(125 days)
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.
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.
The device in question is a Non-Sterile Surgical Mask manufactured by A.R. Medicom Inc. The filing is a 510(k) Summary, indicating a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the traditional sense of AI/medical imaging device performance.
Therefore, the "acceptance criteria" for a surgical mask are typically based on recognized performance standards, which in this case is ASTM F2100-04, "Standard Specification for Performance of Materials Used in Medical Face Masks." The "study" that proves the device meets these criteria would involve various material and barrier property tests, not a clinical trial with human readers or AI.
Given the nature of the device (a surgical mask) and the provided document (a 510(k) Summary for a medical device cleared in 2005), many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, AI standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/software as a medical device or diagnostic imaging devices, not a physical barrier device like a surgical mask.
However, I will address the relevant aspects based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For surgical masks, "acceptance criteria" and "reported device performance" are typically defined by recognized consensus standards. In this case, ASTM F2100-04 is listed as the recognized performance standard. This standard categorizes masks into different levels based on their performance in a series of tests. While the exact performance levels for this specific mask are not detailed in the provided 510(k) summary (only the standard itself is mentioned as being applicable), the various tests and their criteria from ASTM F2100-04 are implied to be the 'acceptance criteria'.
The 510(k) summary states that the device is "substantially equivalent" to predicate devices K955513 and K040333, implying it meets similar performance standards. The device's description (3-ply, spun-bound polypropylene outer layers, melt-blown polypropylene filter media, medical grade tissue paper or SBPP inner layer) strongly suggests the materials are chosen to meet these performance characteristics.
| Test Parameter from ASTM F2100-04 (Implied Acceptance Criteria) | Reported Device Performance (Implied from 510(k) based on substantial equivalence to predicate and meeting ASTM F2100-04) |
|---|---|
| Bacterial Filtration Efficiency (BFE) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., ≥95% or ≥98%) |
| Particle Filtration Efficiency (PFE) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., ≥95% or ≥98% at 0.1 micron) |
| Fluid Resistance | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., 80, 120, or 160 mmHg) |
| Differential Pressure (Breathability) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., <5.0, <6.0 mm H2O/cm²) |
| Flammability | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., Class 1) |
Note: The 510(k) summary explicitly refers to "ASTM 2100-04" as a "Recognized Performance Standard" and states that "Refer to Appendix B for a list of applicable standards." This indicates that the device's performance was evaluated against the requirements of this specification, and thus it meets the stated performance levels defined within ASTM 2100-04 for surgical masks. Without Appendix B or the full testing report, the exact numerical performance values (e.g., a specific BFE percentage) are not detailed in this summary.
Study that Proves the Device Meets the Acceptance Criteria:
The filing is a 510(k) summary, which indicates a submission to demonstrate substantial equivalence to existing legally marketed devices, rather than a novel study designed to establish acceptance criteria for an entirely new technology. The "study" here refers to the collection of data and tests (likely in-vitro and material property tests) performed to show that the surgical mask complies with the recognized performance standard ASTM F2100-04 and is substantially equivalent to the predicate devices.
The evidence for meeting acceptance criteria is typically derived from laboratory testing of the mask materials and design according to the methods prescribed by the ASTM F2100-04 standard. These tests would evaluate parameters such as bacterial filtration efficiency, particle filtration efficiency, fluid resistance, breathability, and flammability. The results of these tests, when compared against the thresholds defined in ASTM F2100-04, demonstrate compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the 510(k) summary. For material performance tests like those required for surgical masks, sample sizes are typically determined by the testing methodology outlined in the relevant ASTM or ISO standards to ensure statistical validity for the specific tests (e.g., multiple masks or multiple samples from a mask might be tested for each parameter).
- Data Provenance: Not explicitly stated, but the manufacturer is A.R. Medicom Inc., located in Lachine, Quebec, Canada. Testing would likely be conducted at certified laboratories, either internal or third-party, which may be in Canada or elsewhere. The nature of these tests is not "retrospective" or "prospective" in the clinical trial sense, but rather laboratory-based characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a physical barrier device like a surgical mask, "ground truth" is not established by clinical experts in the way it is for diagnostic imaging or AI devices. The "ground truth" is based on objective, quantifiable measurements from standardized laboratory tests (e.g., the measured bacterial filtration efficiency percentage). The "experts" involved would be laboratory technicians and engineers experienced in conducting ISO/ASTM standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting medical images or clinical data. This is not relevant for the performance testing of a surgical mask.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are used to evaluate the diagnostic performance of human readers, often with and without AI assistance, typically in medical imaging. This is not relevant for a surgical mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the evaluation of an AI algorithm's performance without human interaction. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a surgical mask's performance is established by objective measurements from physical property tests conducted according to recognized standards (e.g., ASTM F2100-04). Examples include:
- Bacterial Filtration Efficiency (measured percentage)
- Particle Filtration Efficiency (measured percentage)
- Fluid penetration resistance (measured pressure in mmHg)
- Differential pressure (measured value in mm H2O/cm²)
- Flammability (classification per standard test)
These are empirical facts determined by standardized test methods, not subjective consensus or clinical outcomes from patients.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of medical device.
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SEP 2 0 2005
510 (K) Summary
| 5.1 Device Trade Name: | Non-Sterile Surgical Mask |
|---|---|
| 5.2 Named and Address ofManufacturer: | A.R. Medicom Inc.1200 55th Avenue,Lachine, QuebecH8T 3J8 Canada |
| EstablishmentRegistration Number: | 9680179 |
| Contact Person: | Luc TrepanierCorporate Director, Regulatory Affairs and QualityQuality AssuranceTel: (514) 636-6262Fax: (514) 636-6267E-mail: ltrepani@medicom.ca |
| 5.3 Device ClassificationName: | Mask, Surgical |
| Classification/Panel: | Class II, §878.4040 |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Product Code: | FXX |
| Recognized PerformanceStandard | ASTM 2100-04Refer 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 beloware indicated as a protective nose and mouth coveringfor health care workers and patients involved in medicaland surgical procedures. The masks are indicated inany procedure or situation where there is a risk of |
| microorganism, body fluid, and particulate aerosoltransfer. | |
| A list of mask models may be found in Appendix A.Further details regarding indications for use may befound in the Substantial Equivalence Summary inSection 8. | |
| 5.6 510(k) Statement | A 510(k) statement for the new device, as required by21 CFR 93, is replaced with this 510(k) summary. |
| 5.6 Truthful and AccurateStatement | A truthful and accurate statement as required by 21CFR807.87(j) may be found in Appendix D |
| 5.7 Proposed Labeling | A draft copy of the proposed labeling may be found inAppendix E. Samples of the predicate device labelingmay be found in Appendix F. |
| 5.8 Device Description | The new surgical masks are pleated 3-ply masks. Theouter layers are made with 100% spun-boundpolypropylene (SBPP). The filter media is composed of100% melt-blown polypropylene (MBPP). The innerlayer is made of either 100% medical grade tissue paperor 100% SBPP. The ear loops are made of flat latexand fiberglass free elastic. The nosepieces are made ofmalleable aluminum wire. All of the materials used inthe construction of the new masks are being used incurrently marketed devices. Please refer to Section 6 forthe complete device description summary. |
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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.
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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
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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
Page 1 of 2
§ 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.