MERIT PRELUDE SHEATH INTRODUCER

K050962 · Merit Medical Systems, Inc. · DRE · May 6, 2005 · Cardiovascular

Device Facts

• Record ID: K050962
• Device Name: MERIT PRELUDE SHEATH INTRODUCER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Prelude is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Story

The Merit Prelude Sheath Introducer facilitates percutaneous vascular access. The device consists of a sheath introducer with a side port extension, a 3-way stopcock, a hemostasis valve, a suture ring, and a vessel dilator that snaps into the sheath hub. It is used by clinicians in clinical settings to provide a conduit for the introduction of various diagnostic or therapeutic devices into the venous or arterial systems. By maintaining hemostasis during the procedure, the device helps prevent blood loss and allows for the safe exchange of catheters or other interventional tools. The device is operated manually by the physician or clinical staff.

Clinical Evidence

Bench testing only. Comparative performance testing against the predicate device included radiodetectability, valve leak pressure, tip insertion force, sheath hub/cap snap fit, dilator snap fit, and guide wire compatibility. Results demonstrated that the device meets performance requirements and is substantially equivalent to the predicate.

Technological Characteristics

Sheath introducer with side port extension, 3-way stopcock, hemostasis valve, and vessel dilator. Materials are similar to the predicate device. Features include snap-fit hub design and radiodetectability. No electronic components or software.

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures. Used to introduce devices into veins or arteries while maintaining hemostasis.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Cordis Avanti®+ Catheter Sheath Introducer System (K013488)

Submission Summary (Full Text)

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K650962

Image /page/0/Picture/1 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a combination of solid black and outlined letters. The word "MEDICAL" is outlined, and there is a small circle above and to the right of the "A" in "MEDICAL".

# MAY - 6 2005

Merit Medical Systems, Inc. I 500 W/EST MERIT PARKWAY SOUTH JORDAN, UTAH 84095 PHONE [phone] FAX [phone] www.merit.com

### Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

#### Premarket Notification [510(k)] Summary of Safety and 11.0 Effectiveness

| Submitter | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, Utah 84095-2416 USA |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| Establishment Registration Number | 1721504 |
| Contact Person(s) | |
| Primary Contact Person | Jerrie Hendrickson |
| Title | Regulatory Affairs Specialist<br>Merit Medical Systems, Inc. |
| Phone | [phone] |
| Fax | [phone] |
| e-mail | [e-mail] |
| Alternate Contact Person | Stephanie A. Erskine |
| Title | Vice President Regulatory Affairs |

Phone Fax e-mail

Date Prepared

Merit Medical Systems, Inc. [phone] [phone]

[e-mail]

March 2, 2005

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#### Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)} CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

| Name of Medical Device | Merit Prelude Sheath Introducer |
|---------------------------------|-------------------------------------------------------------------------|
| Classification Name: | Vessel Dilator for Percutaneous<br>Catheterization<br>(21 CFR 870.1310) |
| Common/Usual Name: | Vessel Dilator/Introducer Sheath |
| Trade/Proprietary Name: | Merit Prelude Sheath Introducer |
| Device Classification | |
| Panel: | Cardiovascular |
| Device Class: | Class II |
| Product Code: | 74 DRE |
| Regulation Number: | 21 CFR 870.1310 |
| Predicate Device Identification | |
| Device Brand Name | Cordis Avanti®+ Catheter Sheath<br>Introducer System |
| Classification Name | Dilator, Vessel, For Percutaneous<br>Catheterization |
| Device Class | Class II |
| Classification Panel Number | 870 Cardiovascular Devices |
| Product Code | DRE |

### Device Description

Manufacturer

Registration Number

Merit's Prelude consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 3-way stopcock is affixed to the proximal end of the side port extension. The Prelude assembly includes a vessel dilator that snaps securely into the sheath introducer hub.

Cordis Corporation

1016427

#### Intended Use

The Prelude is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

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#### Summary of Characteristics in Relation to Predicate Device

#### Does the new device have the same indication statement as the predicate device? Yes.

Although there are minor differences, the intended use is the same, (i.e., to gain intravascular access).

#### Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?

Yes.

The Merit Prelude Sheath Introducer employs a similar method of operation and design as compared to the predicate device. Both devices consist of a sheath introducer that has a side port extension tube with a stopcock attached to it and a vessel dilator. Both devices are comprised of similar materials and are the same sizes.

### Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?

No.

Bench testing was conducted on the Prelude in order to establish substantial equivalence. Comparative testing with the predicate device performed includes radiodetectability of the sheath introducer and vessel dilator, valve leak pressure, tip insertion force, sheath hub/cap snap fit, dilator snap fit to sheath hub, and guide wire compatibility.

#### Are performance data available to assess effects of the new device as compared to the predicate device?

Yes.

Performance testing was conducted according to international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Prelude, comparison with the predicate device was conducted (i.e., valve leak, tip insertion force).

## Does performance data demonstrate equivalence?

Yes.

Performance data demonstrate that the Prelude is substantially equivalent to the predicate device.

#### Conclusion: "Substantial Equivalence" Determination

Based on CDRH's substantial equivalence decision tree, the Prelude is substantially equivalent to the predicate device.

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

MAY - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kema Quality B.V. c/o Ms. Jerry Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416

K050962 Re: Trade Name: Merit Prelude™ Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: II Product Code: DRE Dated: April 15, 2005 Received: April 18, 2005

Dear Ms. Hendrickson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booseer a red the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the entrobate) in the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 2017 11:31 in accordance with the provisions of the Federal Food, DNIg, devices that have occh recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (1107 market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 If your device is onashined (600 world) als. Existing major regulations affecting your device can may be subject to sable additions, 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. Jerry Hendrickson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a buceaux complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a decertifications administered by other Federal agencies. You must light or any Federal statures and regulations daministered of registration and listing (21 l
ecomply with all the Act's requirements, including, but not limited to: set comply with an the Act s requirements, moreans, and manufacturing practice requirements as sets CHR Part 807); labeling (21 CFR Part 800); government 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (Decisions of the as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your dev I his letter will anow you to oegin manoling of substantial equivalence of your device to a legally premarket nothleation. THC PDF maining of basessification 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 (1 CFR Part 801), please If you desire specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Complaned at (210) 276 - 17 - 17 807.97). You may obtain " Misoranaling by telefonec to promantee nowlite as act from the Division of Small other general information on your responsible in a sais and its toll-free number [phone] or and index bttps: Manufacturers, International and Consulter Prosisions of the more of the many of the states html.

Sincerely yours,

Ouma R. Kidner

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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#### Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL

### INDICATION(S) FOR USE STATEMENT *

510(k) Number (if known): Kb50962

Device Name:

Merit Prelude™ Sheath Introducer

Indications for Use:

The Merit Prelude™ Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

X Prescription Use (Part 21 CFR 901 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart O)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 050962