(298 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
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical mask, which is a protective barrier, not a treatment.
No
A diagnostic device is used to identify or detect a disease or condition. This device, a surgical mask, is indicated for protection against the transfer of microorganisms, body fluids, and particulate material, not for diagnosis.
No
The device description clearly states it is a physical surgical mask made of materials like PP, Meltblown, elastic loops, and a nosepiece, and the performance studies are physical tests (biocompatibility, flammability, filtration efficiency, etc.), not software performance metrics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Pasture 60S Surgical Mask Function: The description clearly states that the Pasture 60S Surgical Mask is used by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample.
The information provided about the mask's performance (filtration efficiency, fluid resistance, etc.) relates to its ability to act as a barrier, which is consistent with its intended use as a surgical mask, not an IVD.
N/A
Intended Use / Indications for Use
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.
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 during 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)
Performance Tests:
- Biocompatibility test: SUPER LABORATORY SGS (TAIWAN) LTD
- Flammability test : Taiwan Textile Research Institute
- Synthetic Blood Penetration test : Taiwan Textile Research Institute
- Particulate Filtration Efficiency : Nelson Laboratories
- Bacterial filtration efficiency: Taiwan Textile Research Institute
- Differential pressure testing: Taiwan Textile Research Institute
Key results:
- Fluid Resistance Performance: Pass@120mmHg
- Particulate Filtration Efficiency Performance (%): 99.4
- Bacterial Filtration Efficiency Performance (%): 99.76
- Differential Pressure (Delta-P) (mmH2O/cm2): 3.33
- Flammability Class: Class 1
- Sterile: Non-sterile
- Size: 184 +/- 1 x 144 +/- 1 mm
- Biocompatibility Test: Cytotoxicity: non-cytotoxic, Sensitization: non-sensitizing, Primary skin irritation: non-irritating
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance: Pass@120mmHg
- Particulate Filtration Efficiency Performance (%): 99.4
- Bacterial Filtration Efficiency Performance (%): 99.76
- Differential Pressure (Delta-P) (mmH2O/cm2): 3.33
- Flammability Class: Class 1
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 contains the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a graphic representation of a human figure, with three profiles layered on top of each other to create a sense of depth and dimension.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2015
Pasture Pharma Pte. Ltd Mrs. Sarah Hassan US Med Pharm Supplies, Inc. 38129 Spring Canyon Drive Murrieta, CA 92563
Re: K141875
Trade/Device Name: Pasture 60S Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: March 24, 2015 Received: April 3, 2015
Dear Ms. Hassan.
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 - Mrs. Hassan
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 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
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Indications for Use
510(k) Number (if known) K141875
Device Name Pasture 60S Surgical Mask
Indications for Use (Describe)
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92(c)
The assigned 510(k) number is: K141875
Manufacturer:
CHAMPAK ENTERPRISE CO., LTD. 27-1, Jhaiming St., Dasi Township, Taoyuan County, 335, Taiwan (R.O.C.)
Official Correspondent:
Lloyd Soong President & CEO Pasture Pharma Pte, Ltd 8 Boon Lay Way #04-01 Trade Hub 21, Singapore 609964
US agent and correspondent:
Mrs. Sarah Hassan US Med Pharm Supplies, Inc 38129 Spring Canyon Drive Murrieta, CA 92563 Phone: 951-239-1933 Fax: 951-239-1933 E-mail: sarah@usmedpharm.com
Date of Submission:
May 1, 2015
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Classification name:
Surgical Apparel
Proprietary Name:
Pasture 60S Surgical Mask
Device Classification and Product Code
Classification Name: Surgical Mask (21 CFR §878.4040) Class: Class II Classification panel: General and Plastic Surgery Product Code: FXX
Common name:
Surgical Mask
Regulatory Reference:
21 CFR 878.4040
Predicate Device:
TIDI PRODUCTS, LLC TIDI® Facemasks K092580
Labels/ Labeling:
Pasture 60S Surgical Mask will be marketed as single use disposable surgical mask for the Intended Use purpose below.
Intended Use:
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material
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Device Description:
Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.
Comparison to Predicated Devices:
The subject device is substantially equivalent to TIDI® Facemasks cleared under K092580.
| Description | Predicate
K092580 TIDI®
Facemasks | Pasture 60S Surgical
Mask |
|-----------------|-----------------------------------------------------------------|-----------------------------------------------------------|
| Outer layer | Polypropylene | Polypropylene |
| Filter Media | Melt-blown | Meltblown |
| Inner layer | Polypropylene | Polypropylene |
| Nose Piece | Aluminum | Combination of zinc wires
and embedded polyester |
| Ear Attachment | Elastic | Synthetic elastic |
| Mask style | Flat Pleated | Flat Pleated |
| Design features | 3 layers of non-woven
fiber with filter web in the
middle | 4 layers of non-woven
fiber containing a filter
web |
| Test | K092580 | Pasture 60S Surgical Mask |
|---|---|---|
| Fluid Resistance Performance | Pass@80mmHg | Pass@120mmHg |
| (mmHg) | ||
| Particulate Filtration | 99.6 | 99.4 |
| Efficiency Performance (%) | ||
| Bacterial Filtration Efficiency | >99.9 | 99.76 |
| Performance (%) | ||
| Differential Pressure | ||
| (Delta-P) (mmH2O/ cm2) | 3.4 | 3.33 |
| Flammability Class 1 | Class 1 | Class 1 |
| Sterile | Non-sterile | |
| Single use | Non-sterile | |
| Single use | ||
| Size | 7.0 x 3.5 inches | $184\pm1$ x $144\pm1$ mm |
| Indication for Use | Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material. | Pasture 60S Surgical Mask is a surgical mask indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. |
| Biocompatibility Test | Not available | |
| Not available | ||
| Not available | Cytotoxicity: non-cytotoxic | |
| Sensitization: non-sensitizing | ||
| Primary skin irritation: non-irritating |
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7
Performance Tests:
Test Performed Laboratory
1. Biocompatibility test: SUPER LABORATORY SGS (TAIWAN) LTD
-
- Flammability test : Taiwan Textile Research Institute
-
- Synthetic Blood Penetration test : Taiwan Textile Research Institute
-
- Particulate Filtration Efficiency : Nelson Laboratories
-
- Bacterial filtration efficiency: Taiwan Textile Research Institute
-
- Differential pressure testing: Taiwan Textile Research Institute
Conclusions:
The test data submitted in this submission demonstrate that the subject device is as safe and as effective as the predicate and technological characteristics do not raise any new questions of safety and as effectiveness. Pasture 60S Surgical Mask is substantially equivalent to the predicate cleared in K092580.