(514 days)
Altra 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.
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 renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the 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.
The provided text describes the Altra Flux® 200 Hemodialyzer with multiple use labeling, focusing on its substantial equivalence to an already marketed single-use device and its validation for reuse. However, it does not explicitly detail specific quantitative acceptance criteria or the full study design with all the requested information for a device performance study.
Based on the information provided, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
The document states that "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." This implies the acceptance criterion was "as safe and effective as the predicate device" after reprocessing.
However, specific quantitative metrics (e.g., clearance rates, ultrafiltration rates, fiber bundle volume integrity) and their acceptable ranges are not provided in this summary. Therefore, a table cannot be fully completed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness after reprocessing "as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer" | "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." (Specific quantitative metrics or comparison results are not provided in this document.) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the "testing performed on reprocessed devices." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring ground truth established by experts. The "ground truth" for a hemodialyzer's performance would be objective measurements of its function.
4. Adjudication method for the test set
This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or AI tools evaluated by multiple human readers. The Altra Flux® 200 Hemodialyzer is a therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a hemodialyzer. The device itself performs its function (filtration), and its performance is measured directly, not through an algorithm or human interpretation.
7. The type of ground truth used
The "ground truth" for the performance of a hemodialyzer would be direct measurements of its functional parameters (e.g., clearance of waste products, ultrafiltration rates, integrity of the membrane). While not explicitly stated, these are typically measured in laboratory settings or in simulated clinical conditions. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical device.
{0}------------------------------------------------
1 2
ა "
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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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
{3}------------------------------------------------
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.
§ 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.”