(377 days)
The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. For adult use.
The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier.
The provided document is a 510(k) summary for a surgical mask (Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01). It outlines the device's technical specifications and performance testing results to demonstrate substantial equivalence to a predicate device, rather than a study proving an AI/ML medical device meets acceptance criteria.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML clinical study (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document describes the physical and performance characteristics of a surgical mask, not the performance of an algorithm.
However, I can extract the acceptance criteria and performance data for the surgical mask based on the provided tables.
Acceptance Criteria and Device Performance (Surgical Mask)
| Item Tested | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| AA-US-SURGICAL-01 | ASTM F1862 | Fluid Resistance to Synthetic Blood | 160 mmHg | No penetration at 160 mmHg |
| AA-US-SURGICAL-01 | ASTM F2299 | Particulate Filtration Efficiency | >98% | Average 99.48% |
| AA-US-SURGICAL-01 | ASTM F2101 | Bacterial Filtration Efficiency | >98% | Average 99.4% |
| AA-US-SURGICAL-01 | ASTM F2100 | Differential Pressure | <5mmH2O | Average 4.7mm H2O |
| AA-US-SURGICAL-01 | CPSC CS-191-53 (16 CFR 1610) | Flammability | Class 1 | IBE, Class 1 |
| AA-US-SURGICAL-01 | ISO 10993-5 | Cytotoxicity | No signs of Toxicity | Grade 0, Non-Cytotoxic. PASS. |
| AA-US-SURGICAL-01 | ISO 10993-10 | Intracutaneous Irritation | Negligible signs of irritation | Non-irritant. PASS. |
| AA-US-SURGICAL-01 | ISO 10993-10 | Maximization Sensitization | Negligible signs of sensitization | Non-sensitizer. PASS. |
Regarding the AI/ML-specific questions, based on the provided document:
- Sample size used for the test set and the data provenance: Not applicable. This is for a physical medical device (surgical mask), not an AI/ML algorithm. The performance tests (e.g., fluid resistance, filtration efficiency) are conducted on samples of the mask, not a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a surgical mask's physical performance is established by standardized test methods and laboratory measurements, not expert consensus.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the physical mask, ground truth is established by the specified ASTM and CPSC standards and ISO biocompatibility tests, which define the measurable characteristics and acceptance criteria.
- The sample size for the training set: Not applicable. There is no training set for a physical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes the regulatory clearance of a surgical mask, not an AI/ML-driven medical device, hence information related to AI/ML study design is not present.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
January 26, 2022
Armbrust Inc. Landon Morales President Armbrust Inc, 3813 Helios Way Building B, Suite 290, Pflugerville, TX 78660 USA. 3813 Helios Way Building B, Suite 290 Pflugerville, Texas 78660
Re: K210101
Trade/Device Name: Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: December 21, 2021
Dear Landon Morales:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210101
Device Name
Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01
Indications for Use (Describe)
The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. For adult use.
| 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 G) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K210101
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. Sponsor | Armbrust Inc.3813 Helios WayBuilding B, Suite 290Pflugerville, TX 7866 |
|---|---|
| II. 510(k) Contact Person: | Landon MoralesPresident, Armbrust Inc.Email: landon@armbrustusa.comPhone: 561-809-1586 |
| Date : January 24, 2022 |
III. Device
| Name of the Device: | Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01 |
|---|---|
| Common Name: | Mask, Surgical |
| Classification Name: | Surgical Apparel (21 CFR §878.4040) |
| Device Product Code: | FXX |
| Regulatory Class: | Class II |
| IV. Predicate Device | |
| Predicate device 510(k): | K111402 |
| Predicate device name: | Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 FaceMask(s) |
This predicate device has not been subject to a design-related recall.
V. Device Description:
The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner
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layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier.
VI. Indications for Use:
The USA-Made Surgical Mask is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. For adult use.
Comparison of Technological Characteristics with the Predicate Device(s) VII.
Table 1 below is a high-level comparison between the subject device. Armbrust Inc. USA-Made Surgical Mask AA-US-SURGICAL-01 (K210101) and the predicate device, Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face Mask(s) (K111402).
| Feature | Subject DeviceUSA-Made SurgicalMask, Model AA-US-SURGICAL-01 | Predicate DeviceKimberly-Clark, ModelKC200 Face Mask(s),KC300 Face Mask(s) | Comparisonof Devices |
|---|---|---|---|
| 510(k) Number | K210101 | K111402 | N/A |
| Manufacturer | Armbrust Inc. | Kimberly-Clark | N/A |
| Indications for Use | The USA-Made SurgicalMask is intended to beworn by adults to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial within aprofessional healthcareenvironment. Thesesurgical masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. Foradult use. | The Kimberly-Clark,KC200 Face Mask(s)and KC300 FaceMask(s) are intended tobe worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure ofthe wearer to blood andbody fluids. TheKimberly-Clark, KC300face mask(s) is a singleuse, disposabledevice(s), provided non-sterile. | Same |
| Feature | Subject DeviceUSA-Made SurgicalMask, Model AA-US-SURGICAL-01 | Predicate DeviceKimberly-Clark, ModelKC200 Face Mask(s),KC300 Face Mask(s) | Comparisonof Devices |
| Design Features | |||
| Color, outer fabric | Blue | Orange | Different |
| Style | Flat, pleated | Flat, pleated | Same |
| Layers | 3 | 4 | Different |
| Physical state | Single use only | Single use only | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Retention features | Elastic ear loops | Elastic ear loops or ties | Different |
| Materials critical tofunctionality | Spunbondpolypropylene,Meltblownpolypropylene, spunbondpolypropylene,Polyester/spandexelastic (earloop),Galvanized iron coatedin polypropylene | PolypropyleneSpunbond,Polypropylenespunbond (4th layeraddition), PolypropyleneMeltblown, Polyestercellulose, PolyesterSpunlace, Polyester/Lycra Knit (earloop),Polyester spunbond(ties), malleablenosewire | Same |
| Dimensions | |||
| Width | 175mm ±7mm | 6.5" ±0.75" | Different |
| Height | 95mm ±7mm | 4" ±0.75" | Different |
| Performance Specification | |||
| ASTM F2100 Level | Level 3 | Level 3 | Same |
| Fluid Resistance(ASTM F1862) | Passed at 160 mmHg | Passed at 160 mmHg | Same |
| Particulate FiltrationEfficiency (PFE) | Passed at >98% | Passed at >98% | Same |
| Bacterial FiltrationEfficiency (BFE) | Passed at >98% | Passed at >98% | Same |
| Differential Pressure | Passed at <5mmH2O | Passed at <5mmH2O | Same |
| Flammability (16CFR 1610) | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| Irritation | Non-irritating | Non-irritating | Same |
| Sensitization | Non-sensitizing | Non-sensitizing | Same |
Table 1 - Summary of Technological Characteristics with the Predicate Device
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VIII Non-Clinical (Performance) Testing
For USA-Made Surgical Mask, Model AA-US-SURGICAL-01, the following table summarizes the performance testing conducted per ASTM F2100 standard:
| Item Tested | Test Method | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|
| AA-US-SURGICAL-01 | ASTM F1862 | Fluid Resistance toSynthetic Blood | 160 mmHg | No penetrationat 160 mmHg |
| AA-US-SURGICAL-01 | ASTM F2299 | Particulate FiltrationEfficiency | >98% | Average99.48% |
| AA-US-SURGICAL-01 | ASTM F2101 | Bacterial FiltrationEfficiency | >98% | Average99.4% |
| AA-US-SURGICAL-01 | ASTM F2100 | Differential Pressure | <5mmH2O | Average4.7mm H2O |
| AA-US-SURGICAL-01 | CPSC CS-191-53(16 CFR 1610) | Flammability | Class 1 | IBE, Class 1 |
Table 2 - Summary of Non-Clinical (Performance) Testing
IBE= Ignited but extinguished
IX. Biocompatibility Testing:
The biocompatibility evaluation for the USA-Made Surgical Mask, Model AA-US-SURGICAL-01 device was conducted in accordance with the FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
| Item Tested | Test Description | Test Methodology | AcceptanceCriteria | Results |
|---|---|---|---|---|
| AA-US-SURGICAL-01 | Cytotoxicity | ISO 10993-5 | No signs ofToxicity | Grade 0, Non-Cytotoxic.Under the conditions of thestudy, the subject deviceextract was determined to benon-cytotoxic. PASS. |
| AA-US-SURGICAL-01 | IntracutaneousIrritation | ISO 10993-10 | Negligiblesigns ofirritation | Non-irritant.Under the conditions of thestudy, the subject device non-polarand polar extracts weredetermined to be |
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| non- irritating.PASS. | ||||
|---|---|---|---|---|
| AA-US-SURGICAL-01 | MaximizationSensitization | ISO 10993-10 | Negligiblesigns ofsensitization | Non-sensitizer.Under theconditions of thestudy, thesubject devicenon- polar andpolar extractswere determinedto be non-sensitizing.PASS. |
Summary of Clinical Performance Test X.
No clinical study is included in this submission.
XI. Conclusions for Substantial Equivalence:
The Armbrust Inc USA-Made Surgical Mask, Model: AA-US-SURGICAL-01 and predicate devices, Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face Mask(s) (K111402) have the same intended use and similar technological characteristics.
The conclusions drawn from the non-clinical tests demonstrates that the subject device Armbrust Inc USA-Made Surgical Mask, Model: AA-US-SURGICAL-01 is as safe and as effective as the legally marketed predicate device.
§ 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.