(284 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a hemodialyzer, with no mention of AI or ML technologies.
Yes.
The device is intended for hemodialysis in patients with renal failure, which is a medical treatment designed to restore the patient's health.
No
The device is a hemodialyzer, used for treating renal failure by filtering blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like hollow fibers, resin, housing, headers, and packaging, 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 "hemodialysis in patients with acute or chronic renal failure." This describes a therapeutic treatment, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device (hemodialyzer) that filters blood directly from the patient. It describes compartments for blood and dialysate, and a membrane for substance exchange. This is consistent with a therapeutic device used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status. The device's function is to remove waste products from the blood during a treatment.
Therefore, the PS 150 Hemodialyzer is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.
Product codes (comma separated list FDA assigned to the subject device)
78KDI
Device Description
The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web.
The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing has been conducted to evaluate the performance of the PS 15® Hemodialyzer. The results of the functional testing attest that the PS 15® Hemodialyzer conforms to its specifications and has demonstrated the suitability of the PS 15® Hemodialyzer for its intended use. Testing included Total Blood Volume Measured, Effective Membrane Surface Area, Wall Thickness, Maximum TMP, and Clearance (Urea, Creatinine, Phosphate, B12).
All appropriate biocompatibility tests have been performed: Cytotoxicity Study (USP Elution Method), ISO Sensitization Study in the Guinea Pig (Maximization Method), Subchronic Intravenous Toxicity Study in the Rat, Acute Intracutaneous Reactivity Study in the Rabbit, Acute Systemic Toxicity Study in the Mouse, ISO Muscle Implantation Study in the Rabbit, Genotoxicity: Salmonella typhimurium Reverse Mutation Study, Genotoxicity: Sister Chromatid Exchange Study, Genotoxicity: Chromosomal Aberration Study in Mammalian Cells, Rabbit Pyrogen Study, Hemolysis Study In Vitro Procedure, Microtoxicity and Hemolysis Test. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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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.”
0
12/7/99
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required by 21 CFR 807.92(c)]
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92(a).
SUBMITTER INFORMATION L.
- Althin Medical, Inc. Company Name: a. 14620 NW 60th Avenue Company Address: b. Miami Lakes, Florida 33014-9308 (305) 823-5240 Company Phone: C. Amaury Sanchez Contact Person: ರ. Compliance Regulatory Senior Coordinator February 24, 1999 Date Summary Prepared: e.
DEVICE IDENTIFICATION ll.
- PS 15® Hemodialyzer Trade/Proprietary Name: a.
- Hemodialyzer Common Name: b.
- High Permeability Hemodialyzer 21 CFR Classification Name: C. 876.5860
Substantially Equivalent Legally Marketed Device: III.
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Althin Medical, Inc. | Altrex 170 | ||
| Hemodialyzer | K945597 | 3/8/95 | |
| Fresenius Medical | |||
| Care | Fresenius F60 | ||
| Polysulfone Dialyzer | K852251 | 7/25/85 |
su
1
The PS 15® Hemodialyzer is substantially equivalent to other predicate devices currently in commercial distribution in terms of their intended use. The fundamental technical characteristics are similar to those of the predicate devices.
IV. DEVICE DESCRIPTION
The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web.
The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.
V. INTENDED USE OF THE DEVICE
The disposable PS 150 Hemodialyzer is Intended for use in conjunction with commercially available blood tubing, blood access devices and relation we hemodialysis equipment. The intended use of the PS 150 Hemodialyzer and predicate Altrex 170 Hemodialyzer is identical in that the devices are intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. Both devices are labeled as sterite, nonpyrogenic, and for single use only. The devices are restricted to sale by or on the order of a physician.
VI. COMPARISON OF TECHNICAL CHARACTERISTICS
The design configuration of the PS 15® Hemodialyzer is similar to legally marketed devices from Althin Medical, Inc. and polysulfone membrane from Fresenius Medical Care.
2
With the exception of polysulfone, the PS 15® Hemodialyzer and predicate Altrex 170 use identical materials, similar manufacturing processes, the same package and are gamma sterilized.
The polysulfone membrane used in the PS 15® Hemodialyzer is substantially equivalent to other polysulfone membranes marketed by Fresenius Medical Care. Results from the functional, chemical and biological tests demonstrate that the PS 15® Hernodialyzer is equivalent to a legally marketed device.
A comparison of the features of the PS 15® Hemodialyzer and those of the previously cleared predicate device are presented in the following table.
| Feature | PS 15®
Hemodialyzer | Altrex 170
Hemodialyzer |
|----------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------|
| Classification Name | High Permeability
Hemodialyzer or
artificial kidney | High Permeability
Hemodialyzer or
artificial kidney |
| Classification | Class III device per
21 CFR 876.5860(b) | Class III device per 21
CFR 876.5860(b) |
| Panel | Gastroenterology and
Urology | Gastroenterology and
Urology |
| Product Code | 78KDI | 78KDI |
| Indications for Use | Same | Same |
| Product Specifications | Similar | Similar |
| Component configuration | Same | Same |
| Component functions | Same | Same |
| Compatible Hemodialysis Equipment | Same | Same |
| Labeling | Similar content | Similar content |
| Intended use | Same | Same |
| Labeled sterile, non-pyrogenic for single use only | Yes | Yes |
| Restricted to sale by or on Order of a Physician | Yes | Yes |
| Materials | Polysulfone
Polycarbonate
Polyurethane
ABS
Polyethylene | Cellulose Acetate
Polycarbonate
Polyurethane
ABS
Polyethylene |
| Design | Similar | Similar |
| Hemolysis |