(31 days)
A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.
The line of Asahi REXEED-SX/LX Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Dialyzers are designed for single use. REXEED-SX/LX Dialyzers are constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subject to electron beam irradiation prior to shipment.
This Special 510(k) describes the following modifications:
- Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED
- Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type)
- Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED
- Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.
This document describes a 510(k) premarket notification for the Asahi REXEED-SX/LX Dialyzers. The focus of the information provided is on demonstrating substantial equivalence to pre-existing predicate devices following certain modifications, rather than a study proving the device meets specific acceptance criteria in a clinical setting with human subjects.
Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness with AI assistance are not applicable based on the provided text. The document primarily outlines the engineering and risk management aspects of the device modifications.
Here's an attempt to extract relevant information for the applicable categories:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
However, it does not explicitly list specific acceptance criteria values or detailed performance metrics for the REXEED-SX/LX Dialyzers in a table format within the provided text. It generally refers to "design verification tests based on the result of risk analysis and design input" and that these tests met acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: The studies are described as "in vitro" ("REXEED SX/LX Dialyzers have been tested in vitro under single use conditions."). The company is based in Japan, so it's likely the tests were conducted there or at facilities contracted by the company. Retrospective or prospective nature is not indicated, but given it's a device modification verification, it would be prospective testing of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. The "ground truth" here relates to engineering and performance specifications validated through testing, not clinical diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is for clinical assessments, not for engineering verification tests.
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
- MRMC Study: No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device modification review is based on engineering specifications, risk analysis (FMEA), and benchmark performance against the predicate device as demonstrated through "design verification tests." These tests would likely involve measuring physical and functional properties of the dialyzers according to established standards for hemodialysis systems.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
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K08251/5
1 of 2
A.0 510(k) Summary of Safety and Effectiveness
A.1 Submitter Information
OCT - 3 2008
| Company Name and Address: | Contact Name: |
|---|---|
| Asahi Kasei Kuraray Medical Company, Ltd. | David L. West, PhD, MPH |
| 9-1, Kanda Mitoshirocho | Vice President, Medical Device Development |
| Chiyoda-ku, Tokyo 101-8482 | 1801 Rockville Pike, Suite 300 |
| Japan | Rockville, MD 20852 |
| Telephone: 301-272-3113 | |
| Fax: 301-272-004 | |
| Email: david.west@quintiles.com |
A.2 Date Prepared: August 29, 2008
A.3 Name of Device
- 3.1 Trade Name: Asahi REXEED-SX/LX Dialyzers
- Common Name: High Flux Hemodialysis Membrane Dialyzer or High 3.2 Flux Hollow Fiber Dialyzer
3.3 Classification Name, Class, Product Code and Panel
| Classification Name andRegulation Number | Class | Product Code | Panel |
|---|---|---|---|
| High Permeability HemodialysisSystems, Title 21 Code of FederalRegulations § 876.5860 | II | KDI | Gastroenterologyand Urology |
A.4 Substantial Equivalence Claimed to Predicate Device
APS/REXEED, cleared for commercial distribution via 510(k) Premarket Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004; and K051187 dated June 8, 2005.
A.5 Device Description
The line of Asahi REXEED-SX/LX Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Dialyzers are designed for single use. REXEED-SX/LX Dialyzers are constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subject to electron beam irradiation prior to shipment.
Company Confidential Page 49 of 104
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Image /page/1/Picture/0 description: The image shows a handwritten text that reads "K082575 2 of 2". The text is written in a bold, black font, and the numbers are clearly visible. The phrase "2 of 2" indicates that this is the second page of a two-page document.
This Special 510(k) describes the following modifications:
- 트 Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED
- Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type)
- Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED
- 트 Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.
A.6 Intended Use and Indications for Use
- REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment 트 of patients who have chronic or acute renal failure.
- REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
- 로 REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.
Evaluation of Design Modifications A.7
As the basis for Asahi Kasei Kuraray Medical'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(2000) "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 risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate.
A.8 Conclusion:
Asahi Kasei Kuraray Medical made modifications to the original APS/REXEED cleared under K001250 K041726 and K051187, resulting in the REXEED-SX/LX Dialyzers. The information and data provided in this Special 510(k) Premarket Notification establish that the REXEED-SX/LX is substantially equivalent in intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the existing unmodified APS/REXEED cleared under K001250, K041726 and K051187.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Kasei Kuraray Medical Co., Ltd. % David L. West, Ph.D., MPH Vice President, Medical Device Development Quintiles Consulting 1801 Rockville Pike, Suite 300 ROCK VILLE MD 20852
OCT - 3 2008
Re: K082515
Trade/Device Name: Asahi REXEED-SX/LX Dialyzers Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 29, 2008 Received: September 3, 2008
Dear Dr. West:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use 6.0
510(k) Number (if known): Unknown
Device Name: Asahi REXEED-SX/LX Dialyzers
Indications for Use:
- A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
- B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
- C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.
Prescription Use: X (21 CFR § 801 Subpart D) AND/OR Over-the-Counter Use: (21 CFR §07 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huls Rem
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Special 510(k) - Asahi REXEED-SX/LX Dialyzers August 29, 2008
Company Confidential Page 22 of 104
§ 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.”