IN-LINE HEMOSTASIS VALVE

K990975 · Merit Medical Systems, Inc. · DYB · Mar 15, 2000 · Cardiovascular

Device Facts

• Record ID: K990975
• Device Name: IN-LINE HEMOSTASIS VALVE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Merit IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.

Device Story

The IN-LINE Hemostasis Valve is a straight-path vascular access accessory used to control blood loss and fluid flow during interventional procedures. It is operated by clinicians in a clinical setting. The device functions by providing a fluid-tight seal around catheters and guide wires inserted into the vasculature. By minimizing back bleeding, it facilitates safer vascular access and procedure management. The device is constructed from plastics with a history of safe blood contact.

Clinical Evidence

Bench testing only. Testing substantiated the claim that the valve provides a leak-proof seal around angioplasty catheters and guide wires.

Technological Characteristics

Straight-path hemostasis valve; manufactured from plastics with history of safe blood contact; provides fluid-tight seal for vascular access; non-electronic; mechanical design.

Indications for Use

Indicated for use in patients undergoing vascular procedures requiring catheter or guide wire placement to minimize back bleeding and maintain a fluid-tight seal around interventional devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Merit Y-adaptor with hemostasis valve

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol followed by the word "MERIT" in bold, black letters. The word "MEDICAL" is written to the right of "MERIT" in an outlined font.

### MAR 1 5 2000

510(k) SUMMARY This summary was prepared on March 19, 1999

| Submitter's name: | Chester McCoy, RA<br>Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, Utah 84095<br>P(801) 253-1600 ext. 404<br>F(801) 253-1684 | MERIT MEDICAL<br>SYSTEMS, INC.<br>1600 WEST<br>MERIT PARKWAY<br>SOUTH JORDAN, |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Contact Person: | Same as above | |
| Name of device: | IN-LINE Hemostasis Valve (Passage | |
| Common name: | Hemostasis Valve | |
| Classification name: | Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting<br>(74DTL) | |
| Predicate device: | Merit Y-adaptor with hemostasis valve | |

#### PRODUCT DESCRIPTION

A hemostasis valve is a device which is used to control the amount of blood loss or fluid 801-253-1600 flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths. FAX [phone]

UTAH 84095

#### INTENDED USE

The Merit IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.

#### SUBSTANTIAL EQUIVALENCE STATEMENT

The IN-LINE Hemostasis Valve is manufactured from plastics that have a history of safe blood contact use. Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires. The IN-LINE Hemostasis Valve's intended use is similar to the predicate device's intended use.

Therefore, Merit Medical Systems, Inc. believes this product is substantially equivalent to the predicate device and that its introduction into interstate commerce will not raise new questions of safety or efficacy.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

Re: K990975 Merit IN-LINE™ Hemostasis Valve Requlatory Class: II (two) Product Code: DYB Dated: December 15, 1999 Received: December 16, 1999

Dear Mr. McCoy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chester McCoy

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Chistopher Alan for.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological 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) | K990975 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | INspector™ Hemostasis Valve |
| Indications for Use | The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires. |

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