(176 days)
Not Found
No
The summary describes a standard hemodialyzer and does not mention any AI/ML components or functionalities.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is for "Hemodialysis... indicated for patients with acute or chronic renal failure" and "may be indicated in the treatment of patients intoxicated with poisons or drugs." This clearly describes a treatment or therapy.
No
The device is a hemodialyzer used to treat renal failure by filtering blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a hemodialyzer, which is a physical medical device with components like polyethersulfone fiber and compartments for blood and dialysate. It is not described as software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for hemodialysis, which is a treatment for renal failure and intoxication. This is a therapeutic procedure performed on the patient's blood outside the body, but the device itself is not used to diagnose a condition by examining a sample in vitro.
- Device Description: The description details how the device functions as an artificial kidney system to remove toxins and fluid from the blood. This is a treatment mechanism, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) to detect a disease or condition.
- Providing information for diagnosis, monitoring, or prognosis.
- Using reagents or assays.
The device is clearly described as a medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Hemodialysis with an ELISIOTM-H or an ELISIOTM-M 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 (comma separated list FDA assigned to the subject device)
KDI
Device Description
The ELISIO-H and ELISIO-M 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 and ELISIO-M 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)
Non-clinical studies included those to assess biocompatibility. Results of these studies establish substantial equivalence to predicate device. Testing performed on the ELISIO-H and ELISIO-M dialyzers indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary per 21 CFR 807.92
DEC 2 0 2013
| 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 |
| Date of Preparation | June 21, 2013 |
| Device Trade Names | Nipro ELISIO™-H Hemodialyzer
Nipro ELISIO™-M Hemodialyzer |
| Device Classification
Name | High permeability hemodialysis system
per 21CFR 876.5860 |
| Common Name | Hemodialyzer |
| Substantial Equivalence | K122347
ELISIO™-H and ELISIO™-M Hemodialyzers |
| Device Description | The ELISIO-H and ELISIO-M 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 and ELISIO-M dialyzers are composed
of polyethersulfone fiber and are available in various
sizes, which are differentiated by membrane surface
area. |
.
1
:
| Intended Use | Hemodialysis with an ELISIOTM-H or an ELISIOTM-
M 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. |
| Technological Aspects | Both the ELISIO-H and ELISIO-M dialyzers and the
predicate dialyzers are composed of polyethersulfone
fiber. The membrane composition is identical between
the ELISIO dialyzers and the predicate devices. The
modification is a replacement of the polycarbonate
casing (housing case and blood traps) of the ELISIO
hemodialyzers with a polypropylene casing. |
| | Non-clinical studies included those to assess
biocompatibility. Results of these studies establish
substantial equivalence to predicate device. |
| Conclusion | Testing performed on the ELISIO-H and ELISIO-M
dialyzers indicates that they are safe, effective and
perform as well as the predicate devices, when used in
accordance with the instructions for use. |
.
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Nipro Medical Corporation Regulatory Affairs % Carolyn K. George Consultant 3150 NW 107th Avenue Miami, FL 33172
Re: K131935
Trade/Device Name: ELISIO™-H and ELISIO™-M Hemodialyzers Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: November 21, 2013 Received: November 25, 2013
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. You must
3
Page 2 -Carolyn K. George
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Elaine Blyskun Acting 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: K131935
Device Name: ELISIO™-H and ELISIO™-M hemodialyzers
Indications for Use:
Hemodialysis with an ELISIO™-H or an ELISIO™-M 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)
Elaine Blyskun for Benjamin Fisher