(195 days)
Not Found
No
The document describes a standard surgical mask and makes no mention of AI or ML technology.
No
The device is a surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Explanation: The Technoweb Surgical Mask is designed to provide a physical barrier to protect against the transfer of microorganisms, body fluids, and particulate material. It does not analyze patient data or provide medical diagnoses, which are characteristics of diagnostic devices.
No
The device description clearly describes a physical surgical mask made of nonwoven layers, indicating it is a hardware device, not software.
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 surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, materials, tie-on/ear-loop). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a surgical mask, which falls under the category of personal protective equipment (PPE) and medical devices used for barrier protection.
N/A
Intended Use / Indications for Use
The Technoweb Sugical Mask is 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.
Product codes
FXX, MSH
Device Description
Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
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
operating room personnel / operating room
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)
Laboratory testing regarding characteristics was performed on Technoweb surgical mask to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of Technoweb surgical mask.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is in bold, uppercase letters.
May 18, 2018
Yts Global Inc. Eddie Nguven Senior Logistics Specialist 7406 Alban Station Court Suite A108 Springfield, Virginia 22150
Re: K172500
Trade/Device Name: Technoweb Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 23, 2018 Received: January 29, 2018
Dear Eddie Nguven:
This letter corrects our substantially equivalent letter of March 01, 2018.
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 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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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Page 2 - Eddie Nguyen
801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
FDA Tina Kiang
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
く
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Indications for Use
510(k) Number (if known) K172500
Device Name Technoweb Surgical Mask
Indications for Use (Describe)
The Technoweb Sugical Mask is 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.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
The assigned 510(k) number is : K172500
| 510(k) Owner/Applicant | Finetex EnE, inc |
|---|---|
| US Correspondent | Eddie Nguyen |
| YTS GLOBAL INC | |
| 7406 ALBAN STATION COURT SUITE A108 | |
| SPRINGFIELD, VA 22150 | |
| (703)340-8178 | |
| Date Prepared | February 26, 2018 |
| Trade Name | Technoweb Surgical Mask, |
| Common Name | Surgical Respirator |
| Classification Name | Surgical Apparel |
| Review Panel | General Hospital |
| Product Code | MSH |
| Device Classification | Class II per 21 CFR 878.4040 |
| Predicate Device | 3M VFlexTM Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S |
| cleared under K121069 |
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| Proprietary | Finetex EnE, inc | 3M Health Care | Substantial
Equivalence | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------|
| Common Name | TechnoWeb Surgical Mask | 3MTM VFlexTM HealTh Care
Particulate Respirator and
Surgical mask, | SAME | |
| Model Number | TM-R, TM-S | 1805/1805S | - | |
| Manufacturer | Finetex EnE, inc | 3M Health Care | - | |
| 510(k) Reference Number | K172500 | K121069 | | |
| Intended use | Surgical Mask/Respirator | Surgical Mask/Respirator | SAME | |
| Design | Image: Finetex EnE, inc mask | Image: 3M Health Care mask | SIMILAR | |
| Single Use | Yes | Yes | SAME | |
| Material | Outside
cover web | Felt | Polypropylene spunbond | SIMILAR |
| | Stiffener web | N/A | Polypropylene spunbond | SIMILAR |
| | Filter web | Felt | Polypropylene | SIMILAR |
| | Inner web | Felt | Polypropylene | SIMILAR |
| | Nose-Clip | Aluminum | Aluminum | SAME |
| | Staple | N/A | Steel | SIMILAR |
| | Headband | Nylon | Polyisoprene | SIMILAR |
| | Nose foam | Plastic coating | N/A | SIMILAR |
| Dimensions | TM-R is 212mm(W), 74mm(H)
and model TM-S is 177.8
mm(W), 138 mm(H). | | SIMILAR | |
| Product style | Flat fold | Flat fold | SAME | |
| Design Features | Ear loops | Advanced Electostatic Media | SIMILAR | |
| Fluid Resistance
(ASTM F1862) | fluid resistance at 12 mmHg. | YES | SIMILAR | |
| Indication for Use | is 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. | is 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. | SAME | |
| Device Description | Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between. | | | |
| Intended Use | The Technoweb Sugical Mask is 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. | | | |
| Model Numbers | TM-R and TM-S (Different Sizes) | | | |
| Technological
Characteristics | Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between. | | | |
| Performance
Testing | Laboratory testing regarding characteristics was performed on Technoweb surgical mask to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of Technoweb surgical mask. | | | |
| Conclusions | Finetex EnE, inc concludes that the Technoweb surgical mask is as safe and as effective and is substantially equivalent to predicate device, 3M Health Care Particulate Respirator and Surgical Mask, | | | |
Table - Substantial Equivalence Comparison.
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