(262 days)
No
The 510(k) summary describes a standard surgical face mask and its performance characteristics based on physical testing methods, with no mention of AI or ML.
No.
The device's intended use is to protect from transfer of microorganisms, body fluids, and particulate material, not to treat or diagnose a disease or condition.
No
The device is a surgical face mask designed to protect against microorganisms and particulate material, not to diagnose medical conditions. Its performance metrics relate to filtration and resistance, not diagnostic accuracy.
No
The device description clearly indicates it is a physical product (Surgical Face Mask) and the performance studies are based on physical properties and filtration efficiency, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protection from transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The device is described as a surgical face mask. Surgical face masks are personal protective equipment (PPE), not diagnostic devices.
- Lack of Diagnostic Elements: The description and performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability. There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status, which are hallmarks of IVDs.
- No Mention of In Vitro Testing: The performance studies are related to the physical properties of the mask itself, not to testing biological samples in vitro (outside the body).
Therefore, based on the provided information, this device is a surgical face mask intended for protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Product codes
FXX
Device Description
Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue
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)
Performance Characteristics:
Fluid Resistance Performance (mmHg) - Test Method: ASTM F 1862 - 80 mmHg, Predicate Results (K022256): No visual detection of penetration., Acceptance Criteria or Results: Passed
Particulate Filtration Efficiency Performance (%) - Test Method: ASTM F2299 - 0.1um, Predicate Results (K022256): 2.0 microns, Acceptance Criteria or Results: 98.7%
Bacterial Filtration Efficiency Performance (%) - Test Method: ASTM F2101-01, Predicate Results (K022256): 97.9%, Acceptance Criteria or Results: 99.9%
Differential Pressure (Delta-P) (mm H2O/cm2) - Test Method: Mil- M369454C, Predicate Results (K022256): 1.8, Acceptance Criteria or Results: 2.0 - 2.5
Flammability class Class 1 - Test Method: 16 CFR 1610, Predicate Results (K022256): 2, Acceptance Criteria or Results: Classified as Class I
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
K093901/5004
Section 5: 510(k) Summary
SEP 1 0 2010
1. Original Preparation Date: December 17, 2009
- Submitted by:
ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
14
Epard Protective Products, Ltd. No. 1 Bailongguan Quijialing District Jinshan Hubei, China 431821
Contact Person/Prepared by:
Darren Reeves Phone: (804) 307-7706 Fax: (866) 393-4954 Email: dpdist@bww.com
3. Device Identification:
Trade Name: Surgical Face Mask Common Name: Mask, Surgical Classification: Surgical Apparel (21 CFR 878.4040, Product Code FXX)
Tucker & Associates, Surgical Face Mask (K022256) Predicate Device: 4.
5. Device Description:
Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue
6. Intended Use:
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
1
K093901/S004
7. Comparison to Predicate:
ri and the comments of the first the first of the first the first the first the first the first the first the first the finished the finance of the finally be the finally the
Device and Predicate Device Descriptions
| Description | Your Device | Predicate = K022256 | |
|---|---|---|---|
| Materials | Same | Outer Coverstock: Spunbond polypropylene | |
| Inner Coverstock: Spunbond polypropylene | |||
| Filter: Melt Blown Polypropylene | |||
| Nose band: Aluminum | |||
| Tape: Polypropylene | |||
| Tie: Polypropylene | |||
| 3-ply, White, Blue, Green, Yellow and Pink | |||
| Specifications and dimensions | Same | 7 X 3.75 pleated mask with 15-16 inch ties and 5 inch aluminum nose band | |
| Mask style | Same | Pleat tucks at 1.5, 2.1 and 2.7 inches | |
| Design features | Same | Tie-On or ear loops | |
| NIOSH certification number (when available) | N/A | N/A | |
| Performance Characteristics | Test Method | Predicate Results (K022256) | Acceptance Criteria or Results |
| Fluid Resistance Performance (mmHg) | ASTM F 1862 - 80 mmHg | No visual detection of penetration. | Passed |
| Particulate Filtration Efficiency Performance (%) | ASTM F2299 - 0.1um | 2.0 microns | 98.7% |
| Bacterial Filtration Efficiency Performance (%) | ASTM F2101-01 | 97.9% | 99.9% |
| Differential Pressure (Delta-P) (mm H2O/cm2) | Mil- M369454C | 1.8 | 2.0 - 2.5 |
| Flammability class Class 1 | 16 CFR 1610 | 2 | Classified as Class I |
.
.
2
K093901/5004
8. Conclusion:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and testing methods.
Similarities/Differences of the proposed device when compared to the predicate: 9.
The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be a stylized representation of a person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Epard Protective Products, Limited C/O Mr. Darren Reeves DP Distribution & Consulting, LLC 15637 Fox Cove Circle Moseley, Virginia 23120
SEP 1 0 2010
Re: K093901
Trade/Device Name: Surgical Face Mask ear loop yellow Surgical Face Mask ear loop blue Surgical Face Mask tie-on vellow Surgical Face Mask tie-on blue
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 31, 2010 Received: September 2, 2010
Dear Mr. Reeves:
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 Aci 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 Eederal Register.
4
Page 2- Mr. Reeves-
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,
Wh for
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
5
K 093901/5004
Indications for Use
510(k) Number (if known):
Device Name:
- Surgical Face Mask ear loop yellow .
- Surgical Face Mask ear loop blue .
- Surgical Face Mask tie-on yellow .
- Surgical Face Mask tie-on blue .
Surgical Face Mask
Indications for Use:
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
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) ोक्ति
(Disister Billing Diffit) (Division of Anastlessiskogy General Hospitalal Division Controlo Dental Devicesses
1093901
510(k) Number.:
SEP 1 0 2010