(96 days)
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.
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.
This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
| Performance Requirements (units) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Bacterial filtration efficiency (%) | ≥95% | Pass, 99.1% |
| Differential pressure (H2O / cm²) | <5.0 mm H2O / cm² | Pass, 4.5 mm H2O / cm² |
| Sub-Micron particulate filtration efficiency (%) | ≥95% | Pass, 99.4% |
| Resistance to penetration by synthetic blood (mm Hg) | ≥80 mm Hg (Accept on 3, reject on 4 per lot, AQL=4%) | Pass (32/32, 30/32, 32/32 passed for 3 lots) |
| Flammability Class | Class 1 Rating | Pass, Class 1 Rating |
| Structural Integrity Failure | Ear loops must not detach when exposed to a 5N load when tested individually (Accept on 0, reject on 1) | Pass, Greater than 5N |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- Bacterial filtration efficiency, Differential pressure, Sub-Micron particulate filtration efficiency, Resistance to penetration by synthetic blood, Flammability Class: 32 each from 3 lots
- Structural Integrity Failure: 23 each from 3 lots
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be standard laboratory/engineering testing for product performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this pertains to a surgical mask and its physical performance characteristics, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" here is established by the standardized test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862-17, 16 CFR Part 1610, NP-TM-2019-0188-1) and their associated measurement protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or AI ground truth establishment. For physical product testing, results are typically objective measurements against defined acceptance criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are for evaluating AI-assisted medical imaging devices impacting human reader performance. This document is about a surgical mask's physical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This refers to AI algorithm performance. The "standalone" performance here is the mask's ability to perform against physical and biological challenges.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the surgical mask's performance is established by standardized laboratory test methods defined by organizations like ASTM, EN, and CFR. These methods provide quantifiable metrics for properties like filtration efficiency, differential pressure, and resistance to synthetic blood penetration. For example, a 99.1% bacterial filtration efficiency is a direct measurement result from the ASTM F2101-19 test method, serving as its own "ground truth" against the acceptance criterion.
8. The sample size for the training set
This is not applicable. This device is a physical product (surgical mask), not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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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.
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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
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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 StreetClinton, MA 01510 |
|---|---|
| Contact: | Ruthann S. Rapp101 Union StreetClinton, 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 DeviceInsta-Guard® ProcedureMask (K142990) | Remark |
|---|---|---|---|
| Classification/Regulation | II per 21CFR878.4040 | II per 21CFR878.4040 | Same |
| Regulation Name/Panel | Surgical Apparel/General & PlasticSurgery | 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/Indicationsfor Use | The nPro surgical masksare intended foroperating roompersonnel and othergeneral health careworkers to protect bothpatients and healthcareworkers from the transferof microorganisms, bloodand body fluids andparticulate materials.nPro Surgical Masks aresingle use, disposabledevices provided non-sterile. | Cardinal Health Insta-Guard®Procedure Masks are intendedto be worn by operating roompersonnel and other generalhealth care workers to protectboth patients and healthcareworkers against the transfer ofmicroorganisms, blood andbody fluids, and airborneparticulates. Cardinal HealthInsta-Guard® ProcedureMasks are single use,disposable devices providednon-sterile. | Same |
| Material Composition | |||
| Outer Facing Layer | Blue non-woven fabriccellulose and polyester | Blue non-woven tissue,cellulose and polyolefinmaterials | Similar |
| Middle Layer | Melt blown polypropylene | Non-woven tissue, cellulose,and polyolefin materials | Similar |
| Inner Facing Layer | White non-woven fabriccellulose and polyester | Non-woven tissue, celluloseand 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 DeviceInsta-Guard® ProcedureMask (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 earloopsMalleable nose wire | Elastic earloopsMalleable 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.
| PerformanceRequirements(units) | Test Method | AcceptanceCriteria | Sample Size | Results |
|---|---|---|---|---|
| Bacterial filtrationefficiency (%) | ASTM F2101-19 | ≥95% | 32 each from 3lots | Pass,99.1% |
| Differential pressure(H2O / cm²) | EN 14683:2019(Annex C) | <5.0 mm H2O /cm² | 32 each from 3lots | Pass,4.5 mm H2O / cm² |
| Sub-Micron particulatefiltration efficiency (%) | ASTM F2299-03 | ≥95% | 32 each from 3lots | Pass,99.4% |
| Resistance topenetration bysynthetic blood(mm Hg) | ASTM F1862-17 | ≥80 mm Hg(Accept on 3,reject on 4 perlot, AQL=4%) | 32 each from 3lots | Pass32 out of 32passed30 out of 32passed32 out of 32passed |
| Flammability Class | 16 CFR Part1610 | Class 1 Rating | 32 each from 3lots | Pass,Class 1 Rating |
| Structural IntegrityFailure | NP-TM-2019-0188-1 | Ear loops mustnot detachwhen exposedto a 5N loadwhen testedindividually(Accept on 0,reject on 1) | 23 each from 3lots | Pass,Greater than 5N |
The materials used in the nPro Surgical Mask device design are shown through testing to meet biocompatibility requirements per ISO 10993-1:2018 based on their level and duration of interaction. The use profile of the device establishes it as having surface contact with intact skin for a prolonged duration. Per FDA guidance, biocompatibility test endpoints for this type of device are defined as cytotoxicity, sensitization and irritation or intracutaneous reactivity. The direct patient contacting materials of the nPro Surgical Mask are the earloops and the inner mask layer, while the entire mask is considered indirect patient contacting. Under the conditions of the test article was found to be non-cytotoxic per ISO 10993-5:2009, non-sensitizing per ISO 10993-10:2013 and non-irritating per ISO 10993-10:2013.
Clinical Tests
No clinical studies were performed for this product.
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Image /page/7/Picture/0 description: The image shows the text "nPro Surgical Mask Traditional 510(k)" followed by "NP Medical Inc." The text appears to be a product name and the name of the company that manufactures it. The text is black and is set against a white background. The text is left-aligned.
Image /page/7/Picture/1 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 combination of dark blue and light blue colors. The text "NPMedical" is written in a simple, sans-serif font, with each letter in a dark blue color.
Conclusion:
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 and materials. The minor differences in material composition 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. The conclusions drawn from the nonclinical tests demonstrate that the nPro Surgical Mask is as safe, as effective and performs as well as the predicate device, the Cardinal Health lnsta-Guard® Procedure Mask, model number AT71021, cleared through 510(k) number K142990.
§ 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.