | Unknown | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. This technologicalcharacteristic is not applicablefor the iCE-SG SubcutaneousElectrode Arrays as the iCE-SGElectrode Arrays are not usedfor stimulation |
| Insertion Procedure | The marked entry/exit sites are prepped in a sterile fashion. The iCE-SG Electrode Array and trocar insertion tool are inserted and tunneled subcutaneously into the exit point of the skin. One placed, the trocar sheath tool is brought out through the skin with help from the exist assist device. The trocar sheath tool is then removed from the subcutaneous pace, leaving the electrode in place in the subcutaneous space. The electrode is secured in position with two stopper devices. A period of monitoring (up to 14 days) occurs. Following completion of monitoring, the iCE-SG Subcutaneous Electrode Array is withdrawn at the bedside. | The entry/exit sites are prepped and draped in sterile fashion. The Depth Electrode and trocar insertion tool are inserted and tunneled subcutaneously to the exit point of the skin. The trocar is brought out through the skin and then removed from the subcutaneous space, leaving the electrode in place in the subcutaneous space. The electrode is secured in position using a stay flange. A period of monitoring (up to 30 days) occurs. Following completion of monitoring, the Depth Electrode is withdrawn at the bedside. | Unknown | Substantially equivalent to the primary predicate. The subject device is inserted for 14 days, less time than the primary predicate. This does not raise new question of safety and effectiveness. |
| Use of Stylet | Stylet removed prior to passage of electrode into sheath and subcutaneous space. | Stylet removed prior to passage into trocar and subcutaneous space. | Unknown | Identical to the primary predicate device. There are no new questions of safety and effectiveness. |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Statement of Equivalence | |
| iCE Neurosystems, Inc. /iCE-SG Subcutaneous Electrode Arrays | Ad-Tech Medical Instrument Corporation /Depth Electrodes (Depth Electrode,Foramen Ovale Depth Eletrodes,Macro Micro Depth Electrode,Spencer Probe Depth Electrodes,Wyler Sphenoidal Depth Electrode) | Radionics, Inc. /Epidural Peg Electrode (EP), SphenoidalElectrode (EDS) and Foramen OvaleDepth Electrode (ED-FO) for EpilepsyMonitoring | ||
| K201678 | K163355 | K961942 | ||
| Impedance Cutofffor Each ElectrodeContact Prior toProduct Release(kΩ) | 0.25 | 0.25 | Unknown | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. |
| Testing | ||||
| Biocompatibility | Per 10993-1 | Per 10933-1 | Unknown | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. |
| PerformanceTesting | Visual testsFunctional testsCadaver studyAnimal study | Functional Tests | Unknown | Substantially equivalent to theprimary predicate. There are nonew questions of safety andeffectiveness. |
| Sterilization | Ethylene oxide | Ethylene oxide | Unknown | Identical to the primarypredicate device. There are nonew questions of safety andeffectiveness. |
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Image /page/11/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. The word "NEUROSYSTEMS" is written in gray below the graphic.
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Image /page/12/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/13/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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§ 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).