Asept Surgical Face Mask

K201137 · Pfm Medical, Inc. · FXX · Aug 19, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201137
• Device Name: Asept Surgical Face Mask
• Applicant: Pfm Medical, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 19, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

ASEPT® Surgical Face Mask is a single-use, three-layer, flat-pleated mask; features ear loops and malleable nose piece. Input: physical barrier requirement for protection against microorganisms and body fluids. Operation: mechanical filtration via spun-bond polypropylene outer/inner layers and melt-blown polypropylene middle filter layer. Output: physical barrier covering nose and mouth. Used in clinical/surgical settings by healthcare workers and patients. Provides protection against fluid penetration and particulate/bacterial exposure. Non-sterile, disposable.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2100-19 and ASTM F1862. Results: Fluid resistance (120 mmHg), Bacterial Filtration Efficiency (≥98%), Particulate Filtration Efficiency (≥98%), and Differential Pressure (<6.0 mm H2O/cm²) met all acceptance criteria. Biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-5 and ISO 10993-10 confirmed non-cytotoxic, non-irritating, and non-sensitizing properties. Flammability testing per 21 CFR 1610 met Class I requirements.

Technological Characteristics

Three-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter). Nose piece: malleable polyethylene with aluminum wire. Ear loops: polyester. Dimensions: 17.5cm x 9.5cm. ASTM F2100 Level 2. Non-sterile, single-use, disposable. No software or electronic components.

Indications for Use

Indicated for healthcare workers and patients as a protective nose and mouth covering during medical and surgical procedures where there is a risk of exposure to microorganisms and body fluids.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Masks (K111559)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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.

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: [e-mail]

#### 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

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.

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## 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.

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