Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile. Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is bule masterbatch. The Single-Use Surgical Mask with Ear Loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with Polyester. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The only difference is the dimension.
The provided text describes the acceptance criteria and study results for the "Single-Use Surgical Mask with Ear Loop" (K201691), demonstrating its substantial equivalence to a predicate device (K153496).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Name of the Test Methodology/Standard | Purpose | Acceptance Criteria | Reported Device Performance (K201691) |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (31 out of 32 pass) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | >99% |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | >99% |
| MIL-M-36954C | Differential Pressure | < 6.0 mm H2O/cm² | < 5.0 mm H2O/cm² |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ISO 10993-5 | Cytotoxicity | No cytotoxicity effect | Under the conditions of the study, no cytotoxicity |
| ISO 10993-10 | Irritation | No irritation effect | Under the conditions of the study, no irritation |
| Sensitization | No sensitization effect | Under conditions of the study, no sensitization |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state the sample sizes for all tests beyond the Fluid Resistance (ASTM F1862) test, which mentions "31 out of 32 pass." The provenance of the data is not specifically detailed, but the tests were conducted to demonstrate compliance with various ASTM and ISO standards. The sponsor, Qiqihar Hengxin Medical Supplies, Ltd., is located in China, suggesting the testing likely occurred there or at a certified lab. The document does not specify if the studies were retrospective or prospective, though performance testing for regulatory submission is typically conducted prospectively.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. The evaluations are based on standardized laboratory performance tests, not expert interpretation of diagnostic images or clinical data requiring ground truth establishment by human experts.
4. Adjudication Method for the Test Set:
This information is not applicable. The evaluations are based on objective measurements from standardized performance tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a surgical mask, and its evaluation relies on physical and biological barrier performance, not human reader interpretation of data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable to a physical medical device like a surgical mask. There is no algorithm or AI involved in its function that would require "standalone" performance testing. The evaluation focuses on the mask's inherent physical and material properties.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation of this device is established by the prescribed methodologies and specifications of the referenced international standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define objective, measurable criteria for fluid resistance, filtration efficiency, differential pressure, flammability, cytotoxicity, irritation, and sensitization.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device (surgical mask) and not an AI/ML-based algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1