PRELUDE 7F SHORT SHEATH INTRODUCER

K122190 · Merit Medical Systems, Inc. · DYB · Aug 17, 2012 · Cardiovascular

Device Facts

• Record ID: K122190
• Device Name: PRELUDE 7F SHORT SHEATH INTRODUCER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 17, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Prelude® 7F Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

Device Story

Prelude® 7F Short Sheath Introducer facilitates percutaneous access to veins/arteries or hemodialysis grafts; maintains hemostasis during diagnostic/therapeutic procedures. Device comprises sheath introducer with integral hemostasis valve, side port extension tubing, detachable 3-way stopcock, and compatible vessel dilator. 7F size; 11cm usable length. Used by clinicians in clinical settings. Side port enables temporary hemodialysis flow. Device provides stable access point for secondary instruments; benefits patient by enabling minimally invasive interventions.

Clinical Evidence

Bench testing only. Testing conducted per ISO 11070:1998 standard, including dimensional verification, force at break (junction between sheath and hub), and surface inspection. Results met all pre-determined acceptance criteria.

Technological Characteristics

7F sheath introducer; 11cm length. Includes integral hemostasis valve, side port extension tubing, 3-way stopcock, and vessel dilator. Sterile, single-use. Complies with ISO 11070:1998. No energy source.

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures, or temporary hemodialysis via native or synthetic grafts. Not indicated for long-term vascular or hemodialysis access.

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

• Prelude® Short Sheath Introducer (K082063)

Submission Summary (Full Text)

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# K122190 Page 1 of 2

Prelude® 7F Short Sheath Introducer Section 5, 510(k) Summary Special Premarket Notification 510(k)

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AUG 1 7 2012

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# Section 5

## 510(k) Summary

| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Contact Person: | Dan Clark |
| | Date of Preparation: | July 23, 2012 |
| | Registration Number: | 1721504 |
| Subject<br>Device | Trade Name: | Prelude® 7F Short Sheath Introducer |
| | Common/Usual Name: | Introducer Catheter |
| | Classification Name: | Introducer, Catheter |
| Predicate<br>Device | Trade Name: | Prelude® Short Sheath Introducer |
| | Classification Name: | Introducer, Catheter |
| | Premarket Notification: | K082063 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| Classification | | Class II |
| | 21 CFR § 870.1340 | |
| | FDA Product Code: DYB | |
| | Review Panel: Cardiovascular | |
| Intended Use | The Prelude® 7F Short Sheath Introducer is intended to provide access<br>and facilitate the percutaneous introduction of various devices into<br>veins and/or arteries while maintaining hemostasis for a variety of<br>diagnostic and therapeutic procedures. This device can also provide<br>access to a native or synthetic graft used for hemodialysis. The side<br>port of the sheath allows adequate flow to perform temporary<br>hemodialysis. The device is not indicated for long term vascular or<br>hemodialysis access. | |
| Device<br>Description | The Prelude® 7F Short Sheath Introducer consists of a sheath<br>introducer with integral hemostasis valve and side port extension tubing<br>extending from the sheath hub. A detachable 3-way stopcock is<br>connected to the side port extension tubing. A compatible vessel dilator<br>is provided with the introducer. The device is available in 7F size with a<br>sheath tubing length of 11cm. The French size designates the size of<br>the catheter the sheath will accept. The 11cm effective length of the<br>sheath introducer refers to the usable length of the sheath. The French<br>size and wire tip size are printed on the dilator hub indicating the size of<br>the catheter and guide wire that the sheath will accept. | |
| Comparison to<br>Predicate<br>Device | The subject device has the same technological characteristics (i.e.,<br>design, material, chemical composition, energy source) as predicate<br>device. The only difference is the sheath tubing on the subject device is<br>11cm in length without a black marker tip and the sheath tubing on the<br>predicate device is 4cm in length with a black marker tip. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514 of<br>the Food, Drug and Cosmetic Act for these devices. Performance<br>testing of the subject Prelude® 7F Short Sheath Introducer was<br>conducted based on the risk analysis and based on the requirements of<br>the following international standard:<br>ISO 11070:1998: Sterile, single-use intravascular catheter<br>introducers The following is a list of all significant testing that was successfully<br>completed: Dimensional verification Force at break - junction between sheath introducer<br>and sheath hub Surface imperfections The results of the testing demonstrated that the subject Prelude® 7F<br>Short Sheath Introducer met the pre-determined acceptance criteria<br>applicable to the safety and efficacy of the device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance<br>testing, the subject Prelude® 7F Short Sheath Introducer meets the<br>requirements that are considered essential for its intended use and is<br>substantially equivalent to the predicate device, the Prelude® Short<br>Sheath Introducer, manufactured by Merit Medical Systems, Inc. | |

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Prelude® 7F Short Sheath Introducer
Section 5, 510(k) Summary
Special Premarket Notification 510(k)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 17 2012

Merit Medical Systems, Inc. % Dan Clark 1600 West Merit Pkwy. South Jordan, UT 84095 US

Re: K122190

Trade/Device Name: Prelude 7F Short Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 23, 2012 Received: July 24, 2012

Dear Mr. Clark:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Dan Clark

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

.g. Holleber

C. 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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Prelude® 7F Short Sheath Introducer Section 4, Indications for Use Special Premarket Notification 510(k)

### Section 4

#### Indications for Use

K122190

510(k) Number (if known):

Device Name: Prelude® 7F Short Sheath Introducer

Indications for Use:

The Prelude® 7F Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ChyAillel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ 1122190