SpectraShield 9500 Surgical N95 Respirator

K150729 · Nexera Medical, Inc. · ONT · Dec 29, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150729
• Device Name: SpectraShield 9500 Surgical N95 Respirator
• Applicant: Nexera Medical, Inc.
• Product Code: ONT · General, Plastic Surgery
• Decision Date: Dec 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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 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.

Device Story

SpectraShield 9500 is a molded, 4-layer surgical mask; features 2-ply meltblown polypropylene middle layer sandwiched between polyester nonwoven fabric layers. Outer layer embedded with silver-copper zeolite agent for antibacterial/antiviral surface activity. Device includes aluminum nose strip and 2 elastic polyamide straps. Used in occupational settings to protect wearers from microorganisms, body fluids, and particulates. Surface treatment inactivates bacteria and influenza viruses upon contact; however, it does not protect against pathogens inhaled around mask edges. No clinical studies compare efficacy against untreated masks. Benefits include reduced surface pathogen load during 8-hour continuous use.

Clinical Evidence

No clinical studies conducted. Evidence is based on bench testing: bacterial filtration efficiency (99.9%), particulate filtration (99.87% at 0.1 microns), fluid resistance (160 mmHg), and in vitro viral/bacterial reduction assays. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) per ISO 10993 passed. Gas-off and leach-off testing confirmed antibacterial/antiviral particles remain within safe inhalation/ingestion limits.

Technological Characteristics

4-layer molded mask: 2-ply meltblown polypropylene core, polyester nonwoven outer/inner layers. Outer layer embedded with silver-copper zeolite. Aluminum nose strip; polyamide/elastic straps. ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101 (BFE), Mil M36954C (differential pressure). Biocompatibility per ISO 10993-10/11. Non-sterile.

Indications for Use

Indicated for occupational use as a single-use, disposable surgical mask to protect against microorganisms, body fluids, and particulate material. Suitable for use by adults in occupational settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SpectraShield 9500 Surgical N95 Respirator (K120244)
• BioFriend™ BioMask™ N95 Surgical Respirator (K122702)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

### 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

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: [phone] ~ Fax: [phone] ~ www.nexeramed.com

{4}------------------------------------------------

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

{5}------------------------------------------------

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<br>K120244 SpectraShield | Predicate Device<br>K122702 BioFriendTM<br>BioMaskTM |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K150729 | K120244 | K122702 |
| Company | NexEra Medical, Inc. | NexEra Medical, Inc. | Filligent (HK) Limited |
| Name/Model | SpectraShield Model<br>9500 Surgical Mask *<br>(*with amended Intended<br>use Statement) | SpectraShield Model<br>9500 Surgical Respirator | BioFriendTM BioMaskTM<br>N95 Surgical Respirator:<br>Professional BF-200-3013AN |
| Fabrics | Nonwoven polyester<br>containing a silver-copper<br>zeolite (antibacterial /<br>aniviral agent) and a<br>meltblown polypropylene<br>substrate. | Nonwoven polyester<br>containing a silver-copper<br>zeolite (antibacterial agent)<br>and a meltblown<br>polypropylene substrate. | 4 layers: spun-bond<br>polypropylene, cellulose /<br>polyester, meltblown<br>polypropylene, spunbond<br>polypropylene. Copper &<br>zinc ion treatment and a<br>hydrophilic plastic coating. |
| Nosepiece | 100% Aluminum | 100% Aluminum | 100% Aluminum |
| Straps | (2) Polyamide fiber and<br>elastic straps, not made<br>with natural latex | (2) Polyamide fiber and<br>elastic straps, latex free | Polyamide/spandex elastic<br>straps, latex free |
| Mask Style | Molded shape | Molded shape | Convex shape |
| Fluid Resistance ASTM<br>F1862 | Pass: Fluid Resistant @<br>160mm Hg | Pass: Fluid Resistant @<br>160mm Hg | 160 mm Hg |
| Particulate Filtration<br>ASTM<br>Efficiency<br>F2299 | Pass: 99.87% at 0.1<br>microns | Pass: 99.87% at 0.1<br>microns | >99.9% |
| Differential Pressure<br>Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 4.3mm H20/cm2 | 4.9mm H20/cm2 |
| Bacterial Filtration<br>Efficiency<br>ASTM<br>F2101 | Pass: 99.9% | Pass: 99.9% | >99.9% |
| | Subject Device | Predicate Device<br>K120244 SpectraShield | Predicate Device<br>K122702 BioFriend™<br>BioMask ™ |
| Flammability Class<br>16CFR 1610 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity 10993-10…