VENTURI NPWT V. II ADVANCED VACUUM SYSTEM

K090258 · Talley Medical · OMP · Aug 25, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090258
• Device Name: VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
• Applicant: Talley Medical
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the Venturi™ NPWT v.II Advanced Vacuum 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 patient's bedside.

Device Story

Venturi™ NPWT v.II Advanced Vacuum System; powered suction pump for fluid removal. Inputs: vacuum pressure; Outputs: suction for wound healing or aspiration of surgical/bodily fluids/tissues/gases. Used in surgery or at patient bedside; operated by clinicians. System includes pump, collection canister, and connection tubing. Benefits: promotes wound healing; removes infectious material from airway/respiratory support systems. Healthcare providers monitor vacuum levels and system alarms to manage patient therapy.

Clinical Evidence

Bench testing only. Performance testing included 100% production unit testing for canister air-tightness, sensor pin recognition, vacuum pump flow and pressure, 48-hour soak tests, and final system functional verification (buttons, calibration, alarms, charging). No clinical data provided.

Technological Characteristics

Powered suction pump; includes collection canister and connection tubing. Operates at same pressure ranges as predicate devices. Features include sensor pins for canister recognition, warning systems, and alarms. Bench testing verifies pressure calibration and air-tightness.

Indications for Use

Indicated for patients requiring suction for wound healing promotion or aspiration of fluids, tissue, gases, or infectious material from airway/respiratory systems during surgery or at bedside. Contraindicated for necrotic tissue, untreated osteomyelitis, fistulas, malignant tissue, or exposed vasculature, bone, nerves, or organs.

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.

Predicate Devices

• Blue Sky Versatile 1 System (K041919)
• Prodigy NPWT System (K082415)

Submission Summary (Full Text)

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AUG 2 5 2009

## 510(k) Summary

## Name: Tallev Medical 1070 E. Wieland Rd. Lansing, MI 48906

Phone: [phone] Fax: Same Contact: Jack Van Dyke. President

Trade Name: Venturi™ NPWT v.Il Advanced Vacuum System.

Common Name: Powered Suction Pump

Device Classification:

Gass II Product Code: BTA Requlation 878.4780 Classification Panel: General and Plastic Surgery

Predicate Devices:

Blue Sky Versatile 1 System KOEI919 Prodigy NPWT System K082415

Device Description: The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.

Intended Use: Use of the Venturi™ NPWT v.Il Advanced Vacuum 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 patient's bedside.

Technological Characteristics: The Talley Venturi™ system includes the same type suction pump as the predicate devices, operating at the same pressure ranges. Consumable accessories include collection canister and connection tubing.

Specific Performance Testing: a) Canister vacuum test is performed on 100% of production units to check for air-tightness and recognition of sensor pins. Loss of vacuum is measured over a prescribed period. Units pass or fail. b) Vacuum pump test is performed on 100% of production sub-assemblies measuring flow and pressure. Tested levels are compared with defined minimum values to determine pass or fail. c } Soak test is performed on 100% of assembled production pump units and are run for 48 hours prior to final test. d) Final system test is performed on 100% of production units. Tests include all functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems and alarms, charging system operational.

Conclusion: The Talley Venturi™ NPWT v.Il Advanced Vacuum System is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Talley Medical % Mr. Jack Van Dyke President 1070 E. Wieland Road Lansing, Michigan 48906

AUG 2 5 2009

Re: K090258

Trade/Device Name: Venturi™ NPWT v.II Advanced Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 13, 2009 Received: August 13, 2009

Dear Mr. Van Dyke:

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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jack Van Dyke

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for use

510(k) # K090258

Device Name: Venturi™ NPWT v.II Advanced Vacuum System

Indications for Use:

Use of the Venturi™ NPWT v.II Advanced Vacuum 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 patient's bedside.

Contraindications for Use:

The Venturi™ v.II NPWT system is contraindicated for use in the presence of:

Necrotic tissue Untreated osteomyelitis Fistula Wounds with malignant tissue Exposed vasculature, bone, nerves, or organs,

Prescription Use: X (Part 21 CFR 801 Subparts 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 of CDRH, Office of Device Evaluation (ODE)

Daniel Krenzer MKM

(Division Siun-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090258