(248 days)
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The Aquarius system allows the patient to be positioned left or right of the instrument. The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options. The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops. The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
The provided text is a 510(k) summary for the Edwards Aquarius system, detailing changes to software and labeling. It explicitly states that no clinical or non-clinical data is presented as part of this submission, and it is a special 510(k). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics like accuracy, sensitivity, or specificity.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Edwards Aquarius system cleared under K070320) despite software and labeling updates.
Here's a breakdown based on the information provided and what is not present:
-
Table of acceptance criteria and the reported device performance:
- Not provided. The document does not define specific performance acceptance criteria (e.g., for fluid management accuracy, solute removal efficiency) for this special 510(k) submission, nor does it report specific device performance results against such criteria. The "Technology Characteristics" table (starting on page 3) compares general technical specifications (weight, dimensions, power supply, etc.) between the predicate and proposed device, noting they are largely the same or that updates (like software version) do not alter fundamental technology.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No test set data or study details are provided in this special 510(k) submission.
-
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 / Not provided. No test set or ground truth establishment is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method for a test set is described.
-
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 / Not provided. This device is a high permeability hemodialysis system, not an AI diagnostic imaging tool that would typically involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. Performance data, whether standalone or with human-in-the-loop, is not presented. The software updates are described as "performing the same functions as the predicate software."
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No ground truth is described because no performance study is detailed.
-
The sample size for the training set:
- Not applicable / Not provided. No training set for an algorithm is discussed in the context of performance. This special 510(k) is about software updates for an existing device.
-
How the ground truth for the training set was established:
- Not applicable / Not provided. No ground truth for a training set is described.
Summary of Device Performance and Acceptance Criteria (Based on the Document's Content):
Since this is a special 510(k) for software and labeling updates, the "acceptance criteria" and "proof" primarily revolve around demonstrating that these changes do not alter the fundamental scientific technology or the intended use and that the device continues to meet safety requirements of UL and EMC standards.
The key "performance" metrics implicitly accepted for this submission are the equivalence of the updated software's functions to the predicate, and that the physical and functional characteristics remain substantially similar.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):
| Acceptance Criteria (Stated/Implied) | Reported Device Performance (Summary from Document) |
|---|---|
| Maintain Intended Use | The proposed device has the "same intended use." (Page 3) |
| Maintain Indications for Use | The proposed device has the "same indications for use." (Page 3) |
| Maintain Fundamental Scientific Technology | The proposed device has the "same fundamental scientific technology with the exception of the algorithm improvements." The algorithms perform the "same functions" as the predicate software. (Page 3) |
| Maintain Hardware Equivalence | The proposed device has the "same hardware." (Page 3) |
| Software Performs Same Functions | "updated software (6.02.00) performing the same functions as the predicate software (version 6.00.04)." (Page 3). The submission mentions "a summary of design control activities and risk/hazard analysis for software changes is presented." (Page 4). |
| Maintain Performance Specifications | The proposed device has the "same performance specifications." (Page 3). However, specific performance metrics are not detailed in this 510(k) summary; they are referenced as being contained in the predicate's 510(k) summary (K070320). |
| Meet Safety Requirements (UL and EMC standards) | The device "continues to meet the safety requirements of UL and EMC standards." (Page 3) |
| Physical Dimensions and Characteristics (No significant change) | "No physical change" to dimensions, "Same as predicate" for weight, scales, fluid warmer, pressure monitoring, degassing unit, monitor/detection parameters. Minor change in power supply range and fluid management (50ml syringe only vs. 30ml/50ml on predicate). (Page 3) The modified device's maximum measured power consumption (350W) is lower than the predicate's theoretical value (500VA). (Page 3) |
The study that "proves" the device meets these criteria is essentially the design control activities and risk/hazard analysis for software changes (Page 4) referenced in the document, which confirm that the modifications do not negatively impact safety or effectiveness or alter the fundamental technology and intended use, thus maintaining substantial equivalence. No separate performance study is described or provided in this special 510(k).
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NOV 1 9 2009
Image /page/0/Picture/2 description: The image shows a logo with the letter 'E' in a stylized font, set against a textured, square background. Below the letter, the word 'Edwards' is printed in a simple, sans-serif font. The overall design is clean and professional, suggesting a corporate or business identity. The letter 'E' is white, contrasting with the darker background.
Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim Germany
Phone: 011 49 89 95475 203 Fax: 011 49 89 95475 305
"510(k) Summary"
as required by section 807.92(c)
Summary:
This summary was prepared on June 9 ", 2009
Submitter:
Robert Madino Director of Regulatory Affairs Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim Germany Phone: 011 49 89 95475 203 Fax: 011 49 89 95475 305 e-mail: robert madino@edwards.com
Owner:
Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim Germany Establishment Registration Number: 3006550990
Contact Person:
Neil R. Armstrong Consultant and RA Advisor to Edwards MeddiQuest Limited BioPark Broadwater Road Welwyn Garden City Herts. AL7 3AX
{1}------------------------------------------------
·
.
:
.
| United Kingdom | |
|---|---|
| Phone (UK): | 011 44 1763 222505 |
| Phone (USA): | (240) 949 2477 |
| Fax: | 011 44 1763 222049 |
| e-Mail: | neil.armstrong@meddiquest.com |
| or | |
| Robert Madjno | |
| Director of Regulatory Affairs | |
| Edwards Lifesciences Services GmbH | |
| Edisonstrasse 6 | |
| 85716 Unterschleissheim | |
| Germany | |
| Phone: | 011 49 89 95475 203 |
| Fax: | 011 49 89 95475 305 |
| e-mail: | robert_madjno@edwards.com |
| Device Trade Name: | Aquarius system |
| Classification Name: | High permeability hemodialysis system |
| Device Classification: | The FDA has classified: 21 CFR 876.5860 High Permeability Hemodialysis System (78 KDI) as a Class II. |
| Common Name: | Hemofiltration System |
| Predicate Device: | Edwards Aquarius system cleared under premarket notification K070320 on June 7, 2007 |
| Brief Description: | The general description of the device has not changed from the predicate version, K070320, except that the system has been validated to use specific legally market filter as opposed to a special Edwards Filter. |
The Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient.
The tubing set has already been the subject of a PreMarket Notification, K063293 Edwards Aqualine Sterile Tubing Sets and suitable legally marketed filters have been identified.
The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician.
. . .
·
{2}------------------------------------------------
The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit.
Toxic substances are removed by filters and clean blood is returned to the patient.
The Aquarius system allows the patient to be positioned left or right of the instrument.
The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes.
Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options.
The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger.
At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops.
The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
Intended Use:
Continuous Renal Replacement Therapy: SCUF. CVVH. CVVHD. CVVHDF Plasma exchange (TPE)
Indications for Use:
"The Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Aquarius System may also be used in Therapeutic Plasma Exchange (TPE) therapies.
"The Aquarius System is indicated for use in a clinical setting and not for home use."
These are the same indications for use as the predicate Aquarius System cleared under K070320.
Substantial Equivalence: The Aquarius System is substantially equivalent to the predicate Aquarius System as follows:
- same intended use .
- same indications for use .
- same labels .
{3}------------------------------------------------
- revised operating manual based on the draft labeling supplied in the . predicate submission
- same operating principle ●
- . same fundamental scientific technology with the exception of the algorithm improvements
- . same hardware
- updated software (6.02.00) performing the same functions as the . predicate software (version 6.00.04)
- . same performance specifications
- same accessories .
- . continues to meet the safety requirements of UL and EMC standards
In summary, the Aquarius System is substantially equivalent to the predicate Aquarius System (K070320), with the same intended use and fundamental scientific technology.
| Technological | |
|---|---|
| Characteristics: |
| Characteristic | Aquarius SystemK070320(Predicate Device) | Modified Aquarius System(Proposed Device) |
|---|---|---|
| Weight | Approx. 75 Kg | Same as predicate. |
| Dimensions (H x W xD) | 170 cm x 50 cm x 60 cm | No physical change,but quoted dimensionscorrected in OperatingManual |
| Power Supply | 115 v (a.c.) ± 10% at60Hz (U.S.) | 104 - 126 v at 47 - 63Hz |
| Power Consumption | 500 VA (theoreticalvalue) | Maxium measuredvalue 350w |
| Fluids Management | All parameters*, except:Heparin syringe size 30ml or 50 ml | Same as predicate,except50 ml only |
| Scales | All parameters* | Same as predicate. |
| Fluid Warmer | All parameters* | Same as predicate. |
| Pressure Monitoring | All parameters* | Same as predicate. |
| Degassing Unit | All parameters* | Same as predicate. |
| Monitor / DetectionParameters | All parameters* | Same as predicate. |
| Software Revision | 6.00.04 | 6.02.00 (see above fordescription ofdifferences betweensoftware revisions) |
{4}------------------------------------------------
- refers to the parameters listed in the 510(k) summary for K070320 bttp://www.fda.gov/cdrh/pdf7/K070320.pdf
Performance Testing:
The submission is a special 510(k) for changes to software and labeling. No clinical or non-clinical data is presented, however a summary of design control activities and risk/hazard analysis for software changes is presented.
Conclusion:
The proposed modifications, included in this submission, update the software and labeling for the device. Edwards Lifesciences Services GmbH have demonstrated that these modifications do not alter the fundamental scientific technology or the intended use.
Edwards Lifesciences believes that these modifications are eligible for review through the Special 510(k) process and that the proposed device is substantially equivalent to the predicate device.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized image of what appears to be an abstract representation of a human figure or symbol. The image is in black and white.
EPARTMENT 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
Edwards Lifesciences Services GMBH c/o Mr. Neil R. Armstrong Consultant and RA Advisor to Edwards Meddiquest Limited Biopark, Broadwater Road Welwyn Garden City, Herts. UNITED KINGDOM AL7 3AX
NOV 1 9 2009
Re: K090682
Trade/Device Name: Edwards' Aquarius system Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 13, 2009 Received: October 20, 2009
Dear Mr. Armstrong:
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. .
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
{6}------------------------------------------------
Page 2 -
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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): K090682
Device Name:
Edwards' Aquarius system
Indications for Use:
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K690682 |
| (Posted November 13, 2003) | Page 1 of 1 |
|---|---|
| ---------------------------- | ------------- |
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”