(77 days)
The Biogel Eclipse Indicator Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel Eclipse Indicator Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
This document describes a 510(k) premarket notification for the Biogel Eclipse, Latex, Sterile, Powder Free, Indicator Underglove. As such, the focus is on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study data for new product claim validation.
Here's a breakdown of the requested information based on the provided text, along with an explanation of why some points are not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from ASTM D3577) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Pass |
| Physical Properties | Meets ASTM D3577 | Pass |
| Freedom from Holes | Meets ASTM D3577 | Pass |
| Biocompatibility (Primary Skin Irritation) | Standard | Pass |
| Biocompatibility (Guinea Pig Sensitization) | Standard | Pass |
| Total Water Extractable Protein | 50 micrograms or less per gram | Less than 50 micrograms per gram |
Explanation: The document explicitly states "The Biogel Eclipse Indicator Underglove meets the technological characteristics of ASTM D3577." The "Pass" indicates compliance with these criteria. The protein content is a specific characteristic mentioned with its own pass/fail threshold.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The document refers to meeting ASTM D3577, which would define the sample sizes for the various tests.
- Data Provenance: Not explicitly stated, but typically, these tests are conducted by the manufacturer or accredited testing laboratories. The data would be specific to lots of the manufactured device. These are likely prospective tests performed on newly manufactured devices to ensure they meet the standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable in this context. The "ground truth" for evaluating surgical glove performance is defined by established international standards like ASTM D3577 and biocompatibility testing protocols, not by expert consensus on individual cases. These standards specify objective physical and chemical tests.
4. Adjudication Method for the Test Set:
- Not Applicable in this context. Since the "ground truth" is based on objective physical and chemical test results against a standard, there is no need for expert adjudication. The test results are either within the specified limits or not.
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:
- Not Applicable. This device is a surgical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and the concept of "human readers" or "AI assistance" do not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical medical device (surgical glove), not an algorithm or software. "Standalone performance" in the context of AI algorithms does not apply here.
7. The Type of Ground Truth Used:
- Objective Test Standards and Specifications: The ground truth for this device is based on
- ASTM D3577: A standard specification for rubber surgical gloves, which defines acceptable levels for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
- Biocompatibility Standards: Specific standards for primary skin irritation and guinea pig sensitization, which define acceptable reactions (or lack thereof) to ensure the device is not harmful to tissue.
- Chemical Analysis: Measurement of total water extractable protein content against a specified limit (50 micrograms or less per gram).
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria is a series of laboratory tests and analyses demonstrating compliance with recognized standards. Specifically:
- The manufacturer performed tests on the Biogel Eclipse Indicator Underglove to ensure it Meets ASTM D3577 for characteristics such as dimensions, physical properties, and freedom from holes.
- Biocompatibility tests (Primary Skin Irritation and Guinea Pig Sensitization) were conducted and the device received a "Pass," indicating it meets established safety standards.
- The total water extractable protein content was measured and found to be "50 micrograms or less per gram," meeting the specified threshold.
The overall conclusion is that "The Biogel Eclipse Indicator Underglove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary." This indicates that the device has undergone the necessary testing to demonstrate its performance and safety against established industry standards for surgical gloves.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).