LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109

K073260 · Device Partners International · DTL · Mar 13, 2008 · Cardiovascular

Device Facts

• Record ID: K073260
• Device Name: LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
• Applicant: Device Partners International
• Product Code: DTL · Cardiovascular
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.

Device Story

LiiSA Lever Integrated Interventional System Adaptor is a Y-connector hemostasis valve for interventional procedures; maintains hemostasis during insertion/withdrawal of guide wires, balloon catheters, and stents. Device features a lever-controlled seal; lever positions (partially open, fully open) identified by audible clicks; allows sensitive adjustment for optimal seal around interventional devices. Includes two external arms for locking guide wires to secure devices without manual holding; Y-side arm facilitates contrast media injection, saline flush, and blood pressure monitoring. Used in clinical settings by medical professionals during angioplasty. Benefits include reduced back bleeding and improved procedural security for introduced devices.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Y-connector hemostasis valve; 9 F (3.0 mm) inner diameter; lever-actuated seal mechanism; two external arms for device locking; Y-side arm for fluid/pressure monitoring. Mechanical operation.

Indications for Use

Indicated for maintaining hemostasis during angioplasty procedures involving the introduction, use, and withdrawal of diagnostic or interventional devices (guide wires, balloon catheters, stents). Compatible with guiding catheters ≤ 9 F and 0.014"-0.038" guide wires.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• CoPilot Bleedback Control Valve (K991102)
• Y-Click Connector (K060759)

Submission Summary (Full Text)

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| | 510(k) Summary | K073260 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Applicant: | Device Partners International<br>4305 Enterprise Drive, Suite E<br>Winston-Salem, NC 27106 | MAR 13 2008 |
| Contact Person: | Monica Early Dougherty<br>4305 Enterprise Drive, Suite E<br>Winston-Salem, NC 27106<br>Phone: [phone] | |
| Date Prepared: | November 20, 2007 | |
| Device: | Device Trade Name: LiiSA Lever Integrated Interventional System<br>AdaptorTM<br>Device Common Name: Hemostatic Valve<br>Device Classification Name: Adaptor, Stopcock, Manifold, Fitting,<br>Cardiopulmonary Bypass<br>Classification: Class II<br>Product Code: DTL<br>Regulation Number: 870.4290 | |
| Predicate Devices: | Predicate devices used to demonstrate substantial equivalence are the<br>CoPilot Bleedback Control Valve marketed by Guidant /Abbott Vascular<br>(K991102) and theY-Click Connector marketed by Elcam Medical<br>(K060759). | |
| Device description: | The LiiSA Lever Integrated Interventional System AdaptorTM is an<br>Adaptor designed for use in all interventional applications where a<br>hemostasis valve is required and has an inner diameter of up to 9 F ( 3.0<br>mm / 0.118"). It has a seal which can be opened and closed by control of a<br>lever. Pushing the lever will open the seal; releasing the lever will close<br>the seal. The lever can be rested in a partially open position or a fully open<br>position. These positions can easily be identified by the position of the<br>lever and by an audible "click". The lever can be further controlled with<br>great sensitivity to have the optimal seal around the interventional device<br>(i.e., guide wire, balloon catheter, stent). This enables the user to<br>experience a minimum of back bleeding with maximum security for his<br>introduced device. The LiiSA Lever Integrated Interventional System<br>AdaptorTM offers two external arms for the purpose of locking introduced<br>devices (i.e., guide wire) to enable users to introduce additional devices<br>without the need to manually hold and secure the devices already<br>introduced and secured. The LiiSA Lever Integrated Interventional System<br>AdaptorTM has a "Y" side arm to facilitate contrast media injection, saline<br>flush and blood pressure monitoring. | |
| Indication for use: | The LiiSA Lever Integrated Interventional System AdaptorTM is a Y-<br>Connector and hemostasis valve which is intended to maintain hemostasis<br>during the introduction, use and withdrawal of diagnostic or interventional | |

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devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.

- Substantial Equivalence: The LiiSA hemostasis valve has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices and is, therefore, substantially equivalent to the predicate devices.
- The safety and effectiveness of the LiiSA hemostasis valve has been Performance Data: demonstrated through data collected from nonclinical bench tests and analysis.
- Conclusion: The evaluation of the LiiSA Lever Integrated Interventional System Adaptor does not raise any additional concerns regarding safety and effectiveness and may therefore is considered substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Device Partners International c/o Ms. Monica Dougherty Director, Regulatory Affairs 4305 Enterprise Drive, Suite E Winston-Salem, NC 27106

Re: K073260

LiiSA Lever Integrated Interventional System Adapter Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL Dated: January 16, 2008 Received: January 17, 2008

Dear Ms. Dougherty:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Monica Dougherty

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K073260

Device Name: LiiSA Lever Integrated Interventional System Adaptor™

Indications For Use:

The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.

> Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardlovascular Dovices 510(k) Number Ko 7 3200 4-4444 -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

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