(271 days)
Hemodialysis with an ELISIO-H or 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.
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.
The provided 510(k) summary for the Nipro ELISIO™-H and ELISIO™-M Hemodialyzers (K122347) describes a medical device, not an AI or software-based diagnostic tool. Therefore, many of the requested categories related to AI/algorithm performance, such as "number of experts used," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable.
The acceptance criteria and study are focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Measure | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analyte Clearance: | Comparable to predicate devices (Baxter Xenium XPH and XPM) | "Results of these studies establish substantial equivalence" |
| - Urea | ||
| - Creatinine | ||
| - Phosphate | ||
| - Vitamin B12 and/or Inulin | ||
| Ultrafiltration Coefficient | Comparable to predicate devices (Baxter Xenium XPH and XPM) | "Results of these studies establish substantial equivalence" |
| Pressure Drop | Comparable to predicate devices (Baxter Xenium XPH and XPM) | "Results of these studies establish substantial equivalence" |
| Safety | Meets established safety standards and is comparable to predicates | "Testing performed... indicates that they are safe, effective and perform as well as the predicate devices" |
| Effectiveness | Meets established effectiveness standards and is comparable to predicates | "Testing performed... indicates that they are safe, effective and perform as well as the predicate devices" |
Note on Acceptance Criteria: The document states "Results of these studies establish substantial equivalence." This implies that the acceptance criteria were that the ELISIO™ hemodialyzers performed comparably to, or at least no worse than, the identified predicate devices (K083778 Baxter Xenium XPH Hemodialyzer and K093120 Baxter Xenium XPM Hemodialyzer) for the measured parameters. Specific numerical thresholds are not provided in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for the non-clinical tests (e.g., how many dialyzers of each type were tested). The data provenance is also not detailed, as these are non-clinical (laboratory/bench) studies on manufactured devices rather than studies on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical medical device; its performance is evaluated through objective physical and chemical measurements in a laboratory setting, not by human expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This is not an AI/software-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (analyte clearance, ultrafiltration coefficient, pressure drop) would be established through:
- Physical and Chemical Measurements: Direct, standardized laboratory measurements of the dialyzers' performance using established methods and calibrated equipment.
- Comparison to Predicate Devices: The performance metrics of the ELISIO™ dialyzers were compared directly to the performance of the legally marketed predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
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K122347
Pg. 1 of 2
510(k) Summarv 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
August 2. 2012
Date of Preparation
Device Trade Names
Device Classification Name
Common Name
High permeability hemodialysis system per 21CFR 876.5860
Nipro ELISIO™-H Hemodialyzer
Nipro ELISIO™-M Hemodialyzer
Hemodialyzer
Substantial Equivalence
Device Description
K083778 Baxter Xenium XPH Hemodialyzer K093120 Baxter Xenium XPM Hemodialyzer
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.
MAY 0 1 2013
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R122347
Pg. 2 of 2
Intended Use
Technological Aspects
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.
dialyzer is indicated for patients with acute or chronic
Hemodialysis with an ELISIO-H or ELISIO-M
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 ELISIO-H and ELISIO-M dialyzers and the predicate dialyzers are composed of polyethersulfone fiber. The dialyzer design and membrane composition are identical between the ELISIO dialyzers and the predicate devices.
Non-clinical studies included those for analyte clearance (urea, creatinine, phosphate, Vitamin B12 and/ or inulin), ultrafiltration coefficient and pressure drop. Results of these studies establish substantial equivalence and are included in product labeling.
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.
Conclusion
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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 & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2013
Nipro Medical Corporation % Ms. Carolyn K. George Consultant Quality System Engineering 6695 River Crest Point SUWANEE GA 30024
Re: K122347
Trade/Device Name: ELISIO™-H and ELISIO™-M Hemodialyzers Regulation Number: 21 CFR& 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 17, 2013 Received: April 17, 2013
Dear Ms. 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.
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Page 2 - Ms. Carolyn K. George
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.
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/CDRHOffices/ycm115809.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/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/Industrv/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: K122347
Device Name: ELISIO™-H and ELISIO™-M Hemodialyzers
Indications for Use:
Hemodialysis with an ELISIO-H or 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)
Herbert P. | @jfjer -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122347 510(k) Number
§ 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.”