(260 days)
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits.
The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.
The provided document describes a medical device called WAVES, a renal preservation system, and discusses its substantial equivalence to predicate devices for 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance metrics, or study details in the format requested, such as test set size, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document focuses on demonstrating substantial equivalence through a comparison of intended use, principle of operation, and specific control aspects (perfusion and hypothermic) with predicate devices. It mentions that certain aspects like pump performance, cooling system performance, and software validation were evaluated. Sterilization and biomaterial testing were also conducted.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
The document primarily asserts substantial equivalence based on:
- Intended Use: All systems perform pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation.
- Principle of Operation: Similar design and function for maintaining kidneys.
- Perfusion Control: WAVES perfusion control (perfusate parameters, pressure, automated features, cassette priming) is "substantially equivalent" and "evaluated through a pump performance testing and a software validation testing."
- Hypothermic Control: WAVES hypothermic control (cassette mounting, cooling method/duration/temperature, heat exchanger) is "substantially equivalent" and "evaluated through a cooling system performance testing and a software validation testing."
- Disposable Cassette Module: Sterilization validated per ISO 11135-1, and shelf life supported by accelerated aging testing.
- Biomaterials: ISO 10993 compliant testing for new biomaterials.
- User Interface: Software validation testing showed user interface operates as expected.
The FDA's letter explicitly states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means a comparative effectiveness study in the sense of AI performance metrics (like sensitivity, specificity, AUC) against human readers or a pathology-confirmed ground truth is not typically required or performed for such a device, as it's a renal preservation system, not a diagnostic imaging AI.
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Traditional 510(k) Premarket Notification WAVES
FEB 1
510(k) Summary
Date Prepared: December 23, 2011
Submitter's Name / Contact Person
| Submitter | Contact Person |
|---|---|
| Waters Medical Systems, LLC | Robert Warren |
| 2112 - 15th Street NW | Phone: 507-288-7777 |
| Rochester, Minnesota 55901 | Email: bobw@wtrs.com |
General Information
| Trade Name | WAVES |
|---|---|
| Common / Usual Name | Renal Preservation System |
| Classification | 21 CFR 876.5880 (Class II) |
| Information | Isolated kidney perfusion and transport system and accessories |
| Predicate Devices | RM3 Renal Preservation System, Waters Medical Systems, LLCLifeport Kidney Perfusion Transporter, Organ Recovery Systems Inc. |
Device Description
The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits.
The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.
Intended Use / Indications
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
Substantial Equivalence and Summary of Studies
The WAVES device is substantially equivalent to the RM3 Renal Preservation System and the Lifeport Kidney Perfusion Transporter. All systems have substantially equivalent intended use and principle of operation. The subject and the two predicate devices are intended to maintain kidneys for transplantation by providing hypothermic physiologic perfusion using a single use, disposable cassette module and perfusion circuit.
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The perfusion control for the WAVES and the predicates is substantially equivalent. The WAVES perfusion control includes the perfusate control parameters, the perfusate pressure, the automatic features operated through the user interface and the cassette priming. The perfusion control of the WA VES has been evaluated through a pump performance testing and a software validation testing.
The hypothermic control for the WAVES and the predicates is substantially equivalent. The WAVES hypothermic control includes the cassette mounting, the cooling method, the cooling duration and temperature and the heat exchanger. The hypothermic control of the WA VES has been evaluated through a cooling system performance testing and a software validation testing.
The WA VES disposable cassette module is provided sterile and labeled with an expiration date as the RM3 disposable cassette. The sterilization cvcle for the WAVES system has been validated in accordance with ISO 11135-1 requirements. The labeled shelf life of the WAVES cassette is supported through accelerated aging testing.
Differences between the WA VES and the predicates are related to the user interface and biomaterials used to construct the disposable cassette module. The software validation testing results have shown the user interface operates as expected. ISO 10993 compliant biomaterial testing has demonstrated that the new biomaterials are safe for their intended biocontact.
Results of evaluations did not raise any new questions of safety or effectiveness when compared to the predicate devices and therefore the WAVES is substantially equivalent to the RM3 and the Lifeport predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Warren General Manager Waters Medical Systems, LLC 2112 - 15th Street NW ROCHESTER MN 55901
FEB 1 6 2012
Re: K111521
Trade/Device Name: WAVES Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: January 27, 2012 Received: January 30, 2012
Dear Mr. Warren:
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
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Ticho
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111521
Device Name: WAVES
Indications for Use:
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
Prescription Use _ X (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K111521 |
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§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).