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.

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.

AI/ML Overview

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.

Summary

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DEKA Research & Development Corp.

AUG 2 3 2011

5. 510(K) SUMMARY

DEKA Tension-Activated Clamp (TAC) Device

Applicant:

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:

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.

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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.

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Device	Rocky Mt. ResearchAutomatic TubingClamp System(K914459)	DEKA TAC	Medivice SidePort™Pinch Clamp Device(K010888)
Technical
Characteristic
Bubble DetectionSensitivity	> 0.35 ul @ 2 l/min	Not applicable	Not applicable
Reverse FlowSensitivity	< 0.5 liters per minute+ 0.25 lpm	Not applicable	Not applicable
Transducer Energy	Continuous 2.5 MHZ,0.03 Watts	Not applicable	Not applicable
External Indicators	Power, air bubbledetected, reverse flowdetected, arterial clampstatus, venous clampstatus, gas powerfailure	None. Relies onaccompanyinghemodialysisinstrument forindication of flowstoppage.	None
External Controls	Power switch, arterialclamp switch, venousclamp switch	None	None
Alarms	3.8 kHz continuousalarm on reverse flow,air detected or clampfault	None. Relies onaccompanyinghemodialysisinstrument forindication of flowstoppage.	None
Response Time	Unspecified	Less than 0.5 seconds	Not applicable

Indications for Use:

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Test 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.

Summary and Conclusions

Based on the information presented above, DEKA has demonstrated that the DEKA TAC is substantially equivalent to the cited predicate devices.

The DEKA TAC presents no new issues of safety or technology to the predicate device and, as such, is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Roger A. Leroux Director of Regulatory and Clinical Affairs DEKA Research & Development Corp. 340 Commercial Street MANCHESTER NH 03101

AUG 2 3 .2011

Re: K093915

Trade/Device Name: DEKA Tension-Activated Clamp (TAC) Device Regulation Number: 21 CFR$ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIG Dated: June 28, 2011 Received: June 29, 2011

Dear Mr. Leroux:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Lemur MD

Herbert P. Lemer, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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4. INDICATIONS FOR USE

510(k) Number (if known): K093915

Device Name: DEKA Tension-Activated Clamp (TAC) Device

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)oncurrence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Gastro-Renal, and Urological Devices

510(k) Number	X093915
Page	of

Regulation Number and Section

§ 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.