GUARDIAN HEMOSTASIS VALVE

K073620 · Zerusa Limited · DTL · Feb 27, 2008 · Cardiovascular

Device Facts

• Record ID: K073620
• Device Name: GUARDIAN HEMOSTASIS VALVE
• Applicant: Zerusa Limited
• Product Code: DTL · Cardiovascular
• Decision Date: Feb 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures.

Device Story

Guardian Hemostasis Valve acts as a conduit for interventional devices (up to 8.0F) into the human vascular system. Device features two independently operated seals: a low-pressure seal (opened/closed via Quikloc cap) and a high-pressure seal (operated by rotating a nut). High-pressure seal secures diagnostic/interventional devices in position and enables pressure injections; low-pressure seal allows for flushing and device advancement/withdrawal. Included accessories: a guidewire introducer (125mm length, 0.6mm ID) to facilitate guidewire entry and a guidewire torquer for steering manipulation. Used by clinicians during vascular procedures to minimize blood loss.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hemostasis valve with dual-seal mechanism (low-pressure Quikloc and high-pressure nut-actuated seal). Accommodates devices up to 8.0F. Includes guidewire introducer (125mm length, 0.6mm ID) and guidewire torquer. Mechanical device; no energy source or software.

Indications for Use

Indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. Includes a guidewire introducer to facilitate guidewire passage and a torque device to manipulate guidewire steering within vascular regions.

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

• Guardian Hemostasis Valve (K052381)

Submission Summary (Full Text)

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K073620

# 510(K) SUMMARY

#### 1. SUBMITTER:

Zerusa Limited 219-220 Business Innovation Centre, NUIG Galway, Ireland 011-353-91-861611 Telephone: Establishment Registration Number: 3005395947

Official contact: Mr. Ger Brett, CEO Phone: [phone] Date Prepared: December 21, 2007

#### 2. DEVICE:

Tradename: Guardian™ Hemostasis Valve Classification Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting Classification: Class II Common Name: Hemostatic Valve Product Code: 74 DTL Regulation Number: 870.4290

### 3. PREDICATE DEVICE:

This current 510(k) Premarket Notification is being submitted for the addition of a Guidewire Torquer. The predicate device used to determine substantial equivalence for this device was the Zerusa Limited's currently marketed Guardian Hemostasis Valve (#K052381).

### DEVICE DESCRIPTION: 4.

The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system.

The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise.

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Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices.

Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").

A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.

#### 5. INTENDED USE:

The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures.

#### INDICATIONS FOR USE: 6.

The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.

The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.

#### COMPARISON OF CHARACTERISTICS: 7.

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.

#### 8. PERFORMANCE DATA:

The Guardian™ Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

FEB 2 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zerusa Limited c/o Mr. Gerard Brett CEO and Official Correspondent 219-220 Business Innovation Centre, NUIG Galway, Ireland

Re: K073620

Guardian™ Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: December 21, 2007 Received: December 26, 2007

Dear Mr. Brett:

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 – Mr. Gerard Brett

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,

B/rimmer for

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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510(k) Number (if known): k073620

Device Name: Guardian™ Hemostasis Valve

Indications for Use: The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.

The Torque device is included to manipulate the steering of the guidewire within the vascular regions.

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Concurence of CDRH, Office of Device Evaulation (ODE)

(Posted July 1, 1998)

(Optional Format 3-10-98)

B.Bummo

510iki Nu