(92 days)
Not Found
Not Found
No
The device description focuses solely on the physical materials and construction of a surgical mask, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical mask intended to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Its primary function is protective, not therapeutic (treating or curing a disease or condition).
No
The device is described as a disposable surgical mask intended to protect both surgical patients and operating room personnel from microorganism transfer, body fluids, and particulate material. Its function is protective and preventative, not diagnostic.
No
The device description clearly details a physical, multi-layered surgical mask made of non-woven polypropylene and meltblown filtration media, including a metal nose strip and elastic ear loops. There is no mention of software components.
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 operating room personnel and patients 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 a surgical mask designed for filtration and barrier protection. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results.
The device is clearly described as a surgical mask, which is a personal protective equipment (PPE) device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
79FXX
Device Description
These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two 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 lavers, is made of "meltblown" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate 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.
Drawings of the Defend Surgical Mask appear in Attachment I. These are intended to be exemplary rather than exhaustive. The mask is formed of three layers and is a flat-fold disposable face mask comprised of pleated segments which open to form a comfortable mask covering the nose and mouth areas of the face. The sides are secured by binding tapes to which is attached the elastic band to secure the mask to the face. The top and bottom of the mask are fused to prevent fabric delamination.
The outer mask surface is of Spunbond non-woven polypropylene (20 g/m'). The middle layer, between the non-woven outer and inner layers, is made of meltblown air filtration media. The characteristics of this media are listed in Attachment VI, This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of Thermobond non-woven polypropylene (15 g/m²). The characteristics of the two outer layers are also listed in Arachment VI. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing.
The mask has a light aluminum strip which bends readily to fit closely over the nose, diminishing fogging of spectacles. It also has a light foam strip fused to this edge to provide more effective coverage and user comfort. Two woven elastic ear loops complete the mask.
The products will be sold non-sterile, prepackaged, and are disposable, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth areas of the face.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel / Operating room
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)
Test data supplied to show the equivalence of this device to Technol and others cited below included:
- a. Penetration by Water Impact Test;
- b. Sensitization test:
- c. Primary Dermal Irritation test;
- d. Particulate Shedding analysis,
- e. Flammability: and
- f. Cytotoxicity.
- g. Filtration Efficiency, Breathability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K971130 JUN 27 1997
XII. 510(k) SUMMARY FOR K-971130, DBFEND4 SURGICAL MASK
A. Submitter: Andrew Parker, Carl Parker Assoc. Inc., 275 Oser Ave., Hauppauge, NY 11788
I. Classification Names and numbers: Surgical Mask, 79FXX
- II. Common/Usual Name: Surgical Mask
- III. Proprietary Names: DEFEND™ Surgical Mask
- IV. Establishment Registration Number: 2433028
- V. Classification: Surgical masks were classified by the General and Plastic Surgery Panel in Class II under code 79FXX and are listed in CFR 878,4040 as "Surgical 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 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 lavers, is made of "meltblown" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate 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.
IX. Substantial Equivalence Statement. The "510(k) "Substantial Equivalence" Decision process
(Detailed) from ODE Guidance Memorandum #86-3 was followed as described below: 1. These products have the same intended use, to act as physical barner 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 uses as similar products currently cleared for marketing by the 510(k) process.
-
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
-
Descriptive information provided shows that the materials from which the Fluid Resistant Pleated Mask is made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market.
-
Test data supplied to show the equivalence of this device to Technol and others cited below included:
- a. Penetration by Water Impact Test;
- b. Sensitization test:
c. Primary Dermal Irritation test;
d. Particulate Shedding analysis,
- e. Flammability: and
f. Cytotoxicity.
g. Filtration Efficiency, Breathability
Repl. p. 8
1
VI. Performance Standard:
None established under section 514.
VII. Description of the Device:
Drawings of the Defend Surgical Mask appear in Attachment I. These are intended to be exemplary rather than exhaustive. The mask is formed of three layers and is a flat-fold disposable face mask comprised of pleated segments which open to form a comfortable mask covering the nose and mouth areas of the face. The sides are secured by binding tapes to which is attached the elastic band to secure the mask to the face. The top and bottom of the mask are fused to prevent fabric delamination.
The outer mask surface is of Spunbond non-woven polypropylene (20 g/m'). The middle layer, between the non-woven outer and inner layers, is made of meltblown air filtration media. The characteristics of this media are listed in Attachment VI, This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of Thermobond non-woven polypropylene (15 g/m²). The characteristics of the two outer layers are also listed in Arachment VI. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing.
The mask has a light aluminum strip which bends readily to fit closely over the nose, diminishing fogging of spectacles. It also has a light foam strip fused to this edge to provide more effective coverage and user comfort. Two woven elastic ear loops complete the mask.
The products will be sold non-sterile, prepackaged, and are disposable, for single use only.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carl Parker Associates, Incorporated ·C/O Mr. Neal Dunning Neal Dunning Associates, Incorporated 8309 Byrant Drive Bethesda, Maryland 20817
K971130 Re : Defend Surqical Mask Trade Name: Requlatory Class: II Product Code: FXX May 20, 1997 Dated: Received: June 10, 1997
JUN 2 7 1997
Dear Mr. Dunning:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Dunning
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. Alturist
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
... .. .. .. ..
.. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VIII.1 Indications for Use: [Separate Page]
510(k) Number: Not Applicable
Device Name: DEFEND™ Surgical Mask
-
- Intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971130 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use X (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------------------- |
ﺴﻨﺔ