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510(k) Data Aggregation
(412 days)
INTAI Surgical Mask (non-sterile)
INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and provided non-sterile.
The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and intended to be single use, disposable device.
This document is a 510(k) premarket notification for a medical device, specifically the INTAI Surgical Mask. It details the device's characteristics and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and performance results directly in Table 2: Comparison of Performance testing on page 5 and the subsequent Summary of Non-Clinical Test table on page 6.
| Item | Reported Device Performance (K210422) | Acceptance Criteria (Level 3) | Result |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | Achieve a 4% AQL at 160mmHg | Achieve a 4% AQL (29 out of 32 pass at 160mmHg) | Pass |
| Sub-Micron Particle Filtration Efficiency (PFE) | ≥98% | ≥98% | Pass |
| Differential Pressure |
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(107 days)
Disposable Surgical Mask (non sterile)
Disposable surgical mask (non sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes a 510(k) premarket notification for a Disposable Surgical Mask (non-sterile), K211451, submitted by Qinhuangdao Taizhi Medical Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182515, Surgical Face Mask by Wuhan Dymex Healthcare Co., Ltd.) through non-clinical testing.
Based on the provided text, the device in question is a Disposable Surgical Mask, not an AI or imaging device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, expert qualification, adjudication method, MRMC study, standalone performance, type of ground truth) typically associated with the development and validation of AI/ML-based medical devices or diagnostic tools are not applicable.
The acceptance criteria and study proving the device meets them are related to the physical and performance characteristics of a surgical mask, as per established standards and guidance for such products.
Here's the information extracted from the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for Disposable Surgical Mask (K211451)
The device demonstrates conformance to recognized standards and requirements for surgical face masks through non-clinical performance and biocompatibility testing. The testing was conducted to establish substantial equivalence to a predicate device (K182515).
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes the performance testing results against established acceptance criteria for surgical masks (specifically, Level 2, ASTM F2100-19):
| Items | Performance Report | Acceptance Criteria (Level 2, ASTM F2100-19) | Result |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | 99.9% | ≥98% | Pass |
| Differential pressure (mmH2O/cm²) | 2.8-3.6 mmH2O/cm² |
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(202 days)
Medical Surgical Mask (Non-sterile)
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 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(s), provided non-sterile.
The proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of the proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of knitted elastic loops (made of nylon and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a galvanized wire with polyethylene covering. The proposed device is provided non-sterile and is intended to be a single use, disposable device.
This document describes the premarket notification (510(k)) for a Medical Surgical Mask (Non-sterile). The acceptance criteria and performance study details are provided in the "Non-clinical Testing" section, specifically in Table 2 "Performance Testing" and Table 3 "Biocompatibility Testing".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical surgical mask and its performance is evaluated against the ASTM F2100-19 standard for materials used in medical face masks. The acceptance criteria are specified for Level 1, Level 2, and Level 3 requirements, and the device reports performance that meets all these levels.
| Test | Purpose | Acceptance Criteria (ASTM F2100-19) | Reported Device Performance (Statistics of three lots) | Verdict |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥29 out of 32 pass at 80 mmHg | 32 out of 32 pass at 80 mmHg | Pass |
| Level 2: ≥29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass | ||
| Level 3: ≥29 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Pass | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify that bacterial filtration efficiency of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥95% | 99.56%~99.99% | Pass |
| Level 2: ≥98% | (Same as above) | Pass | ||
| Level 3: ≥98% | (Same as above) | Pass | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify that particulate filtration efficiency of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: ≥95% | 98.07%~99.24% | Pass |
| Level 2: ≥98% | (Same as above) | Pass | ||
| Level 3: ≥98% | (Same as above) | Pass | ||
| Differential Pressure (Delta-P) (EN 14683) | Verify that differential pressure of the proposed device can simultaneously meet the requirements for Level 1, Level 2 and Level 3 specified in ASTM F2100-19. | Level 1: |
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(196 days)
FACE MASK, SURGICAL MASK, NON-STERILE
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
FACE MASK, SURGICAL
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Face Mask, Surgical Mask, Non-Sterile." This document does not describe an AI/ML device or its performance criteria.
Therefore, I cannot provide the requested information, as the input document does not contain details about:
- Acceptance criteria for an AI/ML device
- A study demonstrating performance against such criteria
- Sample sizes for test or training sets
- Data provenance
- Ground truth establishment or type
- Expert qualifications or adjudication methods
- MRMC studies or standalone algorithm performance.
The document essentially states that the surgical face mask is substantially equivalent to legally marketed predicate devices and can proceed to market.
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(140 days)
SURGICAL MASK (NON-STERILE)
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