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.

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.

AI/ML Overview

ELISIO™-H Hemodialyzer Acceptance Criteria and Study Details

The provided document describes the ELISIO™-H Hemodialyzer, which is an artificial kidney system for treating patients with renal failure. The submission (K131381) focuses on the inclusion of two additional family members (-90H and -250H) to the existing ELISIO-H product line. The primary method of demonstrating substantial equivalence to predicate devices (K122347, K002761, K926005, K082414) was through non-clinical bench studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with pass/fail thresholds. Instead, it refers to performance "as well as" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is a qualitative summary of non-clinical testing results.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Analyte Clearance	Substantially equivalent to predicate hemodialyzers	Testing indicates comparable performance for urea, creatinine, phosphate, Vitamin B12, inulin clearance.
Ultrafiltration Coefficient	Substantially equivalent to predicate hemodialyzers	Testing indicates comparable performance.
Pressure Drop	Substantially equivalent to predicate hemodialyzers	Testing indicates comparable performance.
Safety	Safe for intended use	Testing indicates the device is safe.
Effectiveness	Effective for intended use	Testing indicates the device is effective.

Note: The acceptance criteria are inferred from the statement "Results of bench studies establish substantial equivalence to Fresenius hemodialyzer performance" and "Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models." No specific numerical thresholds are provided for "substantially equivalent" or "as well as."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the non-clinical bench tests (e.g., number of dialyzer units tested for each parameter). It broadly states "non-clinical studies included those for analyte clearance...".
Data Provenance: The studies were non-clinical bench tests, meaning they were conducted in a laboratory setting, not on human subjects. The country of origin for the data is not specified, but the submitter (Nipro Medical Corporation) is located in Miami, FL, USA. The studies are prospective in nature, as they were conducted to evaluate the performance of the ELISIO™-H hemodialyzer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. For non-clinical bench studies of this nature, "ground truth" is established through standardized laboratory measurement techniques and scientific principles, not through expert consensus on interpretation of data. The performance metrics are objectively measured.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there can be inter-observer variability in establishing ground truth (e.g., image interpretation). For non-clinical, objective bench tests, adjudication is not performed in this manner.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study was a non-clinical bench study, not a clinical study involving human readers or interpretation of cases. Therefore, no effect size for human readers improving with AI assistance is applicable or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the studies conducted were standalone "device only" performance tests. The performance of the ELISIO™-H hemodialyzer itself (e.g., its ability to clear analytes, ultrafiltration coefficient) was measured directly. This is implicitly a "standalone" assessment of the device's physical and functional properties.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established through objective laboratory measurements of physical and chemical parameters based on established scientific methods. For example:

Analyte Clearance: Measured concentrations of urea, creatinine, etc., before and after passage through the dialyzer, under controlled conditions.
Ultrafiltration Coefficient: Direct measurement of fluid removal under a given transmembrane pressure.
Pressure Drop: Direct measurement of pressure difference across the dialyzer.

These are not pathology, expert consensus, or outcomes data, but rather direct measurements of the device's functional performance.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of machine learning or AI algorithms being developed or "trained" for this device. The ELISIO™-H hemodialyzer is a physical medical device, not a software algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as no training set was used for an AI/ML algorithm.

Summary

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K131381 Page 1 of 2

ATTACHMENT 4-4

510(k) Summary per 21 CFR 807.92

DEC 1 9 2013

Submitter	Nipro Medical Corporation3150 NW 107th AvenueMiami, FL 33172FDA Establishment #: 1056186
-----------	------------------------------------------------------------------------------------------------------

Contact Person

Jessica Oswaki-McLeod Phone: 305-599-7174 Fax: 305-592-4621

Date of Preparation

November 21, 2013

per 21CFR 876.5860

Nipro ELISIOTM-I-I Hemodialyzer Device Trade Names

Hemodialyzer

Device Classification Name

Common Name

Substantial Equivalence

K 122347 ELISIO™-H Hemodialyzer K002761 Fresenius Hemoflow K926005 Fresenius Hemoflow K082414 Fresenius Optiflux

High permeability hemodialys is system

Device Description

The ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

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Intended 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.

Technological Aspects

Conclusion

Both the original sizes of the ELISIO-I-I hemodialyzer and the new family members (sizes -90H and -250H) are composed of polyethersulfone fiber. The membrane composition and the housing case composition are identical between the existing sizes of the ELISIO dialyzers and the new sizes. The modification is the inclusion of two additional family members to the ELISIO-H product line.

Non-clinical studies included those for analyte clearance (urea, creatinine, phosphate, Vitamin B12, inulin), ultrafiliration coefficient and pressure drop and are included in product labeling. Results of bench studies establish substantial equivalence to Fresenius hemodialyzer performance.

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.

Page 154

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2013

Nipro Medical Corporation Regulatory Affairs % Carolyn K. George Consultant 3150 NW 107th Avenue Miami, FL 33172

Re: K131381

Trade/Device Name: ELISIO™-H Hemodialyzer 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 26, 2013

Dear Carolyn K. 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 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/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/ResourcesforYou/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

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Indications for Use

510(k) Number: K131381

Device Name: ELISIO™-H hemodialyzer

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)

Herbert P. Lerner -S 2013.12.18 15:32:53 -05'00'

014

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.”