(162 days)
The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.
The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.
This document is a 510(k) summary for the Tablo™ Cartridge, a blood tubing set used for hemodialysis. It does not present a study proving the device meets acceptance criteria in the way one might expect for a clinically-oriented AI/software device. Instead, it describes performance testing to demonstrate substantial equivalence to a predicate device for a hardware medical device.
Therefore, many of the requested fields (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be common for AI/software devices. Instead, it lists types of performance testing and a general conclusion of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | Met all performance specifications. The minor differences in technological characteristics (organizer, inner diameter of blood pump segment, access point configuration, pressure measuring component) did not raise new or different questions of safety or effectiveness. |
| Biocompatibility Testing | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Packaging and Shelf Life Testing | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Sterilization Validation | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Pyrogenicity Testing (for blood fluid path) | Demonstrated to be safe and did not raise new or different questions of safety or effectiveness. |
| Applicable Standards and FDA Guidance Documents | Complies with applicable standards and FDA Guidance Documents. |
| Substantial Equivalence | Determined to be substantially equivalent to the Fresenius Blood Tubing Set (K120823). |
2. Sample size used for the test set and the data provenance
This information is Not Applicable to this document as it describes testing of a physical medical device (blood tubing set) rather than an AI/software device with a distinct "test set" of data. The testing mentioned would involve laboratory and engineering tests on physical devices.
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. Ground truth, in the context of expert review for medical images or data, is not relevant for the performance testing described for a blood tubing set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is Not Applicable. Adjudication methods are typically used for expert consensus on ambiguous cases in the context of diagnostic AI/software.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is Not Applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a physical device like a blood tubing set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is Not Applicable. There is no algorithm discussed for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is Not Applicable. The "ground truth" for the performance of a blood tubing set would be established by validated engineering specifications, material standards, and functional requirements rather than medical expert consensus or pathology.
8. The sample size for the training set
This information is Not Applicable. Training sets are relevant for machine learning algorithms, which are not described in this submission for a physical medical device.
9. How the ground truth for the training set was established
This information is Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.