(219 days)
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 (surgical mask) is indicated for protection and prevention of transfer of microorganisms and fluids, not for treating a disease or condition.
No
The device is a surgical mask indicated for protection against microorganism, body fluid, and particulate aerosol transfer, not for diagnosing a medical condition.
No
The device description clearly indicates it is a physical product (pleated 3-ply mask) made of materials like polypropylene and elastic loops, and the performance studies are based on physical tests of the mask's properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for "protective nose and mouth covering" and to prevent the transfer of "microorganism, body fluid, and particulate aerosol." This describes a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies and Key Metrics: The performance studies focus on the physical properties of the mask, such as filtration efficiency, fluid resistance, and flammability. These are relevant to the mask's barrier function, not to diagnostic accuracy or analytical performance.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The GreenCross Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure, or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
Product codes
FXX
Device Description
GreenCross surgical masks, Type: Earloop or Tie-on, are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. All of the materials used in the construction of the GreenCross surgical masks are being used in currently marketed devices, except the nose piece used plastic wire instead of aluminum wire.
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
Health care workers, 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)
Non-clinical tests were performed.
Test: Fluid Resistance Performance ASTM F1862, Our Device: 29 out of 32 pass at 120 mm Hg, Predicate Device (K101000): 31 out of 32 pass
Test: Particle Filtration Efficiency ASTM F2299, Our Device: 99.1%, Predicate Device (K101000): 99.8%
Test: Bacteria Filtration Efficiency ASTM F2101, Our Device: 99.8%, Predicate Device (K101000): 99.9%
Test: Differential Pressure (Delta-P) MIL-M-36945C, Our Device: 2.6-2.9 (mm Water/cm²), Predicate Device (K101000): 3.7-4.0 (mm Water/cm²)
Test: Flammability 16CFR 1610, Our Device: Class 1 None Flammable, Predicate Device (K101000): Class 1 None Flammable
Test: Biocompatibility ISO 10993-5, -10, Our Device: Biocompatible, Predicate Device (K101000): Biocompatible
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particle Filtration Efficiency: 99.1%
Bacteria Filtration Efficiency: 99.8%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Section 2: 510(k) Summary:
JUL 1 7 2013
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Jingzhou Haixin Green Cross Medical Products Co., Ltd Century Building 19F A. Jianghan RD 206 Wuhan City, Hubei 430010, P. R, China Contact person: Bill Liao Tel: +86-278-281-5070
Submitter's FDA Registration Number: N/A
US Agent and Contact Person 1.
Xiangyang Song 6 Vanderblet Road, Acton, MA, 01720 Tel: 312-479-6204 Email: xysong@gmail.com
Date of Summary: December 03, 2012, Date of Revision 1: December 26, 2012, Date of Revision 2: May 17, 2013
2. Regulatory Information
Name of Device: GreenCross Surgical Mask Model No.: GFM12 Type: Tie-on, Earloop Common Name: Surgical Mask Panel: General & Plastic Surgery Device Classification: Class II Regulation Number: 878.4040 Product Code: FXX Classification Name: Mask, Surgical
Predicate Device Information: 3.
K101000: Surgical Mask (For Single Use Only) by Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd
Device description: 4.
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GreenCross surgical masks, Type: Earloop or Tie-on, are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. All of the materials used in the construction of the GreenCross surgical masks are being used in currently marketed devices, except the nose piece used plastic wire instead of aluminum wire. (see predicate information)
Intended Use: ડ.
The GreenCross Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism. body fluid, and particulate aerosol transfer.
6. Comparison to Predicate Devices
GreenCross Surgical Mask is compared with its Predicate devices: K101000: Surgical Mask (For Single Use Only) by Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd. The design, material, and other technical characteristics of these two devices are very similar, except that the nose piece for GreeCross Surgical Mask used plastic wire instead of aluminum wire, also the size, color & design type (Ear Loop or Tie-on) are different to predicate device. These features are not expected to affect the safety and performance of the device.
| Description | Our Device | Predicate Device (K101000) |
|---|---|---|
| Indication for | ||
| Use | Nose and mouth covering for health | |
| care workers and patients to prevent | ||
| microorganism, body fluid, and | ||
| particulate aerosol transfer. | Same | |
| Layers | Three | Three |
| Materials | Outer layer is made of 100% spun- | |
| bond polypropylene. | ||
| Middle player is made of 100% | ||
| meltblown polypropylene filter | ||
| media. | ||
| Inner layer is made of 100% spun- | ||
| bond polypropylene. | ||
| Ear-loops are made of soft latex free | ||
| elastic loops. | ||
| The nose piece is plastic wire | Outer layer is made of 100% spun- | |
| bond polypropylene. | ||
| Middle player is made of 100% | ||
| meltblown polypropylene filter | ||
| media. | ||
| Inner layer is made of 100% spun- | ||
| bond polypropylene. | ||
| Ear-loops are made of soft elastic | ||
| loops. | ||
| The nose piece is malleable | ||
| aluminum wire |
Comparison of Intended Use, Design, Material and Specifications
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| Dimensions | 175±5 mm x90±5 mm | Large: 180x90mm, Medium:
175 x95mm, Small: 145x90 mm |
|------------------------|-------------------|---------------------------------------------------------|
| Mask style | Flat Pleated | Flat Pleated |
| Design | EarLoop, Tie-on | EarLoop |
| Anti Fog
Shield | N/A | N/A |
| Color | white | Blue |
| NIOSH
certification | N/A | N/A |
Comparison of Device Performance
| Test | Our Device | Predicate Device (K101000) |
|---|---|---|
| Fluid Resistance | ||
| Performance | ||
| ASTM F1862 | 29 out of 32 pass | |
| at 120 mm Hg | 31 out of 32 pass | |
| Particle Filtration | ||
| Efficiency | ||
| ASTM F2299 | 99.1% | 99.8% |
| Bacteria Filtration | ||
| Efficiency | ||
| ASTM F2101 | 99.8% | 99.9% |
| Differential Pressure | ||
| (Delta-P) | ||
| MIL-M-36945C | 2.6-2.9 | |
| (mm Water/cm²) | 3.7-4.0 | |
| (mm Water/cm²) | ||
| Flammability | ||
| 16CFR 1610 | Class 1 None Flammable | Class 1 None Flammable |
| Biocompatibility | ||
| ISO 10993-5, -10 | Biocompatible | Biocompatible |
7. Discussion of Non-Clinical Tests Performed to Determine Substantial Equivalence
The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the following standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.
- (1) ASTM F2101 Bacterial Filtration Efficiency (BFE)
- Pressure Differential (Delta P) MIL-M-36945C Cl. MIL-M-36945C (2) 4.4.1.1.1
- ASTM F2299 Latex Particle Challenge (PFFE) (3)
- 16 CFR Part 1610 Flammability (4)
- Biocompatibility per ISO 10993 (5)
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- (6) ASTM F1862 Fluid Resistant - Synthetic Blood Penetration Resistant Test
It is our conclusion that performance testing met all relevant requirements of the above said test standards. More detail comparison of the design, technical, and performance characteristics to the predicted device are summarized in "510(k) Premarket Notification for Jingzhou Haixin Surgical Mask" chapter 4 summary report, section 4.1 to 4.4. More details of non-clinical tests are summarized in Chapter 4, section 4.5 and 4.6
Discussion of Clinical Tests Performed 8. Not applicable
9. Conclusions
.
The GreenCross surgical mask has the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission demonstrates that the technological characteristics of GreenCross Surgical masks do not raise any new questions of safety or effectiveness. Therefore, GreenCross surgical masks By Jingzhou Haixin Green Cross Medical Products Co., Ltd are substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and has a simple, clean design. The eagle is a symbol of strength and freedom, and the logo represents the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2013
Jingzhou Haixin Green Cross Medical Products Company, Limited C/O Mr. Xiangyang Song 6 Vanderbelt Road ACTON MA 01720
Re: K123787
Trade/Device Name: GreenCross Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 16, 2013 Received: June 14, 2013
Dear Mr. Song:
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.
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Page 2 - Mr. Song
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 (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 1: Indication for Use Statement
Device name: GreenCross Surgical Mask
The GreenCross Surgical Masks are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
Prescription Use
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Elizabeth F. Claverie
2013.07.16 18:50:22 -04'00'
(Division Sign-Off) (Division of Anesthestology, General Hospital n Control, Dental I
510(k) Number: K123787
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