SPECTRASHIELD 9500 SURGICAL MASK

{0}------------------------------------------------ K090414 FEB 24 2001 ## ATTACHMENT 2 510(k) SUMMARY | 510(k) Owner: | NexEra Medical, Inc.<br>1556 East Commercial Blvd<br>Oakland Park, Fl 33334-5752 | | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--| | | Contact:<br>Phone:<br>Fax: | Paul Sallarulo, President CEO<br>954-495-2020, x 2031<br>954-491-7281 | | | Establishment<br>Registration<br>Number: | TBD | | | | Date Summary<br>Prepared: | First submittal:<br>Revised:<br>Revised:<br>Revised: | February 12, 2009<br>August 19, 2009<br>December 3, 2009<br>January 23, 2011 | | | Device: | Trade Name:<br>Common /Classification Name:<br>Classification Product Code: | SpectraShield model 9500 Surgical Respirator<br>Surgical Respirator<br>ONT | | | | Regulation Number: | 21CFR 878.4040 | | | | Regulation Class: | II | | | Predicate<br>Device<br>Information: | K061716 Prestige Ameritech Surgical Mask<br>Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach<br>Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach<br>Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow<br>Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach<br>Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach | | | | Device<br>Description: | The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respirator<br>composed of 4 layers of material, molded to form the respirator. A 2-ply meltblown<br>polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester<br>nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include<br>fibers that have been embedded with an antimicrobial agent to provide antimicrobial<br>performance. The respirator has 2 latex-free non-allergenic elastic straps and an<br>aluminum nose strip. | | | | Intended Use: | The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical<br>N95 respirator, embedded with a zeolite carrier containing a silver-copper agent on<br>the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of<br>test bacteria after one hour of contact with the surface of the respirator. In vitro<br>(laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of<br>the respirator when tested in vitro against single isolates of the following test<br>bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus | | | {1}------------------------------------------------ aureus), and Haemophilus influenzae, under tested contact conditions. No clinical studies have been conducted comparing the ability of an 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 | | New Device | Predicate Device | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | 510(k) # | To be determined | K061716 | | Company | NexEra Medical, Inc. | Prestige Ameritech | | Name/Model | SpectraShield model 9500<br>Surgical Respirator | Prestige Ameritech<br>Surgical Mask | | Fabrics: | Nonwoven polyester containing silver-copper<br>zeolite and a meltblown polypropylene<br>substrate. | Cellulose, spun bonded polypropylene,<br>and medical grade tissue | | Nosepiece: | 100% Aluminum | Malleable Aluminum nosepiece strip | | Straps | (2) Polyamide fiber and elastic straps, and does<br>not contain natural rubber latex. | Tie strips or latex free elastic loops | | Mask Style: | Molded shape | Flat folded , pleated | | Fluid<br>Resistance:<br>ASTM F1862 | Pass: Fluid Resistant @ 160mm Hg | Pass: Fluid Resistant | | Particulate<br>Filtration<br>Efficiency:<br>ASTM F2299 | Pass: 99.87% at 0.1 microns | Pass: 98.5% at 0.1 microns | | Differential<br>Pressure:<br>Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 2.6 mm H20/cm2 | | Bacterial<br>Filtration<br>Efficiency:<br>ASTM F2101 | Pass: 99.9% | Pass: 99.6% | ## 510(k) Summary Device Comparison Table Confidential 2/25/2011 {2}------------------------------------------------ | Flammability<br>Class:<br>16CFR 1610 | Class 1 | Class1 | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------| | Cytotoxicity:<br>10993-10 | USP reactivity score = < 2, Pass | Not Available | | Primary skin<br>irritation:<br>ISO10993-10 | PSI Score = 0, Non-irritant, Pass | Not Available | | Repeated Patch<br>Dermal<br>Sensitization<br>ISO 10993-10 | 0% incidence sensitization response<br>"0" severity at each evaluated time point. Pass | Not Available | | Systemic<br>Toxicity<br>ISO 10993-11 | No mortality or evidence of systemic toxicity<br>from the extracts was observed. Pass | Not Available | | Physico-<br>chemical<br>USP<br>Physico-chemical<br>Test-Plastics | Test results met the USP limits. Pass | Not Available | | Gas off Testing | Total antimicrobial particles released from the<br>device were verified to be within safe<br>inhalation levels. | Not Available | | Leach off<br>testing | Total leachable antimicrobial particles released<br>from the device were verified to be within safe<br>orally ingestible levels. | Not Available | It is our conclusion that the SpectraShield model_9500 Surgical Respirator meets the Conclusion: requirements for the tests recommended for evaluation and risk analysis outlined in the (1) Guidance Document for Surgical Masks and the (2) Guidance Document for Medical Devices that Include Antimicrobial Agents. The testing included in this submission demonstrates that the technological characteristics of the SpectraShield model 9500 Surgical Respirator, with the specified antimicrobial agent, does not raise any question of safety and effectiveness, > The SpectraShield model 9500 Surgical Respirator is substantially equivalent in safety and effectiveness to the Prestige Ameritech Surgical Mask (predicate device) named in this submission. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Paul Sallarulo President CEO NexEra Medical. Incorporated 1556 East Commercial Boulevard Oakland Park. Florida 33334-5752 FEB 2 4 2511 Re: K090414 Trade/Device Name: SpectraShield model 9500 Surgical Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Respirator Regulatory Class: II Product Code: ONT Dated: January 24, 2011 Received: January 26, 2011 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {4}------------------------------------------------ Page 2 - Mr. Sallarulo Enclosure 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, SWOGER LUNNS Anthony D. Watson, B.S., MS. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ ## ATTACHMENT 1 ## Indications for Use 510(k) Number: K090414 Device Name: SpectraShield model 9500 Surgical Respirator Indications for Use: The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, 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 single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions. No clinical studies have been conducted comparing the ability of an 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, Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over -the-counter Use X (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - ONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Confidential Edith F. Clamis- Welles 01/23/11 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: