(113 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a surgical face mask, which acts as a protective barrier to prevent exposure to microorganisms and body fluids. It is not designed to treat or alleviate a disease or condition.
No
This device is a surgical face mask designed for protection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, single-use surgical face mask made of polypropylene layers, ear loops, and a nose piece. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a physical barrier to protect the nose and mouth from microorganisms and body fluids during medical and surgical procedures. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the materials and construction of a physical mask. There are no components or mechanisms described that would be used to test or analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on the physical barrier properties and biocompatibility of the mask (fluid resistance, filtration efficiency, flammability, etc.), not on diagnostic accuracy or performance with biological samples.
- Predicate Device: The predicate device is also a "Surgical Mask," which is a non-IVD device.
In summary, the ASEPT® Surgical Face Mask is a medical device intended for physical protection, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers and patients involved in medical and surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Testing Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions
Key Results:
- Fluid Resistance: All samples met the predetermined acceptance criteria.
- Bacterial Filtration Efficiency: All samples met the predetermined acceptance criteria.
- Differential Pressure (Delta P): All samples met the predetermined acceptance criteria.
- Particulate Filtration Efficiency: All samples met the predetermined acceptance criteria.
- Flammability: All samples met the predetermined acceptance criteria.
- Cytotoxicity: All samples met the predetermined acceptance criteria.
- Irritation: All samples met the predetermined acceptance criteria.
- Sensitization: All samples met the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: At least 29 out of 32 specimens show passing results at 120 mmHg
- Bacterial Filtration Efficiency: ≥ 98%
- Differential Pressure (Delta P):
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
Asept Surgical Face Mask
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)
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
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
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.
4
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 |
5
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 | |||
| 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 |