(121 days)
Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.
Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.
The provided text describes a 510(k) summary for "Soothies Gel Pads," a nipple shield. The focus of the document is on establishing substantial equivalence to predicate devices, primarily through material composition and intended use, rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or interventional device.
Therefore, many of the requested elements for describing a study and acceptance criteria are not applicable (N/A) based on the provided text, as this is a regulatory submission for a Class I device and not a performance study report.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a dedicated study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the document does not describe a performance study with a test set in the traditional sense. The safety evaluation mentioned a "residue of acrylamide gel" and its potential ingestion, but this is a risk assessment, not a performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. No test set or ground truth establishment by experts for performance measurement is described in the document.
4. Adjudication Method for the Test Set
This information is not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The document does not describe an MRMC comparative effectiveness study, nor does it quantify human reader improvement with or without AI assistance, as AI is not a component of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical nipple shield, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. Type of Ground Truth Used
This information is not applicable. No performance study with a defined ground truth is described. The "safety" section mentions an "evaluation" based on acrylamide monomer, but this is a risk assessment, not a ground truth for a performance metric.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as the device is a physical product and not an AI/algorithm-based system requiring training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 880.5630 Nipple shield.
(a)
Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.