(224 days)
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No
The summary describes a data management system for dialysis treatments, focusing on data acquisition, processing, and display. There is no mention of AI, ML, or related concepts, nor any description of training or test sets typically associated with such technologies.
No
Exalis is a software application that manages data related to dialysis treatments; it does not directly perform or facilitate therapeutic intervention on the patient. It is an accessory to a haemodialysis system.
No
Exalis is a software application designed to manage and display data related to dialysis treatments and patient information. It is described as an accessory for a haemodialysis system, focused on data acquisition, processing, and supply for treatment rather than diagnosing medical conditions.
Yes
The device is described as a "software application" and an "accessory intended to be used with" a separate hardware system (Gambro Phoenix Haemodialysis system). The description focuses solely on data acquisition, processing, and display functionalities, which are software-based. There is no mention of hardware components included with Exalis itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Exalis is used to acquire, process, and supply data related to running a dialysis treatment. It manages patient data, prescriptions, and treatment information. This is focused on managing the process of dialysis and patient information, not on analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The description reiterates its function in managing data for dialysis treatments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Exalis does not perform this function. It is a data management system for a medical treatment process.
N/A
Intended Use / Indications for Use
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data.
Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
Product codes
78 FKP, KDI
Device Description
Exalis Software 1.15
Catalogue Number: 6041909
Accessory to Hemodialysis Delivery System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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K083158-PAGE 1 OF 1
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401
.
Traditional 510(k) Exalis Software 1.15
| 5.0 510(K) SUMMARY | |
|---|---|
| Submitter's Name | Gambro Renal Products, Inc. |
| Address | 14143 Denver West Parkway, Suite 400 |
| Lakewood, Colorado 80401 | |
| Establishment | |
| Registration Number | 2087532 |
| Date of Summary | March 16, 2009 |
| Telephone Number | |
| Fax Number | (303) 542-5045 |
| (303) 876-9264 | |
| Contact Person | Kae Miller, Regulatory Affairs Manager |
| Name of the Device | Exalis Software 1.15 |
| Catalogue Number: 6041909 | |
| Common or Usual Name | Accessory to Hemodialysis Delivery System |
| Classification Name | Classification Name:-Hemodialysis System and accessories |
| Device Class: II | |
| Product Code: 78 FKP | |
| Regulation Number: 876.5820 | |
| Indications for Use | Exalis is an integrated product able to acquire; process and supply |
| data required when running a dialysis treatment. This software | |
| application makes it possible to insert, modify, acquire, display in | |
| textual and graphical form data about dialysis prescription, ongoing | |
| and performed dialysis treatments and patient personal data. | |
| Exalis is an accessory intended to be used with Gambro Phoenix | |
| Haemodialysis system (starting from software version 3.35) in a | |
| Chronic Dialysis Facility and at Limited Care Centers. | |
| Identification of the | |
| Legally Marketed Device | |
| (Predicate Device) | CyberRen® Clinical Data Management System |
| 510(k) Number: K970989 | |
| Classification Name: Hemodialysis System and accessories | |
| Device Class: II | |
| Product Code: 78KPF, 78FKP | |
| Regulation Number: 876.5820 |
.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kae Miller RA Manager, US Gambro. Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD, CO 80401
JUN - 5 2009
Re: K083158
Trade/Device Name:_ Exalis_Software_1.. 1.5 Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 22, 2009 Received: May 22, 2009
Dear Ms. Miller:
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 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 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.
2
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401
Indications for Use
510(k) Number (if known): K083158
Device Name: Exalis Software 1.15
Indications for Use:
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data.
Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
Prescription Use Over-The-Counter Use X AND/OR (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)
Samue Hasse
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
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