(262 days)
iCE-SG Subcutaneous Electrode Arrays are intended for temporary (
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 ( |
§ 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).