(88 days)
The Surgical Face Mask is 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 fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed device Surgical Face Mask (Model: MGSM-01) is blue color, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear strap is made of Elastics Film. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document describes the premarket notification (510(k)) for a Surgical Face Mask. The device in question is a physical product (a face mask), not an AI/ML powered medical device or software. Therefore, the questions related to AI/ML specific criteria such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth establishment for training and test sets," and "number of experts" are not applicable.
Here's the information extracted from the provided text regarding the acceptance criteria and the study proving the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | ≥ 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.04%, Lot2: 98.87%, Lot3: 98.88% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | Lot1: 98.9%, Lot2: 98.94%, Lot3: 99.04% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | < 6.0 mmH2O/cm² | Lot1: 3.29 mmH2O/cm², Lot2: 3.59 mmH2O/cm², Lot3: 3.48 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Assess the resistance of a mask to ignition | Class 1 | Class 1 | PASS |
Biocompatibility Testing:
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance
For performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability):
- Sample size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used for each respective test.
- Data Provenance: The document does not specify the country of origin of the labs performing the tests. The studies are non-clinical (laboratory tests), not human retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical product (surgical face mask) and the testing involves laboratory performance characteristics, not clinical assessment by experts for "ground truth" related to disease diagnosis or interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This refers to adjudication of clinical ground truth, which is not relevant for this device's testing.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device. The testing conducted was for the physical properties and performance of the mask itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by standardized laboratory testing methods (e.g., ASTM, EN, CFR standards). The acceptance criteria are derived from these established standards for surgical mask performance.
8. The sample size for the training set
Not applicable. This refers to AI/ML model training data, which is not relevant for this device.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML model training data, which is not relevant for this device.
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February 11, 2022
Megasoft (China) Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K213617
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 15, 2021 Received: November 15, 2021
Dear Ivy Wang:
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 (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 mediation-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, Ph.D. 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) K213617
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Mask is 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 fluids. This a single use, disposable device(s), 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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510(k) Summary
K213617
Document Prepared Date:2022/2/3
A. Applicant:
Name: MEGASOFT(CHINA)CO.,LTD. Address: No. 1 xinqiang road, machinery printing base, Gaoxin District, HongShan Town, Shishi city, Fujian province, China Contact Person: Sarah Qiu Tel: +86-188-5999-8002 Mail: SARAH.QIU@CNMEGASOFT.COM
Submission Correspondent: Primary contact: Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th floor 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th floor 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Model: MGSM-01
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate de vice:
| 510K | Device name | ASTM F2100-19level | Manufacturer |
|---|---|---|---|
| K203426 | Surgical Face Mask(non-sterile ) | Level2 | Nantong Taiweishi MedicalTechnology Co., Ltd. |
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MEGASOFT(CHINA)CO., LTD. No.1 xinqiang road, machinery printing base, Gaoxin District, HongShan Town, Shishi city, Fujian province, China
D. Indications for use of the device:
The Surgical Face Mask is 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 fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
Table 1 General Comparison
The Proposed device Surgical Face Mask (Model: MGSM-01) is blue color, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear strap is made of Elastics Film. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
| Device | Proposed Device | Predicate device | Comparison |
|---|---|---|---|
| Manufacturer | MEGASOFT(CHINA)CO.,LTD. | Nantong TaiweishiMedical Technology Co.,Ltd. | - |
| 510K number | K213617 | K203426 | - |
| Device name | Surgical Face Mask | Surgical Face Mask(non-sterile ) | - |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Indications for use | The Surgical Face Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This asingle use, disposable device(s),provided non-sterile. | The Disposable SurgicalFace Masks are intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s) | Similar |
F. Technological Characteristics Comparison
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MEGASOFT(CHINA)CO., LTD.
| Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
|---|---|---|---|---|
| Material | Middlelayer | Melt blown polypropylene filter | Melt blownpolypropylene filter | Same |
| Innerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | Polypropylene ,iron and zinc | Malleable aluminum wire | Different | |
| Ear loops | Elastics Film | Polyester | Different | |
| Color | Blue | Blue | Same | |
| Dimension(Length) | 175mm ± 5mm | 175mm+/-5% | Similar | |
| Dimension(Width) | 95mm ± 5mm | 95mm+/-5% | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2 | Level 2 | Same | |
| Biocompatibility | Meet ISO-10993,provednon-cytotoxicity,non-irritating andnon-sensitizing | Meet ISO-10993,provednon-cytotoxicity,non-irritating andnon-sensitizing | Same |
No.1 xinqiang road, machinery printing base, Goxin District, HongShan Town, Shishi city, Fujian province, China
Difference analysis: The proposed device has different nose clip & ear loops material to the predicate device, but the performance and biocompatibility of the device has been tested, the result has shown the different does not affect the safety of the proposed device.
G. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face
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No.1 xinqiang road, machinery printing base, Gaoxin District, HongShan Town, Shishi city, Fujian province, China
Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
-
ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
| Item | Purpose | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | Assess theperformance of amask to resistanceto a syntheticblood preparationtargeted towardthe mask at a setpressure | 3 non-consecutivelots tested, using asample size of32/lot.32 out of 32 passat 120 mmHg | 29 out of 32 passat 120 mmHg forlevel 2 | PASS |
| ParticulateFiltrationEfficiency ASTMF2299 | Assess theperformance ofa mask topenetration bysub-micronpolystyrenelatex particles of0.1 micron | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 99.04%Lot2: 98.87%Lot3: 98.88% | ≥ 98% | PASS |
| BacterialFiltrationEfficiency ASTMF2101 | Assess theperformance ofa mask topenetration by aprepared solutionwith knownconcentration ofan indicatorbacterial organism | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 98.9%Lot2: 98.94%Lot3: 99.04% | ≥ 98% | PASS |
| DifferentialPressure(DeltaP) EN 14683Annex C | Assess theperformance ofa mask forresistance to | 3 non-consecutivelots tested, using asample sizeof32/lot. | < 6.0mmH2O/cm2 | PASS |
| air movementthrough thematerials of theface of the mask | Lot1: 3.29mmH2O/cm²Lot2: 3.59mmH2O/cm²Lot3: 3.48mmH2O/cm² | |||
| Flammability 16CFR 1610 | Assess theresistance of amask to ignition | 3 non-consecutivelots tested, using asample size of32/lot.Class 1 | Class 1 | PASS |
Table 2 - Performance Testing
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MEGASOFT(CHINA)CO., LTD.
No.1 xinqiang road, machinery printing base, Gaoxin District, HongShan Town, Shishi city, Fujian province, China
Table 3 Biocompatibility Comparison
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk ofCytotoxicity of maskmaterial | Non-Cytotoxic | PASSUnder the conditions of thestudy, the device isnon-cytotoxic. |
| Irritation | Assess the potential risk ofIrritation of mask material | Non-Irritating | PASSUnder the conditions of thestudy, the device isnon-irritating. |
| Sensitization | Assess the potential risk ofSensitization of maskmaterial | Non-Sensitizing | PASSUnder the conditions of thestudy, the device isnon-sensitizing |
H. Summary of Clinical Testing
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Surgical Face Mask (Model: MGSM-01) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203426.
§ 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.