(266 days)
No
The summary describes a hemodialyzer, a physical device for filtering blood, and focuses on its materials, performance characteristics, and clinical study results. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is described as a hemodialyzer intended for the treatment of patients with acute or chronic renal failure, which is a therapeutic purpose.
No
The device description indicates that the ViE-U is a "high flux hollow fiber hemodialyzer" intended for the "treatment of patients who have acute or chronic renal failure." Hemodialyzers are therapeutic devices used to filter waste products from the blood, not to diagnose diseases.
No
The device description clearly states it is a "high flux hollow fiber hemodialyzer," which is a physical medical device used in hemodialysis. It describes the materials and components of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemodialysis for the treatment of patients who have acute or chronic renal failure." This is a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "high flux hollow fiber hemodialyzer." This is a device used to filter blood, which is a treatment process.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, etc.) to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the effectiveness of the dialyzer in removing substances from the blood and its biocompatibility, which are relevant to its function as a treatment device, not a diagnostic device.
- Key Metrics: The metrics reported are related to the performance of the dialyzer (clearance, pressure drop, etc.), not diagnostic metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat renal failure by filtering blood, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
ViE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.
Product codes
KDI
Device Description
The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold sterile and is intended for single use only.
All the materials including the hollow fiber membrane, housing, headers, potting material and stoppers are identical to those previously cleared in the predicate device (APS). The additional coating of vitamin E on the hollow fiber membrane uses an equivalent material and technology to the predicate device (CLIRANS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Biocompatibility testing for external communicating devices, circulating blood, prolonged contact per ISO 10993-1
- In vitro performance testing per ISO 8637 for
- Clearance (urea, creatinine, phosphate, and vitamin B12 at blood flow rates from 200 up to 500 mL/min.)
- Pressure drop
- Kuf
- Priming volume (Blood compartment volume)
- Maximum TMP
- Structural integrity
- Sterilization validation per ISO 11137-2
- Pyrogenicity testing
- Expiration date testing
- Packaging and transportation testing per ASTM D4169-14
- Clinical performance including in vivo KuF and removal rates for urea, albumin, and beta 2-microglobulin.
The clinical study was a prospective, open-label, non-randomized, single-armed, controlled study at a single site in Canada per ISO 14155. Seventeen patients were enrolled in the study and received treatment sessions in three study phases. Each patient began the study by receiving treatments with their current standard of care (control dialyzer) for 6 initial sessions (two weeks), followed by treatments with the ViE-21U for 36 sessions (12 weeks), and concluded the study with 6 final treatments with the control dialyzer (two weeks). The clinical performance of the ultrafiltration coefficient (KuF) and the removal rates for urea, creatinine, albumin and beta 2-microglobulin were evaluated for both the control and the ViE-21U dialyzers. In addition to performance data, biocompatibility and safety data were collected during the study, including: measurements of white blood cells, platelets and complement activation; type and number of adverse events; and type and number of device malfunctions. The clinical performance and biocompatibility were calculated based on the 12 patients who completed the 36 sessions with the ViE-21U dialyzer, while the safety evaluation was performed on all 17 enrolled patients. The clinical performance and biocompatibility evaluation showed equivalence of the ViE-21U and control dialyzers. Two adverse events determined to be possibly related (possible delayed hypersensitivity reaction) to the use of the ViE-21U occurred in one patient: pruritus and full body rash. These events were resolved with medication (diphenhydramine and prednisone) without sequelae, and the patient was transitioned back to the original hemodialyzer. There were no serious adverse events determined to be related to the ViE-21U. The results of this clinical study show that the ViE-U was used effectively as a hemodialyzer in patients who have renal failure and was shown to be safe as compared to the control dialyzer.
Key Metrics
Not Found
Predicate Device(s)
K001250, K041726, K003425, K013550
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
Asahi Kasei Medical Co., Ltd. % Megan Shackelford Principal, Consulting Services Boston Biomedical Associates, LLC 100 Crowley Drive, Suite 216 Marlborough, MA 01752
Re: K162248
Trade/Device Name: Asahi ViE-U Series Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: April 3, 2017 Received: April 4, 2017
Dear Megan Shackelford:
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.
1
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 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
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -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 (if known) K162248
Device Name Asahi ViE-U Series Dialyzer
Indications for Use (Describe)
VIE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.
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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3
510(k) summary
AsahiKASEI
ASAHI KASEI MEDICAL CO., LTD.
(As Required By 21 CFR 807.92)
Date Prepared: April 3, 2017
I. SUBMITTER
Submitter Name and Address | Contact |
---|---|
Asahi Kasei Medical Co., Ltd. | Megan M. Shackelford |
1-105, Kanda Jinbocho, | Principal, Consulting Services |
Chiyoda-ku, Tokyo 101-8101 | Boston Biomedical Associates |
Japan | 100 Crowley Drive Suite 216 |
Marlborough, MA 01752 |
II. DEVICE
Trade Name: | Asahi ViE-U Series Dialyzer |
---|---|
Common Name: | Hemodialyzer, High Permeability |
Hemodialysis System | |
Classification | 21 CFR 876.5860, Class II |
Product Code | KDI |
Panel | Gastroenterology and Urology |
III. PREDICATE DEVICES
Asahi APS Series Dialyzers: |
---|
K001250, August 16, 2000, and K041726, July 23, 2004 |
CLIRANS E-Series Hollow Fiber Dialyzers (Terumo Corporation) |
K003425, February 1, 2001, and K013550, November 20, 2001 |
DEVICE DESCRIPTION IV
The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold sterile and is intended for single use only.
K162248 – 510(K) Summary
4
AsahiKASEI
All the materials including the hollow fiber membrane, housing, headers, potting material and stoppers are identical to those previously cleared in the predicate device (APS). The additional coating of vitamin E on the hollow fiber membrane uses an equivalent material and technology to the predicate device (CLIRANS).
V. INDICATIONS FOR USE
ViE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI PREDICATE DEVICE
The proposed device (ViE-U) is substantially equivalent to the predicate device (APS) in terms of materials, principles of operation and device design. The proposed device was tested and compared with the predicate device (APS) for performance specifications. Additionally, the vitamin E coating of the proposed device uses an equivalent material and technology to that of the predicate device (CLIRANS). Considering these factors together, the proposed device was shown to be substantially equivalent to the predicate devices currently cleared through the 510(k) process.
PERFORMANCE DATA VII
Asahi has performed testing in conformance with the special controls for High Permeability Hemodialysis System, 21 CFR 876.5860, and the FDA document "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers'" including:
- . Biocompatibility testing for external communicating devices, circulating blood, prolonged contact per ISO 10993-1;
- In vitro performance testing per ISO 8637 for
- o Clearance (urea, creatinine, phosphate, and vitamin B12 at blood flow rates from 200 up to 500 mL/min.)
- o Pressure drop
- o Kuf
- o Priming volume (Blood compartment volume)
- o Maximum TMP
- o Structural integrity
5
- Sterilization validation per ISO 11137-2; .
- Pyrogenicity testing; .
- Expiration date testing: .
- Packaging and transportation testing per ASTM D4169-14; .
- Clinical performance including in vivo KuF and removal rates for urea, albumin, and ● beta 2-microglobulin.
The clinical study was a prospective, open-label, non-randomized, single-armed, controlled study at a single site in Canada per ISO 14155. Seventeen patients were enrolled in the study and received treatment sessions in three study phases. Each patient began the study by receiving treatments with their current standard of care (control dialyzer) for 6 initial sessions (two weeks), followed by treatments with the ViE-21U for 36 sessions (12 weeks), and concluded the study with 6 final treatments with the control dialyzer (two weeks). The clinical performance of the ultrafiltration coefficient (KuF) and the removal rates for urea, creatinine, albumin and beta 2-microglobulin were evaluated for both the control and the ViE-21U dialyzers. In addition to performance data, biocompatibility and safety data were collected during the study, including: measurements of white blood cells, platelets and complement activation; type and number of adverse events; and type and number of device malfunctions. The clinical performance and biocompatibility were calculated based on the 12 patients who completed the 36 sessions with the ViE-21U dialyzer, while the safety evaluation was performed on all 17 enrolled patients. The clinical performance and biocompatibility evaluation showed equivalence of the ViE-21U and control dialyzers. Two adverse events determined to be possibly related (possible delayed hypersensitivity reaction) to the use of the ViE-21U occurred in one patient: pruritus and full body rash. These events were resolved with medication (diphenhydramine and prednisone) without sequelae, and the patient was transitioned back to the original hemodialyzer. There were no serious adverse events determined to be related to the ViE-21U. The results of this clinical study show that the ViE-U was used effectively as a hemodialyzer in patients who have renal failure and was shown to be safe as compared to the control dialyzer.
VIII CONCLUSION
All design verification tests and in vivo validation of clinical study demonstrated that ViE-U is substantially equivalent in intended use, design, principle of operation, technology, materials, specifications, and performance to APS cleared under K001250 and K041726 and CLIRANS cleared under K003425 and K013550.
AsahiKASEI