(284 days)
Not Found
No
The document describes a surgical mask with an embedded antimicrobial agent and provides performance data based on in vitro testing. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
Explanation: The device is intended to protect the wearer from microorganisms by killing them on the mask's surface, as opposed to directly treating a disease or condition in a patient.
No
The text describes the device as a 'single use, disposable, surgical mask' intended for protection against microorganisms, body fluids, and particulate material, not for diagnosing a medical condition.
No
The device is a physical surgical mask with embedded materials, not a software program.
Based on the provided text, the SpectraShield 9500 Surgical Mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- SpectraShield 9500's Function: The SpectraShield 9500 is a surgical mask designed to protect the wearer from microorganisms, body fluids, and particulate material by filtering the air and having an antimicrobial/antiviral agent on its surface. It does not perform tests on human samples.
- "In vitro" in the Description: The text mentions "In vitro (laboratory) tests" which refers to tests conducted in a lab setting (outside of a living organism) to evaluate the mask's ability to kill bacteria and inactivate viruses on its surface. This is a test of the device's performance, not the device itself being an IVD.
Therefore, the SpectraShield 9500 Surgical Mask is a protective barrier device, not an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ONT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
occupational use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device underwent various non-clinical performance tests:
Fluid Resistance ASTM F1862: Pass: Fluid Resistant @ 160mm Hg
Particulate Filtration Efficiency ASTM F2299: Pass: 99.87% at 0.1 microns
Differential Pressure Mil M36954C: Pass: 4.3mm H20/cm2
Bacterial Filtration Efficiency ASTM F2101: Pass: 99.9%
Flammability Class 16CFR 1610: Class 1
Cytotoxicity (ISO10993-10): Pass: USP reactivity score = 10^6
Bacterial contact @ 1 hour:
S. pyogenes: >4.40log10 reduction
H. influenzae: >6.20log10 reduction
MRSA: > 4.83log10 reduction
Bacterial Reduction after repeated exposures to perspiration over 12 hours:
T0 Inoculums measured >10^6
Bacterial contact = 1 hour:
S. pyogenes: > 4.25log10 reduction
H. influenzae: > 4.18log10 reduction
MRSA: > 4.11log10 reduction
Viral Reduction:
99.99 % (>4.0 log10) reduction of 16 different strains of Influenza A & Influenza B viruses after 5 minutes contact with the surface of the mask.
Repeat Virus Challenge After Extended Wear by Human Subjects:
99.99 % (>4.0 log10) reduction of 2 virus, Influenza A (H1N1) & Avian Influenza virus (H5N1) viruses after 5 minutes contact with the surface of the masks that had been worn for 4 hours and 8 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacteria Kill: 99.99%
Virus Inactivation: 99.99%
Particulate Filtration Efficiency: 99.87% at 0.1 microns
Bacterial Filtration Efficiency: 99.9%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120244 SpectraShield 9500 Surgical N95 Respirator, K122702 BioFriend™ BioMask ™ N95 Surgical Respirator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 Device
K120244 SpectraShield | Predicate Device
K122702 BioFriendTM
BioMaskTM |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K150729 | K120244 | K122702 |
| Company | NexEra Medical, Inc. | NexEra Medical, Inc. | Filligent (HK) Limited |
| Name/Model | SpectraShield Model
9500 Surgical Mask *
(*with amended Intended
use Statement) | SpectraShield Model
9500 Surgical Respirator | BioFriendTM BioMaskTM
N95 Surgical Respirator:
Professional BF-200-3013AN |
| Fabrics | Nonwoven polyester
containing a silver-copper
zeolite (antibacterial /
aniviral agent) and a
meltblown polypropylene
substrate. | Nonwoven polyester
containing a silver-copper
zeolite (antibacterial agent)
and a meltblown
polypropylene substrate. | 4 layers: spun-bond
polypropylene, cellulose /
polyester, meltblown
polypropylene, spunbond
polypropylene. Copper &
zinc ion treatment and a
hydrophilic plastic coating. |
| Nosepiece | 100% Aluminum | 100% Aluminum | 100% Aluminum |
| Straps | (2) Polyamide fiber and
elastic straps, not made
with natural latex | (2) Polyamide fiber and
elastic straps, latex free | Polyamide/spandex elastic
straps, latex free |
| Mask Style | Molded shape | Molded shape | Convex shape |
| Fluid Resistance ASTM
F1862 | Pass: Fluid Resistant @
160mm Hg | Pass: Fluid Resistant @
160mm Hg | 160 mm Hg |
| Particulate Filtration
ASTM
Efficiency
F2299 | Pass: 99.87% at 0.1
microns | Pass: 99.87% at 0.1
microns | >99.9% |
| Differential Pressure
Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 4.3mm H20/cm2 | 4.9mm H20/cm2 |
| Bacterial Filtration
Efficiency
ASTM
F2101 | Pass: 99.9% | Pass: 99.9% | >99.9% |
| | Subject Device | Predicate Device
K120244 SpectraShield | Predicate Device
K122702 BioFriend™
BioMask ™ |
| Flammability Class
16CFR 1610 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity 10993-10 | Pass: USP reactivity
score = 10⁶
Bacterial contact @ 1 hour
$S.pyogenes: >4.40log_{10}$
reduction
$H.influenzae:>6.20log_{10}$ | T₀ Inoculums measured, >10⁶
Bacterial contact @ 1 hour
$S.pyogenes: >4.40log_{10}$
reduction
$H.influenzae:>6.20log_{10}$ | NA |
| | Subject Device | Predicate Device
K120244 SpectraShield | Predicate Device
K122702 BioFriendTM
BioMask TM |
| Bacterial Reduction:
after repeated exposures to
perspiration over 12 hours | reduction
MRSA:> $4.83log_{10}$
T0 Inoculums measured >106
Bacterial contact = 1 hour
S.pyogenes : > $4.25log_{10}$
reduction H.influenzae :
$4.18log_{10}$ reduction MRSA:
$4.11log_{10}$ reduction | reduction
MRSA:> $4.83log_{10}$
T0 Inoculums measured, >106
Bacterial contact = 1 hour
S.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 different
strains of Influenza A &
Influenza B viruses after 5
minutes contact with the
surface of the mask. | NA | 99.99 % (>4.0 $log_{10}$ )
reduction of 15 different
strains of Influenza A &
Influenza B viruses after 5
minutes contact with the
surface of the mask. |
| Repeat Virus Challenge
After Extended Wear by
Human Subjects: | 99.99 % (>4.0 $log_{10}$ )
reduction of 2 virus,
Influenza A (H1N1) & Avian
Influenza virus (H5N1)
viruses after 5 minutes
contact with the surface of the
masks that had been worn for
4 hours and 8 hours . | NA | NA |
| Intended Use Statement: | 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
outer layer of the respirator when
tested in vitro against single isolates
of the following test bacteria:
Streptococcus pyogenes , MRSA
(Methicillin Resistant | The SpectraShield 9500 Surgical
N95 Respirator is a single use,
disposable, surgical N95 respirator,
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.
In vitro (laboratory) tests have
demonstrated 99.99% kill on the
surface of the outer layer of the
respirator when tested in vitro against | The BioFriendTM BioMaskTM N95
surgical respirator is a single use
NIOSH-approved, disposable N95
surgical respirator with a hydrophilic
plastic coating on the outer layer
(active ingredient: citric acid 2%
w/w, a pH lowering agent), and a
second inner layer treated with metal
ions (active ingredients: copper 1.6%
w/w and zinc 1.6% w/w which form
ionic bonds with negatively charged
side groups on the influenza viruses).
The BioFriend™ BioMask™ N95
surgical respirator inactivates 99.99%
of tested influenza viruses on five
minutes contact with the surface of
the respirator in laboratory ( in vitro )
tests against the following seasonal,
pandemic, avian, swine, and equine |
| Subject Device | Predicate Device
K120244 SpectraShield | Predicate Device
K122702 BioFriendTM
BioMaskTM | |
| 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 ), and
Haemophilus 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 subtype
A/California/04/2009,
A/Brisbane/59/2007,
A/Wisconsin/10/1998, A/New
Jersey/8/1976, A/Puerto
Rico/8/1934),
H3N2(A/Brisbane/10/2007,
A/Wisconsin/67/2005), H2N2
(A/2/Japan/305/1957); the bird flu
subtypes: H5N1 (NIBRG-14), N9N2
(A/Turkey/Wisconsin/1966), H5N2 (
A/Duck/PA/10218/84); the swine flu
subtype: H1N1
(A/Swine/1976/1931); the equine flu
subtype: H3N8
(A/Equine/2/Miami/1963); and
Influenza B
strains: (B/Florida/4/2006,
B/Lee/1940), under tested contact
conditions. Correlation between in
vitro testing results and any clinical
event 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.