TIDI FACEMASK

K100800 · Tidi Products,Llc · FXX · Jun 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100800
• Device Name: TIDI FACEMASK
• Applicant: Tidi Products,Llc
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

Device Story

TIDI Facemask is a non-sterile, pleated, multi-ply surgical mask. Construction includes three layers: outer and inner layers of 100% spun-bound polypropylene (SBPP) and a filter media layer of 100% melt-blown polypropylene (MBPP). Features include an aluminum nosepiece and optional polyester urethane foam anti-fog strip. The mask is secured to the face via ear loops. Used by operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulates. The device functions as a physical barrier; it does not involve electronic or software components.

Clinical Evidence

Bench testing only. The device was evaluated against ASTM F-2100-07 (Standard Specification for performance of Materials Used in Medical Face Masks). Specific tests included: ASTM F1862-07 (synthetic blood penetration resistance), ASTM F2299-03 (particulate filtration efficiency), ASTM F2101-07 (bacterial filtration efficiency using Staphylococcus aureus), and 16 CFR Part 1610 (flammability). Results confirmed the device meets all performance requirements.

Technological Characteristics

Multi-ply pleated design. Materials: 100% spun-bound polypropylene (outer/inner layers), 100% melt-blown polypropylene (filter media). Components: aluminum nosepiece, polyester urethane foam anti-fog strip, elastic ear loops. Non-sterile. Complies with ASTM F-2100-07, ASTM F1862-07, ASTM F2299-03, ASTM F2101-07, and 16 CFR Part 1610.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect the patient and personnel from transfer of microorganisms, body fluids, and particulate material.

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

• TIDI Face mask Model 9010 and 9020 (K092580)
• A.R. Medicom Non-Sterile Surgical Mask (K051291)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a logo for TIDI Products. The logo features a stylized letter "T" with a swooping design, followed by the word "TIDI" in bold, sans-serif font. Below "TIDI" is the word "PRODUCTS" in a smaller, stylized font. The tagline "Care with Confidence" is placed beneath the main logo in a simple, sans-serif font.

NEENAH W RODUCTS LLC

Certmeo in ISO 9001:2000, EN ISO 13485:2003, European CE Mak

## K100800

# 510(k) Summary TIDI® Facemask

# To: Whom it may concern

Date: May 21, 2010

JUN 1 4 2010

Submitter/ Contact - Name and Address

Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah WI 54956 Telephone: [phone] [phone] Fax:

## FDA Registration Number: 2182318

Device Details:

#### Name of the Device

Trade Name: Or Customer Specific trade name Model: Procedure Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Regulation Number: 878.4040

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## Equivalent Legally Marketed Device: Predicate Devices

1) TIDI® Face mask Model 9010 and 9020 2) A.R. Medicom Non-Sterile Surgical Mask 510 K Number: K092580 K051291

#### DESCRIPTION OF THE DEVICE:

The TIDI® Facemask are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of 100% SBPP. The nosepieces are made of aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The face mask covers the nose and mouth, and is secured to the face using ear loops.

#### INTENDED USE:

The TIDI® Facemask intended use is: Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

## Device and Predicate Device Technical Characteristics Summary

TIDI® Facemask has the same intended use and is technologically similar to the predicate device. The TIDI® Facemask and the predicate device are pleated, multi-ply, design and consist of non-woven barrier materials selected and arranged in such a manner as to provide optimal breathability and particulate filtration. Table 5.1 compares the TIDI® Facemask technical characteristics to the predicate devices

Page 5.2

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| Table 5.1 Device and Predicate Device Technical Characteristics |
|-----------------------------------------------------------------|
| Summary |

.

. . . . .

:

:

| Description | TIDI® Facemask<br>Model: Procedure | Predicate Device<br>TIDI® Facemask<br>Model 9010 and 9020<br>K092580 | Predicate Device<br>A.R. Medicom<br>Non-Sterile Surgical Mask<br>K051291 |
|-----------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Material Composition<br>Type of fabric: | | | |
| Outer Layer | Polypropylene<br>Spun-bond | Polypropylene<br>Spun-bond | Polypropylene<br>Spun-bond |
| Filter Media | Melt-blown<br>polypropylene | Melt-blown<br>polypropylene | Melt-blown<br>polypropylene |
| Inner Layer | Polypropylene<br>Spun-bond | Polypropylene<br>Spun-bond | Polypropylene<br>Spun-bond |
| Other Materials: | | | |
| Nose Piece: | Aluminum | Aluminum | Aluminum |
| Ear<br>Attachment: | Elastic | Elastic | Elastic |
| Anti-Fog | Polyester Urethane<br>foam | Polyester Urethane foam | none |
| | | The difference of the anti fog material is the polyester urethane foam. The polyester foam material has been<br>used in medical application on facemask for an anti-fog strip without any toxicity or biological compatibility<br>issues. It has been proven to be non-toxic, non-sensitizing, and non-irritating. | |
| Design<br>Features: | Ear Loop<br>Fluid Resistant | Ear Loop<br>Fluid Resistant | Ear Loop<br>Fluid Resistant |
| Mask Style: | Flat Pleated | Flat Pleated | Flat Pleated |
| Sterile: | No | No | No |

Page 5.3

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## Non-Clinical Performance Data

TIDI® Facemask meet the requirements of ASTM F-2100-07, Standard Specification for performance of Materials Used in Medical Face Masks. The testing required for this specification are, ASTM 1862-07, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

ASTM F 2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres.

ASTM 2101-07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus.

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.

#### Conclusion:

The conclusions drawn from the intended use, technical characteristics and nonclinical testing demonstrate that the TIDI® Facemask is as safe, as effective, and performs as well as the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling an eagle or bird with three wing-like shapes, positioned above a wavy line, representing the department's commitment to health and well-being.

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

Dion Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah, Wisconsin 54956

Re: K100800

JUN 1 4 2010

Trade/Device Name: TIDI Facemask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: March 18, 2010 Received: March 22, 2010

Dear Mr. Brandt:

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. Brandt

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

Sincerely yours.

Susan Runow

Y 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

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# Medical Devices

# Indications for Use Form

#### Indications for Use

510(K) Number (if Known): K100800

Device Name: TIDI® Facemask - Model -Procedure

Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

\$

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

510(k) Number: K100800