(107 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 surgical mask, as described, is a barrier device designed to prevent the transfer of microorganisms and particulates, not to treat or cure a disease or condition.
No
A surgical mask is used to protect against the transfer of microorganisms, blood, and body fluids, and airborne particulates, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layer mask with material components and a nose piece, 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 is to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulates. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of a mask designed to filter and block substances. It does not mention any components or processes related to analyzing samples from the human body.
- Performance Studies and Key Metrics: The performance studies focus on the physical properties of the mask related to its barrier function (fluid resistance, particle filtration, breathability, flammability, biocompatibility). These are not diagnostic metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This surgical mask does not fit that description.
N/A
Intended Use / Indications for Use
The following surgical masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
-face mask (earloop) -face mask (tie-on) -surgical mask (earloop) -surgical mask (tie-on) -surgical face mask (earloop) -surgical face mask (tie-on)
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel and other general healthcare workers
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)
fluid resistance (ASTM 1862) - Fluid resistant; PFE (ASTM F2299) - Average 99.54% at 0.1 micron; BFE (ASTM F2101) - >99.9%; Flammability Class (16CFR 1610) - 1; Delta-P (MIL-M-36945C 4.4.1.1.1) - Average 3.38 mmH2O/cm²; Biocompatibility - No cytotoxicity (ISO 10993-5), No sensitization (ISO 10993-10), No irritation (ISO 10993-10).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(K) Summary
×122717
This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitter's Identification: Tiger Medical Products Ltd. Jaje Plaza, Suite 703 1717 North Sichuan Road Shanghai 200080 China
Contact person: Elaine Fong Tel: +86-21-6386-6300 Fax: +86-21-6386-6031 E-Mail: efong@tigermedicalgroup.com
-
Device Name: Surgical Mask Trade Name: Face Mask, Surgical Mask, Surgical Face Mask
-
Device Common Names: Mask, Surgical
-
Classification Name: Surgical Mask Product Code: FXX
5. Device Description:
Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.
6. Intended Use:
Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
7. SE Comparison to Predicate Device:
K061716 - Prestige Ameritech Face Mask
DEC 2 1 2012
1
・
.
| Description | Surgical mask | Predicate device (K061716) | SE discussion |
|---|---|---|---|
| Materials | Inner layer | ||
| Spunbond polypropylene | Spunbond polypropylene or | ||
| cellulose | Materials are similar | ||
| to the predicate | |||
| device | |||
| Middle | |||
| layer | |||
| Meltblown polypropylene | Meltblown polypropylene | ||
| Outer | |||
| layer | |||
| Spunbond polypropylene | Spunbond polypropylene or | ||
| medical grade tissue | |||
| Nosepiece | |||
| White Aluminum strip with PP | |||
| covering | Aluminum strip | ||
| Headband | |||
| Urethane elastic fiber earloop or | |||
| Spunbond polypropylene tie | Tie strip or elastic loop | ||
| Intended use | Surgical mask is intended for | ||
| single use by operating room | |||
| personnel and other general | |||
| healthcare workers to protect | |||
| both patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, blood and body | |||
| fluids, and airborne particulates. | Prestige Ameritech Surgical | ||
| Masks are single use disposable | |||
| devices intended to be worn in | |||
| the operating room as well as | |||
| dental, isolation and other | |||
| medical procedures to protect | |||
| both the patient and healthcare | |||
| personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | Intended use is the | ||
| same as the predicate | |||
| device | |||
| Mask style | Flat pleated | Flat pleated | Mask style is the |
| same as the predicate | |||
| device | |||
| Design feature | Earloop or tie-on | Earloop or tie-on | Design feature is the |
| same as the predicate | |||
| device | |||
| Performance test | |||
| result | Surgical mask | Predicate device (K061716) | SE discussion |
| Fluid resistance | |||
| (ASTM 1862) | Fluid resistant | Fluid resistant | Fluid resistance |
| performance is the | |||
| same as the predicate | |||
| device | |||
| PFE | |||
| (ASTM F2299) | Average 99.54% at 0.1 micron | 98.5% at 0.1 micron | PFE performance is |
| similar to the | |||
| predicate device | |||
| BFE | >99.9% | 99.6% | BFE performance is |
| (ASTM F2101) | similar to the | ||
| predicate device | |||
| Flammability | |||
| Class | |||
| (16CFR 1610) | 1 | 1 | Flammability is of the |
| same class as the | |||
| predicate device | |||
| Delta-P | |||
| (MIL-M-36945C | |||
| 4.4.1.1.1) | Average 3.38 mmH2O/cm² | 2.6 mmH2O/cm² | Comfort scale of face |
| mask is warm, while | |||
| the predicate device is | |||
| cool. The difference | |||
| does not affect use. | |||
| Biocompatibility | No cytotoxicity (ISO 10993-5) | ||
| No sensitization (ISO 10993-10) | |||
| No irritation (ISO 10993-10) | Pass | Biocompatibility | |
| performance is the | |||
| same as the predicate | |||
| device |
.
.
・
: .
2
8. Conclusion:
·
Materials, intended use, mask style, design feature, and most performance test result of surgical mask is similar to or the same as the predicate device. The difference between surgical mask and the predicate device does not raise any question to safety and effectiveness. Surgical Mask is substantially equivalent to the predicate device.
Date: Aug.30, 2012
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
Ms. Elaine Fong Tiger Medical Products, Limited Jaje Plaza, Suite 703 1717 North Sichuan Road Shanghai, China 200080
Re: K122717
Trade/Device Name: Surgical Mask Regulation Number: .21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: November 28, 2012 Received: November 28, 2012
Dear Ms. Fong:
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.
4
Page 2 - Ms. Fong
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,
Anthony Lo m
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
5
Indications for Use
510(k) Number (if known): K (22-717
Surgical Mask Device Name:
Indications for Use:
The following surgical masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
-face mask (earloop) -face mask (tie-on) -surgical mask (earloop) -surgical mask (tie-on) -surgical face mask (earloop) -surgical face mask (tie-on)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Elizabeth F. Claverie
2012.12.20 14:00:15 -05'00'
Page I of 1
stheslology, General Hospitial
510(k) Number: