(736 days)
Not Found
No
The summary describes a physical respirator with an antimicrobial coating and provides performance data related to filtration and material properties, with no mention of AI or ML.
No
The device is described as a surgical N95 respirator intended for protection against microorganisms, body fluids, and particulate material, not for treating a disease or condition. The antimicrobial feature is stated as "not an antimicrobial drug."
No
The device is described as a "Surgical N95 Respirator" intended for protection against microorganisms, body fluids, and particulate material. It is a filter or barrier device, not one used to identify the presence of diseases or conditions.
No
The device description clearly indicates it is a physical respirator composed of multiple layers of material, elastic straps, and an aluminum nose strip. It is a hardware device with an embedded antimicrobial agent, not a software-only device.
Based on the provided information, the SpectraShield 9500 Surgical N95 Respirator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for occupational use to protect against microorganisms, body fluids, and particulate material. This is a protective function, not a diagnostic one.
- Device Description: The device is a respirator designed to filter air and provide a barrier. It has an antimicrobial agent on the surface, but this is to kill bacteria on the mask itself, not to diagnose a condition in a patient.
- Lack of Diagnostic Function: An IVD device is used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not perform any such examination.
- Performance Studies: The performance studies focus on the protective capabilities of the respirator (filtration efficiency, fluid resistance, etc.) and the antimicrobial activity on the mask's surface. They do not involve analyzing patient samples for diagnostic purposes.
- Predicate Devices: The predicate devices listed are other surgical masks and respirators, which are also not IVD devices.
While the device mentions "in vitro (laboratory) tests" to demonstrate the antimicrobial activity on the mask's surface, this refers to testing the device itself in a lab setting, not using the device to perform a diagnostic test on a patient sample.
Therefore, the SpectraShield 9500 Surgical N95 Respirator is a protective medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONT
Device Description
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.
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 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, based on:
Fluid Resistance: Pass: Fluid Resistant @ 160mm Hg
Particulate Filtration Efficiency: Pass: 99.87% at 0.1 microns
Differential Pressure: Pass: 4.3mm H20/cm2
Bacterial Filtration Efficiency: Pass: 99.9%
Flammability Class: Class 1
Cytotoxicity: USP reactivity score =
§ 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
FEB 24 2001
ATTACHMENT 2 510(k) SUMMARY
| 510(k) Owner: | NexEra Medical, Inc.
1556 East Commercial Blvd
Oakland Park, Fl 33334-5752 | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--|
| | Contact:
Phone:
Fax: | Paul Sallarulo, President CEO
954-495-2020, x 2031
954-491-7281 | |
| Establishment
Registration
Number: | TBD | | |
| Date Summary
Prepared: | First submittal:
Revised:
Revised:
Revised: | February 12, 2009
August 19, 2009
December 3, 2009
January 23, 2011 | |
| Device: | Trade Name:
Common /Classification Name:
Classification Product Code: | SpectraShield model 9500 Surgical Respirator
Surgical Respirator
ONT | |
| | Regulation Number: | 21CFR 878.4040 | |
| | Regulation Class: | II | |
| Predicate
Device
Information: | K061716 Prestige Ameritech Surgical Mask
Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach
Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach
Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow
Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach
Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach | | |
| Device
Description: | 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. | | |
| Intended 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 | | |
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 | |
| Surgical Respirator | Prestige Ameritech | |
| Surgical Mask | ||
| Fabrics: | Nonwoven polyester containing silver-copper | |
| zeolite and a meltblown polypropylene | ||
| substrate. | Cellulose, spun bonded polypropylene, | |
| and medical grade tissue | ||
| Nosepiece: | 100% Aluminum | Malleable Aluminum nosepiece strip |
| Straps | (2) Polyamide fiber and elastic straps, and does | |
| not contain natural rubber latex. | Tie strips or latex free elastic loops | |
| Mask Style: | Molded shape | Flat folded , pleated |
| Fluid | ||
| Resistance: | ||
| ASTM F1862 | Pass: Fluid Resistant @ 160mm Hg | Pass: Fluid Resistant |
| Particulate | ||
| Filtration | ||
| Efficiency: | ||
| ASTM F2299 | Pass: 99.87% at 0.1 microns | Pass: 98.5% at 0.1 microns |
| Differential | ||
| Pressure: | ||
| Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 2.6 mm H20/cm2 |
| Bacterial | ||
| Filtration | ||
| Efficiency: | ||
| ASTM F2101 | Pass: 99.9% | Pass: 99.6% |
510(k) Summary Device Comparison Table
Confidential
2/25/2011
2
| Flammability
Class:
| 16CFR 1610 | Class 1 | Class1 |
|---|---|---|
| Cytotoxicity: | ||
| 10993-10 | USP reactivity score = 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: