(94 days)
The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.
The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.
This information describes the testing and acceptance criteria for a medical face mask, not an AI/ML powered device. As such, many of the typical questions regarding AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.
Below is a summary of the requested information based on the provided document, focusing on the relevant acceptance criteria and the studies performed for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Subject Device) | Predicate Device Performance | Comparison |
|---|---|---|---|---|
| Performance Testing | ||||
| Bacterial Filtration Efficiency (ASTM F2101-19) | $\ge$ 98% filtration efficiency (for Level 2 & 3) | All 96 samples tested at least 98% filtration efficiency. Specifically, the subject device achieved >99.9% filtration efficiency. | 99.9% filtration efficiency | Similar; both the subject device and predicate device passed the test at the same level ($\ge$ 98%). |
| Differential Pressure (Delta-P) (EN 14683:2019 + AC 2019 (E) Annex C) | < 6.0 mmH2O/cm2 | All 96 samples measured an average differential pressure of 5.3 mmH2O/cm2. | 5.04 mmH2O/cm2 | Similar; both the subject device and predicate device pass the test with a differential pressure < 6.0mmH2O/cm2. |
| Sub-Micron Particulate Filtration Efficiency at 0.1um (ASTM F2299/F2299M-03) | $\ge$ 98% filtration efficiency (for Level 2 & 3) | All samples filtered at a level $\ge$ 98% filtration efficiency. Specifically, the subject device achieved >99.4% filtration efficiency. | 99.1% filtration efficiency | Similar; both the subject device and predicate device passed the test at the same level ($\ge$ 98%), meeting the requirements for Level 2 and Level 3. |
| Resistance to Penetration by Synthetic Blood (F1862/F1862M-17) | No visual blood penetration (at specified mmHg) | None of the tested samples showed penetration of synthetic blood up to 160 mmHg. | Resisted penetration at 120 mmHg | Similar; the subject device resisted blood penetration at least as well as the predicate device (performing at a higher mmHg level). |
| Flammability (16 CFR 1610) | Class 1 criteria: Does not ignite (DNI) or ignites but extinguishes (IBE), or burn time $\ge$ 3.5 seconds | All samples either did not ignite (DNI) or ignited but extinguished (IBE). All samples met the requirements for Class 1 Flammability. | Class 1 | Same |
| Biocompatibility Testing | ||||
| Cytotoxicity (ANSI/AAMI/ISO 10993-5:2009) | Cell morphology graded $\le$ 2 | Not considered to have a cytotoxic effect. | Non-Cytotoxic | Same |
| Sensitization (ISO 10993-10:2010) | No sensitization reactions | No sensitization reactions or patterns were noted. The test animals did not receive scores higher than those of the negative control animals. | No Sensitization Occurred | Same |
| Intracutaneous (Intradermal) Reactivity Test (ISO 10993-10:2010) | Difference between test article extract average score and control average score $\le$ 1.0, and no failure at any observation period | Did not elicit biologically significant irritation reactions when compared to the control. | No Irritation Reaction Observed | Same |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For performance testing (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, Resistance to Penetration by Synthetic Blood), 32 samples from 3 non-sequential lots (total of 96 samples) of the Puravita Medical Fold Flat Surgical Mask were tested. For biocompatibility testing, the sample sizes were:
- Cytotoxicity: 1 mask (components tested as composite from Lot No. 12142020A)
- Sensitization: 6 masks (components tested as composite from Lot No. 12142020A)
- Intracutaneous Reactivity: 2 masks (components tested as composite from Lot No. 12142020A)
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. However, based on the context of FDA submission, these are typically prospective, laboratory-based bench tests conducted by qualified testing facilities to regulatory standards. The predicate device information was obtained from FDA's public database.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This is not applicable for this type of medical device submission. The "ground truth" for these tests is established by adhering to recognized international and national standards (e.g., ASTM, ISO, EN, 16 CFR). The tests are objective measurements of physical properties and biological responses, not subjective interpretations by human experts in a clinical context. The results are quantitative (e.g., filtration efficiency percentages, pressure values, burn times) or qualitative (e.g., pass/fail for cytotoxicity, presence/absence of irritation) against defined scientific criteria.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the tests involve objective measurements against predefined acceptance criteria from recognized standards, not subjective assessments requiring adjudication by multiple experts.
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. This device is a physical medical mask, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical mask, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on established regulatory and industry standards for performance and safety:
- Quantitative measurements against specified thresholds (e.g., filtration efficiency percentages, differential pressure values, burn times).
- Qualitative biological responses observed in controlled laboratory settings (e.g., non-cytotoxic, non-sensitizing, non-irritating) defined by specific protocols.
- The "pass/fail criteria" for each test, as detailed in the Acceptance Criteria column of the table, represent the ground truth for acceptability.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product and does not involve training data for an algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2021
Puravita M, LLC % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC P.O. Box 56436 Virginia Beach, Virginia 23456
Re: K212740
Trade/Device Name: Puravita Medical Fold Flat Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: August 30, 2021
Dear Rhonda Alexander:
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, Ph.D. 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)
K212740
Device Name Puravita Medical Fold Flat Surgical Mask
Indications for Use (Describe)
The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.
| 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 C) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K212740
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of Summary: November 24, 2021
Contact Information
| Submitter: | Submitter Contact: |
|---|---|
| PuraVita M, LLC | Jefferson Nemelka |
| 1287 W 300 S | Plant Manager |
| Lindon, UT 84042 | 801-836-7940 |
| jefferson@puravita.com |
| Consultant: | Dr. Rhonda Alexander |
|---|---|
| Sr. Consultant, Regulatory Strategy | |
| IUVO Consulting, LLC | |
| (757) 582-4337 | |
| ralexander@iuvoconsulting.com |
Device Information
| Trade Name: | PuraVita Medical Fold Flat Surgical Mask |
|---|---|
| Common Name: | Surgical Face Mask |
| Classification Name: | Mask, Surgical |
| Classification: | Class II per 21 CFR 878.4040 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
Predicate Device:
| Manufacturer: | Guangdong Kingfa Sci. & Tech. Co., Ltd, |
|---|---|
| Product: | Medical Protective Mask |
| 510(k) Number: | K202107 |
Intended Use Statement:
The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat 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, disposable device that is provided non-sterile.
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Device Description:
The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.
| Device | Predicate Device: K202107Guangdong Kingfa Sci. & Tech. Co.,LTD, Medical Face Mask, ModelKF-A F02(N) | Subject Device: K212740PuraVita Medical Fold FlatSurgical Mask | Comparison |
|---|---|---|---|
| IntendedUse/Indications forUse | The Medical Protective Mask isintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. TheMedical Protective Mask is intendedfor use in infection control practices toreduce the potential exposure to bloodand body fluids. This is a single use,disposable device, provided non-sterile | The PuraVita Medical Fold FlatSurgical Mask is intended to be wornto protect both patients and healthcarepersonnel from transfer ofmicroorganisms, body fluids, andparticulate material. The PuraVitaMedical Fold Flat Surgical Mask isintended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids.This is a single-use, disposable devicethat is provided non-sterile. | Similar |
| Materials | |||
| Outer Layer | Polypropylene spunbond | Polypropylene spunbond | Same |
| Middle Filter Layer#1 | Polypropylene Meltblown | Polypropylene Meltblown | Same |
| Middle Filter Layer#2 | Non-woven Polypropylene | Polypropylene Meltblown | Different. Althoughthe 2nd filter layer ofthe subject device isdifferent than thepredicate device, thedevice met allstandards when tested. |
| Inner Layer | Polypropylene spunbond | Polypropylene spunbond | Same |
| Ear Loops | Spandex and Polyester | Spandex and Nylon | Different. Althoughthe material used in thesubject device isslightly different thanthe predicate device, itpassed allbiocompatibility testrequirements. |
| Nose Piece | Iron core polypropylene strip | Dual Iron core polypropylene strip | Similar |
| Latex | Not made with natural rubber latex | Not made with natural rubber latex | Same |
| Description | |||
| Color | White | White | Same |
| Style | Extended chamber flat-folded | Fold Flat | Similar |
| Single Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-sterile | Same |
| Length | $16.2cm ± 0.5cm$ | $16.3cm ± 0.5cm$ | Different. Althoughthe specifications anddimensions of thesubject device areslightly different thanthe predicate device. |
| the predicate device,the differences areminimal. | |||
| Width | $10.2cm \pm 0.5cm$ | $10.6cm \pm 0.5cm$ | Different. Althoughthe specifications anddimensions of thesubject device areslightly different thanthe predicate device,the differences areminimal. |
| Performance Testing | |||
| ASTMPerformance Level | ASTM Level 2 | ASTM Level 3 | Different. Although theperformance of thesubject device differsfrom that of thepredicate device, thesubject device performsat least as well as thepredicate. |
| Fluid/BloodPenetration F1862 | Pass at 120 mmHg | Pass at 160mmHg | Different, however thesubject device filters aswell as the predicatedevice. |
| ParticulateFiltration F2299 | 99.1%, filtration efficiency | >99.4% filtration efficiency | Different; however, thesubject and predicatedevices both pass thetest at ≥98% filtrationefficiency. |
| Bacterial FiltrationF2101 | 99.9% | >99.9% | Same |
| Diff. Pressure(Delta-P)MIL-M-36954C | On average of 5.04 mmH2O/cm2 | On average 5.3 mmH2O/cm2 | Different, both thesubject device andpredicate device passthe test with adifferential pressure<6.0mmH2O/cm2. |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility Testing | |||
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Same |
| Skin Irritation | Non-Irritating | Non-Irritating | Same |
| Skin Sensitization | Non-Sensitizing | Non-Sensitizing | Same |
Comparison to predicate device:
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- Middle Layer #2 the subject device is constructed using meltblown polypropylene, . while the predicate device is constructed with non-woven polypropylene. The mask meets the same testing requirements as the subject device.
- Ear Loops the subject device's ear loops are constructed with spandex and nylon, while ● the predicate device's loops are made with spandex and polyester. Despite this difference in material composition, the ear loops of the subject device meet all biocompatibility requirements; the difference does not negatively affect performance of the device.
- The dimensions (length and width) of the subject and predicate devices differ by 0.1cm. . This is within normal limits of variation (± 0.5cm).
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- . Performance Testing (Fluid/Synthetic Blood Penetration ASTM F1862) – the subject and predicate devices differ in performance of fluid penetration testing. The subject device resists penetration by blood at the same level as the predicate device.
- Performance Testing (Particulate Filtration Efficiency ASTM F2299) the subject . performed differently from the predicate device; however, subject and predicate devices both passed the test at ≥ 98% filtration efficiency, meeting the requirements for levels 2 and 3.
- Performance Testing (Differential Pressure EN 14683:2019) While the average . differential pressures differ between the subject and predicate devices, both have average differential pressure values that pass the test at <6.0mmH2O/cm2.
- There were no differences between the biocompatibility of the subject and predicate . devices.
| Test | Device Description/Sample Size | TestMethod/ApplicableStandards | Acceptance Criteria | UnexpectedResults/SignificantDeviations | Results | Test | Predicate | Subject | Comparison |
|---|---|---|---|---|---|---|---|---|---|
| BacterialFiltrationEfficiencyASTM F2101-19Standard TestMethod forEvaluating theBacterial FiltrationEfficiency (BFE)of Medical FaceMask Materials,Using a BiologicalAerosol ofStaphylococcusaureusFDA RecognitionNumber: 6-427Objective of thetest:Evaluate thebacteria filtrationefficiency (BFE)of face maskssamples, using abiological aerosolof Staphylococcusaureus. | Test articles used inthe test32 samples of PuraVitaMedical Fold FlatSurgical Masks from 3non-sequential lots(total of 96 samples)were tested; finalfinished devices | Test methods andprocedures(including anyspecific testconditions)ASTM F2101-19method wasfollowed understandard conditionswith no deviations | Study endpoint, i.e., thespecific parametermeasuredBacterial filtrationefficiencyPre-defined acceptanceor pass/fail criteria.Level 2 Barrier: ≥ 98%filtration efficiencyLevel 3 Barrier: ≥ 98%filtration efficiency | None | All samples tested at least98% filtration efficiency.All 96 samples meet the"pass" criteria of the testfor levels 2 and 3.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsperformance can beobtained from FDA'spublic database.The predicate devicepassed at 99.9% filtrationefficiency.When compared to theinformation in the publicsummary, the subjectdevice and predicatedevice are Similar. | Bacterial FiltrationEfficiency | $> 99.1% FiltrationEfficiencyPass$ | $\ge 98% FiltrationEfficiencyPass$ | Similar, both the subjectdevice and predicatedevice passed the test atthe same level ( $\ge$ 98%). |
| DifferentialPressure (Delta-P) | Test articles used inthe test | Test methods andprocedures(including any | Study endpoint, i.e., thespecific parameter | None | All 96 samples measuredan average differential | Differential Pressure(Delta-P) | $< 6.0 mmH_2O/cm^2$Pass | $< 6.0 mmH_2O/cm^2$Pass | Same |
| EN 14683:2019 +AC 2019 (E)Annex C: MedicalFace Masks -Requirements andTest Methods;Method fordetermination ofbreathabilityObjective of theTest: Determinethe breathability ofmasks bymeasuring thedifferential airpressure on eitherside of the testarticle using amanometer, at aconstant flow rateof 8 L/min. | 32 samples of PuraVitaMedical Fold FlatSurgical Masks from 3non-sequential lots(total of 96 samples)were tested; finalfinished devices | specific testconditions)EN 14683:2019 +AC 2019 (E) AnnexC method wasfollowed understandard conditionswith no deviations | Pressure in mmH2O/cm2Pre-defined acceptanceor pass/fail criteria.Passing differentialpressure must be< 6.0mmH2O/cm2. | (The average pressure was5.3mmH2O/cm2.)Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsperformance can beobtained from FDA'spublic database. Thepredicate device had anaverage differentialpressure of5.04mmH2O/cm2.When compared to theinformation in the publicsummary, the subjectdevice and predicatedevice were found to beSimilar. | Sub-MicronParticulate FiltrationEfficiency at 0.1umof Polystyrene LatexSpheres | 99.9% filtrationefficiencyPass | $\ge$ 98% filtrationefficiencyPass | Similar; both the subjectdevice and predicatedevice passed the test atthe same level ( $\ge$ 98%). | |
| Sub-MicronParticulateFiltrationEfficiency at0.1um ofPolystyrene LatexSpheresASTM F2100-19StandardSpecification forPerformance ofMaterials Used inMedical FaceMasks(Parent Standardof ASTMF2299/F2299M-03(Reapproved 2017)- Test Method forDetermining theInitial Efficiencyof Materials usedin Medical FaceMasks toPenetration byParticulates UsingLatex Spheres)Objective of Test:Determine theInitial Efficiencyof Materials Usedin Medical FaceMasks toPenetration byParticulates UsingLatex Spheres | Test articles used inthe test32 samples of PuraVitaMedical Fold FlatSurgical Masks from 3non-sequential lots(total of 96 samples)were tested; finalfinished devices | Test methods andprocedures(including anyspecific testconditions)ASTMF2299/F2299M-03(reapproved 2017)method wasfollowed understandard conditionswith no deviations | Study endpoint, i.e., thespecific parametermeasuredSub-micron particulatefiltration at 0.1 micronPre-defined acceptanceor pass/fail criteria.Level 1 Barrier: ≥ 95%filtration efficiencyLevel 2 Barrier: ≥ 98%filtration efficiencyLevel 3 Barrier: ≥ 98%filtration efficiency | None | All samples filtered at alevel ≥ 98% filtrationefficiencyAll samples meet thestandard's requirements forLevel 2 filtration and metthe same criteria as thepredicate.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsperformance can beobtained from FDA'spublic database.The predicate device'sparticulate filtrationefficiency was 99.1%.When compared to theinformation in the publicsummary, the subjectdevice and predicatedevice were found to beSimilar, as they meet therequirements of the samelevel of filtrationefficiency. | Resistance toPenetration bySynthetic Blood | Fluid resistant claimedat 120mmHgPass | Fluid resistance at160mmHgPass | Similar- the subjectdevice resisted bloodpenetration at least aswell as the predicatedevice. |
| Flammability16 CFR 1610Standard for theflammability ofclothing textiles.73 FR 62187, Oct.20, 2008Objective of theTest: Evaluate theflammability offace mask samples,prohibiting the useof any dangerousflammablematerials | Test articles used inthe test32 samples of PuraVitaMedical Fold FlatSurgical Masks from 3non-sequential lots(total of 96 samples)were tested; finalfinished devices | Test methods andprocedures(including anyspecific testconditions)The methoddescribed in 16 CFR1610 was followedunder standardconditions with nodeviations | Study endpoint, i.e., thespecific parametermeasuredTextile's burn time (thetime elapsed fromignition until the stopthread is severed asmeasured by the timingmechanism of the testapparatus.)Pre-defined acceptanceor pass/fail criteria.Class I criteria:The sample does notignite (DNI) or ignitesbut extinguishes (IBE).Or burn time, as definedby the standard is ≥ 3.5seconds | None | All samples either did notignite (DNI) or ignited butextinguished (IBE).All samples met therequirements for Class IFlammability.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsperformance can beobtained from FDA'spublic database. Thepredicate device met therequirements for Class Iflammability.When compared to theinformation in the publicsummary, the subjectdevice and predicatedevice were found to beSimilar. | Flammability | Class 1 | Class 1 | Same |
| Resistance toPenetration bySynthetic BloodF1862/F1862M-17Standard TestMethod forResistance ofMedical FaceMasks toPenetration bySynthetic Blood(HorizontalProjection of FixedVolume at aKnown Velocity)FDA RecognitionNumber: 6-406Objective of theTest:Measure theresistance ofmedical facemasks samples topenetration bysynthetic blood. | Test articles used inthe test32 samples of PuraVitaMedical Fold FlatSurgical Masks from 3non-sequential lots(total of 96 samples)were tested; finalfinished devices | Test methods andprocedures(including anyspecific testconditions)The methoddescribed inF1862/F1862M-17was followed understandard conditionswith no deviations | Study endpoint, i.e., thespecific parametermeasuredVisual detection ofsynthetic bloodpenetration.Pre-defined acceptanceor pass/fail criteria.Pass criteria: No visualblood penetration | None | None of the tested samplesshowed penetration ofsynthetic blood up to160mmHg.All samples passed therequirements of the testand performed as well asthe predicate.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsblood penetrationperformance can beobtained from FDA'spublic database.The predicate deviceresisted penetration at120mmHg.When compared to theinformation in the publicsummary, the subjectdevice and predicatedevice were found to beSimilar. |
Summary of Bench Performance Testing
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Comparison of Performance Testing
When compared to FDA's public information regarding the predicate's performance, the subject device was found to perform similarly to or exactly the same as the predicate.
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Summary of Biocompatibility Testing
The nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is limited (≤24h). The following tests were conducted on the final, finished form of the subject device to demonstrate that the subject device is biocompatible and safe for its intended use:
| Test | Device Description/Sample Size | Test Method/ApplicableStandards | Acceptance Criteria | UnexpectedResults/SignificantDeviations | Results |
|---|---|---|---|---|---|
| Cytotoxicity -MEM ElutionTestFDA RecognitionNumber: 2-245Objective of thetest:The purpose of thistest was toevaluate thecytotoxic potentialof extracts ofpolymericmaterials or anyother materialsintended to beimplanted in thehuman body orthat may come intocontact with bodilyfluids or injectablesolutions. | Test articles used inthe test1 Puravita MedicalFold Flat SurgicalMask; final finisheddevice; all componentstested together ascomposite.(Lot No. 12142020A) | Test methods andprocedures(including anyspecific testconditions)The testing standardANSI/AAMI/ISO10993-5:2009 wasfollowed understandard conditionswith no deviationsor amendments. | Study endpoint, i.e.,the specific parametermeasuredThe morphology of cellswas observed at the 24and 48 hour examinationpoints according to thecriteria stated in the ISO10993-5 guidelines. Theaverage score for thethree test wells andcontrols at the 48-hourpoint was used todetermine the cytotoxicresponse.Pre-defined acceptanceor pass/fail criteria.Cell morphology gradedgreater than 2 isconsidered to have acytotoxic effect. | None | Pass.Based on qualitativeevaluation of the cellsexposed to the test articleextract, the test article wasnot considered to have acytotoxic effect.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsbiocompatibility can beobtained from FDA'spublic database.When compared to theinformation in the publicsummary, the subjectdevice and predicate devicewere both found to be non-cytotoxic. |
| Sensitization -MaximizationTest for Delayed-TypeHypersensitivityin Hartley GuineaPigs (ISO 10993-10:2010)FDA RecognitionNumber: 2-174Objective of thetest:The purpose of thistest was todetermine to whatextent the testarticle has thepotential to act as acontact sensitizerin guinea pigs. | Test articles used inthe test6 Puravita MedicalFold Flat SurgicalMasks; final finisheddevices; allcomponents testedtogether as composite.(Lot no. 12142020A) | Test methods andprocedures(including anyspecific testconditions)The study wasperformedaccording to ISO10993-10guidelines, with nodeviations oramendments. | Study endpoint, i.e.,the specific parametermeasuredIn the final analysis ofdata, consideration wasgiven to the overallpatterns, intensity,duration, and the natureof reactions of the test ascompared with thecontrol.Pre-defined acceptanceor pass/fail criteria.Any skin reaction scoresreceived by the testgroup, which weregreater than the scoresreceived by the negativecontrol group, wereconsidered to representsensitization. | None | Pass.No sensitization reactionsor patterns were noted inanimals exposed to testarticle extracted in eithersaline or cottonseed oil.The test animals did notreceive scores higher thanthose of the negativecontrol animals.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsbiocompatibility can beobtained from FDA'spublic database.When compared to theinformation in the publicsummary, the subjectdevice and predicate devicewere both found to be non-sensitizing. |
| Intracutaneous(Intradermal)Reactivity TestISO 10993-10:2010Intracutaneous(Intradermal)Reactivity Test inNew ZealandWhite RabbitsFDA RecognitionNumber: 2-174Objective of thetest:The purpose of thistest was toevaluate localresponses toextracts of the testarticle followingintracutaneousinjections intorabbits. | Test articles used inthe test2 Puravita MedicalFold Flat SurgicalMasks final, finisheddevices; allcomponents testedtogether as composite.(Lot No 12142020A) | Test methods andprocedures(including anyspecific testconditions)The study wasperformedaccording to ISO10993-10guidelines, with nodeviations oramendments. | Study endpoint, i.e.,the specific parametermeasuredInjection sites wereobserved for erythema,eschar formation,edema, and necrosis, andscored at $24 \pm 2$ hours,$48 \pm 2$ hours, and $72 \pm 2$hours. The averagescores for the test siteswere calculated andcompared to the averagescores for the controlsites.Pre-defined acceptanceor pass/fail criteria.According to ISO10993-10, therequirements of the testare met if the differencebetween the test articleextract average scoreand the control averagescore is 1.0 or less andthe test does not fail atany observation period. | Pass.Based on erythema andedema scores, the testarticle extracted in salineor cottonseed oil did notelicit biologicallysignificant irritationreactions when comparedto the control after beinginjected intracutaneously.Both the subject andpredicate devices werefound to be non-irritating.Comparative testing of thepredicate device was notperformed, sinceinformation regarding itsbiocompatibility can beobtained from FDA'spublic database.When compared to theinformation in the publicsummary, the subjectdevice and predicate devicewere both found to be non-irritating. |
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Comparison of Biocompatibility Results Between the Subject & Predicate Devices
| Predicate Device(K202107) | Subject DevicePuraVita MedicalFold Flat SurgicalMask | Comparison | |
|---|---|---|---|
| Cytotoxicity | Not Cytotoxic | Not Cytotoxic | Same |
| Sensitization | No SensitizationOccurred | No SensitizationOccurred | Same |
| Intracutaneous(Intradermal)Reactivity Test | No Irritation ReactionObserved | No Irritation ReactionObserved | Same |
Animal & Clinical Performance Testing
No animal or clinical tests were performed on the subject device for this submission.
IVD Statement
The subject device is not an in vitro diagnostic device.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K212740, the PuraVita Medical Fold Flat Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202107.
§ 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.