(157 days)
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No
The summary describes a kit of existing components (I.V. sets, transducer protectors, bloodlines) and focuses on their functional testing, biocompatibility, and integrity. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The document describes a kit containing components like I.V. sets, transducer protectors, and bloodlines, which are used for monitoring and connection purposes, rather than directly treating a disease or condition. The text focuses on safety, efficacy, and equivalence to legally marketed components, not on a therapeutic effect.
No
The document describes "I.V. sets and transducer protectors" and "arterial and venous bloodlines" which are used for delivering fluids or managing blood flow, not for diagnosing conditions. The testing mentioned (functional, biocompatibility, integrity) is related to the safety and performance of these fluid/blood handling components, not diagnostic capabilities.
No
The device description explicitly mentions physical components like I.V. sets, transducer protectors, arterial and venous bloodlines, and bonded connections, indicating it is a hardware-based medical device kit.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- The description focuses on components used in blood delivery and monitoring: The text mentions "I.V. sets," "transducer protectors," "arterial and venous bloodlines," and "monitor lines." These are all components typically used in procedures involving the circulatory system, such as intravenous therapy or blood pressure monitoring.
- The testing described relates to physical and functional properties: The performance studies focus on "functional testing," "biocompatibility," and the "integrity of bonded connections." These are tests relevant to devices that come into contact with blood and are used in a clinical setting, not tests related to analyzing biological samples in vitro.
- There is no mention of analyzing biological samples: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not describe any such analytical function.
Therefore, the device described is a medical device used in a clinical setting, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
No new claims or indications are made.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided.
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)
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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.
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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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1 80 SUMMARY OF SAFETY AND EFFICACY NOV
The proposed kit raises no new issues of safety or efficacy. In incorporating the components into a kit no modifications have been made which will affect safety or efficacy. Sterilization method and packaging are essentially the same.
The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided.
The integrity of the bonded connections of the bloodlines and of the connection of the transducer protectors to the monitor lines have been tested and data provided.
No new claims or indications are made.