Who is the manufacturer of PREVENA INCISION MANAGEMENT SYSTEM?

Kci USA, Inc. filed the 510(k) submission for PREVENA INCISION MANAGEMENT SYSTEM (K100821).

What is the FDA product code for PREVENA INCISION MANAGEMENT SYSTEM?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PREVENA INCISION MANAGEMENT SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PREVENA INCISION MANAGEMENT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PREVENA INCISION MANAGEMENT SYSTEM

Q: What are the predicate devices for PREVENA INCISION MANAGEMENT SYSTEM?

ActiV.A.C.® Therapy System (K063692 and K091585).

K100821 · Kci USA, Inc. · OMP · Jun 11, 2010 · General, Plastic Surgery

Device Facts

Record ID	K100821
Device Name	PREVENA INCISION MANAGEMENT SYSTEM
Applicant	Kci USA, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Jun 11, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Device Story

Prevena Incision Management System provides continuous negative pressure wound therapy (NPWT) to closed surgical incisions. System components include a single-use, sterile, multi-layer dressing; a battery-powered negative pressure therapy unit; and a sterile, disposable canister for exudate collection. Dressing applied via peel-and-place process. Device intended for use in clinical or home settings; operated by healthcare professionals or patients. System maintains closed environment and removes exudate to manage incision site. Healthcare providers monitor therapy via unit interface and alarms. Benefits include protection from external contamination via microbial barrier and fluid management. Usability validated for both simulated patients and nurses.

Clinical Evidence

Bench testing only. Included software verification/validation, electromagnetic compatibility/electrical safety (UL 60601-1, EN 60601-1-2), and equivalency testing to predicate. Microbial barrier efficacy verified via Phi-X 174 bacteriophage challenge (no viral penetration). Wicking study confirmed fluid movement capability. In vitro log reduction tests performed on silver-coated fabric against 6 microorganisms (E. coli, P. aeruginosa, S. aureus, K. pneumonia, C. albicans, A. niger) showed log reductions ranging from 1.4 to 4.5. Biocompatibility confirmed per ISO 10993-1. Usability validated in home care setting with simulated patients and nurses.

Technological Characteristics

System consists of a single-use, battery-powered negative pressure pump and a multi-layer dressing with a polyurethane shell and silver-coated polyester fabric. Sensing/actuation via negative pressure suction. Connectivity is standalone. Sterilization method not specified. Software is embedded firmware. Biocompatibility per ISO 10993-1. Electrical safety per UL 60601-1 and EN 60601-1-2.

Indications for Use

Indicated for management of surgical incisions that continue to drain following sutured or stapled closure in patients requiring negative pressure wound therapy.

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

ActiV.A.C.® Therapy System (K063692 and K091585)

Related Devices

K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jan 15, 2013
K150006 — Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing · Kci USA, Inc. · Nov 6, 2015
K141017 — PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, · Kci USA, Inc. (Kinetic Concepts, Inc.) · Aug 20, 2015
K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System · Kci USA, Inc. · Mar 9, 2018
K161897 — PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 4, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ k100821 pg. 1 of 3 ## 510(k) SUMMARY # JUN 1 1 2010 | | PrevenaTM Incision Management System | | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Date prepared | June 10, 2010 | | | 510(k) owner | KCI, Inc. | | | Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | | | Address | 6203 Farinon Drive; San Antonio, Texas 78249 | | | Fax number | 210 255-6727 | | | Name of contact person | Margaret Marsh | | | Contact telephone number | 1 800 275-4524; Request Regulatory Affairs. | | | Name of the device | | | | Trade or proprietary name | PrevenaTM Incision Management System | | | Common or usual name | Negative pressure wound therapy system | | | Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) | | | Legally marketed device(s) to which equivalence is claimed | ActiV.A.C.® Therapy System (K063692 and K091585) | | | Device description | Negative pressure wound therapy system for application to surgically closed incisions. | | | Device design | The PrevenaTM Incision Management System consists of the following components: A single use, sterile dressing that is applied in a simple peel and place process.Negative pressure is provided to the dressing via a negative pressure therapy unit.Wound fluids are collected in a sterile, disposable canister. | | | | The PrevenaTM Incision Management System is intended for continuous application of negative pressure wound therapy to the closed surgical incision immediately after surgery. | | | Intended use of the device | The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. | | {1}------------------------------------------------ : | Summary of the technological characteristics of the device compared to the predicate device | The subject device was found to be equivalent to the predicate device in delivery of negative pressure wound therapy to the indicated wound type. The devices are equivalent in terms of functional components. | | | | | | |------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|--| | | Feature | PrevenaTM Incision Management System | ActiV.A.C.® Therapy System | | | | | | Indicated wound types | Surgical incisions, a subset of acute wounds | Chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts | | | | | | Dressing | Single, one size, multi-layer dressing. | Multiple dressing components | | | | | | Therapy unit | Single patient use only; battery powered | Multiple patient use; battery and AC powered | | | | | Summary of tests conducted | The PrevenaTM Incision Management System and components were evaluated under a number of design verification and validation tests in order to assure conformance to design specifications. This testing included:: | | | | | | | | • Software verification and validation testing that confirm the ability of the software to meet all software requirements specifications. • Electromagnetic compatibility and electrical safety tests conducted per UL 60601- 1 and EN 60601-1-2, documenting compliance with the standards. • Equivalency testing of the Prevena Incision Management System to the ActiV.A.C. Therapy System with respect to delivery of negative pressure wound therapy. Testing demonstrated that the two systems are equivalent under all test conditions. • The ability of the polyurethane shell of the dressing to serve as a microbial barrier (to protect the wound site from external contamination) was verified through a Phi-X 174 bacteriophage challenge of the polyurethane film. This testing indicated that there was no viral penetration. • The ability of the skin contact layer of the dressing to move fluid away from the skin was verified through a wicking study. The results confirmed that in the absence of negative pressure, the fabric has a high wicking capability for the test fluid. The study also confirmed that during this testing, silver ions did not migrate out of the fabric. • In vitro log reduction tests were conducted on the polyurethane-coated polyester fabric with silver. Tests were conducted without application of negative pressure and exposed samples of the fabric with silver to six log challenges of 6 species of microorganisms. Following inoculation, samples were tested for microbial counts immediately (day 0) and after incubation at 32° C in diluted nutrient broth for 1, 3, 5 and 7 days. The log reductions from the day 0 values are provided in the table below. | | | | | | | | Challenge Organism | Day 1 | Day 3 | Day 5 | Day 7 | | | | Escherichia coli (ATCC 8739) | 2.2 | 4.0 | 3.9 | 4.5 | | | | Pseudomonas aeruginosa (ATCC 09027) | 2.0 | 3.9 | 3.5 | 3.7 | | | | | Mean Log Reduction from Day 0 | | | | | | | Challenge Organism | Day 1 | Day 3 | Day 5 | Day 7 | | | | Staphylococcus aureus (ATCC 6538) | 1.6 | 3.6 | 3.6 | 3.5 | | | | Klebsiella pneumonia (ATCC 4352) | 1.4 | 1.8 | 2.7 | 3.5 | | | | Candida albicans (ATCC 10231) | 2.5 | 3.1 | 3.2 | 3.2 | | | | Aspergillus niger (ATCC 16404) | 2.2 | 4.1 | 4.0 | 3.6 | | | | • Cytotoxicity, irritation, and sensitization testing was performed in accordance to ISO 10993-1 standards, and results demonstrated that the device is biocompatible according to these standards. • A validation of the usability of the Prevena System in home care was assessed by two sets of participants - a simulated patient group (without health care experience) and a group of operating room nurses. Both studies confirmed the ability of the participants to use the therapy system, understand labeling and respond to alarms. | | | | | | | Conclusions drawn | Testing demonstrates that the Prevena™ Incision Management System and its predicate device are substantially equivalent in terms of both indications and technology, and that the System has the appropriate design characteristics for its intended use. | | | | | | {2}------------------------------------------------ . {3}------------------------------------------------ . . . . . . . . . . . Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure with three curved lines representing its body and wings. The image is in black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 KCI USA. Inc. % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249 ### JUN 1 1 2010 Re: K100821 Trade/Device Name: Prevena™ Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: May 28, 2010 Received: June 02, 2010 Dear Ms. Marsh: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. 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 {4}------------------------------------------------ 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 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/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark A. Milkeess Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): K100821 Device Name: Prevena™ Incision Management System Indications for Use: . The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed inolono that ochain to arain lone wis the application of negative pressure wound therapy. Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page ol (Posted November 13, 2003) David Krone (Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K100621