(80 days)
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.
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. The PrevenaTM Incision Management System is intended for continuous application of negative pressure wound therapy to the closed surgical incision immediately after surgery.
The provided document is a 510(k) summary for the Prevena™ Incision Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (ActiV.A.C.® Therapy System) and includes various tests to assure conformance to design specifications.
However, the document does not describe acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a device as one would typically expect for an AI/algorithm-driven device's clinical performance. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering, biocompatibility, and usability tests, as well as demonstrating equivalence in delivering negative pressure wound therapy.
Therefore, the requested tables and details related to performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not available and cannot be extracted from the provided text. The device is a physical system that delivers negative pressure wound therapy, not an algorithm that makes diagnostic or prognostic predictions requiring such clinical performance criteria.
Here's a breakdown of what can be extracted, reinterpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and product safety/efficacy based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't present acceptance criteria in terms of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of various tests designed to demonstrate substantial equivalence and functional safety. The "reported device performance" refers to the outcomes of these tests.
| Acceptance Criteria (Implied by Test Objective) | Reported Device Performance |
|---|---|
| Functional Equivalence: Delivery of negative pressure wound therapy equivalent to predicate device. | Testing demonstrated that the Prevena Incision Management System and the ActiV.A.C. Therapy System are equivalent under all test conditions for delivery of negative pressure wound therapy. |
| Software Functionality: Meet all software requirements specifications. | Software verification and validation testing confirmed the ability of the software to meet all software requirements specifications. |
| Electrical Safety & EMC: Compliance with UL 60601-1 and EN 60601-1-2 standards. | Electromagnetic compatibility and electrical safety tests conducted per UL 60601-1 and EN 60601-1-2, documenting compliance with the standards. |
| Microbial Barrier: Polyurethane shell serves as a microbial barrier (no viral penetration). | A Phi-X 174 bacteriophage challenge of the polyurethane film indicated no viral penetration. |
| Fluid Wicking: Skin contact layer moves fluid away from skin (high wicking capability, no silver ion migration). | A wicking study verified that the fabric has a high wicking capability for the test fluid in the absence of negative pressure, and confirmed no silver ions migrated out of the fabric. |
| Antimicrobial Activity: Significant log reduction against tested microorganisms. | In vitro log reduction tests on polyurethane-coated polyester fabric with silver showed significant reductions from Day 0 values for various microorganisms:- Escherichia coli: Day 1=2.2, Day 3=4.0, Day 5=3.9, Day 7=4.5- Pseudomonas aeruginosa: Day 1=2.0, Day 3=3.9, Day 5=3.5, Day 7=3.7- Staphylococcus aureus: Day 1=1.6, Day 3=3.6, Day 5=3.6, Day 7=3.5- Klebsiella pneumonia: Day 1=1.4, Day 3=1.8, Day 5=2.7, Day 7=3.5- Candida albicans: Day 1=2.5, Day 3=3.1, Day 5=3.2, Day 7=3.2- Aspergillus niger: Day 1=2.2, Day 3=4.1, Day 5=4.0, Day 7=3.6 |
| Biocompatibility: Meet ISO 10993-1 standards (cytotoxicity, irritation, sensitization). | Cytotoxicity, irritation, and sensitization testing performed in accordance with ISO 10993-1 standards demonstrated the device is biocompatible. |
| Usability: System can be used by lay users and healthcare professionals (understand labeling, respond to alarms). | A validation of the usability was assessed by a simulated patient group (without healthcare experience) and a group of operating room nurses. Both studies confirmed the ability of participants to use the therapy system, understand labeling, and respond to alarms. |
Regarding the other requested information (2-9):
The provided document describes a medical device, specifically a negative pressure wound therapy system, not an AI/algorithm-driven diagnostic or assistive tool. Therefore, the concepts of "test set," "training set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," and "standalone algorithm performance" as typically applied to AI systems are not applicable to this device and are not mentioned in the document.
The "studies" described are design verification and validation tests for the physical device, its components, and its functional properties, rather than studies assessing the performance of an algorithm against a ground truth dataset.
Specifically:
- Sample size used for the test set and the data provenance: Not applicable. The "tests" are engineering and biological evaluations, not clinical performance studies on a "test set" of patients or data in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is not an interpretive AI device. Experts were involved in the usability studies (operating room nurses, simulated patient group), but not for establishing a "ground truth" for a dataset.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a therapy system, not an AI assistance tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being assessed for standalone performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to physical properties (e.g., presence/absence of viral penetration, wicking capability, microbial count reduction, electrical safety standards compliance).
- The sample size for the training set: Not applicable. No training set for an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
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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. |
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| Summary ofthetechnologicalcharacteristicsof the devicecompared tothe predicatedevice | The subject device was found to be equivalent to the predicate device in delivery ofnegative pressure wound therapy to the indicated wound type. The devices areequivalent in terms of functional components. | |||||
|---|---|---|---|---|---|---|
| Feature | PrevenaTM IncisionManagement System | ActiV.A.C.®Therapy System | ||||
| Indicated wound types | Surgical incisions, a subsetof acute wounds | Chronic, acute, traumatic,subacute and dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic, pressure or venousinsufficiency), flaps andgrafts | ||||
| Dressing | Single, one size, multi-layerdressing. | Multiple dressingcomponents | ||||
| Therapy unit | Single patient use only;battery powered | Multiple patient use; batteryand AC powered | ||||
| Summary oftestsconducted | The PrevenaTM Incision Management System and components were evaluated undera number of design verification and validation tests in order to assure conformance todesign specifications. This testing included:: | |||||
| • Software verification and validation testing that confirm the ability of the softwareto 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 theActiV.A.C. Therapy System with respect to delivery of negative pressure woundtherapy. Testing demonstrated that the two systems are equivalent under all testconditions.• 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 aPhi-X 174 bacteriophage challenge of the polyurethane film. This testingindicated that there was no viral penetration.• The ability of the skin contact layer of the dressing to move fluid away from theskin was verified through a wicking study. The results confirmed that in theabsence of negative pressure, the fabric has a high wicking capability for the testfluid. The study also confirmed that during this testing, silver ions did not migrateout of the fabric.• In vitro log reduction tests were conducted on the polyurethane-coated polyesterfabric with silver. Tests were conducted without application of negative pressureand exposed samples of the fabric with silver to six log challenges of 6 species ofmicroorganisms. Following inoculation, samples were tested for microbial countsimmediately (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 tablebelow. | ||||||
| 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 Reductionfrom 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 toISO 10993-1 standards, and results demonstrated that the device isbiocompatible according to these standards.• A validation of the usability of the Prevena System in home care was assessedby two sets of participants - a simulated patient group (without health careexperience) and a group of operating room nurses. Both studies confirmed theability of the participants to use the therapy system, understand labeling andrespond to alarms. | ||||||
| Conclusionsdrawn | Testing demonstrates that the Prevena™ Incision Management System and itspredicate device are substantially equivalent in terms of both indications andtechnology, and that the System has the appropriate design characteristics for itsintended 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
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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
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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
§ 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.