(736 days)
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,
The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respirator composed of 4 layers of material, molded to form the respirator. 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 antimicrobial agent to provide antimicrobial performance. The respirator has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.
Here's an analysis of the acceptance criteria and study information for the SpectraShield model 9500 Surgical Respirator based on the provided text:
Device: SpectraShield model 9500 Surgical Respirator
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (from predicate/guidance) | SpectraShield 9500 Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Fluid Resistant | 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 | Class 1 |
| Cytotoxicity (ISO 10993-10) | Score < 2 | USP reactivity score = < 2, Pass |
| Primary Skin Irritation (ISO 10993-10) | Non-irritant | PSI Score = 0, Non-irritant, Pass |
| Repeated Patch Dermal Sensitization (ISO 10993-10) | 0% incidence sensitization response "0" severity | 0% incidence sensitization response "0" severity at each evaluated time point. Pass |
| Systemic Toxicity (ISO 10993-11) | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity from the extracts was observed. Pass |
| Physico-chemical (USP) | Met USP limits | Test results met the USP limits. Pass |
| Gas off Testing | Antimicrobial particles within safe inhalation levels | Total antimicrobial particles released from the device were verified to be within safe inhalation levels. |
| Leach off Testing | Leachable antimicrobial particles within safe orally ingestible levels | Total leachable antimicrobial particles released from the device were verified to be within safe orally ingestible levels. |
| Antimicrobial Efficacy (surface) | 99.99% kill after one hour of contact | 99.99% kill on the surface of the outer layer against Streptococcus pyogenes, MRSA, and Haemophilus influenzae |
Note: For several tests (Particulate Filtration Efficiency, Differential Pressure, Bacterial Filtration Efficiency), explicit numerical acceptance criteria from the predicate or regulatory guidance are not stated in the provided text, but the device's performance is listed as "Pass." The acceptance criteria for these would typically be derived from the relevant ASTM/Mil standards or comparison to the predicate device's performance if not explicitly noted. In this case, the predicate device's performance for these tests is generally lower, implying the SpectraShield's performance meets or exceeds the necessary thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes various performance tests for the SpectraShield 9500. However, it does not specify the sample sizes used for each individual test (e.g., how many respirators were tested for fluid resistance, filtration efficiency, etc.).
Data Provenance: The tests are described as in vitro (laboratory) tests. There is no mention of country of origin for the data, nor whether the studies were retrospective or prospective, as they are laboratory performance evaluations of the device itself, not clinical studies involving human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to the type of studies described. The "ground truth" here is established by standardized test methods (e.g., ASTM, ISO, Mil standards) and objective measurements, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
This information is not applicable. The tests performed are objective, laboratory-based measurements against established standards, not studies requiring adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states: "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." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The testing performed for the SpectraShield 9500 is entirely standalone in the sense that it evaluates the device's physical and biological performance characteristics (e.g., filtration, fluid resistance, antimicrobial kill rate) directly, without human interaction or interpretation involved in the measurement process itself. The "device performance" in the table reflects these standalone results.
7. The type of ground truth used:
The ground truth for the performance tests is based on standardized test methodologies and objective measurements according to established industry and regulatory standards (e.g., ASTM F1862, ASTM F2299, Mil M36954C, ASTM F2101, 16CFR 1610, ISO 10993-10, ISO 10993-11, USP). For the antimicrobial efficacy, the "ground truth" results are the measured kill rates against specified bacteria under controlled in vitro conditions.
8. The sample size for the training set:
Not applicable. This device is a physical product (surgical respirator), not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device.
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FEB 24 2001
ATTACHMENT 2 510(k) SUMMARY
| 510(k) Owner: | NexEra Medical, Inc.1556 East Commercial BlvdOakland Park, Fl 33334-5752 | ||
|---|---|---|---|
| Contact:Phone:Fax: | Paul Sallarulo, President CEO954-495-2020, x 2031954-491-7281 | ||
| EstablishmentRegistrationNumber: | TBD | ||
| Date SummaryPrepared: | First submittal:Revised:Revised:Revised: | February 12, 2009August 19, 2009December 3, 2009January 23, 2011 | |
| Device: | Trade Name:Common /Classification Name:Classification Product Code: | SpectraShield model 9500 Surgical RespiratorSurgical RespiratorONT | |
| Regulation Number: | 21CFR 878.4040 | ||
| Regulation Class: | II | ||
| PredicateDeviceInformation: | K061716 Prestige Ameritech Surgical MaskPrestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, PeachPrestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, PeachPrestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, YellowPrestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, PeachPrestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach | ||
| DeviceDescription: | The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respiratorcomposed of 4 layers of material, molded to form the respirator. A 2-ply meltblownpolypropylene middle layer is sandwiched by inner and outer layers of 100% polyesternonwoven fabric. The inner and outside layers of polyester nonwoven fabric includefibers that have been embedded with an antimicrobial agent to provide antimicrobialperformance. The respirator has 2 latex-free non-allergenic elastic straps and analuminum nose strip. | ||
| Intended Use: | The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgicalN95 respirator, embedded with a zeolite carrier containing a silver-copper agent onthe outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% oftest 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 ofthe respirator when tested in vitro against single isolates of the following testbacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus |
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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 9500Surgical Respirator | Prestige AmeritechSurgical Mask |
| Fabrics: | Nonwoven polyester containing silver-copperzeolite and a meltblown polypropylenesubstrate. | Cellulose, spun bonded polypropylene,and medical grade tissue |
| Nosepiece: | 100% Aluminum | Malleable Aluminum nosepiece strip |
| Straps | (2) Polyamide fiber and elastic straps, and doesnot contain natural rubber latex. | Tie strips or latex free elastic loops |
| Mask Style: | Molded shape | Flat folded , pleated |
| FluidResistance:ASTM F1862 | Pass: Fluid Resistant @ 160mm Hg | Pass: Fluid Resistant |
| ParticulateFiltrationEfficiency:ASTM F2299 | Pass: 99.87% at 0.1 microns | Pass: 98.5% at 0.1 microns |
| DifferentialPressure:Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 2.6 mm H20/cm2 |
| BacterialFiltrationEfficiency:ASTM F2101 | Pass: 99.9% | Pass: 99.6% |
510(k) Summary Device Comparison Table
Confidential
2/25/2011
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| FlammabilityClass:16CFR 1610 | Class 1 | Class1 |
|---|---|---|
| Cytotoxicity:10993-10 | USP reactivity score = < 2, Pass | Not Available |
| Primary skinirritation:ISO10993-10 | PSI Score = 0, Non-irritant, Pass | Not Available |
| Repeated PatchDermalSensitizationISO 10993-10 | 0% incidence sensitization response"0" severity at each evaluated time point. Pass | Not Available |
| SystemicToxicityISO 10993-11 | No mortality or evidence of systemic toxicityfrom the extracts was observed. Pass | Not Available |
| Physico-chemicalUSPPhysico-chemicalTest-Plastics | Test results met the USP limits. Pass | Not Available |
| Gas off Testing | Total antimicrobial particles released from thedevice were verified to be within safeinhalation levels. | Not Available |
| Leach offtesting | Total leachable antimicrobial particles releasedfrom the device were verified to be within safeorally 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.
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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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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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
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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:
§ 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.