CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE

K103303 · Crosstex International, Inc. · FXX · Dec 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103303
• Device Name: CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
• Applicant: Crosstex International, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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® Surgical Earloop Mask - White - Crosstex® Surgical Earloop No Fog Mask White . - Crosstex® Surgical Earloop No Fog Masks with Splash Visor- White .

Device Story

Crosstex Surgical Masks are single-use, non-sterile, flat-pleated face masks designed for infection control. Construction includes cellulose inner layer, spunbonded polypropylene outer layer, and meltblown polypropylene filter media. Features include aluminum wire nose piece and optional melt-blown polypropylene anti-fog strip; secured via non-latex elastic earloops. Used by healthcare personnel to minimize cross-contamination of microorganisms and provide barrier protection against blood and body fluids. Device functions as a physical barrier; no electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence established through bench testing including fluid resistance (synthetic blood penetration), bacterial filtration efficiency (BFE), differential pressure (ΔP), flammability, and biocompatibility (ISO 10993).

Technological Characteristics

Materials: cellulose inner layer, 100% spunbonded polypropylene outer layer, 100% meltblown polypropylene filter media, aluminum wire nose piece, non-latex elastic earloops. Form factor: flat pleated mask. Single-use. Non-sterile. Biocompatibility per ISO 10993.

Indications for Use

Indicated for use in infection control practices to minimize contamination from inhaled/exhaled microorganisms and reduce wearer exposure to blood and body fluids. Suitable for general population use in clinical or healthcare settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Crosstex Ultra Fluid Resistant No Fog Earloop Face Mask

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) SUMMARY

DEC 2 3 2010

K103303

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.

The assigned 510(k) number is:

#### 1. Submitter's Identification:

Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No .: 631-582-677 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

#### 2. Name of Device:

- Crosstex® Surgical Earloop Mask White .
- Crosstex® Surgical Earloop No Fog Mask White .
- Crosstex® Surgical Earloop No Fog Masks with Splash Visor- White .

#### 3. Predicate Device Information:

Crosstex Ultra Fluid Resistant No Fog Earloop Face Mask

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

#### 4. Device Description:

The Crosstex Surgical Masks are constructed of a cellulose inner facing, a 100% spunbonded polypropylene white outer facing, a 100% meltblown polypropylene filter media, with white non-latex elastic loops. The nose piece for the Crosstex Surgical Masks is aluminum wire while the no fog strip (if applicable) is made of melt blow polypropylene.

#### న. Intended Use:

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® Surgical Earloop Mask - White
- Crosstex® Surgical Earloop No Fog Mask White .
- Crosstex® Surgical Earloop No Fog Masks with Splash Visor- White .

#### 6. Comparison to Predicate Devices:

| Description | Crosstex Surgical Masks | Predicate Device |
|----------------------------------|--------------------------|--------------------------|
| 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<br>Dimensions | Same | 7" x 3.5" |
| Mask Style | Same | Flat Pleated |
| Sterile | No | No |
| Single Use | Yes | Yes |

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

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

- Fluid Resistance: Synthetic Blood Penetration Test a.
- Bacterial Filtration Efficiency (BFE) / Differential Pressure (△P) Tests b.
- Flammability Testing ﻥ
- d. Latex Particle Challenge Test
- e. Biocompatibility Testing Per ISO 10993

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

#### 8. Discussion of Clinical Test 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.

{3}------------------------------------------------

Image /page/3/Picture/1 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" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Crosstex International, Incorporated C/O Mr. Richard M. Ormsbee Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447

DEC 2 3 2010

Re: K103303

Trade/Device Name: Crosstex® Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: December 6, 2010 Received: December 7, 2010

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.goy/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

{5}------------------------------------------------

K103303

| |:

# Indications for Use

510(k) Number (if known):

Device Name: Crosstex® Surgical Masks

DEC 2 3 2010

Indications for Use:

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® Surgical Earloop Mask White ●
- Crosstex® Surgical Earloop No Fog Mask White .
- Crosstex® Surgical Earloop No Fog Mask with Splash Visor White .

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)

Page 1 of 1

Elizabeth F. Clami. William.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 人 (0330 シ