(152 days)
Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).
Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Skintact® Neutral Electrodes for Neonates consist of a backing material, conductive layer and conductive adhesive gel. The Neutral Electrodes for Neonates are applied on a release liner. The only change in construction materials is a slight modification of the conductive hydrogel. This modification was carried out to adapt the gel to the skin of neonates. Skintact® Neutral Electrodes for Neonates are accessories to surgery devices.
Skintact® Neutral Electrodes for Neonates are passive devices and do not contain active electronics, software or firmware Skintact® Neutral Electrodes for Neonates are packaged in water-vapour-proofed, heat-sealed, non-transparent, aluminized pouches.
Here's a breakdown of the acceptance criteria and study information for the Skintact® Neutral Electrodes for Neonates, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance (per EN60601-2-2:2009) | ||
| NE Thermal Performance | (Implied: Meet thermal performance requirements) | "Results are within limits," including comparative testing against predicate product. |
| NE Contact Impedance | (Implied: Meet contact impedance requirements) | "Results are within limits." |
| NE Adhesion | (Implied: Meet adhesion requirements) | "Results are within limits." |
| Material Properties (durability) | Release test after 43 days at +23°C | "Results are within limits." |
| Material Properties (shelf-life) | Accelerated aging test after 43 days at +75°C | "Results are within limits." |
| Biocompatibility | No new risks or adverse reactions from direct skin contact | "Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks." |
| Substantial Equivalence | Same indications for use as predicate devices, with expanded target population (neonates). Physical and technical characteristics similar to predicate devices. | Device has the same indications for use as K030362 and K063161, expanded with neonates (like K994428). Technical characteristics are listed as "single patient use, disposable, self-adhesive, non-sterile, sealed foil pouch, backing material, conductive layer, conductive adhesive hydrogel, cover material." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted according standard EN60601-2-2:2009" and "Biocompatibility testing has been performed."
3. Number of Experts Used and Qualifications
Not applicable. This device is a passive, non-diagnostic accessory (neutral electrodes) and its performance evaluation does not involve expert interpretation or ground truth establishment in the manner of an AI diagnostic device. The evaluation is based on objective physical, electrical, and biological safety standards.
4. Adjudication Method
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers or comparative effectiveness in that context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a passive medical device, not an algorithm or software. Its performance is inherent to its physical properties and material composition.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by adhering to recognized international standards and specifications for medical electrodes:
- Engineering Standards: EN60601-2-2:2009 for thermal performance, contact impedance, and adhesion.
- Material Science Standards: Tests for material durability (release and shelf-life) and biocompatibility.
These standards define the acceptable range of physical, electrical, and biological properties for safe and effective use.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.