EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE

K042060 · Millimed A/S · DTL · Oct 6, 2004 · Cardiovascular

Device Facts

• Record ID: K042060
• Device Name: EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
• Applicant: Millimed A/S
• Product Code: DTL · Cardiovascular
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter. The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.

Device Story

Y-connector hemostatic valve; includes rotating luer lock, sidearm, and valve opener cap with center passage tube. Valve opened by pushing cap distally; closed by pulling proximally. Passage tube provides smooth lumen for device insertion. Used in clinical settings by medical professionals during interventional procedures. Includes guide wire insertion tool and torquer for guide wire manipulation. Maintains hemostasis during introduction, use, and withdrawal of diagnostic/interventional devices.

Clinical Evidence

Bench testing only.

Technological Characteristics

Y-connector body with rotating luer lock, sidearm, and hemostasis valve. Includes guide wire insertion tool and torquer. Mechanical operation.

Indications for Use

Indicated for patients undergoing procedures requiring diagnostic or interventional devices with an outer diameter of 7 French or smaller; facilitates guide wire introduction and manipulation.

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)

Submission Summary (Full Text)

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OCT 2004

10-2

## 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter's Name: | Millimed A/S |
|-----------------------------|---------------------------------------------|
| Submitter's Address: | Langebjerg 2<br>DK-4000 Roskilde<br>Denmark |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jannie Funch, Quality Manager |
| Date Prepared: | July 30, 2004 |
| Device Trade Name: | EasyPass™ US Y-connector Hemostatic Valve |
| Device Common Name: | Hemostasis Device |
| Device Classification Name: | Cardiovascular Surgical Devices |

Device Classification: Class II

Summary of Substantial Equivalence:

The EasyPass Y-connector Hemostatic Valve is substantially equivalent to Guidant Corporation's Copilot Bleedback Control Valve (K991102)

Device Description:

The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.

Intended Use:

The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.

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The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.

K042060

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The torquer, inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.

Technological Characteristics:

Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device.

Performance Data:

The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 6 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Millimed A/S c/o Ms. Jannie Funch Quality Manager Langebjerg 2 DK-4000 Roskilde Denmark

K042060 Re:

EasyPass™ US Y-connector hemostatic 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: July 30, 2004 Received: July 30, 2004

Dear Ms. Funch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regars comment date of the Medical Device Amendments, or to commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have been receised in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercerore, market the Act include requirements for annual registration, listing of general controls provisions of the 110 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 II your device is classified (Socure) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA Inay be subject to sable additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

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## Page 2 - Ms. Jannie Funch

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Ввиташов

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 Statement

| 510(k) Number (if known) | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EasyPass™ US Y-connector Hemostatic Valve |
| Indications for Use | The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.<br>The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.<br>The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire. |
| Prescription Use | X |
| OR Over-The-Counter Use | |
| | (Per 21 CFR 801.109) |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| | <div> <img alt="Signature" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" width="200"/> </div> <div>(Division Sign-Off)</div> <div>Division of Cardiovascular Devices</div> <div>510(k) Number K042060</div> |