(514 days)
K926373/B
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No
The description focuses on the physical components and function of a hemodialyzer, with no mention of AI or ML capabilities.
Yes
The device is intended for hemodialysis, which is a treatment for renal failure, directly treating a medical condition.
No
Explanation: The device is a hemodialyzer, which is used to treat renal failure by filtering blood, not to diagnose a condition.
No
The device description clearly describes a physical hemodialyzer with semipermeable hollow fibers and compartments for blood and dialysate, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute or chronic Hemodialysis," which is a treatment for renal failure. This is a therapeutic procedure performed on a patient's blood outside the body, but it's not for the purpose of diagnosing a condition.
- Device Description: The description details how the device functions as an artificial kidney to remove waste products and excess water from the blood. This is a treatment mechanism, not a diagnostic one.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood or other biological samples to determine the presence or absence of a disease, condition, or physiological state.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Altra Fluxed 200 Hemodialyzer is a therapeutic device used in a treatment process.
N/A
Intended Use / Indications for Use
Altra Flux® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI, 78 MSF
Device Description
The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic The blood from a patient flows through the arterial tubing of the renal failure. extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.
A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K926373/B
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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Altra Flux® 200 Hemodialyzer with Multiple Use Labeling
510(k) Summary of Safety and Effectiveness
(in accordance with the requirements of SMDA 1990 and 21 CFR 807.92)
The assigned 510(k) number for the Altra Flux 200 Hemodialyzer with multiple use labeling is: K970679.
Applicant Information:
| Date Prepared: | March 10, 1997 |
|---|---|
| Name: | Althin Medical, Inc. |
| Address: | 14620 N.W. 60th Ave. |
| Miami Lakes, FL 33014-9308 | |
| Contact Person: | Mary Lane |
| Phone Number: | (305) 825-5368 |
| Fax Number: | (305) 825-5322 |
Device Information:
| Trade Name: | Altra Flux® 200 Hemodialyzer |
|---|---|
| Common Name: | high permeability hemodialyzer or artificial kidney |
| Classification Name: | Dialyzer, High Permeability with or without Sealed Dialysate System (21 CFR 876.5860) Product Code - 78 KDI |
Equivalent Device:
Altra Flux® 200 Hemodialyzer (single use device) cleared for marketing via Premarket Notification 510(k) number K926373/B.
Device Description:
The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic The blood from a patient flows through the arterial tubing of the renal failure. extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.
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1-2-22
A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.
Intended Use:
Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The multiple use device can be reused on the same patient.
Comparison to Predicate Device:
The Altra Flux® 200 Hemodialyzer with multiple use (reuse) labeling is identical to the currently marketed Altra Flux® 200 single use device. The product drawings, material list, chemical structure, production process flow for the membrane or dialyzer, and physical characteristics of the Altra Flux® 200 reusable hemodialyzer is identical to the currently marketed Altra Flux® 200 single use hemodialyzer which received marketing clearance via the original 510(k) Premarket Notification K926373/B, dated February 13, 1995.
The only difference between the two products is that the multiple use device has been validated for multiple uses. Reprocessing between uses was performed according to the Renatron® operator's manual. Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles facing to the right.
July 2 3 1998
Mr. Gordon Robertson Director, Regulatory Affairs Althin Medical, Inc. 14620 N.W. 60th Avenue Miami Lakes, FL 33014
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K970679 Multiple Use Labeling for the Altra Flux® 200 Hemodialyzer Dated: April 22, 1998 Received: April 24, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 MSF
Dear Mr. Robertson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reslassified in accordance with the provisions of the Federal Food. Drue, and Cosmetic Act (Act). 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, against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmarm.html".
Sincerely your;
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Device Name:
Altra Flux® 200 Henrodialyzer
Indications for Usc:
Alles Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CRF 801.109) OR
Over-The-Counter Use
Robert R. Sather/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K972679.