(146 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a surgical mask intended for infection control and protection from blood and body fluids, not for treating a disease or condition.
No
Explanation: The document clearly states that the surgical masks are intended for infection control practices by minimizing contamination, not for diagnosing any medical condition.
No
The device description and performance studies clearly indicate a physical medical device (surgical masks) with material properties and physical performance metrics. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for "infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids." This describes a barrier device used for personal protection, not a device used to perform tests on samples taken from the human body to diagnose or monitor a medical condition.
- Device Description: The description details the physical construction of a mask, not components or reagents used for in vitro testing.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability, Delta-P) are all related to the physical barrier properties and safety of a mask, not the analytical performance of an in vitro test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile)
- Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue .
- Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue .
- Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor Blue .
Product codes
FXX
Device Description
The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner facing, a 100% meltblown polypropylene inter media, with non facil cae no fog strip (if applicable) is made of melt blow polypropylene.
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
Not Found
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)
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
- a. Fluid Resistance: Synthetic Blood Penetration Test
- a. Fruid Resistance: Bynalone ey (BFE) / Differential Pressure (△P) Tests
- c. Flammability Testing
- d. Latex Particle Challenge Test
- Biocompatibility Testing Per ISO 10993 e.
It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.
Discussion of Clinical Test Performed: 8. Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance: ASTM 1862: 32 of 32 pass at 80mm Hg
Particulate Filtration Efficiency: ASTM F2299: 99.01% at 0.1 µm
Bacterial Filtration Efficiency: ASTM F2101: 99.8%
Flammability Class: 16CFR1610: 1
Delta-P: Mil M36954C: 2.5
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in
t CEP 8807 000 1000 - 1.01 CEP 1000 - 1.01 CED 5807 02 This Sunfiliary of 510(tc) Sareey and 61000 and 21 CFR §807.92.
OCT - 6 2011
The assigned 510(k) number is: K111343
Submitter's Identification: 1.
Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No.: 631-582-6777 Fax No.: 631-582-1726
Contact Person:
Mr. Gary Steinberg President Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No.: 631-582-6777 Fax No.: 631-582-1726
Date Summary Prepared: November 4, 2010
Name of Device: 2.
- Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue
- · Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue
- Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor -Blue
Predicate Device Information: 3.
Crosstex® Isofluid FogFree Earloop Face Mask
1
Device Description: 4.
The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner The Crosstex Isonulu Prus Burgiour rivens outer facing, a 100% meltblown facing, a 100% Spundonded porypropyitent elastic loops. The nose piece for the polypropyiene inter firedia, with non facil cae no fog strip (if applicable) is made of melt blow polypropylene.
Intended Use: న.
The following Crosstex Isofluid Plus Surgical Masks are intended for use in The following Crossics Isoftula Fras Dargeramination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue
- . Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue
- Crosstex® Isofluid Plus Fog: 100 Cargeree Surgical Earloop Face Mask with Splash Visor -Blue
The State of Children Comments of Children Comments of Children Was Party Contract
| Description | Crosstex Surgical Masks | Predicate Device: K082258 |
|---|---|---|
| Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene |
| Filter Media | Melt Blown Polypropylene | Melt Blown Polypropylene |
| Inner Layer | Cellulose | Spunbond Polypropylene |
| Nose Piece | Aluminum Wire | Aluminum Wire |
| Attachment | Earloop | Earloop |
| Anti-Fog (If Applicable) | Melt Blown Polypropylene | Melt Blown Polypropylene |
| Specifications and | ||
| Dimensions | Same | 7" x 3.5" |
| Mask Style | Same | Flat Pleated |
| Sterile | No | No |
| Single Use | Yes | Yes |
Comparison to Predicate Devices: 6.
2
| Description | Crosstex Surgical Masks | Predicate Device: K082258 |
|---|---|---|
| Fluid Resistance: ASTM 1862 | 32 of 32 pass at 80mm Hg | 30 of 32 pass at 80mm Hg |
| Particulate Filtration | ||
| Efficiency: ASTM F2299 | 99.01% at 0.1 µm | 98.5% at 0.5 µm |
| Bacterial Filtration Efficiency: | ||
| ASTM F2101 | 99.8% | 99.8% |
| Flammability Class: | ||
| 16CFR1610 | 1 | 1 |
| Delta-P: Mil M36954C | 2.5 | 2.86 |
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
- a. Fluid Resistance: Synthetic Blood Penetration Test
- a. Fruid Resistance: Bynalone ey (BFE) / Differential Pressure (△P) Tests
- c. Flammability Testing
- d. Latex Particle Challenge Test
- Biocompatibility Testing Per ISO 10993 e.
It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.
Discussion of Clinical Test Performed: 8.
Not Applicable
Conclusions: 9.
The Crosstex® Isofluid Plus Surgical Masks have the same intended use and technological characteristics as the predicate device. Moreover, bench testing technological characterission demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. The Crosstex® do not raise any now question e substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Crosstex International. Incorpoated C/O Mr. Richard M. Ormsbee Corporate Regulatory Affairs Manager Minntech Corporation 14605 28" Avenue North Minneapolis. Minnesota 55447
OCT - 6 2011
Re: K111343
Trade/Device Name: Crosstex® Isofluid Plus Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: September 20, 2011 Received: September 21, 2011
Dear Mr. Ormsbee;
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. Ormsbee
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 Flealth'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/MedicallDevices/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-five 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.
Cinton D. m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Qffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K | 1/343
Device Name: Crosstex® Isofluid Plus Surgical Masks
Indications for Use:
The following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile)
- Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue .
- Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue .
- Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor Blue .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elliott T. Claire-Will
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111343