(184 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
This device is a surgical mask intended to prevent the transfer of microorganisms and body fluids, not to treat a disease or condition.
No
This device is a surgical mask intended for protecting against microorganisms and fluids, not for diagnosing any medical condition. Its performance metrics relate to filtration efficiency and fluid resistance, not diagnostic accuracy.
No
The device description clearly outlines a physical product (a surgical mask) made of multiple layers of material with ear loops and a nosepiece. The performance studies are related to the physical properties of the mask, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Jian Yu Surgical Mask Function: The Jian Yu surgical mask is a physical barrier worn on the face to prevent the transfer of microorganisms, body fluids, and particulate material between individuals. It does not perform any diagnostic tests on samples from the body.
- Intended Use: The intended use clearly states its purpose is for protection and infection control, not for diagnosing any condition.
- Device Description: The description details the physical construction and materials of the mask, not components for performing diagnostic tests.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration efficiency, resistance to penetration), which are relevant to its function as a physical barrier, not a diagnostic tool.
Therefore, based on the provided information, the Jian Yu surgical mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
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
Not Found
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)
Performance tests have been conducted on Surgical mask per ASTM F2100-19, and all testing results met ASTM F2100-19 Level 3 acceptance criteria.
Detailed testing conducted:
- Bacterial filtration efficiency (BFE)
- Differential pressure
- Particulate filtration efficiency (PFE)
- Resistance to penetration by synthetic blood
- Flammability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency (BFE): Passed at ≥99.9% ASTM F2101
- Differential pressure: Passed at
§ 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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December 30, 2020
Jiangsu JianYu Health Medical Co., Ltd. Andy Shu Regulatory Affairs Specialist No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou, Jiangsu 213241 China
Re: K201754
Trade/Device Name: JianYu Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 16, 2020 Received: December 29, 2020
Dear Andy Shu:
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 (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
2
Indications for Use
510(k) Number (if known)
Device Name
JianYu Surgical Mask
Indications for Use (Describe)
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device 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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3
510(k) Summary
(as requested by 21 CFR 807.92)
| 510K Number: | K201754 |
|---|---|
| Submitter / 510(k) owner: | Jiangsu JianYu Health Medical Co., Ltd. |
| Address: No. 88 Longxi Avenue, Zhulin Town, Jintan District, | |
| Changzhou City, Jiangsu, CN 213241 | |
| Tel: +86-519-82445588 | |
| Fax: +86-519-82442788 | |
| Contact Person: | Andy Shu |
| Regulatory Affairs Specialist | |
| E-mail: andy_smiths@sina.com | |
| Date of preparation: | June 15th, 2020 |
| Proposed device: | |
| Trade Name: | JianYu Surgical Mask |
| Common/Classification Name: | Surgical Mask Regulation |
| Name: | Surgical Apparel |
| Product Code: | FXX |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 878.4040 |
| Legally Marketed Predicate Device: | |
| Trade Name: | Surgical Face Mask (EL30000) |
| 510(k) Number: | K160269 |
| Submitter of 510(k)/holder: | SAN-M PACKAGE CO., LTD. |
Device Description:
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
Intended Use:
JianYu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
4
Comparison of Technological Characteristics between the subject and predicate devices:
JianYu Surgical mask has the same technological characteristics as the predicate device. The design, material, form, fit, function and method of operation are similar.
| Element of
Comparison | Subject Device
K201754 | Predicate Device
K160269 | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | JianYu surgical mask is intended to
be worn to protect both patients and
healthcare workers from transfer of
microorganisms, body fluids, and
particulate material. The surgical
mask is intended for use in infection
control practices to reduce the
potential exposure to blood and body
fluids. The JianYu surgical mask is a
single use, disposable device
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,
provided non-sterile. | Same |
| Material
Composition | Three-layer mask constructed of:
Outer layer: spunbond polypropylene
Filter layer: meltblown polypropylene
Inner layer: spunbond polypropylene
Ear loops: spandex
Nose clip: malleable aluminum
wire/PVC | Outer layer: Polypropylene
Filter media:
- Polypropylene spunbond
- Polypropylene meltblown Inner
layer: Polypropylene
Ear loop: Polyester, polyurethane
Nose lamps: Polyethylene coated
steel wire | Similar |
| Dimension | Length: 175±5mm, Width: 95±5mm | Length: 175±5mm, Width: 90±3mm | Similar |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Design feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single use; Disposable | Single use; Disposable | Same |
| Color | Blue | White or blue | Same |
| Biocompatibility | The surgical mask was tested with
following standards:
• AAMI /ANSI/ ISO
10993-5:2009,
Under the testing conditions, the
subject surgical mask did not show
potential cytotoxicity
• AAMI /ANSI/ ISO
10993-10:2010,
Under the testing conditions, the
subject surgical mask did not cause
significant irritation or sensitization
reaction to the test animals | The surgical mask was tested in
accordance with ISO10993 and
passed acceptance
criteria. | Same |
5
| Product performance specification per ASTM F2100-19 meets Level 3 | ||||
|---|---|---|---|---|
| Bacterial | ||||
| filtration | ||||
| efficiency | ||||
| (BFE) | Passed at ≥99.9% ASTM F2101 | Passed at ≥99% ASTM F2101 | Same | |
| Differential | ||||
| pressure | Passed at |