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 .

Device Description

The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner 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.

AI/ML Overview

The provided text describes the acceptance criteria and performance of Crosstex® Isofluid Plus Surgical Masks, focusing on non-clinical tests to demonstrate substantial equivalence to a predicate device.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria (Predicate Device K082258)	Reported Device Performance (Crosstex Surgical Masks)
Fluid Resistance: ASTM 1862	30 of 32 pass at 80mm Hg	32 of 32 pass at 80mm Hg
Particulate Filtration Efficiency: ASTM F2299	98.5% at 0.5 µm	99.01% at 0.1 µm
Bacterial Filtration Efficiency: ASTM F2101	99.8%	99.8%
Flammability Class: 16CFR1610	1	1
Delta-P (Differential Pressure): Mil M36954C (or similar)	2.86 (implied from predicate)	2.5

Note: The "Acceptance Criteria" column is derived from the reported performance of the predicate device, as the submission states that the new device meets "all relevant requirements of the aforementioned test standards" and is "substantially equivalent." Typically, substantial equivalence is established by meeting or exceeding the performance of the predicate device for relevant parameters.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a separate "test set" in the context of a dataset for an AI/ML device. Instead, the performance evaluation is based on bench testing of the physical masks.

Fluid Resistance (ASTM 1862): "32 of 32 pass at 80mm Hg" for the new device, suggesting a sample size of 32 units tested. The predicate device had "30 of 32 pass at 80mm Hg," also implying 32 units tested for the predicate.
Other tests (PFE, BFE, Flammability, Delta-P): Specific sample sizes are not explicitly stated for these tests within the provided text, but they would typically involve multiple samples to ensure statistical validity.
Data Provenance: The data provenance is from non-clinical laboratory bench testing conducted to evaluate the physical and performance characteristics of the surgical masks. There is no information about the country of origin of the data beyond the submitter's identification in New York, USA. The nature of these tests makes them prospective in the sense that they are performed on manufactured products for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. The device is a physical surgical face mask, and its performance is evaluated through standardized bench tests (e.g., fluid resistance, particulate filtration). There is no "ground truth" in the context of expert consensus, pathology, or clinical outcomes that would require human experts to interpret data for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective, standardized physical performance tests rather than subjective human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (surgical face mask), not an AI/ML-driven diagnostic or image analysis system. Therefore, an MRMC study and the concept of "human readers improving with AI" are irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these surgical masks is established by standardized laboratory test methods (e.g., ASTM 1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101 for bacterial filtration, 16CFR1610 for flammability, and Mil M36954C for Delta-P). These methods define objective criteria and measurements to determine the performance against established industry standards and the predicate device's performance.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set, there is no corresponding ground truth for it.

Summary

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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 andDimensions	Same	7" x 3.5"
Mask Style	Same	Flat Pleated
Sterile	No	No
Single Use	Yes	Yes

Comparison to Predicate Devices: 6.

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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 FiltrationEfficiency: 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.

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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.

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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

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Indications for Use

510(k) Number (if known): _K | 1/343

Device Name: Crosstex® Isofluid Plus Surgical Masks

Indications for Use:

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

Regulation Number and Section

§ 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.