(511 days)
Kawasumi Blood Tubing Line, gambro® Blood line set for hemodialysis
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No
The document describes standard blood tubing sets for hemodialysis and does not mention any AI or ML components or functionalities.
No
The device is described as blood tubing sets used to transport blood to and from a hemodialyzer. While necessary for hemodialysis, the tubing itself does not treat or cure a disease; it facilitates the connection to a therapeutic device (hemodialyzer). Therefore, the tubing set is an accessory to a therapeutic device rather than a therapeutic device itself.
No
Explanation: The device is a blood tubing set used to transport blood and fluids during hemodialysis. Its function is to facilitate the flow of substances, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components made of various materials (polyethylene, PVC, etc.) and describes their functions (transporting blood, capturing air, infusing medications), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transport blood or fluids to and from a patient's vascular access device and a hemodialyzer. This is a direct interaction with the patient's circulatory system for therapeutic purposes (hemodialysis), not for the in vitro examination of specimens derived from the human body.
- Device Description: The description details components used for transporting, pumping, filtering, and monitoring blood flow during dialysis. These are all related to the physical process of hemodialysis, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test biological specimens (like blood, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
The device falls under the category of a medical device used for a therapeutic procedure (hemodialysis), specifically a blood access device as described in 21 CFR 876.5540.
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Intended Use / Indications for Use
The blood tubing sets are used to transport blood or fluids to a patient's vascular access device from a hemodialyzer. The reverse is also true in that the tubing set is used as to transport blood or fluids from a patient's vascular access device to a hemodialyzer.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The tubing sets that we intend to market include arterial and venous dialysis blood tubing (nonimplanted blood access device) as described in 21 CFR 876.5540. Various models of blood tubing sets are being manufactured for application with different dialysis machines. Twenty-seven arterial line models (A001 - A021, A026, A029-A032, and A035) and 14 venous line models are described (V600 -V607, V609 - V613, and V616). All components of blood tubing, including drip chambers, infusion tubing, monitor lines, ports and segments which are used to pump blood, retain and capture air and blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices are included. The materials used for the components include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polycarbonate (PC) and polyethylene high density (PEHD).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance and biocompatibility tests were performed on the subject device as well as the legally marketed devices for comparison:
- Priming Volume Test: Auxiliary tubing is closed with clamp connectors and pathways are filled with distilled water. The tubing set is weighed and then the water is drained. Empty tubing sets are weighed again. Volume is expressed in milliliters (ml). Observations found to be within acceptable range and tests results were similar to values obtained for Kawasumi and gambro blood tubing sets.
- Pull Force at Connecting Joints (A tensile strength tester is used.):
a. Between the main tubing (or saline line) and connected parts or other tubing.
b. Between heparin lines and connected parts.
A 50 mm sample of tubing with the connected part or other tubing is cut and set on the apparatus. After disengagement of the test tubing from the part or other tubing, the result is recorded from the printer. The specification is defined as ±10% variance from nominal values mean of outer diameter of the pump segment. The subject and the legally marketed devices conformed to this specification. - Torque Force: The torque gauge is connected to the tubing which is connected with a female luer lock. The male luer lock cap is turned by hand and torque force read and recorded from dial gauge.
- Endurance Test of the Pump Segment: The diameter of the rolling tube is measured before and after pumping at 200 ml/min for 4 hours at 37 C. The percentage of diameter increase is calculated and recorded. The specification is defined as ±10% variance from nominal values mean of outer diameter of the pump segment. The subject and the legally marketed devices conformed to this specification.
- Air Leakage above Atmospheric Pressure: Air compressor is set at 2.5 kgf/cm2 G and connections of tubing attached appropriately. Sample is then immersed into the water bath and pressure applied at 0.1kgf/cm² G within seconds. If there is no leakage at the connection, then pressure is gradually increased at 0.1 kgf/cm2 G intervals. The pressure at which leakage occurs is recorded. Results were similar to those obtained with legally marketed devices. Leaks occurred at pressures more than 2.0 kgf/cm^2G. No clogging was noted.
- Air Leakage below Atmospheric Pressure: The access port is punched 6 times in the same location using an 18G needle. The blood line is then attached to the appropriate fitting and the pathway filled with distilled water. The pressure is set 200 mmHg below atmospheric pressure at sea level. The presence or absence of air bubbles in the pathway is noted. No air bubbles occurred in samples tested and results were similar in legally marketed devices for comparison.
The following tests were conducted on the finished sterilized device: pyrogenicity, cytotoxicity, acute toxicity (systemic injection) test, intracutaneous reactivity (skin reaction), sensitization, hemolysis, mutagenicity, and implantation. Results indicate that the blood tubing sets conform to the specifications set forth. Predicate devices for comparison show similar results when tested using these methods.
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.
Kawasumi Blood Tubing Line, gambro® Blood line set for hemodialysis
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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§ 876.5820 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.
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