(80 days)
Not Found
No
The summary describes a negative pressure wound therapy system with standard components and testing, with no mention of AI or ML capabilities.
Yes
The device is described as a "Negative pressure wound therapy system" intended to "manage the environment of surgical incisions" and "removing exudate via the application of negative pressure wound therapy," which are direct therapeutic actions.
No
The device is described as a system for managing surgical incisions by applying negative pressure wound therapy to remove exudate and maintain a closed environment, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components: a sterile dressing, a negative pressure therapy unit, and a sterile, disposable canister. The performance studies also include hardware-related testing like electromagnetic compatibility, electrical safety, microbial barrier testing, and wicking studies.
Based on the provided information, the Prevena Incision Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage the environment of surgical incisions by applying negative pressure and removing exudate. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The device is a negative pressure wound therapy system applied externally to a closed surgical incision. It collects wound fluids, but the purpose is for removal, not for in-vitro analysis to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) in vitro to provide diagnostic information about a patient's health status. The system manages the wound environment and removes exudate, which is a physical process.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Prevena system does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
Negative pressure wound therapy system for application to surgically closed incisions.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surgical incisions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Mean Log Reduction from Day 0
Challenge Organism: Escherichia coli (ATCC 8739)
Day 1: 2.2
Day 3: 4.0
Day 5: 3.9
Day 7: 4.5
Challenge Organism: Pseudomonas aeruginosa (ATCC 09027)
Day 1: 2.0
Day 3: 3.9
Day 5: 3.5
Day 7: 3.7
Mean Log Reduction from Day 0
Challenge Organism: Staphylococcus aureus (ATCC 6538)
Day 1: 1.6
Day 3: 3.6
Day 5: 3.6
Day 7: 3.5
Challenge Organism: Klebsiella pneumonia (ATCC 4352)
Day 1: 1.4
Day 3: 1.8
Day 5: 2.7
Day 7: 3.5
Challenge Organism: Candida albicans (ATCC 10231)
Day 1: 2.5
Day 3: 3.1
Day 5: 3.2
Day 7: 3.2
Challenge Organism: Aspergillus niger (ATCC 16404)
Day 1: 2.2
Day 3: 4.1
Day 5: 4.0
Day 7: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
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. | | | | | |
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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