(249 days)
Not Found
No
The description focuses on the physical mechanism of ultrafiltration using semi-permeable membranes and mentions a pneumatic processor, but there is no mention of AI or ML.
No
The device is described as an "ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements." It is not intended for direct patient connection and does not perform the function of a therapeutic device which directly treats or prevents disease. Instead, it is a medical device used to prepare blood for reintroduction to the patient.
No
The device is described as an "ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood" and its function is to "remove plasma water from dilute blood plasma proteins, increasing the concentration of plasma proteins and formed cellular elements." This is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical device constructed of semi-permeable hollow fibers and connectors, which is a hardware component. It also mentions potential use with a "pneumatically driven device," further indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to selectively remove plasma water and small dissolved solutes from blood outside the body, specifically in cases of acute hemodilution. This is a therapeutic process performed on blood, not a diagnostic test performed on a sample to gain information about a patient's health status.
- Device Description: The description details a device that physically separates components of blood using a semi-permeable membrane. This is a filtration process, not a diagnostic assay or test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample to detect, measure, or identify substances or characteristics related to a disease or condition. The device's function is purely physical separation.
- Comparison to Predicate Device: The predicate device (K971710 Quantic Biomedical, Inc. UltraCon™ Ultrafiltrator) is also described as an ultrafiltrator, which aligns with a therapeutic/processing function rather than a diagnostic one.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is to process blood for therapeutic purposes, not to provide diagnostic information.
N/A
Intended Use / Indications for Use
The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
78 FJI
Device Description
The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable hollow fibers which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.
When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded.
The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator.
The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.
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
qualified personnel who understand its operation.
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)
Not Found
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.
Not Found
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
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
DEC | 1 1998
510(k) SUMMARY
SUBMITTED BY
Lynn Rodarti Manager, Regulatory Affairs INTERPORE Cross International 181 Technology Drive Irvine, California 92618 (714) 453-3200
Date Submitted: April 3, 1998
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Conventional Hemodialyzer |
|---|---|
| Common/Usual Name: | Ultraconcentrator |
| Product Classification: | Class II |
| Proprietary Name: | UltraConcentrator™ Permeability Hemodialyzer |
PREDICATE DEVICE
Quantic Biomedical, Inc. UltraCon™ Ultrafiltrator freference 510(k) K971710]
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
INDICATIONS FOR USE
The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.
DEVICE DESCRIPTION
The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable hollow fibers which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion
1
ge 2 of 4
headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.
When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded.
The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator.
The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.+
ULTRACONCENTRATOR SPECIFICATIONS
| Overall unit length (cm): | 15 |
|---|---|
| Effective fiber length (cm): | 11 |
| Unit diameter (cm): | 1.8 |
| Membrane area, nominal (m²): | 0.11 |
| Perfusate flow resistance, nominal (mm Hg/mL/min): | 0.15 |
| Maximum allowable transmembrane pressure (mm Hg): | 500 |
| Priming volume (mL): | 5 |
| Residual volume (mL): | 1 |
| Hemoconcentration (kUF) typical rate (mL/hr/mm Hg): | 1 |
| Molecular weight nominal cutoff (Daltons): | 002 |
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