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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for Nipro ELISIO™-H and ELISIO™-M Hemodialyzers, which are medical devices used for hemodialysis in patients with renal failure.

Based on the provided text, there is no information related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document is a regulatory submission (510(k) summary) and primarily focuses on:

Device Identification: Trade names, classification, common name.
Device Description: What the device is, how it works, and its components (polyethersulfone fiber membrane, polypropylene casing).
Intended Use: Conditions for which the device is indicated (acute or chronic renal failure, drug/poison intoxication).
Technological Aspects and Substantial Equivalence: Comparison to predicate devices, noting the membrane composition is identical and the modification is a change in casing material from polycarbonate to polypropylene. It mentions non-clinical studies for biocompatibility demonstrating substantial equivalence.
Conclusion: States that testing indicates the ELISIO™-H and ELISIO™-M dialyzers are safe, effective, and perform as well as predicate devices.
FDA Communication: Formal letter from the FDA granting substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, or ground truth establishment as it is not present in the provided text. The document focuses on regulatory approval based on demonstrating equivalence to an existing predicate device, primarily through material changes and biocompatibility testing, rather than detailed performance metrics against specific acceptance criteria.

Summary

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510(k) Summary per 21 CFR 807.92

DEC 2 0 2013

Submitter	Nipro Medical Corporation3150 NW 107th AvenueMiami, FL 33172FDA Establishment #: 1056186
Contact Person	Jessica Oswald-McLeodPhone: 305-599-7174Fax: 305-592-4621
Date of Preparation	June 21, 2013
Device Trade Names	Nipro ELISIO™-H HemodialyzerNipro ELISIO™-M Hemodialyzer
Device ClassificationName	High permeability hemodialysis systemper 21CFR 876.5860
Common Name	Hemodialyzer
Substantial Equivalence	K122347ELISIO™-H and ELISIO™-M Hemodialyzers
Device Description	The ELISIO-H and ELISIO-M hemodialyzers aremedical devices used as an artificial kidney system forthe treatment of patients with renal failure. Duringtreatment, blood is circulated from the patient throughthe hemodialyzer's blood compartment, while thedialysate solution flows countercurrent through thedialysate compartment. In this process, toxins and/orfluid are transferred across the membrane from theblood to the dialysate compartment.
	The ELISIO-H and ELISIO-M dialyzers are composedof polyethersulfone fiber and are available in varioussizes, which are differentiated by membrane surfacearea.

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Intended Use	Hemodialysis with an ELISIOTM-H or an ELISIOTM-M hemodialyzer is indicated for patients with acute orchronic renal failure when conservative therapy isjudged to be inadequate. It also may be indicated inthe treatment of patients intoxicated with poisons ordrugs.
	The device is for prescription use only. This productis intended for single use only. The performanceproperties of reused dialyzers have not beenestablished.
Technological Aspects	Both the ELISIO-H and ELISIO-M dialyzers and thepredicate dialyzers are composed of polyethersulfonefiber. The membrane composition is identical betweenthe ELISIO dialyzers and the predicate devices. Themodification is a replacement of the polycarbonatecasing (housing case and blood traps) of the ELISIOhemodialyzers with a polypropylene casing.
	Non-clinical studies included those to assessbiocompatibility. Results of these studies establishsubstantial equivalence to predicate device.
Conclusion	Testing performed on the ELISIO-H and ELISIO-Mdialyzers indicates that they are safe, effective andperform as well as the predicate devices, when used inaccordance with the instructions for use.

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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

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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

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Indications for Use

510(k) Number: K131935

Device Name: ELISIO™-H and ELISIO™-M hemodialyzers

Indications for Use:

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

Regulation Number and Section

§ 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.”