(125 days)
Not Found
No
The device description and intended use clearly describe a physical surgical mask made of standard materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device acts as a protective barrier to prevent transfer of microorganisms and particulates, rather than actively treating a medical condition or disease.
No
The device is described as a protective nose and mouth covering (surgical mask) used in medical procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components (polypropylene, tissue paper, elastic, aluminum wire) and does not mention any 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 provide a physical barrier for the nose and mouth to protect against the transfer of microorganisms, body fluids, and particulate aerosols during medical and surgical procedures. This is a protective function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of a mask. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This mask does not perform any such function.
N/A
Intended Use / Indications for Use
The medical/surgical masks listed below are 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The new surgical masks are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% medical grade tissue paper or 100% 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. Please refer to Section 6 for the complete device description summary.
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)
Not Found
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
SEP 2 0 2005
510 (K) Summary
| 5.1 Device Trade Name: | Non-Sterile Surgical Mask |
|---|---|
| 5.2 Named and Address of | |
| Manufacturer: | A.R. Medicom Inc. |
| 1200 55th Avenue, | |
| Lachine, Quebec | |
| H8T 3J8 Canada | |
| Establishment | |
| Registration Number: | 9680179 |
| Contact Person: | Luc Trepanier |
| Corporate Director, Regulatory Affairs and Quality | |
| Quality Assurance | |
| Tel: (514) 636-6262 | |
| Fax: (514) 636-6267 | |
| E-mail: ltrepani@medicom.ca | |
| 5.3 Device Classification | |
| Name: | Mask, Surgical |
| Classification/Panel: | Class II, §878.4040 |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Product Code: | FXX |
| Recognized Performance | |
| Standard | ASTM 2100-04 |
| Refer to Appendix B for a list of applicable standards | |
| 5.4 Predicate Devices, | |
| 510(k) Number | 1. Surgical Mask (non-sterile), K955513 |
| 2. Valumax Surgical Masks (Blue, Pink, Green, | |
| Yellow) K040333 | |
| 5.5 Intended Use: | The medical/surgical masks listed below |
| are 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. | |
| A list of mask models may be found in Appendix A. | |
| Further details regarding indications for use may be | |
| found in the Substantial Equivalence Summary in | |
| Section 8. | |
| 5.6 510(k) Statement | A 510(k) statement for the new device, as required by |
| 21 CFR 93, is replaced with this 510(k) summary. | |
| 5.6 Truthful and Accurate | |
| Statement | A truthful and accurate statement as required by 21 |
| CFR | |
| 807.87(j) may be found in Appendix D | |
| 5.7 Proposed Labeling | A draft copy of the proposed labeling may be found in |
| Appendix E. Samples of the predicate device labeling | |
| may be found in Appendix F. | |
| 5.8 Device Description | The new surgical masks are pleated 3-ply masks. The |
| outer layers are made with 100% spun-bound | |
| polypropylene (SBPP). The filter media is composed of | |
| 100% melt-blown polypropylene (MBPP). The inner | |
| layer is made of either 100% medical grade tissue paper | |
| or 100% 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. Please refer to Section 6 for | |
| the complete device description summary. |
1
2
Image /page/2/Picture/1 description: The image contains the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Public Health Service
SEP 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Luc Trepanier Corporate Director, RA/QA A.R. Medicom, Incorporated 1200 55th Avenue Lachine, Quebec H8T 3J8 CANADA
Re: K051291
Trade/Device Name: Non-Sterile Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: August 25, 2005 Received: August 29, 2005
Dear Mr. Trepanier:
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 approvisions 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wr device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device tax may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Trepanier
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rood that 122 a determination that your device complies with other requirements mount that I Driving may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouchar title Act's requirements, including, but not limited to: registration r od intist contify with and and manufacturing (21 CFR Part 801); good manufacturing practice alle fishing (21 OF re rate over), systems (QS) regulation (21 CFR Part 820); and if requirements as set form in at radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter while with J . The FDA finding of substantial equivalence of your device to a premarrest notified bredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), if you donte the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Fart 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snette Y. Michael Im-D
Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K051291
Device Name: Refer to Attachment SII-1
Indications For Use:
The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks for indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aeroso! transfer.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use X ============================================================================================================================================================================ (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)
Shiela A. Murphy, MD 9/20/05
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 051241
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