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510(k) Data Aggregation
(108 days)
The Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.
The provided document (K210030 510(k) Summary for the Medical Surgical Mask) describes the performance and testing of a medical surgical mask, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for training set, MRMC study, ground truth establishment for training, number of experts for test set ground truth) are not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the medical device described.
Summary of Device Performance and Testing (Medical Surgical Mask)
The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards. No clinical studies were included.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the requirements for ASTM F2100-19, which defines performance levels for medical face masks. The proposed device includes both Level 2 and Level 3 masks.
| Performance Metric | Acceptance Criteria (ASTM F2100-19) - Level 2 | Reported Device Performance - Level 2 Mask | Acceptance Criteria (ASTM F2100-19) - Level 3 | Reported Device Performance - Level 3 Mask |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | Average 99.7% | ≥98% | Average 99.9% |
| Particulate Filtration Efficiency (PFE) | ≥98% @ 0.1 micron | Average 99.71% | ≥98% @ 0.1 micron | Average 99.93% |
| Differential Pressure (Delta P) |
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(155 days)
The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.
This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids. | No penetration at 120 mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) | To determine the bacterial filtration efficiency (BFE) of the test article. | $\ge 98%$ | Average 98.61% |
| Particulate Filtration Efficiency (PFE) | To determine the Particle Filtration Efficiency. | $\ge 98%$ | Average 98.58% |
| Differential Pressure (Breathability) | To determine the differential pressure, indicating how easily one can breathe through the mask. | $ |
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(133 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is 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.
The Surgical Mask is 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 mask is manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. Theelastic ear loops are made with Polyester fiber and Polyurethane. 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 Polyethylene and Metal Wire. The mask is sold non-sterile and are intended to be single-use, dis posable devices and the colorant used for mask is TiO2 + Phthalocyanine Blue BGS + Pigment Violet23.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Surgical Mask (K202640), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ASTM F2100 Level 2 Requirements) | Reported Device Performance (Proposed Device K202640) |
|---|---|---|
| Fluid Resistance (ASTM) | 120 mmHg | 120 mmHg |
| Particulate Filtration Efficiency (ASTM) | ≥ 98% | ≥99.73% |
| Bacterial Filtration Efficiency (ASTM) | ≥ 98% | ≥99.07% |
| Differential Pressure (Delta P) | ` |
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(120 days)
The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is 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.
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is 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.
The proposed device(s) are White 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 polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Non Sterile 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 30% polyamide and 70% polyurethane.
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 polypropylene and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask-Non Sterile. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets criteria in an AI/algorithm context. Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific AI-related ground truths, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the device's performance based on the non-clinical tests conducted for this medical device.
Acceptance Criteria and Reported Device Performance
| Title of the Test | Acceptance criteria and source of references | Reported Device Performance (Results) |
|---|---|---|
| In Vitro Cytotoxicity | No cytotoxicity effect as the test method of ISO 10993-10 | Under the conditions of the study, not cytotoxicity effect |
| Skin Irritation | No irritation effect as the test method of ISO 10993-5 | Under the conditions of the study, not an irritant |
| Skin Sensitization | No sensitization effect as the test method of ISO 10993-5 | Under conditions of the study, not a sensitizer. |
| Fluid Resistance | 120 mmHg as the test method of ASTM F1862 | 120 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥98% as the test method of ASTM F2299 | ≥99% |
| Bacterial Filtration Efficiency (BFE) | ≥98% as the test method of ASTM F2101 | ≥99% |
| Differential Pressure (Delta P) |
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