(22 days)
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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.
FILTECH M201 Disposable Surgical Mask is a single use, that-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in blue of outside and white of inside. FILTECH M201 Disposable Surgical Mask is provided non-sterile and for single use.
Here's an analysis of the acceptance criteria and study information for the Disposable Surgical Mask (FILTECH M201), extracted from the provided text:
1. Acceptance Criteria and Reported Device Performance:
| Performance tests | Acceptance Criteria | Reported Device Performance (FILTECH M201) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.6% |
| Differential Pressure (Delta-P), MIL-M-36954C | < 6.0mmH2O/cm² | 5.5mmH2O/cm² |
| Flammability (16CFR 1610) | Class 1 | Class 1 |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862): 32 samples were used.
- Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta-P), and Flammability (16CFR 1610): The specific sample sizes for these tests are not explicitly stated within the provided document. However, since these are non-clinical performance tests on the device itself, the data provenance is from laboratory testing of the manufactured product.
- Data Provenance: The tests were performed on the proposed device (FILTECH M201) manufactured by HANGZHOU FILTECH INTELLIGENT CO., LTD in China. The data would be considered retrospective as it was collected before the submission date for the 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the provided document describes non-clinical performance testing of a physical product (a surgical mask), not a diagnostic or AI-driven medical device that requires expert ground truth for interpretation of results. The "ground truth" for these tests is defined by the objective measurement standards outlined in the ASTM and CFR standards.
4. Adjudication method for the test set:
This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretation (e.g., radiologists reviewing images), not for objective physical performance testing of a device.
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 information is not applicable. The device is a Disposable Surgical Mask, which is a physical protective barrier. It is not an AI-driven device or an imaging product that involves human readers or AI assistance. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a Disposable Surgical Mask, not an algorithm or AI system.
7. The type of ground truth used:
For the performance tests, the "ground truth" is established by adherence to recognized international and national standards:
- Fluid Resistance: ASTM F1862 standard.
- Particulate Filtration Efficiency: ASTM F2299 standard.
- Bacterial Filtration Efficiency: ASTM F2101 standard.
- Differential Pressure: MIL-M-36954C standard.
- Flammability: 16CFR 1610 standard.
- Biocompatibility: The results are derived from laboratory testing against established biological evaluation standards (e.g., cytotoxicity, irritation, sensitization).
8. The sample size for the training set:
This information is not applicable. The Disposable Surgical Mask is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
September 18, 2020
Unisources Group LLC % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 403 Ludlum, Florida 33155
Re: K202463
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 26, 2020 Received: August 27, 2020
Dear Rafael Aguila:
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 (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 CAPT. Elizabeth Claverie, M.S. 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) K202463
Device Name
Disposable Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The disposable surgical mask is 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.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| ☐ Exporting Items with EAR99 Designations Only☒ Items That Incorporate USML-Controlled Items | ☐ Exporting Items with EAR99 Designations Only | ☒ Items That Incorporate USML-Controlled Items | |
| ☐ Exporting Items with EAR99 Designations Only | ☒ Items That Incorporate USML-Controlled Items |
| | 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}------------------------------------------------
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K202463 |
|---|---|
| Date: | September 18th, 2020 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Applicant/US importer: | UNISOURCES GROUP LLC7460 NW 52 street, Miami, Florida, 33166, USA |
| Manufacturer: | HANGZHOU FILTECH INTELLIGENT CO., LTDRoom 302, Building 9, No. 360 Tianmushan West Road, Yuhang StreetYuhang District, Hangzhou, Zhejiang, China 311121 |
| Contact person: | Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Disposable Surgical Mask |
|---|---|
| Model | FILTECH M201 |
| Common Name: | Surgical mask |
| Classification Name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Product Code: | FXX |
| Device Class: | II |
| Review Panel: | General Hospital |
3. Predicate device
Surgical Face Mask, K182515 WUHAN DYMEX HEALTHCARE CO., LTD This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. Device Description
FILTECH M201 Disposable Surgical Mask is a single use, that-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in blue of outside and white of inside. FILTECH M201 Disposable Surgical Mask is provided non-sterile and for single use.
{4}------------------------------------------------
5. Indication for use
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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.
6. Comparison of technological characteristics with the predicate device:
Table 1 General comparison
| Device | Proposed device | Predicate device | Result |
|---|---|---|---|
| 510(k) Holder | UNISOURCES GROUP LLC | WUHANDYMEXHEALTHCARE CO., LTD | -- |
| 510(k) Number | K202463 | K182515 | -- |
| Name | Disposable Surgical Mask | Surgical Face Mask | -- |
| Model | FILTECH M201 | / | -- |
| Classification | Class II Device, FXX (21 CFR 878.4040) | Class II Device, FXX (21 CFR 878.4040) | Same |
| Intended use | The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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 Surgical Face Masks 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 fluids. This is a single use, disposable device(s), provided non-sterile. | Same |
| Mask style | Flat Pleated | Flat Pleated | Same |
| Design | Ear loop | Ear loop | Same |
| Layers | Three | Three | Same |
| Color | Blue outside; white inside | Yellow | SimilarNote 1 |
| Target population | Adults | Adults | Same |
| Dimension (Length) | $175mm\pm5mm$ | $17.5cm\pm0.2cm$ | Similar |
| Dimension (Width) | $95mm\pm5mm$ | $9.5cm\pm0.2cm$ | Note 2 |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of use | OTC | OTC | Same |
| Outer facing layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Ear loops | Spandex | Spandex | Same |
| Nose piece | Malleable polyethylene wire | Malleable polyethylene wire | Same |
| Colorants | Polypropylene (PP) master batch | Unknown | SimilarNote 1 |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
| Biocompatibility (limited contact (<24h) surface devices on intact skin) | |||
| Cytotoxicity | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Under the conditions of the study, the predicate device extract was determined to be non-cytotoxic. | Same |
| Irritation | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non-irritating. | Under the conditions of the study, the predicate device non-polar and polar extracts were determined to be non-irritating. | Same |
| Sensitization | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non-sensitizing. | Under the conditions of the study, the predicate device non-polar and polar extracts were determined to be non-sensitizing. | Same |
{5}------------------------------------------------
Differences between New device and Predicate Device:
Note 1:
The difference in color does not raise additional questions for safety and effectiveness. Biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
Note 2:
The tolerance of dimension are a little different between proposed device and predicate device. By investigating similar legally market products, the tolerance of 5mm is acceptable for surgical face mask. And performance testing results demonstrate that our proposed device meet the expected requirements. Therefore this difference doesn't raise any new safety and effectiveness issues.
7. Non-clinical test performed on the proposed device:
The proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
| Performance tests | Proposed device | Predicate device | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|---|
| FluidResistancePerformanceASTM F1862 | 32 out of 32 pass at120mmHg | 32 out of 32 pass at120mmHg | 29 out of 32 pass at120mmHg | Same | ||
| Particulate FiltrationEfficiencyASTM F2299 | 98% | 99.7% | ≥ 98% | Similar | ||
| Bacterial FiltrationEfficiencyASTM F2101 | 99.6% | 99.9% | ≥ 98% | |||
| Differential(Delta-P) | Pressure | 5.5mmH2O/cm² | 4.0mmH2O/cm² | < 6.0mmH2O/cm² |
Table 2 Performance Testing
{6}------------------------------------------------
| MIL-M-36954C | ||||
|---|---|---|---|---|
| Flammability class16CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
8. Clinical test conclusion
No clinical study is included in this submission.
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated K182515.
§ 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.