SKYVAL

K973610 · Pyramid Air Systems · FYD · Dec 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973610
• Device Name: SKYVAL
• Applicant: Pyramid Air Systems
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

The SKYVAC is a central smoke evacuation system. This system is intended to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.

Device Story

Skyvac is a central smoke evacuation system used in operating rooms by medical personnel. It functions by capturing and removing smoke plumes generated during laser and electro-surgical procedures. The device operates as a vacuum system to clear the surgical field, improving visibility for the surgeon and reducing exposure to surgical smoke. It is intended for professional use in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Central smoke evacuation system; vacuum-based smoke removal; intended for integration with laser and electro-surgical units.

Indications for Use

Indicated for use by medical personnel to remove surgical smoke generated during laser and electro-surgical procedures.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 1997

Mr. Mark McKee President Pyramid Air Systems 122 Harris Street Grainvalley, Missouri 64029

Re: K973610 Trade Name: Skyval Regulatory Class: II Product Code: FYD Dated: September 8, 1997 Received: September 22, 1997

Dear Mr. McKee:

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 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 action. In addition, FDA may publish further announcements 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

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Page 2 - Mr. McKee

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,

to coello

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973610 510(k) Number (if known):

SKYVAC Devicc Name:

Indications For Use:

This system is intended The SKYVAC is a central smoke evacuation system. to be used by medical personnel for the purpose of removing smoke generated during operating procedures by laser and electro-surgical units.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sich-Om

Division of Dontal, Info and General Hospital De 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)

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