SVED WOUND TREATMENT SYSTEM

K093564 · Innovative Therapies, Inc. · OMP · Nov 25, 2009 · General, Plastic Surgery

Device Facts

Record IDK093564
Device NameSVED WOUND TREATMENT SYSTEM
ApplicantInnovative Therapies, Inc.
Product CodeOMP · General, Plastic Surgery
Decision DateNov 25, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.4780
Device ClassClass 2
AttributesTherapeutic, 3rd-Party Reviewed

Intended Use

The Sved® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.

Device Story

Sved® Wound Treatment System is a portable, AC-powered suction pump with battery backup; designed for vacuum-assisted drainage and controlled delivery of topical wound treatment solutions. System utilizes polyurethane foam SVAMP® dressings for wound irrigation with sterile saline or topical solutions. Device applies negative pressure during and after irrigation to facilitate removal of infectious materials and fluids from wound bed. Used in clinical settings for management of chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, and grafts. Healthcare providers operate the device to manage wound healing; output consists of controlled suction and irrigation delivery. Benefits include enhanced wound bed preparation and fluid management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and identical functional design to the predicate device.

Technological Characteristics

Powered suction pump; polyurethane foam dressings (SVAMP®); AC-powered with battery backup; plastic enclosure; 300cc collection canister. System provides vacuum-assisted drainage and irrigation delivery.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, and grafts requiring vacuum-assisted drainage and topical wound irrigation.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 102 K093564 510(k) Summary Sved® Wound Treatment System Innovative Therapies, Inc. Confidential ## な 510(k) Summary SVED® WOUND TREATMENT SYSTEM NOV 2 5 2009 Innovative Therapies, Inc. Name/Address of Submitter: 1. 12 Meem Ave., Suite C Gaithersburg. MD 20877 Judith Harbour 2. Contact Person: Director, Regulatory and Quality 866.484.6798 x 105 3. Date Summary Prepared: October 26, 2009 Sved® Wound Treatment System Name of Device: 4. Powered Suction Pump న. Classification Name: 21 CFR 878.4780 Class II ANTLIA ITM Wound Irrigation System 6. Predicate Device: 510(k) No.K071301 #### Description of Device 7. The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing. ### 8. Indication For Use The Sved ® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical {1}------------------------------------------------ Confidential K6933864 solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids. # 9. Technological Characteristics and Substantial Equivalence The Sved® Wound Treatment System Unit is smaller in size and weighs less compared to the predicate powered suction pump, yet and when same technological characteristics and identical functions. # 10. Conclusion The substantial equivalence for the Sved® Wound Treatment System is based on the same indications, intended use, and technological features of the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. Public Health Service NUV 2 5 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Innovative Therapies, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313 Re: K093564 Trade/Device Name: Sved® Wound Treatment System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 16, 2009 Received: November 18, 2009 Dear Mr. Job: 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 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 {3}------------------------------------------------ Page 2 - Mr. Mark Job device-related adverse events) (21 CFR 803); 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. 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/CDRHQffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark A. Milkman Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: _Sved® Wound Treatment System Indications for Use: The Sved® Wound Treatment System is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The intended use for the Sved® Wound Treatment System is for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark M. Milkeves (Division Sign-Oft) (Division Sign-One), Orthopedic, Division of Restorative Devices K093564. 510(k) Number . Page 1 of 1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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