MEDIPORT 2000 MOBILE

K013585 · Servox Medizintechnik GmbH · BTA · Jan 28, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013585
• Device Name: MEDIPORT 2000 MOBILE
• Applicant: Servox Medizintechnik GmbH
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mediport 2000 suction device can be generally used in the ENT sector and is equally suitable for both in-patient and outpatient patients. It can be used for laryngectomy and in the event of heavy secretion or other operations in the mouth and throat area. The device is designed for the applications listed above.

Device Story

Mediport 2000 Mobile is a powered suction pump used in ENT clinical settings. Device provides vacuum suction for removal of secretions or fluids during oral/throat surgeries or laryngectomy procedures. Operated by healthcare professionals in hospital or outpatient environments. Device functions as a standard suction pump to assist in maintaining clear airways and surgical fields. Benefits include improved patient safety and procedural efficiency by managing secretions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered suction pump; Class II device; Product Code BTA. Operates via electrical power to generate vacuum suction. Form factor is mobile unit for clinical use.

Indications for Use

Indicated for ENT patients, including those undergoing laryngectomy or requiring suction for heavy secretions or oral/throat surgical procedures. Suitable for both in-patient and outpatient settings.

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

JAN 2 8 2002

Mr. Martin Herberg Export-Manager Servox Medizintechnik GmbH Servatiusstrasse 69 d, 51109 Köln, Germany

Re: K013585

Trade/Device Name: Mediport 2000 Mobile Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: October 12, 2001 Received: October 30, 2001

Dear Mr. Herberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. 3 ro(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) w the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1970, as easily the provisions of the Federal Food, DNI, 3 devices that have boon require approval of a premarket approval application (PMA). and Costinctle rice (11ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, morelore, mains of the Act include requirements for annual registration, listing of general ocures, 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 rr your device is classince (soo are rols. 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 nean r rouse of acribed a determination that your device complies with other requirements of the Act that I Dr Has Internations and regulations administered by other Federal agencies. You must or any I 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Martin Herberg

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

isiam C. Provost

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

Enclosure

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Page 1 of 1

510 (k) NUMBER (IF KNOWN) : K013585 -----

_MEDIPORT 2000 mobile_____ DEVICE NAME:

The Mediport 2000 suction device can be INDICATIONS FOR USE: generally used in the ENT sector and is equally suitable for generally used in the ENT Seconal patients. It can be used for faryngectomy and outpatient purposes. both in-patient and outpactent portion event of heavy secretion The device is designed introse in one of the organisms or other operations in the mouth and throut area. operations in the mobile may only be used for the applications listed above.

(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_ (Optional Format 1-2-96)

Muriam C. Parrott

510(k) Number K013585