GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

K052381 · Zerusa Limited · DTL · Nov 21, 2005 · Cardiovascular

Device Facts

• Record ID: K052381
• Device Name: GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
• Applicant: Zerusa Limited
• Product Code: DTL · Cardiovascular
• Decision Date: Nov 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended 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.

Device Story

Guardian Hemostasis Valve acts as conduit for interventional devices (up to 8.0F) into human vascular system; minimizes blood loss during procedures. Device features two independently operated seals: low-pressure seal (opened/closed via cap/Quikloc mechanism) and high-pressure seal (operated via rotating nut). Low-pressure seal allows flushing and advancement/withdrawal of devices; high-pressure seal secures device position and enables pressure injections. Includes guidewire introducer (125mm length, 0.6mm ID) to facilitate guidewire passage. Used by clinicians in vascular interventional settings.

Clinical Evidence

Bench testing only. Full battery of performance testing conducted to demonstrate safety and effectiveness.

Technological Characteristics

Hemostasis valve with dual-seal mechanism (low-pressure/high-pressure). Accommodates devices up to 8.0F. Includes guidewire introducer (125mm length, 0.6mm ID). Mechanical operation via cap/nut manipulation. No software or electronic components.

Indications for Use

Indicated for maintaining hemostasis around diagnostic/interventional devices up to 8.0F (2.67 mm) diameter during vascular procedures.

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)
• EasyPass Y-connector Hemostatic Valve (K042060)

Submission Summary (Full Text)

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## 1052381 PE 1082

# NOV 2 1 2005

# 510(K) SUMMARY

#### SUBMITTER: 1.

Zerusa Limited 219-220 Business Innovation Centre, NUIG Galway, Ireland Telephone: [phone] Establishment Registration Number: Pending

Official contact: Ms. Oonagh Sweeney, Quality Systems Manager Phone: [phone] Date Prepared: August 24, 2005

#### 2. DEVICE:

Guardian Hemostasis Valve with Guidewire Introducer Tradename: 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:

The predicate devices used to determine substantial equivalence for the Zerusa Limited Guardian Hemostasis Valve were the CoPilot Bleedback Control Valve marketed by Guidant (#K991102) and the EasyPass Y-connector Hemostatic Valve marketed by Millimed A/S (#K042060).

### 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").

### 5. INTENDED 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.

### 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.

### 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 with Guidewire Introducer 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zerusa Limited c/o Ms. Oonagh Sweeney Quality Systems Manager 219-220 Business Innovation Centre, NUIG

Galway, Ireland

Re: K052381

Guardian Hemostasis Valve with Guidewire Introducer Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (Two) Product Code: DTL Dated: August 24, 2005 Received: August 30, 2005

NOV 2 1 2005

Dear Ms. Sweeney:

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. Oonagh Sweeney

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,

Dmna R. Vichner

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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K052381

Page 1 of 1

510(k) Number (if known): #K052381

Device Name: Guardian Hemostasis Valve with Guidewire Introducer

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.

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

# Concurence of CDRH, Office of Device Evaulation (ODE)

(Posted July 1, 1998)

(Optional Format 3-10-98)

Duma R. Klines
(Di

Divi... Vascular Dens

510(N) Namb