PRODIGY NPWT SYSTEM MODEL PRODIGY 800V

K082415 · Premco Medical Systems, Inc. · OMP · Nov 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082415
• Device Name: PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
• Applicant: Premco Medical Systems, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.

Device Story

Prodigy™ 800V NPWT System is a powered suction pump; provides negative pressure wound therapy or general surgical suction. Device operates by generating vacuum to aspirate fluids, tissues, gases, or infectious materials. Used in clinical settings (OR or bedside) by healthcare professionals. Output consists of controlled suction; assists in wound healing or airway clearance. Benefits include removal of debris/fluids to facilitate healing or maintain airway patency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered suction pump; 21 CFR 878.4780; Class II; Product Code OMP. Device provides vacuum-based aspiration for wound therapy and airway/surgical fluid removal.

Indications for Use

Indicated for patients requiring suction for wound healing promotion or aspiration/removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious material from the airway or respiratory support system in surgical or bedside 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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Public Health Service

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Premco Medical Systems, Inc. % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Re: K082415

Trade/Device Name: Prodigy™ NPWT System, Model: Prodigy™ 800V Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: November 10, 2008 Received: November 12, 2008

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of November 25, 2008.

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 (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 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

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Page 2 - Mr. Jeff D. Rongero

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 (QS) 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 continue 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 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/dsma/dsmamain.html.

Sincerely yours,

for Nogh

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 Statement

Image /page/2/Picture/1 description: The image shows the logo for PREMCO MEDICAL SYSTEMS INC. The logo features a stylized globe or sphere on the left, followed by the company name in bold, sans-serif font. The words "MEDICAL SYSTEMS INC." are smaller and positioned below "PREMCO".

## Section 5. Indications for Use Statement

510(k) number: (to be assigned)

Device Name: Prodigy™ NPWT System, Model: Prodigy™ 800V

Indications for Use:

The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.

Prescription Use: Yes and/or (Part 21 CFR 801 Subparts D)

Over the Counter Use: No (21 CFR 801 Subpart C)

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Mark Milleson

Cad Neurologic

**§10(k) Number** K082415