(56 days)
Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators (and as also to be offered for sale under various private label tradenames) consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH02 [all materials cleared in existing 510(k) K041883]. Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proof, heatsealed, non-transparent, aluminized pouches, non-sterile and single-use.
This 510(k) summary describes a device that is essentially identical to a previously cleared predicate device, with no significant differences in materials or design. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device meeting the same standards and specifications as the predicate device, demonstrated through bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device standards) | Reported Device Performance |
|---|---|
| Meets performance and safety requirements of ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003 | "Skintact Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators met the same requirements as those of the predicate. Performance and safety tests were conducted according to ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003..." |
| Materials cleared in existing 510(k) K041883 | "All materials were cleared in 510(k) K041883" |
| Demonstrates acceptable skin irritation and sensitization | "Results of updated testing for skin irritation and sensitization testing are included." (Implies results were acceptable, as the device was cleared) |
| Maintain performance over a 30-month shelf-life | "Leonhard Lang has met requirements for 30 months shelf-life." |
| Device performance does not introduce new issues of safety or effectiveness | "Bench testing demonstrated that the performance of the Skintact® Multifunction Electrodes with DH02 Gel available with different compatible with different defibrillators meets is specifications." and "Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators does not introduce new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance and safety tests were conducted," but not the specific number of units tested.
- Data Provenance: The tests were conducted by SGS, an independent third-party testing organization, presumably in Austria where Leonhard Lang GmbH is located. This is a prospective test for this specific device, demonstrating its performance against established standards, rather than analyzing existing datasets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable in this context. The "ground truth" for this device's performance is defined by adherence to recognized international standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003) for defibrillation electrodes, not by expert consensus on clinical findings. The "experts" are likely the engineers and technicians at SGS who performed the tests according to these standards. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation). For bench testing against objective standards, the "adjudication" is whether the test results fall within the specified acceptance criteria of the standards.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. This submission is for a medical electrode.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This device is a physical electrode, not a software algorithm. Its performance is evaluated through physical and electrical testing.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective engineering and safety standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003).
8. The Sample Size for the Training Set
- This document describes a medical device, not a machine learning model. Therefore, there is no training set in the context of artificial intelligence/machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.