(119 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's intended use is for protection against transfer of microorganisms, body fluids, and particulate aerosols, rather than for treating or preventing a disease or condition.
No
Explanation: This device is a surgical mask intended for protection and covering, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components (pleated 3-ply mask, spun-bond polypropylene, meltblown polypropylene, elastic ear-loops, aluminum nose piece) and performance metrics related to filtration and fluid resistance, indicating a physical medical device, not software.
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, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description and Intended Use: The Wellmien Surgical Masks are described as a physical barrier to protect the nose and mouth from the transfer of microorganisms, body fluids, and particulate aerosols. They are used on the body as a protective covering.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose or detect anything. Its function is purely protective.
- Performance Metrics: The performance metrics listed (Particle Filtration Efficiency, Bacteria Filtration Efficiency, etc.) relate to the mask's ability to filter and resist fluids, not to any diagnostic capability.
Therefore, based on the provided information, the Wellmien Surgical Mask is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wellmien 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
WELLMIEN's surgical masks (for single use only) 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 elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices.
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 and patients involved in 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)
The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the respective consensus standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.
- Bacterial Filtration Efficiency (BFE) : ASTM F2101-07 (1)
- Pressure Differential (Delta P) (2)
- (3) Latex Particle Challenge(PFE): ASTM F2299-03
- Flammability: 16 CFR 1610 (4)
- Biocompatibility per ISO 10933 (5)
- Fluid Resistant Synthetic Blood Penetration Resistant Test: ASTM (6) F1682-07
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particle Filtration Efficiency: 99.8%
Bacteria Filtration Efficiency: 99.9%
Differential Pressure (Delta-P): 3.7-4.0 (mm Water/cm²)
Flammability: Class 1 None Flammable
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
K101000
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
1. Contact Information
AUG - 5 ZUIU
Submitter & Foreign Manufacturer Identification Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd 1-711, No.636 Ganjiang East Road Suzhou, Jiangsu Province, China, Zip code: 215005 Tel: 86-512-81881706
Submitter's FDA Registration Number : N/A
US Agent and Contact Person Chengyu Shen Manton Business and Technology Services 5 Carey Street, Pennington, NJ 08534 Tel: 608-217-9358, Email: cyshen@aol.com
Date of Summary: March 23, 2010 Date of Revision 1: June 5, 2010
2. Regulatory Information
Name of Device: Surgical Mask (For Single Use Only) Panel: General Hospital Class: Class 2 Regulation Number: 21 CFR 807.4040 Product Code: FXX Classification Name: Mask, Surgical
Predicate Device Information: 3.
K060776: Surgical Face Mask (Yellow, White, Green, Pink) by Hong Ya Non-Woven Products Co., Ltd
4. Device description:
WELLMIEN's surgical masks (for single use only) 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 elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices. (see Predicate Device information )
1
5. Intended Use:
The Wellmien 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
WELLMIEN Surgical Mask (for single use only) is compared with it Predicate Device: K060776: Surgical Face Mask (Yellow, White, Green, Pink) by Hong Ya Non-Woven Products Co., Ltd. The design, material, and performance of both devices are very similar, and the two products are substantially equivalent in safety and effectiveness.
| Description | Our Device | Predicate Device (K060776) |
|---|---|---|
| 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. | Outer layer is made of 100% spun-bond polypropylene. |
| Middle player is made of 100% meltblown polypropylene filter media. | Middle player is made of 100% meltblown polypropylene filter media. | |
| Inner layer is made of 100% spun-bond polypropylene. | Inner layer is made of 100% spun-bond-polypropylene. | |
| Ear-loops are made of soft elastic loops. | ||
| The nose piece is malleable aluminum wire | Ear-loops are made of soft elastic loops. | |
| The nose piece is malleable aluminum wire | ||
| Dimensions | Large: 18x9cm, Medium: | |
| 17.5x9.5cm, Small: 14.5x9 cm | N/A | |
| Mask style | Flat Pleated | Flat Pleated |
| Design | Ear Loop | Ear Loop |
| Color | Blue | Yellow, White, Green, Pink |
| NIOSH | ||
| certification | N/A | N/A |
Comparison of Intended Use, Design, Material, and Specifications
2
| Comparison of Device Performance | ||
|---|---|---|
| Test | Our Device | Predicate Device (K060776) |
| Fluid Resistance | ||
| Performance | Fluid Resistance | Fluid Resistance |
| Particle Filtration | ||
| Efficiency | 99.8% | 96.8% |
| Bacteria Filtration | ||
| Efficiency | 99.9% | At least 99.9% |
| Differential | ||
| Pressure (Delta-P) | 3.7-4.0 (mm Water/cm²) | Average 2.34 (mm Water/cm²) |
| Flammability | Class 1 None Flammable | Class 1 None Flammable |
| Biocompatibility | 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 respective consensus standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.
- Bacterial Filtration Efficiency (BFE) : ASTM F2101-07 (1)
- Pressure Differential (Delta P) (2)
- (3) Latex Particle Challenge(PFE): ASTM F2299-03
- Flammability: 16 CFR 1610 (4)
- Biocompatibility per ISO 10933 (ર)
- Fluid Resistant Synthetic Blood Penetration Resistant Test: ASTM (6) F1682-07
More detailed comparison of the design, technical, and performance characteristics to the predicate device are summarized in Section 7: Summary Report. More details of non-clinical tests are summarized in Section 7.5 and 7.6.
8. Discussion of Clinical Tests Performed Not applicable
9. Conclusions
The WELLMIEN's surgical masks (for single use only) have the same intended use and technological characteristics as the predicate devices.
3
Moreover, bench testing contained in this submission demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness。 WELLMIEN's surgical masks (for single use only) are substantially equivalent to the predicate device
:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wellmien (Suzhou) Import and Export Company, Limited C/O Mr. Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, New Jersey 08534
Re: K101000
Trade/Device Name: Wellmien Surgical Mask (for single use only) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: June 2, 2010 Received: June 25, 2010
Dear Mr. Shen:
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.
AUG - 9 2010
5
Page 2- Mr. Shen
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan Ruines
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
01000
Indications for Use
510(k) Number (if known): K101000
AUG - 9 2010
Device Name: Wellmien Surgical Mask (for single use only)
Indications for Use:
The Wellmien 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eliz. H. F. Llanetto Wills
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Douises Division Control, Dental Devices
01 000 510(k) Number: