(160 days)
Not Found
No
The summary describes a physical device (a respirator) with an antibacterial coating. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The performance studies focus on material properties and antibacterial efficacy, not algorithmic performance.
No.
The device is a surgical N95 respirator used for protection against microorganisms, body fluids, and particulate material, not for treating a disease or condition. While it has an antibacterial agent on its surface, the "Intended Use" explicitly states it "is not an antimicrobial drug" and no clinical studies have shown it protects wearers from infection, indicating it's not a therapeutic device.
No
Explanation: The SpectraShield 9500 Surgical N95 Respirator is designed to protect from microorganisms and particulate matter, not to diagnose medical conditions.
No
The device description clearly outlines a physical, multi-layered surgical mask with embedded materials and physical components like straps and a nose strip. There is no mention of software as the primary or sole component.
Based on the provided text, the SpectraShield 9500 Surgical N95 Respirator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "single use, disposable, surgical N95 respirator, intended for occupational use to protect against microorganisms, body fluids, and particulate material." This describes a personal protective equipment (PPE) device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical construction of a mask with antibacterial properties on the outer layer. This aligns with a protective barrier device.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration, fluid resistance, flammability) and the antibacterial efficacy on the surface of the mask against specific bacteria in vitro. These are tests of the device's protective capabilities and surface properties, not diagnostic tests performed on human samples.
- Key Metrics: The key metrics listed are related to the performance of the mask as a barrier and its biocompatibility, not diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV which are typical for IVDs.
- No mention of analyzing human specimens: There is no indication that this device is used to collect, prepare, or analyze specimens from the human body (like blood, urine, tissue, etc.) for diagnostic purposes.
In summary, the SpectraShield 9500 Surgical N95 Respirator is a protective device designed to filter airborne particles and provide an antibacterial surface on its exterior. It does not perform diagnostic tests on human samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
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 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.
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 meitblown 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 agent to provide antibacterial performance. The mask has 2 latex-free non-allergenic elastic straps 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 predicate device (K090414) was tested for bio-efficacy after repeated exposures to perspiration over a 12 hour period (see K090414 Repeat Challenge Protocol and Testing). The repeat challenge testing required the predicate device be repeatedly exposed to perspiration over a 12 hour period. Following the 12 hour exposure the predicate device was tested and demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae under tested contact conditions. The intention of the repeated challenge and sustained exposure was to demonstrate that the device would still function as intended (99.99% kill) after wearing the device for 12 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 10993-10: Pass: USP reactivity score = 10e6
S.pyogenes: > 4.40log10reduction - 1 hour
H.influenzae: > 6.20log10reduction - 1 hour
MRSA: > 4.83log10reduction - 1 hour
BioEfficacy after repeated exposures to perspiration over 12 hours:
To Inoculums measured, >10e6
S.pyogenes: > 4.25log10reduction - 1 hour
H.influenzae: > 4.18log10reduction - 1 hour
MRSA: > 4.11log10reduction - 1 hour
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.
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
K120244
Image /page/0/Picture/1 description: The image shows the logo for "NEXERA MEDICAL". The logo is in black and white, with the word "NEXERA" in large, bold letters. Above the X is a diamond shape. Below the ERA is the word "MEDICAL" in smaller letters.
JUL 5 5 2012
Section 5.0: 510(k) SUMMARY
510(k) Owner: NexEra Medical, Inc. 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 |
Establishment TBD Registration Number: Date Summarv July 2, 2012 Prepared: Device: Trade Name: SpectraShield model 9500 Surgical Mask Common /Classification Name: Surgical mask Classification Product Code: ONT Regulation Number: 21CFR 878.4040 Predicate K090414 SpectraShield 9500 Surgical N95 Respirator Device Information: The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed Device of 4 layers of material, molded to form the mask. A 2-ply meitblown polypropylene Description: 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 agent to provide antibacterial performance. The mask has 2 latex-free non-allergenic elastic straps and an aluminum nose strip. Intended Use: 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 3343 West Commercial Blvd., Suite 103 - Ft. Lauderdale, FL 33309 USA Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
Section 5.0: 510(K) Summary Page | 1
1
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 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.
| New Device | Predicate Device | |
|---|---|---|
| 510(k) # | To be determined | K090414 |
| Company | NexEra Medical, Inc. | NexEra Medical, Inc. |
| Name/Model | SpectraShield 9500 Surgical N95 Respirator * | |
| (*with amended Intended use Statement) | SpectraShield 9500 Surgical N95 Respirator | |
| Fabrics | Nonwoven polyester containing a silver- | |
| copper zeolite (antibacterial agent) and a | ||
| meltblown polypropylene substrate. | Nonwoven polyester containing a silver- | |
| copper zeolite (antibacterial agent) and a | ||
| meltblown polypropylene substrate. | ||
| Nosepiece | 100% Aluminum | 100% Aluminum |
| Straps | (2) Polyamide fiber and elastic straps, latex free | (2) Polyamide fiber and elastic straps, latex free |
| Mask Style | Molded shape | Molded shape |
| Fluid Resistance | ||
| ASTM F1862 | Pass: Fluid Resistant @ 160mm Hg | Pass: Fluid Resistant @ 160mm Hg |
| New Device | Predicate Device | |
| Particulate | ||
| Filtration Efficiency | ||
| ASTM F2299 | Pass: 99.87% at 0.1 microns | Pass: 99.87% at 0.1 microns |
| Differential | ||
| Pressure | ||
| Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 4.3mm H20/cm2 |
| Bacterial | ||
| Filtration | ||
| Efficiency | ||
| ASTM F2101 | Pass: 99.9% | Pass: 99.9% |
| Flammability | ||
| Class 16CFR 1610 | Class 1 | Class 1 |
| Cytotoxicity | ||
| 10993-10 | Pass: USP reactivity score = 106 | |
| S.pyogenes: > 4.40log10reduction - 1 hour | ||
| H.influenzae: > 6.20log10reduction - 1 hour | ||
| MRSA: > 4.83log10reduction - 1 hour | To Inoculums measured, >106 | |
| S.pyogenes: > 4.40log10reduction - 1 hour | ||
| H.influenzae: > 6.20log10reduction - 1 hour | ||
| MRSA: > 4.83log10reduction - 1 hour | ||
| BioEfficacy : | ||
| after repeated | ||
| exposures to | ||
| perspiration over | ||
| 12 hours | To Inoculums measured, >106 | |
| S.pyogenes: > 4.25log10reduction - 1 hour | ||
| H.influenzae: > 4.18log10reduction - 1 hour | ||
| MRSA: > 4.11log10reduction - 1 hour | To Inoculums measured, >106 | |
| S.pyogenes: > 4.25log10reduction - 1 hour | ||
| H.influenzae: > 4.18log10reduction - 1 hour | ||
| MRSA: > 4.11log10reduction - 1 hour | ||
| Intended Use | ||
| Statement | 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 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 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, 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 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. | ||
| New Device | Predicate Device | |
| The SpectraShield 9500 Surgical N95 | ||
| respirator is a single use device intended for | ||
| occupational use to protect against | ||
| microorganisms, body fluids and particulate | ||
| material. | respirator is a single use device intended for | |
| occupational use to protect against | ||
| microorganisms, body fluids and particulate | ||
| material. |
510(k) Summary Device Comparison Table
3343 West Commercial Blvd., Suite 103 - Ft. Lauderdale, FL 33309 USA Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
2
Image /page/2/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The logo is in black and features a stylized "X" with a diamond shape above it. The word "MEDICAL" is written in smaller letters below the "ERA" portion of "NEXERA".
3343 West Commercial Blvd., Suite 103 – Ft. Lauderdale, FL 33309 USA Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
3
Image /page/3/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The logo is in black and white. The word "NEXERA" is in large, bold letters, with a diamond shape above the "X". Below "NEXERA" is the word "MEDICAL" in smaller letters.
3343 West Commercial Blvd., Suite 103 – Ft. Lauderdale, FL 33309 USA Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
4
The subject device (SpectraShield model 9500 Surgical mask with the revised IFU Conclusion: referencing "tested for continuous use up to 8 hours"), and the predicate device (K090414) are the same device. The intention of this 510k submittal is to change the IFU to include the statement "tested for continuous use up to 8 hours".
The predicate device (K090414) was tested for bio-efficacy after repeated exposures to perspiration over a 12 hour period (see K090414 Repeat Challenge Protocol and Testing). The repeat challenge testing required the predicate device be repeatedly exposed to perspiration over a 12 hour period. Following the 12 hour exposure the predicate device was tested and demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae under tested contact conditions. The intention of the repeated challenge and sustained exposure was to demonstrate that the device would still function as intended (99.99% kill) after wearing the device for 12 hours.
The IFU for the predicate device references "single use, disposable device". The proposed change to the IFU would read "single use, disposable device, tested for continuous use up to 8 hours."
It is our conclusion that the proposed change to the IFU does not change the intended use of the device, and we believe the change to the IFU further clarifies the intended use of the device. Additionally, we note the proposed change to the IFU demonstrate the device is as safe and as effective as the predicate device and performs equally as well.
3343 West Commercial Blvd., Suite 103 - Ft. Lauderdale, FL 33309 USA Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Paul Sallarulo Nexera Medical Incorporated 3343 West Commercial Boulevard Suite 103 Fort Lauderdale, Florida 33309
5 2012 JUL
Re: K120244 Trade/Device Name: SpectraShield Model 9500 Surgical Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: June 21, 2012 Received: June 25, 2012
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.
6
Page 2- Mr. Sallarulo
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement Section 4.0:
510(k) Number: 510(k) submission K12 0244
SpectraShield model 9500 Surgical Respirator Device Name:
Indications for Use:
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 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 – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Nalip. hanyhim. 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: