(186 days)
Not Found
No
The device description and performance metrics relate to the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The surgical mask is a protective barrier device designed to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Surgical masks are barrier devices designed to prevent the transfer of microorganisms and fluids, not to diagnose medical conditions.
No
The device description clearly outlines physical components (polypropylene, aluminum, elastic, etc.) and performance metrics related to material properties and filtration, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical mask is for protecting both the surgical patient and operating personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection. There is no mention of components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to synthetic blood, Flammability) are all related to the mask's ability to act as a physical barrier and filter. These are not metrics typically associated with IVD performance (like sensitivity, specificity, accuracy in detecting analytes).
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing information about a patient's health status based on such tests.
In summary, the TIDI® Facemask is a medical device intended for personal protective equipment (PPE) and barrier protection in a surgical setting, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Product codes
FXX
Device Description
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
The following is a list of models of the TIDI® Facemasks with a description.
Model 9010 -This is the standard facemask model with ear loop attachments.
Model 9020-This facemask model is supplied with an anti-fog strip of polyurethane foam. The foam is attached over the nose wire on the inside of the mask.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel during surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Performed for Determination of Substantial Equivalents are as Follows:
The following is a list of test methods for the TIDI® Facemask in accordance with ASTM 2100 specification for surgical masks. It was our conclusion that testing was conducted and met the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask.
| Performance Characteristics | Face Mask Requirements by Performance Class (ASTM F 2100-07) Low Barrier | Moderate Barrier | High Barrier | TIDI® Facemask Test Results Summary |
|---|---|---|---|---|
| Bacterial Filtration Efficiency Performance (%) (ASTM 2101) | ≥95 | ≥98 | ≥98 | >99.9 |
| Differential Pressure (Delta-P) (mm H2O/cm²) (MIL-M 36954C) | 99.9% | |||
| Differential Pressure (Delta-P): 3.4 mm H2O/cm² | ||||
| Sub-micron Particulate Filtration Efficiency at 0.1 micron: 99.6% | ||||
| Resistance to penetration by synthetic blood: Pass @ 80 mm Hg | ||||
| Flammability Class: Class 1 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows a logo for TIDL Products. The logo features a stylized letter "T" with swooping lines above it. Below the "T" is the word "TIDL" in bold, followed by "PRODUCTS" in a smaller font. The tagline "Care with Confidence" is written in a cursive font below the main text.
Certified in 190 9001:2000, EN/ISO 13485:2003, European CE Mark
510(k) Summary TIDI® Facemask
FEB 2 8 2010
To: Whom it may concern
Date: February 12, 2010
Submitter/ Contact - Name and Address
Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah WI 54956 Telephone: (920) 751-4386 (920) 751-4370 Fax:
FDA Registration Number: 2182318
Device Details:
Trade Name: TIDI® Facemasks or Customer trade names Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Regulation Number: 878.4040
Equivalent Legally Marketed Device:
The TIDI® Facemasks are similar to the predicate device in material composition, design, style and dimensions. The similarities in materials, design, style along with performance testing supports that the TIDI® Facemasks are substantially equivalent to the predicate device. The comparison table on the following page out-lines the similarities and any differences between the TIDI® Facemask and the predicate device.
1
Predicate Devices
- A.R. Medicom Non-Sterile Surgical Mask 2) Crosstex Isolite Surgical Mask
.
| Description | TIDI® Facemask | Predicate:
Non-Sterile Surgical Mask
K051291 and K012602 |
|----------------|--------------------------|----------------------------------------------------------------|
| Materials | | |
| Outer layer | Polypropylene Spun-bond | Same |
| Filter Media | Melt-blown polypropylene | Same |
| Inner Layer | Polypropylene Spun-bond | Same |
| Nose Piece | Malleable aluminum | Same |
| Ear Attachment | Elastic | Same |
| Anti-Fog | Foam | N/A |
| Dimensions | | |
| Length | 7.0 inches | Same |
| Width | 3.5 inches | Same |
| Design | | |
| Style | Flat, Pleated | Same |
| | Fluid resistant | Same |
| | Elastic Ear loops | Same |
| Sterile | No | Same |
2
DESCRIPTION OF THE DEVICE:
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
The following is a list of models of the TIDI® Facemasks with a description.
Model 9010 -This is the standard facemask model with ear loop attachments.
Model 9020-This facemask model is supplied with an anti-fog strip of polyurethane foam. The foam is attached over the nose wire on the inside of the mask.
INTENDED USE:
The TIDI® Facemask intended use is: Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Page 3 of 5
3
Device and Predicate Device Technical Characteristics:
| Description | TIDI® | Predicate Device | Predicate Device | |||||
|---|---|---|---|---|---|---|---|---|
| Facemask | K012602 | K051291 | ||||||
| Crosstex® Ultra | Safe+Mask® Premier | |||||||
| Fluid Resistant No- | Elite Ear loop Mask | |||||||
| Fog® Ear Loop Face | ||||||||
| Mask | ||||||||
| Material Composition | ||||||||
| Type of fabric: | ||||||||
| Outer Layer | Polypropylene | Polypropylene | Polypropylene | |||||
| Spun-bond | Spun-bond | Spun-bond | ||||||
| Filter Media | Melt-blown | Melt-blown | Melt-blown | |||||
| polypropylene | polypropylene | polypropylene | ||||||
| Inner Layer | Polypropylene | Polypropylene | Polypropylene | |||||
| Spun-bond | Spun-bond | Spun-bond | ||||||
| Other Materials: | ||||||||
| Nose Piece: | Aluminum | Aluminum | Aluminum | |||||
| Lar | Elastic | Elastic | Elastic | |||||
| Attachment: | ||||||||
| Anti-Fog | Polyester | Polyester Urethane | none | |||||
| Urethane foam | foam | |||||||
| The difference of the anti fog material is the polyester urethane foam. The | ||||||||
| polyester foam material has been used in medical application on facemask for | ||||||||
| an anti-fog strip without any toxicity or biological compatibility issues. It has | ||||||||
| been proven to be non-toxic, non-sensitizing, and non-irritating. | ||||||||
| Specification and Dimensions: | ||||||||
| Dimensions: | ||||||||
| Length: | 7.0 inches | 7.0 inches | 7.0 inches | |||||
| Width: | 3.5 inches | 3.5 inches | 3.5 inches | |||||
| Design | Ear Loop | Ear Loop | Ear Loop | |||||
| Features: | ||||||||
| Mask Style: | Flat Pleated | Flat Pleated | Flat Pleated | |||||
Page 4 of 5
4
Nonclinical Tests Performed for Determination of Substantial Equivalents are as Follows:
The following is a list of test methods for the TIDI® Facemask in accordance with ASTM 2100 specification for surgical masks. It was our conclusion that testing was conducted and met the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask.
| | Face Mask Requirements by
Performance Class (ASTM F 2100-07) | | | |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------|--------------|-------------------------------------------|
| Performance Characteristics | Low
Barrier | Moderate
Barrier | High Barrier | TIDI® Facemask
Test Results
Summary |
| Bacterial Filtration Efficiency
Performance (%) (ASTM
2101) | ≥95 | ≥98 | ≥98 | >99.9 |
| Differential Pressure (Delta-P)
(mm H2O/cm²) (MIL-M
36954C) |