The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Device Description

ASEPT® Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. The ASEPT® Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

AI/ML Overview

The document describes the acceptance criteria and performance of the ASEPT® Surgical Face Mask.

1. A table of acceptance criteria and the reported device performance

Item	Standard	Acceptance Criteria	Reported Device Performance
Fluid Resistance Performance	ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood	At least 29 out of 32 specimens show passing results at 120 mmHg	All samples met the predetermined acceptance criteria.
Bacterial Filtration Efficiency	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	≥ 98%	All samples met the predetermined acceptance criteria.
Differential Pressure (Delta P)	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	< 6.0 mm H2O/cm²	All samples met the predetermined acceptance criteria.
Particulate Filtration Efficiency	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	≥ 98%	All samples met the predetermined acceptance criteria.
Flammability	21 CFR 1610	Class I, Does not Ignite	All samples met the predetermined acceptance criteria.
Cytotoxicity	ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Non-cytotoxic	All samples met the predetermined acceptance criteria.
Irritation	ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Non-irritating	All samples met the predetermined acceptance criteria.
Sensitization	ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Non-sensitizing	All samples met the predetermined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Fluid Resistance Performance: At least 32 specimens were used for testing (acceptance criteria states "29 out of 32 specimens").
For Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, Cytotoxicity, Irritation, and Sensitization, the document states "All samples met the predetermined acceptance criteria," implying that a sample set was tested for each, but the exact number of samples for these tests is not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 device (surgical face mask) is evaluated based on non-clinical performance standards and biocompatibility tests, not clinical evaluations requiring expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a diagnostic context does not apply here. The results are from standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the evaluation is based on objective laboratory testing against pre-defined standards, not on subjective expert consensus or adjudication.

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 a medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing, not a diagnostic AI device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by the specified standards and acceptance criteria for each performance characteristic (e.g., ASTM F1862 for fluid resistance, ASTM F2100-19 for filtration efficiency, ISO 10993 for biocompatibility). The device's performance is measured directly against these objective benchmarks in a laboratory setting.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not a machine learning model.

Summary

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August 19, 2020

PFM Medical, Inc Jessica Jho Director of Regulatory Affairs 1916 Palomar Oaks Way, Suite 150 Carlsbad, California 92008

Re: K201137

Trade/Device Name: Asept Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 19, 2020 Received: July 23, 2020

Dear Jessica Jho:

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 Actinclude 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-devices/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 (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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Asept Surgical Face Mask

K201137

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K201137

As required by 21CFR 807.92 Date of Preparation: July 19, 2020

Applicant Information

510(k) Applicant: PFM Medical, Inc. Applicant Address: 1916 Palomar Oaks Way, Suite 150, Carlsbad, CA 92008 Contact Person: Jessica Jho, RAC Email: JJho@pfmmedicalusa.com

Device Information

Trade Name: ASEPT® Surgical Face Mask Common Name: Mask, Surgical Classification Name: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR §878.4040

Predicate Device Information

Trade Name: Surgical Masks Premarket Notification: K111559 Product Code: FXX, Regulation Number: 21 CFR §878.4040 Manufacturer: Shanghai Neo-Medical Import & Export Co.

Device Description

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Indications for Use

Comparison of Technological Characteristics Between the Predicate and Subject Devices

The following is a summary of the technological characteristics of the ASEPT® Surgical Face Mask as compared to the predicate device. The subject and predicate devices are the identical devices manufactured by the identical supplier.

Items	Subject Device	Predicate Device	Comparison
Manufacturer	PFM Medical, Inc.	Shanghai Neo-Medical Import & Export Co.	N/A
510(k) Number	K201137	K111559	N/A
FDA Product Code	FXX	FXX	Identical
Indications for Use	The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.	The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.	Identical with grammatical correction.
Materials	Inner and Outer Layers	Spun-bond polypropylene	Spun-bond polypropylene	Identical
	Middle Layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Identical
	Ear loops	Polyester	Polyester	Identical
	Nose Piece	Malleable polyethylene with aluminum wire	Malleable polyethylene with aluminum wire	Identical
Dimensions	17.5cm length x 9.5cm height	17.5cm length x 9.5cm height	Identical
Mask Style	Pleated	Pleated	Identical
Design Features	Malleable nosepiece, flat pleated, elastic ear loops	Malleable nosepiece, flat pleated, elastic ear loops	Identical
Sterility	Non-sterile	Non-sterile	Identical
Use	Single Use, Disposable	Single Use, Disposable	Identical
Color	Blue and White	Blue and White	Identical
ASTM F2100 Level	Level 2	Level 2	Identical
Biocompatibility	Cytotoxicity, ISO 10993-5:2009	Non-cytotoxic	Non-cytotoxic	same
	Irritation, ISO 10993-10:2002	Non-irritating	Non-irritating	same
	Sensitization, ISO 10993-10:2002	Non-sensitizing	Non-sensitizing	same

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Summary of Non-Clinical Testing

Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification
[510(k)] Submissions, the below testing has been completed on the subject device:

ltem	Standard	Acceptance Criteria	Results
Fluid ResistancePerformance	ASTM F1862: Standard TestMethod for Resistance of MedicalFace Masks to Penetration bySynthetic Blood	At least 29 out of 32specimens show passingresults at 120 mmHg	All samples met thepredeterminedacceptance criteria.
Bacterial FiltrationEfficiency	ASTM F2100-19: StandardSpecification for Performance ofMaterials Used in Medical FaceMasks	≥ 98%	All samples met thepredetermined acceptancecriteria.
DifferentialPressure (Delta P)	ASTM F2100-19: StandardSpecification for Performance ofMaterials Used in Medical FaceMasks	< 6.0 mm H2O/cm²	All samples met thepredetermined acceptancecriteria.
ParticulateFiltration Efficiency	ASTM F2100-19: StandardSpecification for Performance ofMaterials Used in Medical FaceMasks	≥ 98%	All samples met thepredetermined acceptancecriteria.
Flammability	21 CFR 1610	Class I, Does not Ignite	All samples met thepredeterminedacceptance criteria.
Cytotoxicity	ISO 10993-5: Biological evaluationof medical devices - Part 5: Testsfor in vitro cytotoxicity	Non-cytotoxic	All samples met thepredeterminedacceptance criteria.
Irritation	ISO 10993-10: Biologicalevaluation of medical devices -Part 10: Tests for irritation andskin sensitization	Non-irritating	All samples met thepredetermined acceptancecriteria.
Sensitization	ISO 10993-10: Biologicalevaluation of medical devices -Part 10: Tests for irritation andskin sensitization	Non-sensitizing	All samples met thepredeterminedacceptance criteria.

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) K201137, the ASEPT® Surgical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K111559.

Regulation Number and Section

§ 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.