(96 days)
Not Found
No
The summary describes a physical surgical mask and its performance characteristics based on standard testing methods. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a surgical mask intended for protection from transfer of microorganisms, blood, and particulate materials, not for therapeutic purposes.
No
This device is a surgical mask intended to prevent the transfer of microorganisms, blood, and particulate materials; it does not diagnose any condition.
No
The device description clearly details a physical surgical mask made of non-woven fabric and other materials, with performance studies focused on physical properties like filtration efficiency and resistance to penetration. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting both patients and healthcare workers from the transfer of microorganisms, blood, and particulate materials. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical construction and materials of the mask, designed to filter and block substances. It does not describe any components or processes related to analyzing samples from the human body to diagnose a condition.
- Performance Studies: The performance studies evaluate the mask's physical properties and filtration capabilities (bacterial filtration, particulate filtration, resistance to blood penetration, etc.). These are tests of the device's barrier function, not its ability to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.
The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.
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
operating room personnel and other general healthcare workers
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 Testing:
Bacterial filtration efficiency (%): Test Method - ASTM F2101-19, Acceptance Criteria - >=95%, Sample Size - 32 each from 3 lots, Results - Pass, 99.1%
Differential pressure (H2O / cm²): Test Method - EN 14683:2019 (Annex C), Acceptance Criteria - =95%, Sample Size - 32 each from 3 lots, Results - Pass, 99.4%
Resistance to penetration by synthetic blood (mm Hg): Test Method - ASTM F1862-17, Acceptance Criteria - >=80 mm Hg (Accept on 3, reject on 4 per lot, AQL=4%), Sample Size - 32 each from 3 lots, Results - Pass, 32 out of 32 passed, 30 out of 32 passed, 32 out of 32 passed
Flammability Class: Test Method - 16 CFR Part 1610, Acceptance Criteria - Class 1 Rating, Sample Size - 32 each from 3 lots, Results - Pass, Class 1 Rating
Structural Integrity Failure: Test Method - NP-TM-2019-0188-1, Acceptance Criteria - Ear loops must not detach when exposed to a 5N load when tested individually (Accept on 0, reject on 1), Sample Size - 23 each from 3 lots, Results - Pass, Greater than 5N
Biocompatibility requirements per ISO 10993-1:2018 were met. The test article displayed non-cytotoxicity per ISO 10993-5:2009, non-sensitization per ISO 10993-10:2013, and non-irritation per ISO 10993-10:2013.
No clinical studies were performed for this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency (%): 99.1%
Differential pressure (H2O / cm²): 4.5 mm H2O / cm²
Sub-Micron particulate filtration efficiency (%): 99.4%
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.
Cardinal Health Insta-Guard® Procedure Mask/K142990
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2021
NP Medical Inc % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K203265
Trade/Device Name: nPro Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 26, 2021 Received: January 27, 2021
Dear Prithul Bom:
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.
1
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 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 (OS) 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 Elizabeth F. Claverie-Williams Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name nPro Surgical Mask
Indications for Use (Describe)
The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices 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)
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Image /page/3/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a stylized blue shape on the left, followed by the text "NPMedical" in a dark blue sans-serif font. The stylized shape appears to be a combination of geometric shapes, with a darker blue section inside a lighter blue outline.
K203265 510(k) Summary nPro Surgical Mask
| Manufacturer: | NP Medical Inc.
101 Union Street
Clinton, MA 01510 |
|----------------------------|----------------------------------------------------------|
| Contact: | Ruthann S. Rapp
101 Union Street
Clinton, MA 01510 |
| Telephone Number: | (978) 365-8105 |
| Fax Number: | (978) 365-4025 |
| Summary Date: | 5 February 2021 |
| Trade Name: | nPro Surgical Mask |
| Model Number: | 6409996 |
| Classification Panel: | General & Plastic Surgery |
| Classification/Regulation: | Class II per 21CFR878.4040 |
| Regulation Name: | Surgical Apparel |
| Common Name: | Surgical Mask |
| Product Code: | FXX |
| Submission Type: | Traditional 510(k) |
| Predicate Name/510(k): | Cardinal Health Insta-Guard® Procedure Mask/K142990 |
Device Description:
The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.
The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.
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Image /page/4/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue icon on the left and the text "NPMedical" on the right. The icon is a stylized shape with a darker blue section on the left and a lighter blue section on the right. The text "NPMedical" is in a dark blue sans-serif font.
Intended Use and Indication for Use:
The nPro Surgical Masks are intended for operating room personnel and other general healthcare workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and body fluids, and particulate materials. The nPro Surgical Masks are single use, disposable devices provided non-sterile.
Comparison of Technological Characteristics:
The nPro Surgical Mask, model number 6409996 is very similar to the Cardinal Health Insta-Guard® Procedure Mask, model number AT71021, cleared through 510(k) number K142990 with regards to claims, safety, effectiveness, design, performance and intended use. The nPro Surgical Mask is compared to the predicate device in the Table 1 below.
| Element of Comparison | nPro Surgical Mask | Predicate Device
Insta-Guard® Procedure
Mask (K142990) | Remark |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Classification/Regulation | II per 21CFR878.4040 | II per 21CFR878.4040 | Same |
| Regulation Name/Panel | Surgical Apparel/
General & Plastic
Surgery | Surgical Apparel/General &
Plastic Surgery | Same |
| FDA Product Code | FXX | FXX | Same |
| Model Number | 6409996 | AT71021 | N/A |
| OTC Use | Yes | Yes | Same |
| Intended Use/Indications
for Use | The nPro surgical masks
are intended for
operating room
personnel and other
general health care
workers to protect both
patients and healthcare
workers from the transfer
of microorganisms, blood
and body fluids and
particulate materials.
nPro Surgical Masks are
single use, disposable
devices provided non-
sterile. | Cardinal Health Insta-Guard®
Procedure Masks are intended
to be worn by operating room
personnel and other general
health care workers to protect
both patients and healthcare
workers against the transfer of
microorganisms, blood and
body fluids, and airborne
particulates. Cardinal Health
Insta-Guard® Procedure
Masks are single use,
disposable devices provided
non-sterile. | Same |
| Material Composition | | | |
| Outer Facing Layer | Blue non-woven fabric
cellulose and polyester | Blue non-woven tissue,
cellulose and polyolefin
materials | Similar |
| Middle Layer | Melt blown polypropylene | Non-woven tissue, cellulose,
and polyolefin materials | Similar |
| Inner Facing Layer | White non-woven fabric
cellulose and polyester | Non-woven tissue, cellulose
and polyolefin materials | Similar |
| Nose Wire | Polyethylene, Paper,
Steel | Nose wire | Similar |
Table 1: Predicate Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue icon on the left and the text "NPMedical" on the right. The icon is a stylized shape that resembles a rounded square with a cutout in the middle. The text "NPMedical" is written in a sans-serif font, with the "NP" in a darker blue than the "Medical".
| Element of Comparison | nPro Surgical Mask | Predicate Device
Insta-Guard® Procedure
Mask (K142990) | Remark |
|-----------------------|-----------------------------------------------------------|--------------------------------------------------------------|---------|
| Ear Loop | Polyester and Spandex, not made with natural rubber latex | Polyester and Spandex, not made with natural rubber latex | Same |
| Specifications | | | |
| Dimensions | 6.9 in x 3.7 in (before opening) | 7 in x 3.375 in (before opening) | Similar |
| Layers | 3 Layers | 3 Layers | Same |
| Style | Pleated | Pleated | Same |
| Features | Elastic earloops
Malleable nose wire | Elastic earloops
Malleable nose wire | Same |
| Performance | Meets ASTM F2100-19 level 1 requirements | Meets ASTM F2100-11 level 1 requirements | Similar |
| Manufacturing | Sonically sealed edges and earloops | Sonically sealed edges and earloops | Same |
| Packaging | 50 Masks per carton | 50 Masks per carton | Same |
| Sterilization Method | Provided non-sterile | Provided non-sterile | Same |
| Use Profile | Single Use | Single Use | Same |
The nPro Surgical Mask is as safe, as effective, and performs as well as the predicate device, the Cardinal Health Insta-Guard® Procedure Mask, model number AT71021 in terms of design, materials, intended use, technological characteristics, performance, and materials. The minor differences in material composition, the issue date of the performance standards and size do not pose any concerns related to safety, effectiveness or performance when compared to the predicate device. The nPro Surgical Mask conforms to very similar performance requirements as the predicate device since both products meet ASTM level 1 requirements.
Non-Clinical Testing
Non-clinical tests were conducted to verify that the nPro Surgical Mask met all design specifications and was very similar to the predicate device. A summary of the non-clinical performance requirements, test methods, acceptance criteria, sample size and test results of the nPro Surgical Mask is provided in the table below:
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Image /page/6/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue abstract shape on the left, followed by the text "NPMedical" in a thin, sans-serif font. The "NP" is in a darker blue, while "Medical" is in a lighter blue.
| Performance
Requirements
(units) | Test Method | Acceptance
Criteria | Sample Size | Results |
|---------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------|
| Bacterial filtration
efficiency (%) | ASTM F2101-19 | ≥95% | 32 each from 3
lots | Pass,
99.1% |
| Differential pressure
(H2O / cm²) | EN 14683:2019
(Annex C) |