(134 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the Livocare Surgical Mask is for protection against transfer of microorganisms, body fluids, and particulate material, and for infection control practices, not for treating any specific medical condition.
No
Explanation: The device, a surgical mask, is intended for protection against microorganisms and fluids, not for diagnosing medical conditions. Its performance metrics relate to filtration efficiency and fluid resistance, not diagnostic accuracy.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose piece) and performance studies focus on material properties and physical performance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Livocare Surgical Mask Function: The Livocare 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 involve the analysis of any biological specimens.
The description clearly states its purpose is for infection control practices and to reduce potential exposure to blood and body fluids by acting as a physical barrier. This is a completely different function than an IVD.
N/A
Intended Use / Indications for Use
The Livocare Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The Livocare Surgical Mask is a single use, three-layer, flat-folded mask with ear loops and nose piece. The Surgical Mask is 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 surgical mask. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile.
This device is not made from Natural Rubber Latex.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-19, ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
- Performance testing:
- Fluid Resistance ASTM F1862: 32 out of 32 passed at 120 mmHg (Acceptance criteria: 29 out of 32 pass at 120 mmHg) - Pass
- Particulate Filtration Efficiency ASTM F2299: > 98% (Acceptance criteria: ≥98%) - Pass
- Bacterial Filtration Efficiency ASTM F2101: > 99% (Acceptance criteria: ≥98%) - Pass
- Differential Pressure (Delta P) MIL-M-36954C:
§ 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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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 7, 2020
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China
Re: K201380
Trade/Device Name: Livocare Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2020 Received: July 10, 2020
Dear Liu Yi:
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.
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
1
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 (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-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 Elizabeth Claverie 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) K201380
Device Name
Livocare Surgical Mask
Indications for Use (Describe)
The Livocare Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
_ | 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
(In accordance with 21 CFR 807.92)
1.0 Submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street, Ya An Road, Nankai District, Tianjin |
| P. R. China | |
| Phone number: | 86-22-87611660 |
| Fax number: | 86-22-87612379 |
| Contact: | Liu Yi |
| Date of preparation: | October 5, 2020 |
2.0 Device information
Livocare Surgical Mask Trade name: Common name: Surgical mask Regulation name: Surgical Apparel
3.0 Classification
Product code: FXX Regulation number: 21 CFR §878.4040 Classification: Class II Panel: General Hospital
4.0 Predicate device information
WUHAN DYMEX HEALTHCARE CO., LTD Manufacturer: SURGICAL FACE MASK Device: 510(k) number: K182515
5.0 Intended use
The Livocare Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control
4
practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.
6.0 Device description
The Livocare Surgical Mask is a single use, three-layer, flat-folded mask with ear loops and nose piece. The Surgical Mask is 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 surgical mask. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile.
This device is not made from Natural Rubber Latex.
| Item | Subject Device | Predicate Device (K182515) | Comparison |
|---|---|---|---|
| Manufacturer | Andon Health Co., Ltd | WUHAN DYMEX | |
| HEALTHCARE | |||
| CO., LTD | - | ||
| 510K number | K201380 | K182515 | - |
| Product name | Livocare surgical | Surgical face mask | - |
| Classification | Class II, FXX, 21 CFR | ||
| 878.4040 | Class II, FXX, 21 CFR | ||
| 878.4040 | Same | ||
| Indications for Use | The Livocare Surgical Mask is | ||
| intended to be worn to protect | |||
| both the patient and | |||
| healthcare personnel from | |||
| transfer of microorganisms, | |||
| body fluids and particulate | |||
| material. The surgical mask is | |||
| intended for use in infection | |||
| control practices to reduce | |||
| potential exposure to blood | |||
| and body fluids. The 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(s), provided non-sterile. | Same |
7.0 Comparison of technological characteristics with predicate device
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| Model | Ear loops, flat pleated, 3 layers | Ear loops, flat pleated, 3 layers | Same | |
|---|---|---|---|---|
| Materials | Outer | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middle | ||||
| layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner | ||||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose | ||||
| piece | Malleable polyethylene wire | Malleable polyethylene wire | Same | |
| Ear | ||||
| loops | Spandex and Nylon | Spandex | Similar | |
| Color | Outer layer: Blue | |||
| Middle and inner layers: White | Yellow | Different | ||
| Dimension (Width) | $9.5 \pm 1.0$ cm | $9.5 \pm 0.2$ cm | Same | |
| Dimension (Length) | $17.0 \pm 1.0$ cm | $17.5 \pm 0.2$ cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
8.0 Non-clinical testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-19, ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
| Performance testing: | ||||
|---|---|---|---|---|
| Item | Acceptance criteria | |||
| (Level 2) | Proposed device | Predicate device | ||
| (K182515) | Results | |||
| Fluid Resistance | ||||
| ASTM F1862 | 29 out of 32 pass at | |||
| 120 mmHg | 32 out of 32 passed at | |||
| 120 mmHg | 32 out of 32 passed | |||
| at 120 mmHg | Pass | |||
| Particulate Filtration | ||||
| Efficiency ASTM F2299 | ≥98% | > 98% | 99.7% | Pass |
| Bacterial Filtration | ||||
| Efficiency ASTM F2101 | ≥98% | > 99% | 99.9% | Pass |
| Differential Pressure (Delta P) | ||||
| MIL-M-36954C |