PROCEDURE MASKS: PM4-301 AND PM4-304

K011789 · Primeline Medical Products, Inc. · FXX · Jun 22, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011789
• Device Name: PROCEDURE MASKS: PM4-301 AND PM4-304
• Applicant: Primeline Medical Products, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 22, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Story

Procedure masks (PM4-301, PM4-304) function as surgical apparel; worn by operating room personnel; provide physical barrier against microorganisms, body fluids, and particulate material; intended to protect both patient and staff during surgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Surgical mask; physical barrier apparel; class II device; product code FXX.

Indications for Use

Indicated for use by operating room personnel during 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.

Submission Summary (Full Text)

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JUN 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katherine Co Regulatory Affairs Primline Medical Products, Incorporated 10707 100th Avenue, Suite 300 Edmonton, Alberta, CANADA

K011789 Re : Procedure Masks: PM4-301 and PM4-304 Trade/Device Name: 878.4040 Requlation Number: Requlatory Class: II Product Code: FXX June 5, 2001 Dated: Received: June 8, 2001

Dear Ms. Co:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Ms. Co

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations.

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

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo ny 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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Statement of Indications for Use

K011789 510(k) Number: K001951

Device Name : PrimeLine Medical Products Inc. Procedure Masks PM 4-301 + Pm4-31

Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical Surgical Masks are surgical apparel, ficentined and surgical procedures to device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial. .

Katharine C.

Katherine Co Manager of Regulatory Affairs PrimeLine Medical Products Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-the counter Use |
|---------------------|----|----------------------|
| (Pcr 21 CFR 801 109 | | |

*Clus S. Lin*
(Division Sign-Off)
Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | K011789 |
|---------------|---------|
|---------------|---------|

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