PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

K081633 · Primed Medical Products, Inc. · FXX · Aug 11, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081633
• Device Name: PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
• Applicant: Primed Medical Products, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

PRIMAGARD™ Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedured to protect both the surgical patient and the operating room personnel from transfer of microcogniss is, body fluids, and particulate material. The PRIMAGARD™ Surgical Masks may also be worn outide of the operating room for non-surgical procedure use.

Device Story

Rectangular, waterfall-pleated or soft-bill surgical masks; manufactured from non-woven materials (polypropylene or wet-laid cellulose). Designed to provide breathability, particulate filtration, and fluid-penetration barrier. Used by operating room personnel during surgical procedures and in non-surgical settings to protect patients and staff from transfer of microorganisms, body fluids, and particulates. Provides defined fluid resistance based on specific material weight combinations.

Clinical Evidence

Bench testing only. Performance validated via fluid resistance testing per ASTM F2100-07 standard.

Technological Characteristics

Non-woven materials (polypropylene or wet-laid cellulose); rectangular, waterfall-pleated or soft-bill form factor. Fluid resistance tested per ASTM F2100-07. No electronic components or software.

Indications for Use

Indicated for operating room personnel and other users during surgical or non-surgical procedures to provide a barrier against 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

• Surgical Mask (K001951)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitted by: | priMED Medical Products Inc.<br>#900, 10707-100 Avenue<br>Edmonton, Alberta T5J 3M1<br>Telephone: [phone] | AUG 11 2008 |
|----------------------|----------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Raymond G. Marusyk | |
| Date Prepared: | June 10, 2008 | |
| Proprietary Name: | PRIMAGARD™ Surgical Mask | |
| Common Name: | Surgical Mask | |
| Classification Name: | Surgical Mask, 878.4040; Product Code FXX | |
| Predicate Device: | Surgical Mask<br>510(k) #K001951 | |

Description of the Device: These surgical masks are rectangular, waterfall-pleated or soft-bill devices manufactured from selected non-woven materials (polypropylene or wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative, to the degree w of protection required during intended use.

Intended Use of the Device: PRIMAGARD™ Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedured to protect both the surgical patient and the operating room personnel from transfer of microcogniss is, body fluids, and particulate material. The PRIMAGARD™ Surgical Masks may also be worn outide of the operating room for non-surgical procedure use.

Technological Characteristics: PRIMAGARD™ Surgical Masks are technologically similar to the predicate device (K001951) in that both devices consist of non-woven barrier materials sected and arranged in such a manner as to provide, at the time of design, and under the conditions of use, optimal breathability and particulate filtration. The PRIMAGARD™ Surgical Masks are an improvement in that non-woven materials production technologies have advanced and there is a better undersvanions of the physical aspects of the filtration capability. Accordingly, the non-woven products unlilianed in the PRIMAGARD™ Surgical Masks, when used in specific weight (gsm, grams per square meter) combinations are able to provide defined fluid resistance (as measured by the ASTM F2100-07 Stindard Synthetic Blood Fluid Resistance test).

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest feathers. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Raymond G. Marusyk Director, Design and Development PriMED Medical Products, Incorporated #900, 10707-100 Avenue Edmonton, Alberta, Canada T5J-3M1

AUG 1 1 2008

Re: K081633

Trade/Device Name: PrimaGARD™ 80, 120, 160 Surgical Face Masks Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 31, 2008 Received: August 1, 2008

Dear Mr. Marusyk:

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.

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Page 2 -- Mr. Marusyk

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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Chris S. Lim, Ph.D.

Chiu S. Lin. Ph. D Division 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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## Indications for Use Statement

KOBI633

510(k) Number (if known) K001951 (original for which modification is requested)

Device Name PRIMAGARD™ Surgical Masks

PRIMAGARD™ Surgical Masks (see complete list of specific Indications For Use model names and numbers on following page) are surgical apparel as identified in 21 CFR 878.4040 and 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.

## PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109) OR Over-The-Counter Use

Shule A Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081633

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| Mask Name | Model Number |
|---------------|--------------|
| primaGARD 80 | PG4-1201 |
| primaGARD 80 | PG4-2121 |
| primaGARD 80 | PG4-2421 |
| primaGARD 80 | PG4-4021 |
| primaGARD 80 | PG4-4241 |
| primaGARD 120 | PG4-1092 |
| primaGARD 120 | PG4-1592 |
| primaGARD 120 | PG4-2092 |
| primaGARD 120 | PG4-2592 |
| primaGARD 160 | PG4-1073 |
| primaGARD 160 | PG4-1573 |
| primaGARD 160 | PG4-2073 |
| primaGARD 160 | PG4-2473 |
| primaGARD 160 | PG4-3073 |
| primaGARD 160 | PG4-3473 |
| primaGARD 160 | PG4-3573 |
| primaGARD 160 | PG4-4073 |
| primaGARD 160 | PG4-5073 |

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## List of PRIMAGARD™ Surgical Masks Included as Subjects of this Submission