(141 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is a surgical face mask, which primarily provides a barrier to protect the user and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. While it contributes to infection control, it does not directly treat or prevent a disease in a therapeutic sense.
No
The device is a surgical face mask, an infection control barrier, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical face mask made of multiple layers of nonwoven polypropylene and melt blown fiber, secured with elastic ear loops. It is a tangible, disposable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction of a face mask, which is a physical barrier.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Impertech Surgical Face Mask are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile. The mask is in accordance to ASTM F2100 Level 3. The proposed device is not made from natural rubber latex.
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
healthcare personnel
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)
Non-Clinical Performance Testing: The Impertech Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004.
Key results:
- Bacterial filtration efficiency %: >=98, Pass
- Differential pressure, mm H2O/cm squared: =98, Pass
- Resistance to penetration by synthetic blood, minimum press in mm Hg for pass result: 160, Pass
- Flammability: Class I, Pass
Biocompatibility Evaluation: The biocompatibility evaluation for the Impertech Surgical Face Mask was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Impertech Surgical Face Mask is classified as a surface contacting device.
Key results:
- Cytotoxicity: Not cytotoxic, Pass
- Sensitization: Non sensitizing, Pass
- Irritation: Negligibly irritating, Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency %: >=98
- Differential pressure, mm H2O/cm squared: =98
- Resistance to penetration by synthetic blood, minimum press in mm Hg for pass result: 160
- Flammability: Class I
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 18, 2021
Impertech Industries Ltd. Vaibhav Rajal Official Correspondent for Impertech Industries Ltd. mdi Consultants Inc 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K212046
Trade/Device Name: Impertech Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 14, 2021 Received: October 18, 2021
Dear Vaibhav Rajal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212046
Device Name Impertech Surgical Face Mask
Indications for Use (Describe)
The Impertech Surgical Face Mask are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Impertech Surgical Face Mask ASTM F2100 Level 3 Surgical Face Mask 510(k) Submission
510(k) SUMMARY
The assigned 510(k) number is: K212046.
1. Submitter's Identification:
Impertech Industries Ltd. 20 Derech Barkan St. Barkan Industrial Zone, Barkan, IL 4482000
Contact Person: Mohamad Khweis Quality Assurance Manager Position: Phone: +972-3-9367682 mohamadk@supergum.co.il Email:
Date Prepared: November 15, 2021
2. Name of the Device:
| Trade Name: | Impertech Surgical Face Mask |
|---|---|
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | FXX |
3. Information for the 510(k) Cleared Device (Predicate Device):
| Trade/Device Name: | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical
Face Mask |
|--------------------|-----------------------------------------------------------------------|
| 510(k) Number: | K202595 |
| Common Name: | Mask, Surgical |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical apparel. |
| Regulatory Class: | Class II |
| Product Code: | FXX |
4. Device Description:
The device description for the Impertech Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks -Premarket Notification [510K)] Submissions issued on March 5, 2004. The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.
The mask is in accordance to ASTM F2100 Level 3.
The proposed device is not made from natural rubber latex
4
5. Indications for Use:
The Impertech Surgical Face Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--|
| Product Name | Impertech Surgical Face Mask | Premier Guard USA 3 Layer
Ear
Loop ASTM Level 3 Surgical
Face Mask | Similar | |
| 510(k) Reference | K212046 | K202595 | Similar | |
| Product Owner | Impertech Industries Ltd. | Premier Guard USA LLC | Similar | |
| Product Code | FXX | FXX | Same | |
| Indications for Use | The Impertech Surgical Face
Mask are intended to be worn to
protect both patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These face 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 Premier Guard USA 3
Layer Ear Loop ASTM Level 3
Surgical Face Masks are
intended to be worn to
protect both patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These face 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. | Same | |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Mask Style | Flat Pleated, Ear Loops, 3
Layers | Flat Pleated, Ear Loops, 3
Layers | Same | |
| Mask Color | White | Blue | Similar | |
| Materials | | | | |
| Nose Piece
(material) | Polypropylene laminated soft
annealed carbon steel wire | Polyethylene laminated soft
annealed carbon steel wire | Same | |
| Ear Loops (material) | Nylon and Spandex | Nylon and Spandex | Same | |
| Outer Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same | |
| Middle Layer | Melt blown fiber | Melt blown fiber | Same | |
| Inner Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same | |
| Dimensions - Width | 175 mm | 175 mm | Same | |
| Dimensions -
Length | 95 mm | 95 mm | Same | |
| ASTM F2100 Level | Level 3 | Level 3 | Same | |
| Biocompatibility | | | | |
| Cytotoxicity | Under the conditions of the
study, the device is noncytotoxic | Under the conditions of the
study, the device is
noncytotoxic | Same | |
| Sensitization | Under the conditions of the
study, the device is
nonsensitizing | Under the conditions of the
study, the device is
nonsensitizing | Same | |
| Irritation | Under the conditions of the
study, the device is nonirritating | Under the conditions of the
study, the device is
nonirritating | Same | |
| Prescription vs.
OTC | OTC | OTC | Same | |
| Sterile vs. Non-
Sterile | Non-Sterile | Non-Sterile | Same | |
| Disposable vs. Non-
Disposable | Disposable | Disposable | Same | |
| Single Use vs.
Reusable | Single Use | Single Use | Same | |
5
Discussion of Similarities and Differences between subject device and predicate device:
The subject Impertech Surqical Face Mask subject device surgical mask and the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask predicate device are same with all the parameters except for the color of the mask. The color of the subject device mask is without Color (white) whereas the predicate device is blue in color. The change in the mask between the subject device and the predicate device does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device.
None of the biocompatibility testing or performance testing results demonstrated any safety hazards or any design characteristics that violated the requirements set forth in the Guidance for Industry regarding Premarket Notification Submissions of Surgical Masks
7. Non-Clinical Performance Testing
The Impertech Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the quidance document the following testing has been performed.
6
- Fluid Resistance per ASTM F1862 ●
- Particulate Filtration Efficiency per ASTM F2299 .
- Bacterial Filtration Efficiency per ASTM F2101 ●
- Differential Pressure (Delta P) per EN 14683 ●
- Flammability per 16 CFR 1610 ●
| Performance Testing | ||
|---|---|---|
| Surgical Mask Characteristics – ASTM F2100 | Level 3 | |
| Barrier | Result | |
| Bacterial filtration efficiency % | ≥98 | Pass |
| Differential pressure, mm H2O/cm² |