Y-CLICK CONNECTOR

K060759 · Elcam Medical Acal · DTL · Jun 29, 2006 · Cardiovascular

Device Facts

• Record ID: K060759
• Device Name: Y-CLICK CONNECTOR
• Applicant: Elcam Medical Acal
• Product Code: DTL · Cardiovascular
• Decision Date: Jun 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires.

Device Story

Y-Click Connector is a Y-connector hemostatic valve accessory for angiographic catheters; prevents blood loss during interventional procedures. Device features a slit septum for guide-wire/catheter passage; includes a side arm for contrast media injection, saline flushing, and blood pressure monitoring. Operator (physician/clinician) uses a mechanical cover/lever mechanism to toggle between three states: closed (hemostasis), semi-unsealed (reduced friction for manipulation), and unsealed (full opening for device passage). Audible 'clicks' confirm state changes. Used in clinical settings during angioplasty to facilitate device navigation while maintaining arterial pressure seal.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Y-connector hemostatic valve; compatible with up to 9 Fr guide catheters and 0.014"-0.038" guide wires. Features a mechanical septum with three-position control (closed, semi-unsealed, unsealed) operated via a lever/cover mechanism. Includes a side arm for fluid/pressure monitoring. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients undergoing angioplasty procedures requiring the introduction, use, and withdrawal of diagnostic and interventional devices (guide catheters, guide wires, balloons, stents) while maintaining hemostasis. Compatible with guide catheters up to 9 Fr and guide wires 0.014"-0.038".

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

• EasyPass™ US Y-Connector Haemostatic Valve (K042060)

Submission Summary (Full Text)

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K@60759
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JUN 2 9 2006

# 510(K) SUMMARY FOR ELCAM Y-CLICK CONNECTOR

DATE PREPARED: JUNE 21, 2006

Company Name: Elcam Medical ACAL

## Contact Person:

Ms. Tali Hazan RA Specialist Telephone: [phone] [phone] Fax: E-mail: [e-mail]

## Authorized US Agent:

Mr. Ehud Raivitz – CEO Elcam Medical, Inc. 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA

Phone: [phone] Fax: E-mail: ehud(@elcam-medical.com

Y-Click Connector Trade Name:

Classification name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class: II Panel identification: Cardiovascular devices Product code: DTL Regulation number: 872.4290

Predicate Devices: EasyPass™ US Y-Connector Haemostatic Valve from Millimed A/S, Roskilde, Denmark cleared under 510(k) no. K042060

# Device description:

The Y-Click connector is an accessory that can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters. The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum)

Image /page/0/Picture/18 description: The image shows a logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other on the left side of the image. To the right of the text is a stylized graphic that appears to be the letters "I" and "C" with a dot above the "I". The logo is black and white.

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K060759

Image /page/1/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" in a bold, sans-serif font, with the word "Elcam" stacked on top of the word "Medical". Above the words is a stylized graphic that appears to be made up of small dots. The graphic has a vertical line and a curved line with a solid circle above it.

without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position.

The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.

An illustration of the Y-Click connector and its parts is presented in Sections 10 and 11 of this submission.

### Indications for Use:

The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires.

#### Substantial Equivalence:

The Y-Click Connector has the same intended use and the same principle of operation as the EasyPass™of Millimed A/S, cleared under 510(k) no. K042060 and is therefore substantially equivalent to the predicate device.

#### Conclusion:

The evaluation of the Y-Click Connector does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate 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 consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

Elcam Medical, ACAL c/o Ms. Tali Hazan R.A. Specialist Kibbutz BarAm MP Merom HaGalil 13860 ISRAEL

Re: K060759 Y-Click Connector Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock. Manifold, or Fitting Regulatory Class: Class II (Two) Product Code: DTL Dated: May 21, 2006 Received: May 24, 2006

Dear Ms. Hazan:

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 uc-recuse 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 max. therefore, market the device, subject to the general controls provisions of the Act. The peneral controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbrandon, alsulteration,

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. FIDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tali Hazan

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 (2) CFR Paris 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 xyour device to 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 obtitler, 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/cdr/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 (if known): K060759

Device Name: Y-Click Connector .

Indications for Use:

The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" -- 0.038" diameter guide wires.

V Prescription Use (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 OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off) ് vision of Cardiovascular

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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