(86 days)
The LONG LIFE PAD™ is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Omron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.
The LONG LIFE PAD™ is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Omron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.
The LONG LIFE PADs™ are non-sterile, disposable, laminated, flexible structures composed of the following three main construction layers from bottom to top:
. Polyester protective film,
. gel,
. carbon layer,
. non-skin contact polyethylene lamination layer
. snap connection
The electrodes are designed for single-patient/multiple application use. Because of the Adhesive's nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin.
The pad patient contacting surface is a biocompatible hydrogel. The electrode has one connection point that is used to connect the stimulation device to the electrodes. This connection point is compatible only with the Omron PM3030.
The information provided is about a 510(k) premarket notification for a medical device called "LONG LIFE PAD™," which is a cutaneous electrode. This document details the device's comparison to a predicate device and bench testing performed to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary states that the Long Life Pads met all requirements, specifications, and the "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode." While specific numerical acceptance criteria are not explicitly detailed in the provided text, the document indicates compliance with the following types of tests:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Compliance with Guidance | Met all requirements, specifications, and "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode." (Implies compliance with electrical safety, biocompatibility, performance, and labeling standards.) |
| Material Biocompatibility | Patient contacting materials of the electrode tested in accordance with ISO 10993-1 and FDA Guidance. |
| Dispersion | Passed Dispersion Test Protocol Report Summary. (Implies satisfactory electrical current distribution and minimization of hot spots.) |
| Adhesion | Passed Adhesion Test Protocol Report Summary. (Implies satisfactory adherence to skin over the intended use period without premature detachment or excessive residue.) |
| Stability (Storage Conditions) | Passed Stability Testing (Storage Conditions). (Implies the device maintains its performance and integrity under specified storage conditions.) |
| Shelf Life | Passed Stability Test Protocol Report (Shelf life). (Implies the device maintains its performance and integrity over its stated shelf life.) |
| Shipment Stability | Passed Stability Shipment Test Report Summary. (Implies the device maintains its performance and integrity during shipping and handling.) |
| Substantial Equivalence (General) | Found substantially equivalent to the predicate (Well-Life Self Adhesive Electrodes K082065) in indications for use, patient population, environment for use, technology characteristics, specifications, and performance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench tests" but does not specify the sample sizes (number of pads tested) or the provenance (country of origin, retrospective/prospective) of the data for these tests. It only states that the tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the provided document. The performance evaluation presented is based on bench testing of the device's physical and electrical properties, not on clinical assessment or interpretation by human experts.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically associated with clinical studies involving human interpretation or outcomes, not bench testing of device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission is for a cutaneous electrode and relies on bench testing to demonstrate substantial equivalence to a predicate device, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This concept is not applicable to the device described. The "LONG LIFE PAD™" is a physical medical device (cutaneous electrode), not an algorithm or AI system. Its performance is inherent to its physical properties and design, not an "algorithm only" performance.
7. The Type of Ground Truth Used:
For the bench tests, the "ground truth" would be the established scientific and engineering standards and specifications (e.g., electrical resistance limits, adhesion strength targets, material biocompatibility standards as per ISO 10993-1) against which the device's performance was measured. It is not an expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).