(203 days)
K-830890, K-9321375, K-934974
K-830890, K-9321375, K-934974
No
The description focuses on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is described as a disposable surgical mask intended as a physical barrier for protection, not for treating a disease or condition.
No
The device is described as a "disposable surgical mask" intended as a physical barrier and for filtration, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical, multi-layered surgical mask made of non-woven polypropylene and air filtration media. It undergoes physical performance testing like blood penetration resistance and bacterial filtration efficiency.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a physical barrier for protection, filtration of particles and droplets, and comfort during use. These are characteristics of personal protective equipment (PPE), specifically a surgical mask.
- Device Description: The description details the physical construction of a surgical mask (layers of non-woven material and filtration media).
- Performance Studies: The performance studies mentioned (Synthetic Blood Penetration Resistance, Bacterial Filtration Efficiency, Delta P, Dermal Irritation, Particulate Shedding, Flammability, Cytotoxicity) are all standard tests for evaluating the performance and safety of surgical masks.
- Predicate Devices: The predicate devices listed are all surgical masks.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
These products have the same intended use, to act as physical barrier including fluidresistant properties, provide only very low impediment to breathing, avoid fogging of surgeons glasses, effective filtration of particles, droplets, not hinder speech. These are the same as those of the predicate devices These products also have the same intended yses as similar products currently cleared for marketing by the 510(k) process
Product codes
79FXX
Device Description
These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two arcuale segments which form a comfortable mask covering the nose and mouth areas of the face The outer mask surface is of non-woven polypropylene The middle layer, between the non-woven outer and inner layers, is made of "Web Dynamics" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to faciliate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Test data supplied to show the equivalence of this device to Technol and others cited below included
a Synthetic Blood Penetration Resistance Test, Protocol 9617002-01 selected as more definitive than Peneration by Water Impact Test,
b. Bacterial Filtration Efficiency and Delta P tests,
c. Primary Dermal Irritation test,
d Particulate Shedding analysis, flammability, and
e Cytotoxicity
Key Metrics
Not Found
Predicate Device(s)
K-830890, K-9321375, K-934974
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
JAN 2 7 1997
XII. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. Jan. 16, 1997. [Separate Pages] 962659
A. Submitter Andrew Parker Assoc. Inc., 275 Oser Ave., Hauppauge, NY 11788
I. Classification Names and numbers. Surgical Mask, 79FXX
II Common/Lisual Name Surgica Mask
111 Proprietary Names Conpleat Surgical Mask
IV Establishment Registration Number 2433028
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V. Classification. Surgical masks were classified by the General and Plastic Surgery Panel in Class II under code 79F.XX and are listed in CFR 878 4040 as "Suryical Apparel" Most examples are Class I except for surgical gowns and masks which are Class II
VI Performance Standard None established under section 514, -
VII. Description of the Device. These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two arcuale segments which form a comfortable mask covering the nose and mouth areas of the face The outer mask surface is of non-woven polypropylene The middle layer, between the non-woven outer and inner layers, is made of "Web Dynamics" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to faciliate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing
VIII. Labels of the product and competitive devices are provided
1X. Substantial Equivalence Statent The "SIO(k) "Substantial Equivalence" Decision process (Detailed) from ODE Guillance Memorandom #86-3 was followed as described below
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These products have the same intended use, to act as physical barrier including fluidresistant properties, provide only very low impediment to breathing, avoid fogging of surgeons glasses, effective filtration of particles, droplets, not hinder speech. These are the same as those of the predicate devices These products also have the same intended yses as similar products currently cleared for marketing by the 510(k) process
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The technological characteristics for this product are the same as those for the predicate devices and those currently on the market
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Descriptive information provided shows that the materials from which the Conpleat Surgical Mask is made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market.
4 Test data supplied to show the equivalence of this device to Technol and others cited below included
a Synthetic Blood Penetration Resistance Test, Protocol 9617002-01 selected as more definitive than Peneration by Water Impact Test,
b. Bacterial Filtration Efficiency and Delta P tests,
c. Primary Dermal Irritation test,
d Particulate Shedding analysis, flammability, and
e Cytotoxicity
Repl. p 8
1
4 The FDA "Decision-Naking Process" chart was used.
The Conpleat Surgical Miss is substantially equivalent to the originally classified device. described under CFR 878 4040, to preamendment devices and to devices currently on the marker, cleared by the the 510(k) process The Conpleat Surgical Mask is substantially equivalent to (for example) the following devices Softwear. Fluid Resistant Masks, Busse Hosp Disposables, K-830890, Fluid Shield Procedure Mask, Technol Inc., K-9321375. Fluid Resistant Mask, Mi 4 America Medical, Inc., K-934974.
.
End of Summary
Repl. p. 8a