The following Crosstex® 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.

Crosstex® Isolite® Earloop Face Masks Blue, Pink .
Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue ●
Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue

Device Description

The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of medical grade tissue or 100% spunbonded polypropylene, a 100% facing of mediour grade tiesas of Tea, with white elastic loops and/or a fogfree strip. monown performs most (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).

AI/ML Overview

The provided text describes the submission for 510(k) premarket notification for Crosstex® Surgical Masks. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document states: "It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards." This indicates that the Crosstex® Surgical Masks met the acceptance criteria for each test. However, the specific quantitative acceptance criteria and the exact reported performance values are not provided in the document.

The "aforementioned test standards" refer to the non-clinical tests performed:

Test Type	Acceptance Criteria	Reported Device Performance
a. Fluid Resistance (Liquid (Water) Resistance Test/Impact Penetration Test)	(Not specified in document, but implied to be regulatory standards for fluid resistance in surgical masks)	Met all relevant requirements
b. Bacterial Filtration Efficiency (BFE) / Differential Pressure (ΔP) Tests	(Not specified in document, but implied to be regulatory standards for BFE and ΔP in surgical masks)	Met all relevant requirements
c. Flammability Testing	(Not specified in document, but implied to be regulatory standards for flammability in medical devices)	Met all relevant requirements
d. Latex Particle Challenge Test	(Not specified in document, but implied to be regulatory standards for particle filtration in surgical masks)	Met all relevant requirements
e. Biocompatibility Testing Per ISO 10993	(Not specified in document, but implied to be the standards outlined in ISO 10993 for biocompatibility)	Met all relevant requirements

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the non-clinical tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench) tests, the concept of "prospective" or "retrospective" data provenance for patient data doesn't directly apply. The data would have been generated in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The document describes non-clinical laboratory tests (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility) of a physical device (surgical masks). These tests do not involve expert interpretation or establishment of ground truth in the way a diagnostic imaging study would. The 'ground truth' for these tests is based on the objective measurements against established test standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described are objective laboratory measurements, not subject to adjudication by experts.

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

There was no MRMC comparative effectiveness study done. The device is a surgical mask, and the evaluation involved non-clinical performance testing against established standards, not a comparison of human reader performance with or without AI assistance. This type of study is entirely irrelevant to the device under review.

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

A "standalone" performance evaluation in the context of AI refers to the algorithm's performance without human intervention. This concept is not applicable here as the device is a physical surgical mask, not an AI algorithm. The performance tests were conducted on the masks themselves, which is analogous to a "standalone" evaluation of the physical product's capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests described is the objective measurement against the specified test standards and methodologies. For example:

Fluid Resistance: Ground truth would be the measurable resistance to fluid penetration as defined by the Liquid (Water) Resistance Test/Impact Penetration Test standard.
Bacterial Filtration Efficiency (BFE): Ground truth would be the measurable percentage of bacteria filtered out, according to the BFE test standard.
Flammability: Ground truth would be the measurable flammability characteristics as defined by the flammability test standard.
Biocompatibility: Ground truth would be the biological response (or lack thereof) observed in accordance with ISO 10993 guidelines.

It is not expert consensus, pathology, or outcomes data, as these are clinical forms of ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical medical product (surgical mask), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided, as there is no training set for a physical surgical mask.

Summary

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Attachment #2

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

س2012 The assigned 510(k) number is:_KO124

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. Richard Allen, Sr. President Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No.: 631-582-6777 Fax No.: 631-582-1726

Date Summary Prepared: July 27, 2001

Name of the Device: 2.

Crosstex® Isolite® Earloop Face Masks Blue, Pink ●
Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach ●
Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue

Predicate Device Information: 3.

American Threshold Industries, Surgical Masks, K# 801036, Asheville, a. North Carolina

{1}------------------------------------------------

American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka, b. North Carolina

Device Description: 4.

Intended Use: ട.

Crosstex® Isolite® Earloop Face Masks Blue, Pink .
Crosstex® Isofluid® Earloop Face Masks -- Blue, Pink, White, Green .
Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow ●
Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue ●
Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -. Blue

Comparison to Predicate Devices: 6.

See Attached

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

a. Fluid Resistance:
- Liquid (Water) Resistance Test/Impact Penetration Test
b. Bacterial Filtration Efficiency (BFE) / Differential Pressure (ΔΡ) Tests
c. Flammability Testing
d. Latex Particle Challenge Test
e. Biocompatibility Testing Per ISO 10993

{2}------------------------------------------------

It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

The Crosstex® Surgical Masks have the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. The Crosstex® Surgical Masks are substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Crosstex, International C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K012602

Trade/Device Name: Crosstex® Surgical Masks Regulation Number: 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: November 20, 2001 Received: November 26, 2001

Dear Ms. Falk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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Page 2 - Ms. Falk

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

of 1 ہے Page

KO12602 510(k) Number (if known): __

Device Name: Crosstex® Surgical Masks

Indications For Use:

The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled practices to minimize ochtan the potential exposure of the wearer to blood and body fluids.

Crosstex® Isolite® Earloop Face Masks Blue, Pink .
Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green ●
Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach .
Crosstex® Procedural Earloop Face Masks Blue, Pink, Yellow .
Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -● Blue

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number	K012602
---------------	---------

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

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.