(609 days)
The DEKA TAC is an automatic tubing clamp device intended for use in a clinical facility as an accessory to a hemodialysis blood circuit to automatically clamp the blood flow in the hemodialysis circuit upon detection of tension in the venous access line in excess of a pre-defined threshold value. The DEKA TAC may be mounted on, or removed from, already assembled hemodialysis blood circuits.
The DEKA TAC is a multiple-use safety device designed to be used during hemodialysis treatments. The device mounts near the fistula needle on the patient and is designed to clip over the fistula needle tubing. It is designed to occlude the blood flow in the venous blood line should the blood circuit tubing get tangled or tugged or the fistula needle tubing rotated beyond a threshold limit. It will automatically occlude the line once tension, exceeding a pre-established value, is presented to the tubing with a threshold lower than what is required to extract the needle. This occlusion will prevent blood loss should the force on the tubing be great enough to cause the needle to be partially or fully removed from the patient.
The DEKA Tension-Activated Clamp (TAC) device is an automatic tubing clamp intended for use in hemodialysis to automatically clamp blood flow upon detection of tension in the venous access line exceeding a pre-defined threshold. The 510(k) summary provides details on the device's performance through in-vitro testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tubing Interface: Ability to interface with standard 5mm outer diameter hemodialysis fistula needle sets. | Demonstrated using Baxter Seraflo, Nipro SafeTouch 11, and Medisystem ReadySet needle sets. |
| Automatic Activation: Ability to automatically activate based on external conditions, specifically upon tension exceeding a pre-established value on the tubing. | Demonstrated through "Actuation Forces Testing Section" where external forces were applied to test force threshold. |
| Fluid Occlusion: Ability to fully occlude fluid flow once activated. | Demonstrated by testing the effectiveness of the clamp at stopping flow and measuring the leak rate of a closed clamp. |
| Response Time: | Less than 0.5 seconds |
| Force Threshold: | Lower than what is required to extract the needle. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample sizes (e.g., number of tubing sets, number of tests for each criterion) for the performance tests. The testing was described as "in-vitro testing," which typically means the data provenance is from a laboratory environment. The country of origin is not specified but implicitly North America given the applicant is a US company and the submission is to the FDA. The tests were retrospective in the sense that they were conducted to demonstrate the device's capabilities prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The testing appears to be objective performance measurements against technical specifications rather than relying on expert assessment for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as the tests involved objective measurements of device performance rather than interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The device is a safety mechanism, and the testing focused on its functional performance rather than comparing its effectiveness in improving human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the testing described is a standalone performance evaluation of the device. The "Test Results" section details "in-vitro testing" demonstrating the device's ability to:
- Interface with standard tubing.
- Automatically activate based on external conditions (tension).
- Fully occlude fluid flow.
This confirms that the device's functional capabilities were assessed independently.
7. Type of Ground Truth Used:
The ground truth for the performance tests appears to be based on objective technical specifications and measurable physical properties. For example:
- Tubing Interface: Demonstrated by successful physical attachment and function with specific standard needle sets.
- Automatic Activation: Ground truth was the pre-established tension threshold met and confirmed by the device's actuation.
- Fluid Occlusion: Ground truth was the complete cessation of fluid flow and a negligible leak rate.
8. Sample Size for the Training Set:
This information is not applicable and not provided. The DEKA TAC is a mechanical device with a fixed actuation mechanism, not an AI/algorithm-driven device that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the device does not involve an AI algorithm with a training set.
§ 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.