(229 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
A therapeutic device is one that treats or alleviates a disease or condition. This device is a surgical face mask intended to "protect both the surgical patient and the operation room personnel from transfer of bacteria, body fluid and particulate material," which is a protective function, not a therapeutic one.
No
Explanation: The device is a surgical face mask designed to protect against the transfer of bacteria, body fluid, and particulate material. Its intended use is protection during surgical procedures, not for diagnosing any condition or disease.
No
The device description clearly outlines physical components (spunbonded polypropylene, melt blown polypropylene filter material, elastic loops, malleable aluminum wire) and the performance studies are focused on physical properties and filtration efficiency, not software functionality.
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 mask is for protecting both the surgical patient and operating room personnel from the transfer of bacteria, body fluid, and particulate material. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nosepiece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of Diagnostic Elements: The document does not mention any elements related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, differential pressure, flammability, biocompatibility). These are relevant to its function as a barrier, not as a diagnostic tool.
- Key Metrics: The key metrics (BFE, Delta-P, Particulate Filtration Efficiency) are measures of the mask's ability to filter particles and allow for breathing, not diagnostic accuracy.
In summary, the device's purpose and characteristics align with a personal protective equipment (PPE) device designed to prevent the spread of contaminants, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Surgical Face Mask of different colors (Blue, White, and Green) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of bacteria, body fluid and particulate material.
This Surgical Face Mask is non-sterilized and disposable.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops. The nosepiece for all Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are malleable aluminum wire. All the materials used in the construction of the Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are being used in currently marked devices.
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
medical device suppliers, Dentist and Doctor Officers, clinics, Emergency Response Professionals, Hospitals and other healthcare professional
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 Performed for Determination of Substantial Equivalence:
- Fluid Resistance (ASTM F1862-05): Synthetic Blood Penetration Resistance Test
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM F2101-01) and Particulate Filtration Efficiency (latex Particle challenge) (ASTM F1215)
- Differential Pressure (Delta-P) Test (MIL M 36954 C)
- Flammability Test (16CFR 1610)
- Biocompatibility per ISO 10993-5 /-10
Key results: performance testing met all relevant requirements of the aforementioned test standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- BFE(%): Higher than 99.9%
- Delta-P: Average 3.33 (mmH2O/cm²) for Air Exchange Pressure
- Particulate Filtration Efficiency Performance (%): Average 94.79% for Solid Aerosol Filtration Efficiency, More than 99.5% for Viral Filtration Efficiency
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
Acme Filter Mas
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941, Taiwan, R.O.C.
" 510(k) SUMMARY "
MAY 2 0 2013
September 23, 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : __ K123115
Submitter's Name: Acme Filter Mask Inc.
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941,Taiwan, R.O.C.
Date summary prepared:
Device Name:
- Mask, Surgical Classification name: .
- Classification number: FXX, Class II ●
- Regulation Number: 878.4040 .
- Surgical Face Mask with Ear-Loop ● Proprietary name:
YN-501AB, YN-501AW, YN-501AG for Blue, White, Green Product model: One size for different colors (Blue, White, Green)
- Common name of device: Surgical Face Mask, Disposable ●
- Surgical Face Mask, Type: Tie-on, Ear-loop, K063043 . Predicate Device:
- Official Correspondent: Dr. Jen. Ke-Min ●
E-mail: ceirs.jen@msa.hint.net (Tel) +886-3-5208829; (Fax) +886-3-5209783
Description of the device:
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops. The nosepiece for all Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are malleable aluminum wire. All the materials used in the construction of the Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are being used in currently marked devices.
Labels/Labeling:
This device will be marked to medical device suppliers, Dentist and Doctor Officers, clinics, Emergency Response Professionals, Hospitals and other healthcare professional for the Intended Use purpose below:
1
Acme Filter Mask Inc.
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941, Taiwan, R.O.C.
Intended Use:
Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Comparison to Predicate Devices:
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is substantially equivalent for the safety and effectiveness to the Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop:
| | Modern Healthcare Corp.
Surgical Face Mask
(K063043) | ACME Filter Mask Inc.
Surgical Face Mask
(K123115) |
|------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Similarity: | | |
| Fluid Resistance | Fluid Resistance | Fluid Resistance |
| Flammability
Class | Class I
(No Flame Spread) | Class I
(No Flame Spread) |
| Regulatory Class | Class II
(ASTM2100-04 Low Barrier) | Class II |
| BFE(%) | Higher than 99% | Higher than 99.9% |
| Difference: | | |
| Type | Tie-on and Ear-loop
(Green, White, Blue, Pink) | Ear-Loop
(Green, White, Blue) |
| Delta-P | Average 2.6 | Average 3.33 ( $mmH_2O/cm^2$ )
for Air Exchange Pressure |
| Particulate
Filtration
Efficiency
Performance (%) | Average 96.8% at 0.1 micron | Average 94.79% for Solid Aerosol
Filtration Efficiency
More than 99.5% for Viral
Filtration Efficiency |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- Fluid Resistance (ASTM F1862-05): Synthetic Blood Penetration Resistance Test 】.
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM F2101-01) II. and Particulate Filtration Efficiency (latex Particle challenge) (ASTM F1215)
- Differential Pressure (Delta-P) Test (MIL M 36954 C) III.
- Flammability Test (16CFR 1610) IV.
- Biocompatibility per ISO 10993-5 /-10 V.
It was our conclusion that performance testing met all relevant requirements of the aforementioned test standard.
2
Acme Filter Mask Inc.
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941, Taiwan, R.O.C.
Discussion of Clinical Tests Performed:
Not Applicable
Conclusions:
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop has the same intended use and technological characteristics as the predicated devices Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop (K063043). Especially, the predicate device's types are Tie-on and Ear-loop; and the subject device just for Ear-loop. Besides, the bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness.
Thus the new device is substantially equivalent to the predicate devices.
3
Acme Filter Mask Inc
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941, Taiwan, R.O.C.
COMPARISON INFORMATION 7.
We place the 510K information for the predicate device thereafter this section.
Comparison to Predicate Devices:
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is substantially equivalent for the safety and effectiveness to the Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop:
| Item | Modern Healthcare Corp.
Surgical Face Mask
(K063043) | ACME Filter Mask Inc.
Surgical Face Mask
(K123115) |
|------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Similarity: | | |
| Fluid Resistance | Fluid Resistance | Fluid Resistance |
| Flammability
Class | Class I
(No Flame Spread) | Class I
(No Flame Spread) |
| Regulatory Class | Class II
(ASTM2100-04 Low Barrier) | Class II |
| BFE(%) | Higher than 99% | Higher than 99.9% |
| Difference: | | |
| Type | Tie-on and Ear-loop
(Green, White, Blue, Pink) | Ear-Loop
(Green, White, Blue) |
| | | |
| Delta-P | Average 2.6 | Average 3.33 (mmH2O/cm²)
for Air Exchange Pressure |
| Particulate
Filtration
Efficiency
Performance (%) | Average 96.8% at 0.1 micron | Average 94.79% for Solid Aerosol
Filtration Efficiency
More than 99.5% for Viral
Filtration Efficiency |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- I. Fluid Resistance (ASTM F1862-05): Synthetic Blood Penetration Resistance Test
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM F2101-01) X. and Particulate Filtration Efficiency (latex Particle challenge) (ASTM F1215)
- differential Pressure (Delta-P) Test (MIL M 36954 C) XI.
- Flammability Test (16CFR 1610) XII.
- XIII. Biocompatibility per ISO 10993
It was our conclusion that performance testing met all relevant requirements of the aforementioned test standard.
4
Acme Filter Mask Inc.
No.57, Hu Shan Road, Yingge District, New Taipei City, 23941,Taiwan, R.O.C.
Discussion of Clinical Tests Performed:
Not Applicable
Conclusions:
Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop has the same intended use and technological characteristics as the predicated devices Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop (K063043). Especially, the predicate device's types are Tie-on and Ear-loop; and the subject device just for Ear-loop. The performance tests for the Delta-P and Particulate Filtration Efficiency Performance also have the similar effectiveness. Besides, the bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness.
Thus the new device is substantially equivalent to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three abstract human figures intertwined, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the emblem in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 20, 2013
Dr. Ke-Min Jen ACME Filter Mask No. 57 Hu Shan Road Yingge District, New Taipei City, Taiwan R.O.C. 23941
Re: K123115
Trade/Device Name: Surgical Face Mask with Ear-Loop Model: YN-501AB, YN-501AW, YN-501AG for Blue, White, Green Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: April 12, 2013 Received: April 17, 2013
Dear Dr. Jen:
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. 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
6
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 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" (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 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.
Image /page/6/Picture/6 description: The image shows a signature block. The text "Sincerely yours," appears at the top. Below that is a signature and the name "Tejashri Purohit-Sheth, M.D." followed by the title "Clinical Deputy Director" and the acronym "DAGRID". Finally, the word "FOR" is at the bottom right.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________ K123115
Device Name: Surgical Face Mask with Ear-Loop Model: YN-501AB, YN-501AW, YN-501AG for Blue, White, Green
Indications for Use:
The Surgical Face Mask of different colors (Blue, White, and Green) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of bacteria, body fluid and particulate material.
This Surgical Face Mask is non-sterilized and disposable.
Prescription Use
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ri S. Purohitsheth -S 17 13:52:16
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental
510(k) Number:
P 5
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