(173 days)
Not Found
Not Found
No
The device description and performance studies focus on physical properties and filtration efficiency, with no mention of AI or ML.
No.
The device's intended use is to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material, which is a protective function rather than a therapeutic one (treating or alleviating a disease or condition).
No
Explanation: The "Intended Use" states that the device is to "protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material," which describes a barrier function, not a diagnostic one. The performance studies also focus on physical properties related to protection (e.g., fluid resistance, filtration efficiency, tear resistance) rather than diagnostic accuracy.
No
The summary describes a physical device (face mask) with performance metrics related to material properties and filtration, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material." This describes a barrier device used for personal protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: While the description is "Not Found," the performance studies and key metrics clearly relate to the physical properties and filtration capabilities of a protective barrier (like a face mask), not a diagnostic test.
- No mention of biological specimens: There is no indication that this device interacts with or analyzes biological specimens (blood, urine, tissue, etc.).
- Performance Studies: The performance studies (Synthetic Blood Penetration Resistance, Bacterial Filtration Efficiency, Delta P, Particle, Resistance to tears, Elongation, Breaking Force) are all tests relevant to the protective function of a barrier device, not the analytical performance of a diagnostic test.
- Predicate Devices: The predicate devices listed are "Instaguard Procedure Face Mask" and "Surgine™ Face Mask," which are also protective barrier devices, not IVDs.
In summary, the device's intended use, performance characteristics, and predicate devices all point to it being a protective barrier device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The INTENDED MEDICAL USE is to protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nostril and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals at dentist's and doctor's offices, laboratories, clinics and hospitals
Medical & Dental offices
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
Synthetic Blood Penetration Resistance Test: Fluid Resistant
Bacterial Filtration Efficiency (MIL Spec 36954C): 99.28
Delta P (MIL Spec 36954C): 2.35
Particle (MIL Spec 36954C): 3 microns
Resistance to tears (NFPA 1999): 29.54 (max. tear resistance in lbs)
Elongation (ASTM D5034-90): 12.82% (strain at maximum)
Breaking Force (ASTM D5034-90): 23.25 (max. force in lbs)
Key Metrics
Bacterial Filtration Efficiency (MIL Spec 36954C): 99.28
Delta P (MIL Spec 36954C): 2.35
Particle (MIL Spec 36954C): 3 microns
Resistance to tears (NFPA 1999): 29.54 (max. tear resistance in lbs)
Elongation (ASTM D5034-90): 12.82% (strain at maximum)
Breaking Force (ASTM D5034-90): 23.25 (max. force in lbs)
Predicate Device(s)
Not Found
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.
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12963568
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510 (k) Summary
| Device Name: | Proprietary or Trade: | TIA Disposables -- 3-Ply Face Mask |
|---|---|---|
| Common name: | 3-Ply Mask | |
| Classification name: | Surgical Apparel (per 21 CFR 878.4040) | |
| Labels & Labelings: | This product will be marketed to healthcare professionals at dentist's and | |
| doctor's offices, laboratories, clinics and hospitals through its intended use: | ||
| PROTECTIVE APPAREL. Reference Appendix A and B for product | ||
| labeling and applicant's advertising material catalog (in draft form pending | ||
| the results of this submission). | ||
| Intended Use | The INTENDED MEDICAL USE is to protect the healthcare personnel and | |
| patient from transfer of microorganisms, body fluids and particulate | ||
| material. | ||
| Substantial Equivalence: | The Innovative Approach, Corp. believes that the above devices are | |
| SIMILAR to those in commercial distribution. These face masks are made | ||
| of non-woven polypropylene and are to be worn as Protective Apparel. | ||
| Both in their intended uses and/or in their physical characteristics, these | ||
| items are similar to devices currently marketed by major US companies. | ||
| Following is the list (by no means exhaustive) but aims at giving enough | ||
| evidence to show Substantial Equivalence: |
- Instaguard Procedure Face Mask, Baxter
- Surgine™ Face Mask, Johnson & Johson | |
| Test Results (means
and or results) | Synthetic Blood Penetration Resistance Test: Fluid ResistantBacterial Filtration Efficiency (MIL Spec 36954C): 99.28Delta P (MIL Spec 36954C): 2.35Particle (MIL Spec 36954C): 3 micronsResistance to tears (NFPA 1999): 29.54 (max. tear resistance in lbs)Elongation (ASTM D5034-90): 12.82% (strain at maximum)Breaking Force (ASTM D5034-90): 23.25 (max. force in lbs) | |
P.O. Box 194283. San Juan, P.R. 00717-4289 • Calle Italia No. 422. Hato Key. P.K. 60317 • Teléfond (787) 274-8532
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| Descriptive Comparison | Predicate | New Device |
|---|---|---|
| Material Composition | Polypropylene | Polypropylene |
| Weave | Non-woven | Non-woven |
| Design | Earloop | |
| Tie-On | Earloop | |
| Tie-On | ||
| Anatomical sites protection | Nostril and mouth | Nostril and mouth |
| Sterility | Nonsterile | Nonsterile |
| Intended use | Protective | Protective Apparel |
| Target population | Healthcare professionals | Healthcare professionals |
| Use life | Disposable | Disposable |
| Where used | Medical & Dental offices | Medical & Dental offices |
| Bacterial Filter Efficiency | 98.5 | 98.5 |
| Microns | 3.2 | 3 |
,每年,
Sincerely,
dquilyounloado...in..........................................................................................................................................................
Edesia N. Pérez
Elisa N. Pérez President