GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

K122301 · Vascular Solutions Zerusa , Ltd. · DTL · Sep 7, 2012 · Cardiovascular

Device Facts

• Record ID: K122301
• Device Name: GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
• Applicant: Vascular Solutions Zerusa , Ltd.
• Product Code: DTL · Cardiovascular
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures. The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

Device Story

Guardian II and Guardian II NC are hemostasis valves used as conduits for interventional devices (up to 8F) during vascular procedures. Devices feature dual-seal design: low-pressure seal and high-pressure seal. High-pressure seal, activated by rotating a nut, secures diagnostic/interventional devices and enables pressure injections up to 600 psi (40 ATM). Includes optional guidewire introducer and torque device for guidewire steering. Used by clinicians in interventional settings to prevent blood loss while maintaining access for catheters/wires.

Clinical Evidence

Bench testing only. Testing confirmed device performance and integrity at the increased pressure injection limit of 600 psi.

Technological Characteristics

Hemostasis valve with dual-seal mechanism (low-pressure and high-pressure). Supports diagnostic/interventional devices up to 8F. Rated for pressure injections up to 600 psi. Includes guidewire torque device. Mechanical device; no software or electronic components.

Indications for Use

Indicated for maintaining hemostasis around diagnostic or interventional devices up to 8F (2.67 mm) diameter during vascular procedures. Includes guidewire torque device for steering.

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 II NC (K101113)
• Guardian II (K092711)

Submission Summary (Full Text)

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K122301 pg 1 of 2

SEP 7 2012

#### 2 510(k) Summary

Date Prepared: July 30, 2012

#### Submitter's Name / Contact Person

## Manufacturer

Vascular Solutions Zerusa Limited 208 Business Innovation Centre NUI Galway, Newcastle Road Galway, IRELAND Tel: [phone] Establishment Registration # 3005395947

Contact Person Jennifer Ruether Sr. Regulatory Product Specialist Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 Tel: [phone]; Fax: [phone] Establishment Registration # 2134812

## General Information

| Trade Name | Guardian® II and Guardian® II NC |
|---------------------|--------------------------------------------------------------|
| Common / Usual Name | Hemostasis Valves |
| Classification Name | 870.4290; DTL; Cardiopulmonary bypass adaptor, stopcock, |
| | manifold, or fitting; Class II |
| Predicate Devices | K101113 – Guardian II NC (Vascular Solutions Zerusa Limited) |
| | K092711 – Guardian II (Vascular Solutions Zerusa Limited) |

#### Device Description

The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM).

A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.

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#### Intended Use/Indications for Use

Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.

The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

#### Technological/Performance Characteristics

The Guardian II devices consist of the same materials and design as the predicate devices. Labeling changes have been implemented. The pressure injection upper limit has been changed from 150 psi to 600 psi; bench testing confirmed the devices are capable of performing as intended at the increased pressure injection limit.

#### Substantial Equivalence and Summary of Studies

The Guardian II devices are substantially equivalent to the currently marketed predicate devices, based on comparisons of the device classifications, technological characteristics, and the indications for use. Bench test results support the pressure injection upper limit modification. The bench test results did not raise new safety or performance questions and confirmed that the Guardian II devices are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.

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

SEP 7 2012

Vascular Solutions Zerusa Limited c/o Ms. Jennifer Ruether Sr. Regulatory Product Specialist Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Re: K122301

Trade/Device Name: Guardian® II and Guardian® II NC Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting Regulatory Class: Class II Product Code: DTL Dated: July 30, 2012 Received: August 1, 2012

Dear Ms. Ruether:

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.

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#### Page 2 - Ms. Jennifer Ruether

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 (reporting of medical device-related 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/CDRHOffices/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 vours,

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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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K122301

# Indications for Use

K122301 510(k) Number (if known):

Device Name: Guardian® II and Guardian® II NC Hemostasis Valve

Indications for Use:

Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.

The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

vascular Device

510(k) Number K12230

Page 1 of 1 (Posted November 13, 2003)