(29 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 provided document is a 510(k) Summary for the Prevena Incision Management System with Customizable Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance, sample sizes for test and training sets, expert ground truthing, and MRMC studies is not present in this document.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 | Met (stated in "Summary of non-clinical tests") |
| Equivalency in delivery of negative pressure wound therapy | Met (stated in "Summary of non-clinical tests") |
| Safety | Substantially equivalent to predicate (K121883) |
| Efficacy | Substantially equivalent to predicate (K121883) |
| Conformance to design specifications | Met (stated in "Summary of non-clinical tests") |
| Functional components | Equivalent to predicate |
| Indicated wound types | Same as predicate (Closed surgical incisions) |
| Dressing | Same as predicate (Multiple dressing components) |
| Therapy unit | Same as predicate (Single patient use only; battery powered) |
Study Proving Acceptance Criteria:
The document states: "The Prevena Incision Management System with Customizable Dressing was evaluated under a number of design verification and validation tests to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device."
Specifically, the following tests were conducted:
- Biocompatibility testing according to ISO 10993-1.
- Equivalency testing with respect to delivery of negative pressure wound therapy.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document only mentions "design verification and validation tests" and "non-clinical tests."
- Data provenance: Not specified. As these were non-clinical tests, the concept of "country of origin" for patient data isn't directly applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. The tests mentioned are non-clinical (biocompatibility and functional equivalency) and do not involve human interpretation or ground truthing by medical experts in the way an AI diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The tests mentioned are non-clinical and do not require expert adjudication.
5. 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
- No. The document explicitly states: "No clinical tests were necessary." This device is not an AI diagnostic tool that would typically involve MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (negative pressure wound therapy system), not an algorithm or AI. The "performance" refers to its mechanical and biological functionality, not an analytical algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Ground truth would be established by validated laboratory assays and compliance with ISO 10993-1 standards.
- For equivalency in negative pressure delivery: Ground truth would be established by engineering specifications and direct measurement/comparison to the predicate device's performance.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device that requires a training set.
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K123878
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510(k) SUMMARY Prevena Incision Management System with Customizable Dressing
JAN 1 5 2013
| Submitter Information [21 CFR 807.929(a)(1)] | ||
|---|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | |
| Address | 6203 Farinon Drive | |
| San Antonio, TX 78249 | ||
| Phone number | 210-515-4368 | |
| Fax number | 210-255-6727 | |
| EstablishmentRegistration Number | 1625774 | |
| Name of contact person | Shannon Scott, Regulatory Affairs Senior Manager | |
| Date prepared | December 14, 2012 | |
| Name of the device[21 CFR 807.92(a)(2)] | ||
| Trade or proprietaryname | Prevena Incision Management System with Customizable Dressing | |
| Common or usual name | Negative Pressure Wound Therapy System | |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) | |
| Classification panel | General and Plastic Surgery | |
| Regulation | 878.4780 | |
| Product Code(s) | OMP | |
| Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)] | Prevena Incision Management System with Customizable Dressing (K121883) | |
| Device description[21 CFR 807.92(a)(4)] | Negative pressure wound therapy system for application to surgically closedincisions. | |
| Indications for use[21 CFR 807.92(a)(5)] | The Prevena Incision Management System is intended to manage theenvironment of surgical incisions that continue to drain following sutured orstapled closure by maintaining a closed environment and removing exudatevia the application of negative pressure wound therapy. | |
| Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)] | ||
| The subject device was found to be equivalent to the predicate device in delivery of negative pressure tothe indicated wound type. The devices are equivalent in terms of functional components. | ||
| Characteristic | New DevicePrevena™ Incision ManagementSystem with CustomizableDressing | PredicatePrevena™ Incision Management Systemwith Customizable DressingK121883 |
| Indicated wound types | Same as predicate | Closed surgical incisions |
| Dressing | Same as predicate | Multiple dressing components |
| Therapy unit | Same as predicate | Single patient use only; battery powered |
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Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)] ..... ・・
The Prevena Incision Management System with Customizable Dressing was evaluated under a number of design verification and validation tests to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device. The following tests were conducted:
- Biocompatibility testing according to ISO 10993-1 .
Equivalency testing with respect to delivery of negative pressure wound therapy ●
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
No clinical tests were necessary.
Conclusions drawn [21 CFR 807.92(b)(3)]
Testing demonstrates that the Prevena Incision Management System and its predicate (K121883) are substantially equivalent in terms of safety, function and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
KCI USA. Incorporated (Kinetics Concepts, Incorporated) % Ms. Shannon Scott Regulatory Affairs Senior Manager 6203 Farinon Drive San Antonio, Texas 78249
January 15, 2013
Re: K123878
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: December 14, 2012 Received: December 17, 2012
Dear Ms. Scott:
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 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 - Ms. Shannon Scott
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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K123878 510(k) Number (if known):
(Posted November 13, 2003)
Prevena Incision Management System_ Device Name: 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 environment and removing exudate via the application of negative pressure wound therapy.
Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (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)
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David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number _K123878
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§ 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.