(61 days)
The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
The Aquadex System 100 removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.
Here's an analysis of the provided text regarding the Aquadex System 100, focusing on acceptance criteria and the supporting study:
Aquadex System 100 Adjustable Blood Flow Rate - K04-0489
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study related to "adjustable blood flow rate" for the Aquadex System 100.
However, based on the Safety & Performance and Conclusion sections, the implicit acceptance criteria are that the device remains safe and effective for its intended use, specifically with the software change to allow for adjustable blood flow rate and compatibility with various catheters.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Device safety | Demonstrated through bench testing, applying ISO 14971:2000 principles. Data demonstrated the Aquadex System 100 continues to be safe. |
| Device effectiveness | Demonstrated through bench testing. Data demonstrated the Aquadex System 100 continues to be effective. |
| Software change validation | Bench testing was performed to validate the software change. |
| Catheter compatibility | Bench testing generated data in support of the labeling change which incorporates a catheter compatibility chart. |
| Substantial Equivalence | The software revision has been shown to be safe and effective for its intended use, making it substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench testing was performed". This typically means testing conducted in a laboratory environment, not on human subjects.
- Sample Size for Test Set: Not specified. Bench testing usually involves multiple iterations or units, but a specific number is not provided.
- Data Provenance: The data is generated from bench testing. This implies a controlled laboratory setting. It is not patient or clinical data, and thus, provenance in terms of country of origin or retrospective/prospective is not applicable in the human-clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Bench testing typically relies on engineering specifications and validated test methods rather than expert consensus on a "ground truth" derived from human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret data (e.g., medical images) and their agreements/disagreements need to be resolved to establish ground truth. Bench testing does not involve such human interpretation for its primary results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers or cases. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a medical system (Aquadex System 100) with proprietary software, not an AI algorithm in the typical sense of standalone performance analysis. The "software change" was validated through bench testing, which evaluates the system's (including its software's) operational performance directly. Therefore, while the software's function was tested, it's not a "standalone performance" study of a diagnostic AI algorithm in the way that term is usually applied.
7. Type of Ground Truth Used
The ground truth for the bench testing would be based on engineering specifications, established physical principles, and measurement standards. For example, if testing blood flow rate, the ground truth would be the accurately measured flow rate using calibrated equipment, compared to the device's reported flow rate under various conditions. For catheter compatibility, the "truth" would be successful and safe operation with different catheters as defined by design specifications. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable/not provided. The "software change" was validated through bench testing. This typically involves software verification and validation activities against requirements, rather than an AI model "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The concept of a "training set" and establishing ground truth for it is relevant to machine learning/AI models, which is not the nature of the described software validation.
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Aquadex System 100 Adjustable Blood Flow Rate
APR 2 7 2004
Attachment C
K04-0489
510(k) Summary
Prepared on February 25, 2004
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Trade Names: | Aquadex™ System 100 (trademark pending) | |
|---|---|---|
| Manufacturer: | CHF Solutions, Inc., Suite 170 - 7601 Northland Drive, Brooklyn Park, MN55428 | |
| OfficialContact: | Amy PetersonVice President, RA/QA/CR | Telephone: 763-463-4620Fax: 763-463-4606 |
| DeviceGeneric Name: | Aquadex™ System 100 | |
| Classification: | High permeability dialysis systems - classified as Class II | |
| PredicateDevices: | System 100 (K013733) | PRISMA ™ CFM Systems (K981681) |
| DeviceDescription: | The Aquadex System 100 removes excess fluid from the patient in fluidoverload by ultrafiltration of blood across a hollow-fiber hemofilter at theclinician selected rate. The system is comprised on a console mounted ona cart, proprietary software and accessories (venous access catheters,extensions and a blood pump circuit). Patient access is obtained via eitherperipheral or central venous veins. | |
| Indicationfor Use: | System 100 is indicated for temporary (up to 8 hours) ultrafiltrationtreatment of patients with fluid overload. | |
| Safety &Performance: | Bench testing was performed to validate the software change and togenerate data in support of the labeling change which incorporates acatheter compatibility chart using the principles of ISO 14971:2000 "Medicaldevices - Application of risk management to medical devices. Datagenerated demonstrated the Aquadex System 100 continues to be safe andeffective. | |
| Conclusion: | Based on the similar intended use, patient population, technologycharacteristics, and performance as assessed with bench testing thesoftware revision has been shown to be safe and effective for its intendeduse. This product is substantially equivalent7 and considered acceptable forthe intended use. |
7 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Ms. Amy Peterson Vice-President RA/QA/CR CHF Solutions, Inc. Suite 170-7601 Northland Drive BROOKLYN PARK MN 55428
Re: K040489
Trade/Device Name: Aquadex System 100 and System 100 Ultrafiltration Catheter Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: April 1, 2004 Received: April 2, 2004
Dear Ms. Peterson:
We have reviewed your Scction 510(k) prematket 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 cither class II (Spccial 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); good manufacturing practice requirements as sct 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and wyou've FDA finding of substantial equivalence of your device to a legally prematication. " www.results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desko specific of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Addition of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small mioritactor on 300 consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT (Page 1 of 1)
510(k) Number (if know): ___K04 04 8 9
Device Name: System 100 and System 100 Ultrafiltration Catheter
FDA's Statement of the Indication For Use for Device:
The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
David R. Segerson
OR
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number
§ 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.”