(609 days)
Not Found
No
The device description and performance studies focus on mechanical tension detection and clamping, with no mention of AI/ML algorithms or data processing for decision making.
No
The device is described as an accessory to a hemodialysis blood circuit and a safety device designed to automatically clamp blood flow upon detection of tension, preventing blood loss. While it supports patient safety during a medical procedure, its primary function is not to directly treat a disease or condition.
No
The device is an automatic tubing clamp that mechanically occludes blood flow based on tension in the venous access line, not to diagnose a condition.
No
The device description clearly describes a physical, mechanical device that mounts on tubing and physically occludes blood flow based on tension detection. It is not solely software.
Based on the provided information, the DEKA TAC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's 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... upon detection of tension in the venous access line". This describes a mechanical safety device that interacts with the blood circuit externally.
- Device Description: The description reinforces this, explaining it "clips over the fistula needle tubing" and "occlude the blood flow in the venous blood line should the blood circuit tubing get tangled or tugged". It's a physical mechanism for controlling blood flow.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DEKA TAC does not perform any analysis or testing of bodily fluids or tissues. It's a safety accessory for a medical procedure.
Therefore, the DEKA TAC is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FIG
Device Description
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.
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
clinical facility
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)
Results of in-vitro testing and biocompatibility assessments demonstrate that the DEKA TAC presents no new issues of safety or technology to the predicate device(s) and, as such, is substantially equivalent to the predicate device.
The non-clinical testing intended to support a claim of substantial equivalence is summarized in DKBF-00515-001 starting on page 126 of the original 510(k) submission. In this summary report, the key testing intended to support the claim of substantial equivalence is as follows:
- The DEKA TAC device has the ability to interface with standard tubing by . attaching externally to standard 5mm outer diameter hemodialysis fistula needle sets. This was demonstrated by conducting performance tests using the following needle sets: Baxter Seraflo, Nipro SafeTouch 11 and Medisystem Readyset. Reference section 4.1 of DKBF-00515-001 page 133.
- . The DEKA TAC has the ability to automatically activate based on external conditions. This is shown in The Actuation Forces Testing Section of the original 510 (k) submission. This section provides the results of the device testing with external forces applied to test force threshold. Reference section 4.2 of DKBF-00515-001 page 134.
- The DEKA TAC has the ability to fully occlude fluid flow. This is evidenced by . the testing of the effectiveness of the clamp at stopping the flow in the tubing as well as the leak rate of a closed clamp. Reference section 4.3 of DKBF-00515-001 page 139.
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.
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.
0
DEKA Research & Development Corp.
AUG 2 3 2011
5. 510(K) SUMMARY
DEKA Tension-Activated Clamp (TAC) Device
Applicant:
a
DEKA Research & Development Corporation 340 Commercial Street Manchester, NH 03101-1129
| Contact Person: | Roger Leroux |
|---|---|
| Telephone: | (603) 669-5139 |
| E-mail: | rleroux@dekaresearch.com |
| Date Prepared: | December 18, 2009 |
Device:
DEKA TAC Device Proprietary Name: Automatic Blood Tubing Clamp Common/Usual Name: Classification: Class II: 21 CFR 876.5820; Hemodialysis system and accessories; Product Code: FIG
Device Description:
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.
Predicate Device:
The DEKA TAC is substantially equivalent (i.e., has the same intended use and similar technological characteristics) to the Rocky Mt. Research Automatic Tubing Clamp System (K914459) and the Medivice SidePort Pinch Clamp Device (K010888). DEKA bases this claim of substantial equivalence on intended use and in recognition that the differences in technological characteristics do not affect the safety and effectiveness of the device.
I
1
Rocky Mt. Research Medivice SidePort™ Device Automatic Tubing DEKA TAC Pinch Clamp Device Clamp System (K010888) (K914459) Technical Characteristic Summary The Rocky Mountain The DEKA Tension The Medivice Research Automatic Activated Clamp SidePort Pinch Clamp Tubing Clamp is an (TAC) is a passive is a passive device active device that device intended to that permits a user to monitors blood flow in externally obstruct externally obstruct the a cardiopulmonary the flow of fluid in a flow of fluid in a soft bypass line for air tube. The Pinch soft tube during bubbles and low or hemodialysis. It is Clamp is commonly retrograde flow. Upon triggered when a found on detection of one of force is applied to the hemodialysis blood these conditions, the hemodialysis blood tubing sets and used device automatically tubing line. by caregivers and obstructs the flow of home patients alike. the fluid in the soft tubing by closing its accompanying external tubing clamps and alerting the user to the event. Gross Dimensions Control Box: 11" 3" length. 1.2" width. Approximately 1" in depth, 10" width, 5" 0.71" height all directions height Transducer: 0.75" depth, 2" width, 1.3" height Control Box: 10 lbs. Less than 29 grams Unspecified Weight Arterial and Venous clamps: 1.0 lb each. Transducer: 0.5 lbs. Tubing Compatibility For use with 3/8" or 5.00-5.25 mm OD 2.0-7.3 mm OD 1/2" ID x 3/32" wall tubing Materials ABS. aluminum. Polypropylene (skin Acetal or Nylon polyurethane, stainless contact), aluminum, steel, brass government black Electricity Required Not Required Not Required Actuation Mechanism Pressurized gas based Cocked spring Manual on Air and Flow actuated by tension in sensors the tubing line
The following table illustrates the equivalence between the DEKA TAC and its predicates.
2
| Device | Rocky Mt. Research
Automatic Tubing
Clamp System
(K914459) | DEKA TAC | Medivice SidePort™
Pinch Clamp Device
(K010888) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Technical | | | |
| Characteristic | | | |
| Bubble Detection
Sensitivity | > 0.35 ul @ 2 l/min | Not applicable | Not applicable |
| Reverse Flow
Sensitivity |