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510(k) Data Aggregation
(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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