(412 days)
The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the AURORA™ System 1000® Series Single Patient Dialysis Delivery System includes a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disingection. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System will operate in either the bicarbonate or acetate mode for concentrates. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use.
The AURORA™ System 1000 Series Single Patient Dialysis Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions: 1. Mixes concentrate with water in the appropriate proportions to produce dialysate. 2. Delivers dialysate at the appropriate temperature and ionic concentration to the dialyzer. 3. Removes the appropriate amount of liquid from the patient's blood. 4. Along with the dialyzer and blood pump acts as a total artificial kidney.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format typically used for AI/ML device submissions. Instead, it describes a medical device called the Baxter AURORA™ System 1000® Series Single Patient Dialysis Delivery System, which is a hemodialysis machine.
The document focuses on:
- Description of the device: How it mixes concentrates, delivers dialysate, removes liquid from the patient's blood, and acts as an artificial kidney.
- Intended Use: For high permeability hemodialysis in chronic and acute settings, not for home use. It highlights features like ultrafiltration control, high blood flow, and various bicarbonate and sodium capabilities.
- Substantial Equivalence: It compares the device to several predicate devices (other System 1000® Series Dialysis Delivery Systems) and states that the AURORA™ System 1000® Series is built with the "same fluid path and hardware components."
This type of submission primarily establishes substantial equivalence to already marketed devices, meaning it demonstrates that the new device is as safe and effective as a legally marketed predicate device. It typically relies on design comparisons, performance specifications, and possibly bench testing rather than clinical trials with extensive performance metrics like sensitivity, specificity, or reader studies common in AI/ML device evaluations.
Therefore, I cannot extract the requested information (such as acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because this 510(k) document is for a traditional medical device (a hemodialysis machine) and not an AI/ML-driven diagnostic or treatment device, which would typically involve such performance characterizations.
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DEC 1 2 2002
510(k) SUMMARY Baxter AURORA™ System 1000® Series Single Patient Dialysis Delivery System
| Submitter's name, addresss, phone,fax, contact person | Baxter Healthcare CorporationRenal Division1620 Waukegan RoadMcGaw Park, IL 60085Phone: (847) 473-6335Fax: (847) 473-6952Contact: Robert L. Wilkinson, RAC |
|---|---|
| Date prepared | December 12, 2002 |
| Trade name of device | Baxter AURORA™ System 1000® Series Single PatientDialysis Delivery System |
| Common name | Hemodialysis System |
| Classification name | § 21CFR 876.5860 High Permeability Hemodialysis System |
| Substantially equivalent devices | The predicate substantially equivalent devices include: System1000® Series Dialysis Delivery Systems [510(k) numbersK910215 System 1000, Dialysis Delivery System, K954987AltraTouch 1000 Machine, K955384 SND option, K964922AutoStart option and K970446 Hematocrit and Blood VolumeMonitor option and K992894 Meridian HemodialysisMachine]. |
| Description of the device | The AURORA™ System 1000 Series Single Patient DialysisDelivery System is a dialysate proportioning system forhemodialysis. The system fulfills the following functions:1. Mixes concentrate with water in the appropriate proportionsto produce dialysate.2. Delivers dialysate at the appropriate temperature and ionicconcentration to the dialyzer.3. Removes the appropriate amount of liquid from the patient'sblood.4. Along with the dialyzer and blood pump acts as a totalartificial kidney. |
K013562 PAGE 1 OF 2
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510(k) SUMMARY Baxter AURORA™ System 1000® Series Single Patient Dialysis Delivery System Continued
| Intended use of the device | The AURORA™ System Series 1000® Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the AURORA™ System 1000® Series Single Patient Dialysis Delivery System includes a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disingection. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System will operate in either the bicarbonate or acetate mode for concentrates. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use. |
|---|---|
| Comparison of technological characteristics between new and predicate device | The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is built with the same fluid path and hardware components as the predicate System 1000® Delivery Systems. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850
Robert L. Wilkinson, RAC Director of Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road MCGAW PARK IL 60085
Re: K013562 :
Trade/Device Name: AURORA™ System 1000® Series Single Patient Delivery System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II
Product Code: 78 KDI Dated: September 12, 2002 Received: September 13, 2002
Dear Mr. Wilkinson:
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); 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.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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10(K) Number (if known): · K013562
Device Name:
Baxter AURORA™ System 1000® Series Single Patient Dialysis Delivery
Model: SYS 1000, L3 with N100 Arm, 4B Software
Indications for Use:
The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Aurora System 1000 include a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Aurora System 1000 Instrument will operate in either the bicarbonate or acetate mode for concentrates.
The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Divisional Sign-Off)
Division of Reproductive, Abdominal, & Radiological Devices
510(k) Number K013562
(Optional Format 1/2/96)
§ 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.”