(284 days)
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip.
The provided document is a 510(k) Summary for the SpectraShield Model 9500 Surgical Mask, describing its characteristics and comparing it to predicate devices to demonstrate substantial equivalence. It does not describe an AI medical device. Therefore, it is not possible to answer the request by extracting information about acceptance criteria for an AI device.
However, I can extract the acceptance criteria and performance data for the surgical mask as presented in the document, which are based on standard tests for such devices.
Here's the information regarding the SpectraShield Model 9500 Surgical Mask, formatted as requested for an "AI device," but adapted to fit the context of a physical medical device (surgical mask):
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Predicate Equivalent or Standard) | Reported Device Performance (SpectraShield Model 9500 Surgical Mask) |
|---|---|---|
| Fluid Resistance ASTM F1862 | Fluid resistant @ 160mm Hg | Pass: Fluid Resistant @ 160mm Hg |
| Particulate Filtration ASTM F2299 | >99.9% (Predicate: 99.87% at 0.1 microns) | Pass: 99.87% at 0.1 microns |
| Differential Pressure Mil M36954C | 4.9mm H20/cm2 (Predicate: 4.3mm H20/cm2) | Pass: 4.3mm H20/cm2 |
| Bacterial Filtration ASTM F2101 | >99.9% (Predicate: 99.9%) | Pass: 99.9% |
| Flammability 16CFR 1610 | Class 1 | Class 1 |
| Cytotoxicity ISO 10993-10 | USP reactivity score = < 2 | Pass: USP reactivity score = < 2 |
| Primary skin irritation ISO10993-10 | PSI Score = 0, Non-irritant | Pass: PSI Score = 0, Non-irritant |
| Repeated Patch Dermal Sensitization ISO 10993-10 | 0% incidence sensitization response "0" severity | Pass: 0% incidence sensitization response "0" severity |
| Systemic Toxicity ISO 10993-11 | No mortality or evidence of systemic toxicity | Pass: No mortality or evidence of systemic toxicity |
| Physico-chemical USP | Test results met the USP limits | Pass: Test results met the USP limits |
| Gas off Testing | Within safe inhalation levels | Total antibacterial/antiviral particles within safe inhalation levels |
| Leach off testing | Within safe orally ingestible levels | Total leachable antibacterial/antiviral particles within safe orally ingestible levels |
| Bacterial Reduction (S. pyogenes, H. influenzae, MRSA) (T₀ Inoculums >10⁶, 1 hr contact) | ≥ 99.99% kill (implied >4 log₁₀ reduction) | S. pyogenes: >4.40 log₁₀ reduction; H. influenzae: >6.20 log₁₀ reduction; MRSA: >4.83 log₁₀ reduction |
| Bacterial Reduction after 12 hrs perspiration (S. pyogenes, H. influenzae, MRSA) (T₀ Inoculums >10⁶, 1 hr contact) | ≥ 99.99% kill (implied >4 log₁₀ reduction) | S. pyogenes: >4.25 log₁₀ reduction; H. influenzae: >4.18 log₁₀ reduction; MRSA: >4.11 log₁₀ reduction |
| Viral Reduction (16 strains of Influenza A & B viruses, 5 min contact) | 99.99% (>4.0 log₁₀) reduction | 99.99% (>4.0 log₁₀) reduction |
| Repeat Virus Challenge (H1N1, H5N1 after 4 & 8 hrs wear, 5 min contact) | 99.99% (>4.0 log₁₀) reduction | 99.99% (>4.0 log₁₀) reduction |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. However, it indicates that the tests performed are in vitro (laboratory) tests. Data provenance is not explicitly stated beyond "in vitro (laboratory) tests," implying laboratory settings and not human clinical data or geographical origin. The study is a pre-market notification (510k) using performance data to demonstrate substantial equivalence to predicate devices, not a clinical study on patient outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the tests described are in vitro laboratory tests measuring physical and microbiological properties of the mask, not evaluations requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method for the test set
This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.
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
This is not applicable. The device is a surgical mask, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical mask, not an AI algorithm. The performance data presented are for the mask itself in laboratory settings.
7. The type of ground truth used
For the physical and biological tests (fluid resistance, filtration, pressure, flammability, cytotoxicity, skin irritation, systemic toxicity, physico-chemical, gas/leach-off), the "ground truth" is defined by the objective measurement adhering to established ASTM, Mil, CFR, ISO, and USP standards.
For bacterial and viral reduction, the "ground truth" is the quantitative reduction in viable microorganisms as measured in the in vitro laboratory tests.
8. The sample size for the training set
This is not applicable. The device is a physical product (surgical mask), not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no AI training set involved. The product's characteristics are inherent to its design and manufacturing.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
Nexera Medical Inc. Mr. Paul Sallarulo, President & CEO 3343 West Commercial Blvd. Suite 103 Ft. Lauderdale, FL 33309
K150729 Re:
Trade/Device Name: SpectraShield Model 9500 Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: ONT Dated: November 30, 2015 Received: December 1, 2015
Dear Mr. Sallarulo,
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. 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 statutes and regulations administered by other Federal agencies. You must
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K150729
Device Name SpectraShield model 9500 Surgical Mask
Indications for Use (Describe)
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X" which is green and has a blue diamond shape above it. Below "NEXERA" is the word "MEDICAL" in a smaller, thinner, black font.
Section 5.0: 510(k) SUMMARY (K150729)
| 510(k) | NexEra Medical, Inc. |
|---|---|
| Owner: | 3343 West Commercial Blvd, Suite 103 Ft. Lauderdale, FL 33309 |
| Contact: | Paul Sallarulo, President CEO |
| Phone: | 954-495-2020, x 2031 |
| Fax: | 954-491-7281 |
| Date Summary Prepared: | December 29, 2015 |
| Device: | |
| Trade Name: | SpectraShield model 9500 Surgical Mask |
| Common /Classification Name: | Surgical mask |
| Class: | II |
| Classification Product Code: | ONT |
| Regulation Number: | 21 CFR 878.4040 |
| Predicate Device Information: | K120244 SpectraShield 9500 Surgical N95 Respirator K122702 BioFriend™ BioMask ™ N95 Surgical Respirator |
| Device Description: | The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip. |
| Intended Use: | The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver- copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and |
3343 West Commercial Blvd., Suite 103 - Ft. Lauderdale, FL 33309 USA
Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
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Image /page/4/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, sans-serif font, with "NEX" in blue and "ERA" in blue, and the "X" in green. Above the "X" is a blue diamond shape. Below "NEXERA" is the word "MEDICAL" in smaller, sans-serif font, with the letters spaced out.
inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
510(k) Summary Device Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X", which is green and has a blue diamond shape above it. Below "NEXERA" is the word "MEDICAL" in a smaller, bold, black font.
| Subject Device | Predicate DeviceK120244 SpectraShield | Predicate DeviceK122702 BioFriendTMBioMaskTM | |
|---|---|---|---|
| 510(k) # | K150729 | K120244 | K122702 |
| Company | NexEra Medical, Inc. | NexEra Medical, Inc. | Filligent (HK) Limited |
| Name/Model | SpectraShield Model9500 Surgical Mask *(*with amended Intendeduse Statement) | SpectraShield Model9500 Surgical Respirator | BioFriendTM BioMaskTMN95 Surgical Respirator:Professional BF-200-3013AN |
| Fabrics | Nonwoven polyestercontaining a silver-copperzeolite (antibacterial /aniviral agent) and ameltblown polypropylenesubstrate. | Nonwoven polyestercontaining a silver-copperzeolite (antibacterial agent)and a meltblownpolypropylene substrate. | 4 layers: spun-bondpolypropylene, cellulose /polyester, meltblownpolypropylene, spunbondpolypropylene. Copper &zinc ion treatment and ahydrophilic plastic coating. |
| Nosepiece | 100% Aluminum | 100% Aluminum | 100% Aluminum |
| Straps | (2) Polyamide fiber andelastic straps, not madewith natural latex | (2) Polyamide fiber andelastic straps, latex free | Polyamide/spandex elasticstraps, latex free |
| Mask Style | Molded shape | Molded shape | Convex shape |
| Fluid Resistance ASTMF1862 | Pass: Fluid Resistant @160mm Hg | Pass: Fluid Resistant @160mm Hg | 160 mm Hg |
| Particulate FiltrationASTMEfficiencyF2299 | Pass: 99.87% at 0.1microns | Pass: 99.87% at 0.1microns | >99.9% |
| Differential PressureMil M36954C | Pass: 4.3mm H20/cm2 | Pass: 4.3mm H20/cm2 | 4.9mm H20/cm2 |
| Bacterial FiltrationEfficiencyASTMF2101 | Pass: 99.9% | Pass: 99.9% | >99.9% |
| Subject Device | Predicate DeviceK120244 SpectraShield | Predicate DeviceK122702 BioFriend™BioMask ™ | |
| Flammability Class16CFR 1610 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity 10993-10 | Pass: USP reactivityscore = < 2 | Pass: USP reactivityscore = < 2 | PASS |
| Primary skin irritationISO10993-10 | Pass: PSI Score = 0,Non-irritant | Pass: PSI Score = 0,Non-irritant | PASS |
| Repeated Patch DermalSensitizationISO 10993-10 | Pass: 0% incidencesensitization response"0" severity at eachevaluated time point. | Pass: 0% incidencesensitization response"0" severity at eachevaluated time point. | PASS |
| Systemic Toxicity ISO10993-11 | Pass: No mortality orevidence of systemictoxicity from the extractswas observed. | Pass: No mortality orevidence of systemictoxicity from the extractswas observed. | PASS |
| Physico-chemicalUSPPhysico-chemical Test-Plastics | Pass: Test results metthe USP limits. | Pass: Test results metthe USP limits. | PASS |
| Gas off Testing | Total antibacterial /antiviral particlesreleased from the devicewere verified to bewithin safe inhalationlevels. | Total antibacterialparticles released fromthe device were verifiedto be within safeinhalation levels. | PASS |
| Leach off testing | Total leachableantibacterial / antiviralparticles released fromthe device were verifiedto be within safe orallyingestible levels. | Total leachableantibacterial particlesreleased from the devicewere verified to bewithin safe orallyingestible levels. | PASS |
| Bacterial Reduction: | T₀ Inoculums measured >10⁶Bacterial contact @ 1 hour$S.pyogenes: >4.40log_{10}$reduction$H.influenzae:>6.20log_{10}$ | T₀ Inoculums measured, >10⁶Bacterial contact @ 1 hour$S.pyogenes: >4.40log_{10}$reduction$H.influenzae:>6.20log_{10}$ | NA |
| Subject Device | Predicate DeviceK120244 SpectraShield | Predicate DeviceK122702 BioFriendTMBioMask TM | |
| Bacterial Reduction:after repeated exposures toperspiration over 12 hours | reductionMRSA:> $4.83log_{10}$T0 Inoculums measured >106Bacterial contact = 1 hourS.pyogenes : > $4.25log_{10}$reduction H.influenzae :> $4.18log_{10}$ reduction MRSA:> $4.11log_{10}$ reduction | reductionMRSA:> $4.83log_{10}$T0 Inoculums measured, >106Bacterial contact = 1 hourS.pyogenes : > $4.25log_{10}$reduction H.influenzae :> $4.18log_{10}$ reduction MRSA:> $4.11log_{10}$ reduction | NA |
| Viral Reduction: | 99.99 % (>4.0 $log_{10}$ )reduction of 16 differentstrains of Influenza A &Influenza B viruses after 5minutes contact with thesurface of the mask. | NA | 99.99 % (>4.0 $log_{10}$ )reduction of 15 differentstrains of Influenza A &Influenza B viruses after 5minutes contact with thesurface of the mask. |
| Repeat Virus ChallengeAfter Extended Wear byHuman Subjects: | 99.99 % (>4.0 $log_{10}$ )reduction of 2 virus,Influenza A (H1N1) & AvianInfluenza virus (H5N1)viruses after 5 minutescontact with the surface of themasks that had been worn for4 hours and 8 hours . | NA | NA |
| Intended Use Statement: | The SpectraShield 9500 SurgicalMask is a single use, disposable,surgical mask, tested for continuoususe up to 8 hours, embedded with azeolite carrier containing a silver-copper agent on the outer layer andis not an antimicrobial drug.SpectraShield 9500 kills 99.99% oftest bacteria after one hour of contactwith the surface of the respirator, andinactivates 99.99% of test influenzaviruses after 5 minutes of contactwith the surface of the mask. In vitro(laboratory) tests have demonstrated99.99% kill on the surface of theouter layer of the respirator whentested in vitro against single isolatesof the following test bacteria:Streptococcus pyogenes , MRSA(Methicillin Resistant | The SpectraShield 9500 SurgicalN95 Respirator is a single use,disposable, surgical N95 respirator,tested for continuous use up to 8hours, embedded with a zeolitecarrier containing a silver-copperagent on the outer layer and is not anantimicrobial drug. SpectraShield9500 kills 99.99% of test bacteriaafter one hour of contact with thesurface of the respirator.In vitro (laboratory) tests havedemonstrated 99.99% kill on thesurface of the outer layer of therespirator when tested in vitro against | The BioFriendTM BioMaskTM N95surgical respirator is a single useNIOSH-approved, disposable N95surgical respirator with a hydrophilicplastic coating on the outer layer(active ingredient: citric acid 2%w/w, a pH lowering agent), and asecond inner layer treated with metalions (active ingredients: copper 1.6%w/w and zinc 1.6% w/w which formionic bonds with negatively chargedside groups on the influenza viruses).The BioFriend™ BioMask™ N95surgical respirator inactivates 99.99%of tested influenza viruses on fiveminutes contact with the surface ofthe respirator in laboratory ( in vitro )tests against the following seasonal,pandemic, avian, swine, and equine |
| Subject Device | Predicate DeviceK120244 SpectraShield | Predicate DeviceK122702 BioFriendTMBioMaskTM | |
| contact conditions.In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40.No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti- influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material. | Staphylococcus aureus ), andHaemophilus influenzae under tested contact conditions.No clinical studies have been conducted comparing the ability of the untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.The SpectraShield 9500 Surgical N95 respirator is a single use device intended for occupational use to protect against microorganisms, body fluids and particulate material | pandemic flu subtypeA/California/04/2009,A/Brisbane/59/2007,A/Wisconsin/10/1998, A/NewJersey/8/1976, A/PuertoRico/8/1934),H3N2(A/Brisbane/10/2007,A/Wisconsin/67/2005), H2N2(A/2/Japan/305/1957); the bird flusubtypes: H5N1 (NIBRG-14), N9N2(A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flusubtype: H1N1(A/Swine/1976/1931); the equine flusubtype: H3N8(A/Equine/2/Miami/1963); andInfluenza Bstrains: (B/Florida/4/2006,B/Lee/1940), under tested contactconditions. Correlation between invitro testing results and any clinicalevent has not been tested.The BioFriendTM BioMaskTM N95 surgical respirator, Model: Professional (BF-200-3013AN) is flat folded and expands into a convex-shaped mask with polyamide/spandex elastic head- loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material. |
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Image /page/6/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in blue, except for the "X", which is in green and has a blue diamond above it. Below "NEXERA" is the word "MEDICAL" in black.
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Image /page/8/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X", which is in green. Above the "X" is a blue diamond shape. Below the word "NEXERA" is the word "MEDICAL" in a smaller, bold, black font.
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Image /page/9/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X" which is green and has a blue diamond shape above it. Below "NEXERA" is the word "MEDICAL" in a smaller, bold, black font.
Conclusion: Based on the intended use, technological characteristics, performance data, clinical and nonclinical tests performed, the subject SpectraShield Model 9500 Surgical Mask is substantially equivalent and 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.