(212 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a surgical mask, with no mention of AI or ML technology.
No.
The device is a surgical face mask designed for protection, not for treating or preventing a disease or condition.
No
Explanation: The device, a surgical face mask, is described as a protective nose and mouth covering to prevent the transfer of microorganisms, body fluids, and particulate aerosols. Its intended use focuses on protection and risk reduction during medical and surgical procedures, not on diagnosing any medical condition.
No
The device description clearly outlines physical components like polypropylene, tissue paper, elastic, and aluminum wire, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a protective nose and mouth covering for healthcare workers and patients during medical and surgical procedures. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the materials and construction of a physical mask. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on physical and mechanical properties (filtration efficiency, fluid resistance) and biocompatibility. These are relevant to the protective function of a mask, not to in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results.
In vitro diagnostics are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 10000 melt-blown polypropylene (MBPP). The inner layer is made of either 10000 medical grade tissue paper or 10000 SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices. The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
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
Health care workers and patients involved in medical and surgical 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)
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Angeline Group Ltd. Surgical Face Mask. The physical and mechanical tests were conducted in accordance with EN 14683:2005 Surgical masks, Requirements and test methods, and the biocompatibility tests were conducted in accordance with ISQ10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. All the test results demonstrate the performance of Angeline Group Ltd. Surgical Face Mask meets the requirements of its pre-defined acceptance criteria and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency: 99%
Fluid Resistance: Passed at 120 mmHg (EN 14683: 2005)
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
AUG - 5 2011
Angeline Group Ltd. 510(k) Notification
Type of Submission:
5.1
Surgical Face Mask Type: Tie-on, Ear-loop
510(k) Summary
Traditional
| 5.2 Submitter: | Angeline Group Ltd. |
|---|---|
| Address: | No.9-2f, Lane 206, Jhonggang Road, Hsinjuang City, Taipei, Taiwan, 242 |
| Phone: | +886-2-8993-5668 |
| Fax: | +886-2-2992-7367 |
| Contact: | Charles Sun |
| Establishment Registration Number: | N/A |
5.3 Identification of the Device:
| Proprietary/Trade name: | Surgical Face Mask, Type: Tie-on, Ear-loop |
|---|---|
| Common Name: | Surgical Face Mask, Disposable |
| Classification Name: | Mask, Surgical |
| Device Classification: | II |
| Regulation Number: | 878.4040 |
| Panel: | General & Plastic Surgery |
| Product Code: | FXX |
5.4 Identification of the Predicate Device:
| Predicate Device Name: | Non-Sterile Surgical Mask |
|---|---|
| Manufacturer: | A.R. Medicom Inc. |
| 510(k) Number or Clearance Information: | K051291 |
5.5 Intended Use and Indications for Use of the subject device.
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.
15
1
Surgical Face Mask Type: Tie-on, Ear-loop
5.6 Device Description
Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 10000 melt-blown polypropylene (MBPP). The inner layer is made of either 10000 medical grade tissue paper or 10000 SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices. The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
5.7 Non-clinical Testing
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Angeline Group Ltd. Surgical Face Mask. The physical and mechanical tests were conducted in accordance with EN 14683:2005 Surgical masks, Requirements and test methods, and the biocompatibility tests were conducted in accordance with ISQ10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. All the test results demonstrate the performance of Angeline Group Ltd. Surgical Face Mask meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Angeline Group Ltd. Surgical Face Mask is as safe and effective as the predicate devices.
5.8 Safety and Effectiveness
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
2
Surgical Face Mask Type: Tie-on, Ear-loop
5.9 Substantial Equivalence Determination
The Angeline Group Ltd. Surgical Face Mask submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared A.R. Medicom Inc. Non-Sterile Surgical Mask which is the subject of K051291. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Predicate Device
(K051291, A.R. Medicom Inc. Non-Sterile
Surgical Mask) | Proposed Device
(Angeline Group Ltd.
Surgical Face Mask, Type:
Tie-on, Ear-loop) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Similarity | | |
| Intended Use | Intended as a protective nose and mouth
covering for health care workers and
patients involved in medical and surgical
procedures. The masks are indicated in any
procedure or situation where there is a risk
of microorganism, body fluid, and
particulate aerosol transfer. | Same |
| Materials | Out layer: SBPP
Filter: MBPP
Inner Layer: SBPP
Ear Loop: Elastic
Nosepiece: Aluminum | Same
Same
Same
Same
Same |
| Sample types | Tie-on, Ear-loop | Same |
| Design | Fluid resistant
Flat, pleated | Same
Same |
| Sterile | No | Same |
| Single Use | Yes | Same |
| Difference | | |
| Bacterial Filtration
Efficiency | 98% | 99% |
3
Surgical Face Mask Type: Tie-on, Ear-loop
| Performance (%) | ||
|---|---|---|
| Fluid Resistance | ASTM F1862-05, | EN 14683: 2005, |
| Performance (mmHg) | Passed at 80 mmHg | Passed at 120 mmHg |
5.10Conclusion
Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop has the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the different technological characteristics do not raise any new questions of safety or effectiveness. In conclusion, Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop maintains the same safety and effectiveness as the substantially equivalent predicate devices, Non-Sterile Surgical Mask.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the figure. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Angeline Group Limited C/O Mr. Michael Lee President ACME Biotechs Company, Limited No.45, Minsheng Road Danshui Town Taipei County China (Taiwan) 251
AUG - 5 2011
Re: K110027
Trade/Device Name: Surgical Face Mask, Type: Tie-on, Ear-Ioop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 20, 2011 Received: July 20, 2011
Dear Mr. Lee:
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.
5
Page 2 - Mr. Lee
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
6
Surgical Face Mask Type: Tie-on, Ear-loop
Indications for Use
510(k) Number (if known):
Device Name: Surgical Face Mask, Type: Tie-on, Ear-loop
Colors: White/Light Blue/Light Green/Light Yellow
Indications for Use:
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.
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 IF NEEDED)
ht
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K110027
37