(248 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device's intended use is for protection against transfer of microorganisms and particulate material, not for treating a disease or condition.
No
This device is a surgical face mask designed to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layer mask with ear loops and a nose piece, made of materials like polypropylene and plastic wire. The performance studies focus on physical properties and filtration efficiency, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of a mask designed to filter and block substances. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, resistance to penetration, and flammability. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
The Surgical Face Masks are single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Face Masks are 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of plastic wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
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)
Nonclinical Test:
- Resistance to penetration by synthetic blood ASTM F1862: 32 out of 32 passed in 120 mm Hg. Result: Pass.
- Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2299: >98%. Result: Pass.
- Bacterial filtration efficiency ASTM F2101-19: >98%. Result: Pass.
- Differential pressure EN 14683:2019:
§ 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.
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February 12, 2021
Amphastar Nanjing Pharmaceuticals, Inc. Bob Bao Quality Management Representative No.5 Xinghe Road, Nanjing Economic and Technological Development Zone Nanjing, Jiangsu 210038 China
Re: K201545
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 1, 2020 Received: June 9, 2020
Dear Bob Bao:
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 and Part 809); 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 (OS) 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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201545
Device Name Surgical Face Mask
Indications for Use (Describe)
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.
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
K201545
Date Summary Prepared: 2021-01-06
A. Applicant:
Amphastar Nanjing Pharmaceuticals, Inc. Address: No. 5 Xinghe Road, Nanjing Economic and Technological Development Zone. Jiangsu, China 210038 Contact Person: Bob Bao, Representative of Quality System Management Tel: 86-025-85807880-211 Fax: 86-025-85802275 E-mail: bobb@amphastar.cn FDA Registration Number: 3009805706
B. Device:
Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Model(s): Ear Loop
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:
K182515 Surgical Face Mask Wuhan Dymex Healthcare Co.,Ltd
D. Indications for Use:
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
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the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks are single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Face Masks are 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of plastic wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
| Item(s) | Proposed Device (K201545) | Predicate (K182515) | Comparison | |
|---|---|---|---|---|
| Surgical Face Mask | ||||
| ASTM Level 2 | Surgical Face Mask | |||
| ASTM Level 2 | ||||
| Manufacturer | Amphastar Nanjing Pharmaceuticals, | |||
| Inc. | Wuhan Dymex Healthcare Co., Ltd | - | ||
| 510K number | K201545 | K182515 | - | |
| Model Name | Surgical Face Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| Item(s) | Proposed Device (K201545) | |||
| Surgical Face Mask | ||||
| ASTM Level 2 | Predicate (K182515) | |||
| Surgical Face Mask | ||||
| ASTM Level 2 | Comparison | |||
| Intended Use | 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. | 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 | |||
| Model | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
| Material | Outer Facing | |||
| Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middle | ||||
| Layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner Facing | ||||
| Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose Piece | Plastic wire | Malleable aluminum wire | Different | |
| Ear Loops | Spandex | Spandex | Same | |
| Color | Blue | Yellow | Different | |
| Dimension (Width) | 9.5cm (±5%) | 9.5cm ±0.2 cm | Same | |
| Dimension (Length) | 17.5cm (±5%) | 17.5cm±0.2 cm | Same | |
| Dimension (Nose Piece) | 9 cm ± 5% | 9 cm ± 5% | Same | |
| Dimension (Ear Loops) | 15 cm ± 5% | 15 cm ± 5% | Same | |
| OTC use | YES | YES | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Item(s) | Proposed Device (K201545) | Predicate (K182515) | Comparison | |
| Surgical Face Mask | ||||
| ASTM Level 2 | Surgical Face Mask | |||
| ASTM Level 2 | ||||
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Biocompatibility | ||||
| Cytotoxicity | Under the conditions of the study, the | |||
| device is non-cytotoxic | Same | Same | ||
| Skin Sensitization Test | Under the conditions of the study , the | |||
| device is non-sensitizing | same | Same | ||
| Skin Irritation Test | Under the conditions of the study the | |||
| device is non-irritating | Same | Same |
Table 1 General Comparison
F. Summary of Technological Characteristic
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G. Non-clinical Test performed on the proposed device
The proposed devices were tested and conformed to 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.
Table 2 Performance Testing
| Item(s) | Proposed Device
(K201545) | Predicate
(K182515) | Acceptance
Criteria | Result |
|--------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|--------------------------------------|--------|
| Resistance to
penetration by synthetic
blood
ASTM F1862 | 32 out of 32 passed
in 120 mm Hg | 32 out of 32 passed in
120 mm Hg | 29 out of 32
pass in 120 mm
Hg | Pass |
| Sub-micron particulate
filtration efficiency at
0.1 micron
ASTM F2299 | >98% | 99.7% | ≥98% | Pass |
| Bacterial
filtration
efficiency
ASTM F2101-19 | >98% | 99.9% | ≥98 | Pass |
| Differential pressure
EN 14683:2019 | ≤ 3.0 mm H2O/cm2 | 4.0 mm H2O/cm2 |