(77 days)
K 131381, K 131935
Not Found
No
The summary describes a physical medical device (hemodialyzer) and its function, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "artificial kidney system for the treatment of patients with renal failure," which directly implies a therapeutic function by replacing the function of a failed organ.
No
The device description states that the ELISIO-H hemodialyzers are used as an artificial kidney system for treatment, where toxins and/or fluid are transferred from the blood to the dialysate. This describes a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a hemodialyzer, which is a physical medical device composed of polyethersulfone fiber and used as an artificial kidney system. It involves the circulation of blood and dialysate solution, indicating a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment for renal failure and intoxication by removing toxins and fluid from the blood. This is a therapeutic intervention performed on the patient's blood within the device, not a diagnostic test performed on a sample outside the body to provide information about a patient's health status.
- Device Description: The description details a medical device used as an "artificial kidney system" that circulates blood and dialysate to remove substances across a membrane. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Language: The text does not mention analyzing samples, providing diagnostic information, or any of the typical functions of an IVD.
IVDs are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device performs a therapeutic function directly on the patient's blood.
N/A
Intended Use / Indications for Use
Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only.
This product is intended for single use only. The performance properties of reused dialyzers have not been established.
Product codes
KDI
Device Description
The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. 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 ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 131381, K 131935
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.”
0
APR 1 4 2014
510(k) Summary per 21 CFR 807.92
Submitter
Nipro Medical Corporation 3150 NW 107th Avenue Miami, FL 33172 FDA Establishment #: 1056186
Contact Person
Jessica Oswald-McLeod Phone: 305-599-7174 Fax: 305-592-4621
March 4, 2014 Date of Preparation
Nipro ELISIO™-H Hemodialyzer Device Trade Names
Device Classification Name
High permeability hemodialys is system per 21CFR 876.5860
Hemodialyzer Common Name
Substantial Equivalence
Device Description
K 131381 ELISIO™-H Hemodialyzer
K 131935 ELISIO™-H Hemodialyzer
The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. 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 ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.
1
Intended Use
Technological Aspects
Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.
Both the original ELISIO-H hemodialyzers and the new ELISIO-H family members (sizes -09H and -25H) are composed of polyethersulfone fiber with those of similar membrane size described in K131381. The housing case composition (polypropylene) is identical between the existing sizes of the ELISIO dialyzers described in K131935 and the new sizes. The modification is the inclusion of two additional family members to the ELISIO-H (polypropylene) product line.
Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models, when used in accordance with the instructions for use.
Conclusion
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes entwined around it, topped with wings. The seal is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Nipro Medical Corporation Carolyn George Consultant 3150 NW 107th Avenue Miami. FL 33172
Re: K140191
Trade/Device Name: ELISO™-H hemodialyzer Regulation Number: 21 CFR$ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 22, 2014 Received: March 25, 2014
Dear Carolyn George,
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Carolyn George
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.
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/ReportalProblem/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,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K140191
Device Name: ELISIO™-H hemodialyzer
Indications for Use:
Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
The device is for prescription use only.
This product is intended for single use only. The performance properties of reused dialyzers have not been established.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Herbert P. Lerner -S 2014.04.14 07:52:32