PRELUDE SHEATH INTRODUCER

K070159 · Merit Medical Systems, Inc. · DRE · Jun 21, 2007 · Cardiovascular

Device Facts

• Record ID: K070159
• Device Name: PRELUDE SHEATH INTRODUCER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended 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.

Device Story

Prelude™ Sheath Introducer provides percutaneous vascular access for diagnostic/therapeutic procedures. System comprises sheath introducer, compatible vessel dilator, sideport with extension tubing, 3-way stopcock, integral hemostasis valve, and suture ring. Optional components include guide wire and access needle. Device facilitates introduction of various instruments into veins/arteries while maintaining hemostasis. Used by clinicians in clinical settings. Modified version includes additional sizes, material changes, and dilator tip configuration to accommodate smaller guide wires.

Clinical Evidence

Bench testing only. Verification and validation studies were conducted per clinical risk assessment to confirm that modified devices met all predetermined acceptance criteria.

Technological Characteristics

Vessel dilator for percutaneous catheterization. Includes sheath introducer, dilator, sideport, extension tubing, 3-way stopcock, hemostasis valve, and suture ring. Mechanical device; no energy source or software. Materials modified from predicate; specific standards not provided.

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures. Facilitates introduction of 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

• Prelude™ Sheath Introducer (K050962)

Submission Summary (Full Text)

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

# Attachment 4

JUN 2 1 2007

# 510(k) Summary

# SAFETY AND EFFECTIVENESS SUMMARY

This information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitted by Name/Address: | Merit Medical Systems, Inc<br>1600 West Merit Parkway<br>South Jordan, Utah 84095 |
|------------------------------------|---------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1721504 |
| Primary Contact Person: | Jerrie Hendrickson<br>Regulatory Affairs Specialist II |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Alternate Contact Person: | Stephanie A. Erskine<br>Vice President Corporate Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date Summary Prepared: | January 16, 2007 |
| Trade Name: | Prelude™ Sheath Introducer |
| Common Name: | Vessel Dilator for Percutaneous Catheterization |
| Classification Name | Vessel Dilator for Percutaneous Catheterization,<br>Class II, Product Code DRE (per 21 CFR<br>870.1310) |
| Predicate Device | Prelude™ Sheath Introducer (K050962), manufactured by Merit<br>Medical Systems, Inc. |

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

| Device Description: | Merit Medical System's Prelude™ Sheath Introducer consists of<br>a sheath introducer with compatible vessel dilator that snaps<br>securely into the sheath introducer hub. The sheath is equipped<br>with a sideport attached to a segment of extension tubing<br>terminating in a 3-way stopcock. The sheath hub contains an<br>integral hemostasis valve and suture ring. The device is<br>marketed with and without an appropriately sized guide wire<br>and/ or access needle. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Merit Prelude™ Sheath Introducer is intended to provide<br>access and facilitate the percutaneous introduction of various<br>devices into veins and/ or arteries while maintaining hemostasis<br>for a variety of diagnostic and therapeutic procedures. |
| Technology Comparison | The modified device has the identical intended use and employs<br>the same fundamental technology as the predicate device.<br>Additional sizes have been added, minor changes in materials<br>have been made, and the configuration of the dilator tip has<br>been modified to accept smaller size guide wires. In addition,<br>some kits containing the Prelude™ are now marketed with<br>appropriately sized guide wires and access needles. |
| Performance Testing | Verification and Validation Studies, as identified in the Clinical<br>Risk Assessment, were completed and demonstrated that the<br>modified devices met all of their pre-determined acceptance<br>criteria. |

#### Summary of Substantial Equivalence

Based on:

- Merit's conformance with Design Control requirements, .
- Analyses of Risks associated with the Modified Device; and .
- Results of Verification and Validation tests identified in the Risk Analyses . demonstrating that predetermined acceptance criteria have been met:

the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings forming three distinct, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2007

Ms. Jerrie Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

Re: K070159

> Trade/Device Name: Prelude™ Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catherization Regulatory Class: Class II Product Code: DRE Dated: May 21, 2007 Received: May 23, 2007

Dear Ms. Hendrickson:

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.

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

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Page 2 - Ms. Jerrie Hendrickson

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]. 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 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/industry/support/index.html.

Sincerely yours.

Dma R. bohner

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 Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL

## Attachment 2

# Indications for Use Statement

510(k) Number (if known):

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.

Prescription Use X (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. de Jesus

Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K070159