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510(k) Data Aggregation
(436 days)
For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
The devices are single patient, multiple-use [up to three times] cutaneous electrodes for the application of electrical stimulation. The lead wire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator. The cutaneous electrodes are available in two sizes; one for adult patients and one for youth patients. Both sizes are composed of identical materials. The cutaneous electrodes and lead wire do not contain active electronics, software or firmware. The lead wire connects to the cutaneous electrotherapy device. The cutaneous electrodes are composed of materials commonly used in this application: polyethylene, medical grade adhesives, 'spunlace' non-woven, carbon film, silver, polyester, and hydrogel.
This document is a 510(k) summary for the eSWALLOW USA Electrodes and Leadwire, seeking substantial equivalence to a predicate device. The information provided heavily focuses on bench testing and comparison to the predicate, and explicitly states that no clinical studies were required. Therefore, many of the requested criteria related to clinical performance, ground truth, and expert evaluation cannot be fully addressed from the provided text.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission primarily relying on substantial equivalence to a predicate device and bench testing, "acceptance criteria" here refers to the standards met and characteristics matching the predicate.
| Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated per ISO-10993 for cytotoxicity, primary skin irritation, and delayed contact hypersensitivity, per FDA G-95 requirements for skin-contact devices of limited duration use. Material components (polyethylene, medical grade adhesives, spunlace, carbon film, silver, polyester, hydrogel) are commonly used and deemed biocompatible. |
| Electrical Performance (Impedance & Dispersion) | Tested per ANSI/AAMI EC12:2000/[R] 2010, Disposable ECG Electrodes, for impedance and dispersion testing. (Specific numerical results are not provided, only that testing was done to the standard). |
| Intended Use | Same as predicate: For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction. Device description states intent for application of electrical current to patient skin. |
| Indications for Use | Same as predicate: For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction. |
| Technological Characteristics | Similar to predicate: Single-patient, multiple-use, self-adhering, disposable electrodes and lead wires. To be used with NMES Device. External, anterior pharyngeal region body site. Electrotherapy mode of action. Non-sterile. Similar electrode sizes (Adult: 0.85 inch round electrode; pediatric: 0.688 inch round electrode vs. Predicate Adult: 0.875 inch round; pediatric: 0.6875 inch round). Adhesive butterfly shape, round lead wires with snap connectors. Packaging: sealed pouch. No active electronics, software, or firmware. |
| Safety (implied by material and design similarity) | "The electrodes and lead wires are made of the same biocompatible materials and have similar technological characteristics as previously cleared devices and therefore raise no new issues of safety." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: No clinical test set. The study primarily relies on bench testing for material biocompatibility and electrical performance, and comparison to a predicate device. The document does not specify a "sample size" for the bench tests in terms of number of electrodes or leadwires tested, beyond stating that testing was "done by the contract manufacturer."
- Data Provenance: N/A for a clinical test set. Bench testing was performed by a contract manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical test set or human-in-the-loop performance evaluation was conducted that would require expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No clinical test set requiring adjudication was performed.
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. This device (electrodes and leadwires) does not involve "AI assistance" or "human readers" in the context of diagnostic interpretation. It is a physical medical device for electrical stimulation delivery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is not an algorithm. Bench testing of the physical components (impedance, dispersion) could be considered "standalone" evaluation of the device's electrical characteristics, but not in the conventional sense of an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: The "ground truth" for the bench tests would be the specifications and requirements defined by the referenced standards (ISO-10993 for biocompatibility, ANSI/AAMI EC12:2000/[R] 2010 for electrical performance). The results of these tests (e.g., demonstrating no cytotoxicity, meeting impedance limits) are compared against these standards.
- Substantial Equivalence: The primary "ground truth" for the 510(k) submission's approval is the established safety and effectiveness of the identified predicate device (K083756, SpectraMed, Inc. Guardian 150 electrode). The new device's characteristics are compared directly to this cleared device.
8. The sample size for the training set:
- N/A. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. This device is not an AI/ML algorithm that requires a "training set."
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