PRIMED SHOE COVERS, PRIMED HEAD COVERS

K971076 · Primeline Medical Products, Inc. · FXP · Jan 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K971076
• Device Name: PRIMED SHOE COVERS, PRIMED HEAD COVERS
• Applicant: Primeline Medical Products, Inc.
• Product Code: FXP · General, Plastic Surgery
• Decision Date: Jan 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Intended Use

Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Story

Device consists of disposable shoe and head covers; worn by operating room personnel during surgical procedures. Function is to provide physical barrier; prevents transfer of microorganisms, body fluids, and particulate material between patient and staff. Used in clinical/surgical settings. Benefits include reduced risk of cross-contamination and maintenance of sterile field.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable surgical apparel (shoe and head covers). Materials and construction designed for barrier protection against fluids and particulates. Non-sterile or sterile (implied by surgical use).

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material transfer.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Guy J. Plamondon
President
Primeline Medical Products, Incorporated
2235-27th Avenue, N.E.
Calgary
Alberta,
CANADA

Re: K971076
Trade Name: Primed Shoe Covers, Primed Head Covers
Regulatory Class: I
Product Code: FXP
Dated: December 23, 1997
Received: December 24, 1997

Dear Mr. Plamondon:

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 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 requirement, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Plamondon

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 Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

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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# 7. STATEMENT OF INDICATIONS FOR USE

510(K) NUMBER (if known): K971076

DEVICE NAME: PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers

INDICATIONS FOR USE:

Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Guy J. Plamondon, President,
PrimeLine Medical Products Inc.

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☐
OR
Over-the Counter Use ☑
(Per 21 CFR 801.109)

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