(186 days)
No
The summary describes a hardware-based system with pumps, scales, and monitors for CRRT and TPE, without mentioning any AI/ML components or functionalities.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapies," which are treatments to address specific medical conditions.
No
The device description indicates it is used for continuous solute and/or fluid removal and various therapy modalities (e.g., SCUF, CVVH, TPE), which are treatments, not diagnostic processes.
No
The device description explicitly states that the Accura System hardware consists of blood pumps, scales, and various monitoring detectors and alarms, indicating it is a physical hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Baxter Accura System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload, and for Therapeutic Plasma Exchange (TPE). These are direct treatments performed on the patient's blood within the body or by processing the blood outside the body and returning it to the patient.
- Device Description: The description details hardware for pumping blood, scales, and monitoring for CRRT and TPE modalities. These are all related to processing blood or fluids directly from and to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.) to provide diagnostic information about a patient's condition. IVDs are typically used to test samples in vitro (outside the body) to aid in diagnosis, monitoring, or screening.
The Baxter Accura System is a therapeutic device used for blood purification and fluid management, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.
Product codes
78 KDI
Device Description
The Accura System hardware consists of blood pumps, scales and various monitoring detectors and alarms designed for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange Therapy. This device was developed to provide pump assisted Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD) and Continuous Veno-Venous Hemodiafiltration (CVVHDF); four modalities used for treating acute renal failure and/or fluid overload. Additionally, the Accura System was developed to provide the pump assisted Therapeutic Plasma Exchange (TPE) therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All functions of the Baxter Accura System were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications. Additionally, components of the disposable tubing set have met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices – Part: Guidance on selection of tests. The validation of the sterilization cycle for the Baxter Accura System disposable tubing set is based upon the ANSI/AAMI/ISO 11135:1994 "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization". Additionally, the Baxter Accura™ System meets the following applicable IEC 60601 general and particular standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-16.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993064, K981681, K946279, K973322, K911315/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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NOV 1 8 2002
Auge 1/2
510(K) SUMMARY
| Submitter's Name: | David E. Curtin, RAC |
|---|---|
| Address: | 1620 Waukegan Rd. MPGR-A2E |
| Phone: | (847) 473-6079 |
| Fax: | (847) 473-6952 |
| Contact: | David E. Curtin |
| Date Prepared: | 5/14/02 |
| Trade Name: | Baxter Accura System Therapy |
| Common Name: | Blood Pumping, Ultrafiltration Control and Fluid Replacement |
| System for Continuous Renal Replacement Therapy | |
| Classification Name: | High Permeability Hemodialysis System per 21 CFR 876.5860 |
| Equivalent Predicate: | PRISMATM System (K993064, K981681, K946279) |
| Diapact CRRT (K973322) | |
| Bm11 Blood Monitor Pump Disposable Tubing Set | |
| (K911315/A) | |
| Device Description: | The Accura System hardware consists of blood pumps, scales |
| and various monitoring detectors and alarms designed for | |
| Continuous Renal Replacement Therapy (CRRT) and | |
| Therapeutic Plasma Exchange Therapy. This device was | |
| developed to provide pump assisted Slow Continuous | |
| Ultrafiltration (SCUF), Continuous Veno-Venous | |
| Hemofiltration (CVVH), Continuous Veno-Venous | |
| Hemodialysis (CVVHD) and Continuous Veno-Venous | |
| Hemodiafiltration (CVVHDF); four modalities used for | |
| treating acute renal failure and/or fluid overload. Additionally, | |
| the Accura System was developed to provide the pump assisted | |
| Therapeutic Plasma Exchange (TPE) therapy. | |
| Intended Use: | The Baxter Accura System is indicated for continuous solute |
| and/or fluid removal in patients with acute renal failure or fluid | |
| overload. The Baxter Accura System may also be used in | |
| Therapeutic Plasma Exchange (TPE) therapies. | |
| Summary of the | |
| Technological | |
| Characteristics | |
| Compared to the | The general design and material of the Baxter Accura System |
| is similar to the PRISMAT™ CFM System currently | |
| marketed by Gambro Renal Care Products, and cleared under | |
| K993064, K981681 and K946279 and to the Diapact CRRT | |
| machine marketed by B. Braun Medical and cleared under | |
| K973322. | |
| Predicate Device: | The technological characteristics displayed by the subject |
| Baxter Accura System are similar to the predicate devices and | |
| do not raise any new types of safety and effectiveness issues, | |
| when compared to the PRISMAT™ CFM System or Diapact | |
| CRRT. | |
| Clinical Data: | N/A |
| Conclusions Drawn | |
| from Tests: | All functions of the Baxter Accura System were tested and |
| validated according to design specifications. Based on the | |
| validation results, all functions meet their respective required | |
| specifications. Additionally, components of the disposable | |
| tubing set have met the biological requirements of ISO 10993- | |
| 1: Biological Evaluation of Medical devices – Part: Guidance | |
| on selection of tests. The validation of the sterilization cycle | |
| for the Baxter Accura System disposable tubing set is based | |
| upon the ANSI/AAMI/ISO 11135:1994 "Medical Devices - | |
| Validation and Routine Control of Ethylene Oxide | |
| Sterilization". | |
| Additionally, the Baxter Accura™ System meets the following | |
| applicable IEC 60601 general and particular standards: IEC | |
| 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and | |
| IEC 60601-2-16. | |
| Additional |
1
KO21615
510(k) Premarket Notification Baxter Accura System Page 2 of 2
| Information | |
|---|---|
| Requested by FDA: | None to date |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.
NOV 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David E. Curtin, RAC Associate Director, Regulatory Affairs Renal Division Baxter Healthcare Corporation -1620 Waukegan Road MCGAW PARK IL 60085-6730 Re: K021615 Trade/Device Name: Baxter Accura System. Model 5M5660 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: August 19, 2002 Received: August 20, 2002
Dear Mr. Curtin:
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.
3
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,
Henry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Baxter Accura System for Continuous Renal Replacement Therapy
Indications For Use:
The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Chapman
Division Signof Reproductive
Prescription Use
(Per 21 CFR 801.109)
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