(191 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
The product is a face mask intended to protect against transferring microorganisms and fluids, not to treat a medical condition.
No
Explanation: The document clearly states that the device is a "Disposable Surgical Face Mask" intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its function is to provide a physical barrier, not to diagnose any condition or disease.
No
The device is a physical face mask made of polypropylene and aluminum wire, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask and its components. There is no mention of any reagents, assays, or components designed to detect or measure substances in vitro.
- Lack of Diagnostic Elements: The description and performance studies focus on physical properties like filtration efficiency, fluid resistance, and breathability. There are no tests related to analyzing biological samples or providing diagnostic information.
- Anatomical Site: The anatomical site is the mouth and nose, indicating a physical barrier application.
- No Mention of In Vitro Testing: The performance studies are bench tests evaluating the physical characteristics of the mask, not in vitro tests on biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Disposable 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) 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 model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's 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 contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-11, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
- ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
- Bench Testing for the performance of Dimensions.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance ASTM F1862-13: 32 out of 32 pass at 120 mmHg
- Particulate Filtration Efficiency ASTM F2299: 98.46%
- Bacterial Filtration Efficiency ASTM F2101: 98.7%
- Differential Pressure (Delta P) MIL-M-36954C: 4.2 mmH2O/cm²
- Flammability 16 CFR 1610: Class 1 Non Flammable
- Cytotoxicity: Under the conditions of the study, not cytotoxicity effect
- Irritation: Under the conditions of the study, not an irritant
- Sensitization: Under conditions of the study, not a sensitizer.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Xiantao Rayxin Medical Products Co., Ltd. June 15, 2016 % Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CHINA
Re: K153496
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 11, 2016 Received: May 16, 2016
Dear Mr. Wang:
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. 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
Page 2 - Mr. Wang
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153496
Device Name Disposable Surgical Face Mask Ear Loop and Tie-On
Indications for Use (Describe)
The Disposable 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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EF
3
Tab #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K153496
-
- Date of Preparation:2016/06/11
-
- Sponsor Identification
Xiantao Rayxin Medical Products Co., Itd. No. 258 Pengchang Road, Middle Street, Xiantao city, Hubei 433018, China
Establishment Registration Number: Not yet registered
Contact Person: Liang Zhang Position: General Manager Tel: +86-728-2617592 Fax: +86-728-26177777 Email: zl@rayxin.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Tech. Service Co., Ltd
5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-21-50313932, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Disposable Surgical Face Mask Common Name: Surgical Face Mask Model(s): Tie-On, Ear Loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
Indication for use Statement:
The Disposable 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.
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) 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 model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's 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 contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
5. Identification of Predicate Device(s)
Predicate Device K133070 Surgical Face Mask
5
BH Medical Products Co., Ltd.
-
Non-Clinical Test Conclusion Q.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ASTM F2100-11, Standard Specification For Performance Of Materials Used In Medical Face Masks.
-
ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
-
MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
-
ASTM F2101-14, Standard Test Method For Evaluating The Bacterial Filtration Efficiency > (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
-
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
-
Bench Testing for the performance of Dimensions.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Intended Use | The Disposable 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. | SE | |
| Ear loop model and tie-on model | Ear Loops, Tie-On, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | SE | |
| Materials | Outer Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | SE |
| Middle Layer | Melt blown polypropylene filter | Melt blown polypropylene filter | ||
| Inner Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | ||
| Tieon | Spun-bond polypropylene | Spun-bond polypropylene | ||
| Nose Piece | Malleable aluminum wire | Malleable aluminum wire | ||
| Ear Loops | Polyester | Polyester | ||
| Color | Blue | Blue, Green | SE | |
| Dimension (Width) | 17.5 cm +/- 1cm | 6.8" +/-0.25" (17.27 cm +/- 0.63cm) | SE | |
| Dimension (Length) | 9.5 cm +/- 1cm | 4.2" +/-0.25" (10.67 cm +/- 0.63cm) | ||
| 3.5" +/-0.25" (8.89 cm +/- 0.63cm) | ||||
| OTC use | Yes | Yes | SE | |
| Single Use | Yes | Yes | SE | |
| Sterile | No | No | SE | |
| ASTM F2100 Level | Level 2 | Level 2 | SE |
Table 1 General Comparison
Table 2 Performance Characteristic Comparision
| ITEM | Proposed Device | Predicate Device | ASTM F2100
Requirements for
Level 2
Classification | Remark |
|--------------------------------------------------|-------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------|--------|
| Fluid Resistance
Performance
ASTM F1862-13 | 32 out of 32 pass at 120 mmHg | Meet the ASTM F2100
Requirements for Level 2
Classification | 29 out of 32 pass at 120 mmHg | SE |
| Particulate
Filtration
Efficiency ASTM | 98.46% | Meet the ASTM F2100
Requirements for Level 2
Classification | $\ge$ 98% | |
7
| F2299 | ||||
|---|---|---|---|---|
| Bacterial | ||||
| Filtration | ||||
| Efficiency ASTM | ||||
| F2101 | 98.7% | Meet the ASTM F2100 | ||
| Requirements for Level 2 | ||||
| Classification | ≥ 98% | |||
| Differential | ||||
| Pressure (Delta | ||||
| P) | ||||
| MIL-M-36954C | 4.2 mmH2O/cm² | Meet the ASTM F2100 | ||
| Requirements for Level 2 | ||||
| Classification |