MOBLVAC W.C.

K081185 · Ohio Medical Corporation · BTA · May 2, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081185
• Device Name: MOBLVAC W.C.
• Applicant: Ohio Medical Corporation
• Product Code: BTA · General, Plastic Surgery
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the MOBLVAC W.C. is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient and also as a pleural and wound drainage device.

Device Story

MOBLVAC W.C. is a portable aspirator; functions as a powered suction pump. Device generates vacuum to withdraw fluids or foreign bodies from patient mouth, airway, or wound/pleural sites. Operated by healthcare professionals in clinical settings to maintain patient airway or facilitate drainage. Output is physical suction force; assists in respiration and ventilation. Device provides mechanical fluid evacuation; benefits patient by clearing obstructions and managing drainage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered suction pump; portable form factor. Operates via electrical energy source to generate vacuum. Mechanical aspiration principle. No software or complex algorithms.

Indications for Use

Indicated for patients requiring evacuation of saliva, mucous, vomit, or other aspirants from the mouth/airway to facilitate respiration/ventilation, and for pleural and wound drainage.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2008

Ohio Medical Corporation % Mr. David Platt VP of Engineering and Product Assurance 1111 Lakesidc Drive Gurnee, Illinois 60031

Re: K081185

Trade/Device Name: MOBLVAC W.C. Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 23, 2008 Received: April 25, 2008

Dear Mr. Platt:

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.

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

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Page 2 - Mr. David Platt

forth in the quality systems (OS) 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: MOBLVAC W.C.

Indications For Use:

The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the MOBLVAC W.C. is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient and also as a pleural and wound drainage device.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

> Concurrence Office of Device Evaluation (ODE) w rekom (Division Sign-

Division of General, Restorative, and Neurological Devices

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**510(k) Number** k081185

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