(28 days)
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No
The summary describes a physical medical device (dialyzer) and its intended use, construction, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as "intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure," which indicates it is used for therapy.
No
Explanation: The REXEED-S Series Dialyzer is intended for treatment of renal failure (hemodialysis), not for diagnosing conditions.
No
The device description clearly states it is a physical device constructed of hollow fiber membrane and plastic housing, intended for single use in hemodialysis.
Based on the provided text, the REXEED-S Series Dialyzer is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "hemodialysis for the treatment of patients suffering from acute or chronic renal failure." This is a therapeutic treatment performed directly on the patient's blood, not a test performed on a sample outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical device (hollow fiber dialyzer) used to filter blood. This aligns with a therapeutic device, 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 provide information about a patient's health.
- Providing a diagnosis, monitoring a condition, or screening for a disease.
- Using reagents or assays.
Therefore, the REXEED-S Series Dialyzer is a therapeutic medical device used for hemodialysis, not an IVD.
N/A
Intended Use / Indications for Use
REXED-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
Product codes
KDI
Device Description
The line of Asahi REXEED-S Series Dialyzer (hereafter referred to as REXEED-S) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure.
REXEED-S is designed for single use.
REXEED-S is constructed of hollow fiber membrane housed within a plastic housing of Styrene-Butadiene block copolymer and is subject to gamma-ray irradiation prior to shipment.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Design verification tests based on the result of the risk analysis and design input were performed to verify those modifications. All test results met the acceptance criteria, and proved those modifications to be appropriate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
Asahi Kasei Medical Co., Ltd. % Patsy Trisler Regulatory Consultant Qserve Group Us, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
K153344 Trade/Device Name: Asahi REXEED-S Series Dialyzer Regulation Number: 21 CFR& 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: November 17, 2015 Received: November 19, 2015
Dear Patsy Trisler:
Re:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
for
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Herbert P. Lerner -S
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 (if known)
Device Name
Asahi REXEED-S Series Dialyzer
Indications for Use (Describe)
REXED-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
REXEED-S Series Dialyzer
SUBMITTER
| Submitter Name and Address: | Contact: |
|---|---|
| Asahi Kasei Medical Co., Ltd. | |
| 1-105, Kanda Jinbocho, | |
| Chiyoda-ku, Tokyo 101-8101 | |
| Japan | Patsy J. Trisler, JD, RAC |
| Regulatory Consultant | |
| Qserve Group US, Inc. | |
| Patsy.trisler@qservegroup.com | |
| 301.652.5344 |
Date Prepared: November 17, 2015
DEVICE:
Trade Name: Asahi REXEED-S Series Dialyzer
Common Name: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer
Classification Name, Class, Product Code and Panel
| Classification Name and
| Regulation Number | Class | Product Code | Panel |
|---|---|---|---|
| High Permeability Hemodialysis | |||
| Systems, | |||
| 21 CFR 876.5860 | II | KDI | Gastroenterology |
| and Urology |
PREDICATE DEVICE(S):
Asahi REXEED-S Series Dialyzer:
K001250, August 16, 2000; K041726, July 23, 2004; and K051187, June 8, 2005
DEVICE DESCRIPTION
The line of Asahi REXEED-S Series Dialyzer (hereafter referred to as REXEED-S) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure.
REXEED-S is designed for single use.
REXEED-S is constructed of hollow fiber membrane housed within a plastic housing of Styrene-Butadiene block copolymer and is subject to gamma-ray irradiation prior to shipment.
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DESCRIPTION OF DEVICE MODIFICATIONS:
This Special 510(k) describes the following modifications to the referenced, previouslycleared Asahi dialyzers:
- Change in the material formulation ratio of housing (Styrene-Butadiene block copolymer)
- . Change in the material formulation of Stoppers (blood and dialysate side):
The material formulation change of stoppers from "Composite of Styrene-Ethylene-Butadiene-Styrene (SEBS) elastomer and Polyethylene" to "Polyethylene and Hydrogenated Styrene-Butadiene block copolymer ".
INDICATIONS FOR USE
REXEED-S Series Dialyzer is intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
DESIGN CONTROLS: EVALUATION OF DEVICE MODICATIONS
As the basis for Asahi's device evaluation studies and overall process for managing medical device risk, the company has performed a risk analysis using procedures based on ISO 14971:2007 "Medical Devices – Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA).
Design verification tests based on the result of the risk analysis and design input were performed to verify those modifications. All test results met the acceptance criteria, and proved those modifications to be appropriate.
CONCLUSION OF SUBSTANTIAL EQUIVALENCE
Asahi made modifications as described above to the original REXEED-S Series Dialyzer cleared under K001250, K041726 and K051187. The information and data provided in this Special 510(k) Premarket Notification establish that the modified REXEED-S Series Dialyzer is substantially equivalent in the intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the original referenced REXEED-S Series Dialyzer 510(k)s.