(87 days)
The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non- sterile, disposable device.
The Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.
This document is a 510(k) summary for a surgical mask (Altor Safety 4-Ply Surgical Mask, Model: 62232). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than a study involving human or AI performance. Therefore, many of the requested elements for a study proving a device meets acceptance criteria, particularly for AI/human reader performance, are not applicable to this document.
However, I can extract the acceptance criteria (pass criteria) and reported device performance for the physical and biological characteristics of the surgical mask, as detailed in the non-clinical performance testing section.
Here's a breakdown of the requested information based solely on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F2101-19 (Bacterial Filtration Efficiency - BFE) | Evaluate Bacterial filtration efficiency (%) | ≥98% | 3 lots tested with total 96 samples, 94/96 Passed at ≥98% /Pass (Note: Listed as 99.60% in Table 1) |
| EN 14683: 2019, Annex C (Differential Pressure - Delta-P) | Evaluate Differential pressure (Delta-P) | <6.0 mmH2O/cm² | 3 lots tested with total 96 samples, 92/96 Passed <6 mmH2O/cm² / Pass (Note: Listed as 3.5mmH2O/cm² in Table 1 for average of 3 lots with means of 4.2, 3.2, 3.1) |
| ASTM F2299-03 (Particulate Filtration Efficiency - PFE) | Evaluate Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98% | 3 lots tested with total 96 samples, 96/96 Passed at ≥98% / Pass (Note: Listed as ≥99% in Table 1) |
| ASTM F1862M-17 (Resistance to Penetration by Synthetic Blood) | Evaluate Resistance to penetration by synthetic blood | Fluid resistant claimed at 160 mm Hg | 3 lots tested with total 96 samples, 95 of 96 test articles passed at 160mmHg /Pass |
| 16 CFR Part 1610 (Flammability) | Evaluate Flame spread | Class 1 | 3 lots tested with total 96 samples, 96/96 Passed ≥3 seconds burn Time- Class 1 / Pass |
| ISO 10993-5:2009 (Cytotoxicity) | Evaluate cytotoxicity | Non-cytotoxic | The proposed device extract was determined to be non-cytotoxic. |
| ISO 10993-10:2010 (Skin Irritation) | Evaluate irritation | Non-irritating | The proposed device non-polar and polar extracts were determined to be non-irritating. |
| ISO 10993-10:2010 (Skin Sensitization) | Evaluate skin sensitization | Non-sensitizing | The proposed device non-polar and polar extracts were determined to be non-sensitizing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Non-Clinical Testing: For most performance tests (BFE, Delta-P, PFE, Flammability, Fluid Resistance), 3 lots were tested, with generally 96 samples in total (e.g., 96 samples for BFE, PFE, Flammability; 95 of 96 passed for Fluid Resistance). The specific number of samples for biocompatibility tests (cytotoxicity, irritation, sensitization) is not explicitly stated, but the results indicate tests were conducted.
- Data Provenance: Not specified in the document. This is a 510(k) submission, and the tests would typically be performed by accredited labs, but the country of origin of the labs or the data generation is not mentioned. The data is presented as retrospective in the context of this submission, meaning the tests were already conducted when the submission was prepared.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This document pertains to the physical and biological performance of a surgical mask, not an AI or diagnostic device requiring expert interpretation for ground truth. Ground truth for these tests is established by standardized test methods and laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. As this is not a study involving human or AI interpretation, there is no adjudication method for establishing ground truth. The results are objective measurements from laboratory tests.
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
N/A. No MRMC study was conducted. This is a 510(k) submission for a physical medical device (surgical mask), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. No standalone AI algorithm performance was evaluated.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance criteria discussed in this document is based on established international and national standards for medical devices, specifically surgical masks (e.g., ASTM F2100, EN 14683, ISO 10993 series). The performance of the device is measured against these objective, quantitative criteria.
8. The sample size for the training set
N/A. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
N/A. There is no training set and therefore no ground truth establishment for a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
September 3, 2021
Altor Safety LLC % Dallas Thomas Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418
Re: K211762
Trade/Device Name: Altor Safety 4-Ply Surgical Mask (Model: 62232) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 2, 2021 Received: June 8, 2021
Dear Dallas Thomas:
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 and Part 809 ); medical device reporting (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 Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211762
Device Name Altor Safety 4-Ply Surgical Mask (Model: 62232)
Indications for Use (Describe)
The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non- sterile, disposable device.
Type of Use (Select one or both, as applicable)
| Research Use Only (314 CFR 201.3(x)) Statement | In-Vitro Sensitivity (314 CFR 201.3(s)) Statement |
|---|---|
| ------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
__ 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
K211762
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.
5.1 General Information
Preparation Date: 2 August 2021
Submitter/Holder
Jared Scott Operations Manager Altor Safety LLC 711 Executive Boulevard Suite C, Valley Cottage, NY, USA 10989 Contact Phone#: +1 845-422-8320 Contact Email: jared.scott@altorsafety.com
Primary Submission Contact
Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions 1069 Piccadilly St. Palm Beach Gardens, FL 33418 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com
5.2 Regulatory Information
Subject Device
| Subject Device Name | Altor Safety 4-Ply Surgical Mask (Model:62232) |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Altor Safety 4-Ply Surgical Mask |
| FDA Product Code | FXX |
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| CFR References | 21 CFR 878.4040 |
|---|---|
| Review Panel | General Hospital |
Identification of Predicate Device:
| Predicate Device Name | K192374 |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Cardinal Health™ Level 3 Surgical Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |
5.3 Subject Device Description
The Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch.
The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.
Subject Device Specification 5.4
Design specifications:
- Size/Dimensions:
| Mask Dimensions-Width | 3.625in (92 mm) |
|---|---|
| ----------------------- | ----------------- |
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| Mask Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) |
|---|---|
| Ear Loops Dimensions | Length: .7 inches per each individual ear loop |
- ASTM Level 3
- Product model number: 62232 ●
- Materials of subject device are as listed below. ●
| 2 Outer Facing Layers (Blue) | Spunbond nonwoven polypropylene |
|---|---|
| Outer Layer (Blue) | Spunbond nonwoven polypropylene |
| Middle Layer (White) | Melt blown nonwoven polypropylene |
| Inner Layer (White) | Spunbond nonwoven polypropylene |
| Nose Wire | Virgin polyethylene plastic, 24 gaugesoft annealed carbon steel, and kraft paper(nominal basis weight of 25 lbs. /ream) |
| Ear Band / Loop | Spandex / Nylon |
ર્સ્ડ Indications for Use
The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, nonsterile, disposable device.
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5.6 Summary of Technological Characteristics
Table 1. Summary Comparison of Characteristics
| Device Characteristic | Proposed SubjectDevice | Primary PredicateDevice | ComparisonAnalysis: |
|---|---|---|---|
| Product Name | Altor Safety 4-PlySurgical Mask | Cardinal Health™Level 3 SurgicalMask With Anti-Fog Foam Strip | Different |
| Manufacturer | Altor Safety | Cardinal Health 200,LLC | Different |
| FDA Product Code | FXX | FXX | Same |
| CFR Reference | 878.4040 | 878.4040 | Same |
| Device Class | II | II | Same |
| 510(k) reference | K211762 | K192374 | N/A |
| Similar, | |||
| Indications for usestatement | The Altor Safety 4-Ply Surgical Mask isintended to be wornto protect both thepatient andhealthcare | The CardinalHealth™ Level 3surgical masks withAnti-Fog Foam Stripare intended to beworn by operating | Similar, minorwording differencesdo not impact safetyor efficacy. |
| Device Characteristic | Proposed SubjectDevice | Primary PredicateDevice | ComparisonAnalysis: |
| professional fromtransfer ofmicroorganisms,body fluids, andparticulate material.The Altor Safety 4-Ply Surgical Mask isintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single use, non-sterile, disposabledevice. | room personnel andother generalhealthcare workersto protect bothpatients andhealthcare workersagainst transfer ofmicroorganisms,blood and bodyfluids, and airborneparticulates. TheCardinal Health™Level 3 surgicalmasks are single use,disposable devicesprovided non-sterile. | ||
| Device Generic RawMaterials | 2 Outer FacingLayers: SpunbondnonwovenpolypropyleneMiddle Layer: MeltBlown nonwovenpolypropylene filterInner facing layer:Spunbond nonwovenpolypropyleneEar loop: Spandex /Nylon | SpunbondPolypropyleneMelt BlownPolypropylene FilterEar loop: Spandex /NylonNose Wire -plastic, | Similar materialsbased on publiclyavailable details |
| Device Characteristic | Proposed SubjectDevice | Primary PredicateDevice | ComparisonAnalysis: |
| Nose Wire - Virginpolyethylene plastic,24 gaugesoft annealed carbonsteel, and kraft paper(nominal basisweight of 25 lbs./ream) | |||
| Color (outward facingLayer) | Blue | White | Different - |
| Patient AnatomicalSite for Use of Device | Nose and Mouth | Nose and Mouth | Same |
| Mode of Operation | Protective Mask | Protective Mask | Same |
| Reusable or SingleUse | Single Use | Single Use | Same |
| Sold Sterile or Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Prescription Status | OTC | OTC | Same |
| Fluid ResistancePerformance ASTMF1862-13 | 32 out of 32 pass at160mmHg | 31 out of 32 pass at120mmHg | Similar |
| Particulate FiltrationEfficiency ASTMF2299 | ≥99% | ≥98% | Similar |
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| Device Characteristic | Proposed SubjectDevice | Primary PredicateDevice | ComparisonAnalysis: |
|---|---|---|---|
| Bacterial FiltrationEfficiency ASTMF2101 | 99.60% | ≥ 98% | Similar- |
| Differential Pressure(Delta P) EN 14683 | 3.5mmH 2 0/cm 2(The average of 3lots with means of4.2,3.2 and 3.1)) | < 5.0 mm H 2 O/cm2 | Similar |
| Flammability 16 CFR1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Under the conditionsof the study, theproposed deviceextract wasdetermined to benon-cytotoxic. | Under the conditionsof the study, theproposed deviceextract wasdetermined to benon-cytotoxic. | Same |
| Irritation | Under the conditionsof the study, theproposed devicenon-polar and polarextracts weredetermined to benon-irritating. | Under the conditionsof the study, theproposed devicenon-polar and polarextracts weredetermined to benon-irritating. | Same |
| Sensitization | Under the conditionsof the study, theproposed devicenon-polar and polarextracts weredetermined to benon-sensitizing. | Under the conditionsof the study, theproposed devicenon-polar and polarextracts weredetermined to benon-sensitizing. | Same |
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| Device Characteristic | Proposed SubjectDevice | Primary PredicateDevice | ComparisonAnalysis: |
|---|---|---|---|
| Dimensions-Width | 3.625in (92 mm) | 4in | Similar |
| Dimensions-Length | 6.75-7.00in (171.45mm-177.8mm ) | 7 in | Similar - |
| ASTM F2100 Level | Level 3 | Level 3 | Same |
Summary of Non-Clinical Performance Testing 5.7
| Test Method | Purpose | Pass Criteria | Results |
|---|---|---|---|
| ASTM F2101-19StandardTest Method forEvaluating the BacterialFiltration | The purpose of the test is toevaluate the Bacterial filtrationefficiency (BFE) (%) | ≥98% | 3 lots tested withtotal 96 samples,94/96 Passed at≥98% /Pass |
| EN 14683: 2019, AnnexC Medical face masks -Requirements andtest methods according toASTM F2100:2019 | The purpose of the test is toevaluate the Different pressure(Delta-P) | <6.0mmH2O/cm² | 3 lots tested withtotal 96 samples,92/96 Passed<6 mmH2O/cm²/ Pass |
| ASTM F2299-03Standard Test Method forDetermining the InitialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using LatexSpheres according toASTME2100:2019 | The purpose of the test is toevaluate the Sub-micronparticulate filtration efficiencyat 0.1 micron, % (PFE) | ≥98% | 3 lots tested withtotal 96 samples,96/96 Passed at≥98% / Pass |
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| ASTM F1862M-17Standard Test Method forResistance of MedicalFace Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity) according toASTMF2100:2019forpass result | The purpose of the test is toevaluate the Resistance topenetration by synthetic blood,Minimum pressure in mmHg | Fluidresistantclaimed at160 mm Hg | 3 lots tested withtotal 96 samples,95 of 96 test articlespassed at 160mmHg/Pass |
|---|---|---|---|
| 16 CFR Part 1610 Standardfor the Flammability ofClothing according toASTM F2100:2019 | The purpose of the test is toevaluate the Flame spread | Class 1 | 3 lots tested withtotal 96 samples,96/96 Passed ≥3seconds burn Time-Class 1 /Pass |
- . Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
-
- Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization,
-
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation
-
of medical devices- Part 10: Tests for irritation and skin sensitization.
5.8 Summary of Clinical Performance Testing
No clinical study is included in this submission
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5.9 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211762, the Altor Safety 4-Ply Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, cleared under K192374.
§ 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.