DEKA TAC DEVICE

K093915 · Deka Research & Development Corp. · FIG · Aug 23, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K093915
• Device Name: DEKA TAC DEVICE
• Applicant: Deka Research & Development Corp.
• Product Code: FIG · Gastroenterology, Urology
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

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.

Device Story

DEKA TAC is a passive, tension-activated safety device for hemodialysis. It clips onto fistula needle tubing near the patient. When tubing experiences tension exceeding a pre-set threshold—indicating potential needle dislodgement—the device automatically triggers a mechanical clamp to occlude blood flow. It operates without external power or sensors, relying on physical tension in the line. Used in clinical facilities by healthcare providers, it serves as an accessory to existing hemodialysis circuits. By stopping blood flow during accidental tugging or tangling of the venous line, it prevents patient blood loss. The device is mounted on or removed from assembled circuits as needed.

Clinical Evidence

Bench testing only. No clinical data. Testing included performance verification of the clamping mechanism, actuation force thresholds, and leak rate testing of the closed clamp. Compatibility was validated using Baxter Seraflo, Nipro SafeTouch 11, and Medisystem Readyset needle sets.

Technological Characteristics

Passive mechanical device; no external power or sensors. Materials include polypropylene (skin contact), aluminum, and stainless steel. Dimensions: 1.2" width, 0.71" height. Actuation via tension-triggered mechanical spring mechanism. Designed for 5mm OD hemodialysis fistula needle tubing. Non-electronic; no software or connectivity.

Indications for Use

Indicated for use in clinical facilities as an accessory to hemodialysis blood circuits to automatically clamp blood flow upon detection of excess tension in the venous access line, preventing blood loss from needle dislodgement.

Regulatory Classification

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.

Predicate Devices

• Rocky Mt. Research Automatic Tubing Clamp System (K914459)
• Medivice SidePort Pinch Clamp Device (K010888)

Submission Summary (Full Text)

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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: | [phone] |
| E-mail: | [e-mail] |
| 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

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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. Research<br>Automatic Tubing<br>Clamp System<br>(K914459) | DEKA TAC | Medivice SidePort™<br>Pinch Clamp Device<br>(K010888) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Technical | | | |
| Characteristic | | | |
| Bubble Detection<br>Sensitivity | > 0.35 ul @ 2 l/min | Not applicable | Not applicable |
| Reverse Flow<br>Sensitivity | < 0.5 liters per minute<br>+ 0.25 lpm | Not applicable | Not applicable |
| Transducer Energy | Continuous 2.5 MHZ,<br>0.03 Watts | Not applicable | Not applicable |
| External Indicators | Power, air bubble<br>detected, reverse flow<br>detected, arterial clamp<br>status, venous clamp<br>status, gas power<br>failure | None. Relies on<br>accompanying<br>hemodialysis<br>instrument for<br>indication of flow<br>stoppage. | None |
| External Controls | Power switch, arterial<br>clamp switch, venous<br>clamp switch | None | None |
| Alarms | 3.8 kHz continuous<br>alarm on reverse flow,<br>air detected or clamp<br>fault | None. Relies on<br>accompanying<br>hemodialysis<br>instrument for<br>indication of flow<br>stoppage. | None |
| Response Time | Unspecified | Less than 0.5 seconds | Not applicable |

# 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

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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 [phone] or [phone] 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:

.

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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-----------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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 |

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