PRELUDE SHORT SHEATH INTRODUCER

K082063 · Merit Medical Systems, Inc. · DYB · Oct 15, 2008 · Cardiovascular

Device Facts

• Record ID: K082063
• Device Name: PRELUDE SHORT SHEATH INTRODUCER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Merit's Prelude® 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 Short Sheath Introducer (PSS) provides percutaneous access to veins/arteries; facilitates introduction of diagnostic/therapeutic devices while maintaining hemostasis. Features sheath with integral hemostasis valve; side port for fluid infusion or temporary hemodialysis; vessel dilator. Available in 5F-8F sizes; 4cm length. Used in clinical settings by healthcare professionals. Device allows temporary hemodialysis flow; not for long-term access. Benefits include secure, controlled vascular access for various cardiovascular procedures.

Clinical Evidence

Bench testing only. Performance verified against ISO 11070, ISO 594-1, ISO 594-2, ISO 10993-1, ISO 10993-7, and ISO 11135. No clinical data provided.

Technological Characteristics

Sheath introducer with integral hemostasis valve and vessel dilator. Sizes 5F-8F, 4cm length. Materials evaluated per ISO 10993-1. Conical fittings (Luer) per ISO 594-1/2. Sterilization via ethylene oxide per ISO 11135. Manual operation; 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

• Hemodialysis Introducer Set (Distributed as DialEase™ Introducer Sheath), K961780

Submission Summary (Full Text)

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OCT 1 5 2008

# Traditional 510(k) Premarket Notification 510(k) Summary

# 510(k) SUMMARY

### GENERAL INFORMATION

Submitter Name: Address:

Telephone Number: Fax Number: Contact Person: Date of Preparation: Merit Medical Systems, Inc. 1600 Merit Parkway South Jordan, Utah 84095 801-208-4119 (direct) 801-253-6918 (direct) Jerrie Hendrickson July 18, 2008

### DEVICE INFORMATION

Trade or Proprietary Name: Common or Usual Name: Product Code: Classification Name: Classification Panel:

Prelude® Short Sheath Introducer Catheter Introducer 74 DYB Catheter Introducer (21 CFR 870.1340) Cardiovascular

### PREDICATE DEVICE(S)

- Hemodialysis Introducer Set (Distributed as DialEase™ Introducer Sheath), . K961780
### DEVICE DESCRIPTION

The Prelude® Short Sheath Introducer (PSS) consists of a sheath introducer with integral hemostasis valve. The side port extension tubing extending from the sheath hub may be used to infuse solutions and/or for temporary hemodialysis. A vessel dilator snaps securely into the sheath introducer hub. The PSS devices are available in 5 French (F) through 8F sizes in 4cm effective length. The vessel dilator is tipped specifically to accept either a 0.038" (0.97mm) or a 0.018" (0.46mm) diameter guide wire. The device is marketed with and without an appropriately sized guide wire and/or access needle.

### INTENDED USE

Merit's PSS 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.

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## Traditional 510(k) Premarket Notification

### 510(k) Summary

#### TECHNOLOGICAL COMPARISON

Sheath introducers are manually operated devices that provide a percutaneous arterial or venous access route. Sheath introducers similar to the PSS devices employ the same fundamental technology, basic design and mode of operation.

The technological characteristics of the PSS device are substantially equivalent to those of the predicate device in terms of intended use, clinical utility and mode of operation, user population, basic design, materials, performance, labeling, packaging and sterilization method.

#### NON-CLINICAL PERFORMANCE TESTING

Verification and validation studies were conducted in accordance with in-house protocols to mitigate risks identified in the clinical risk assessment conducted by Merit. Performance testing was conducted or evaluated based on the following FDA Guidance and industry standards:

- ISO 11070: 1998: Sterile, single-use intravascular catheter introducers .
- ISO 594-1: 1986: Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment - Part 1: General Requirements
- ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, . Needles and Certain Other Medical Equipment – Part 2: Lock fittings
- ISO 10993-1: 2003: Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing
- FDA Bluebook memorandum G95-1: Required Biocompatibility Training and . Toxicology Profiles for Evaluation of Medical Devices, May, 1, 1995
- ISO 10993-7: 1995: Biological Evaluation of Medical Devices Part 7: . Ethylene Oxide Sterilization residuals
- ISO 11135: 1994: Medical Devices Validation and routine control of . ethylene oxide sterilization

Results of performance testing met the acceptance criteria and demonstrate substantial equivalence to the predicate devices.

## SUMMARY OF SUBSTANTIAL EQUIVALENCE

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

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merit Medical Systems, Inc. c/o Mrs. Jerrie Hendrickson Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, UT 84095

Re: K082063

Prelude Short Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: September 17, 2008 Received: September 19, 2008

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 - Mrs. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

ee.mee

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 STATEMENT

510(k) Number (if known):

K082063

Device Name:

Prelude® Short Sheath Introducer

### Indications for Use:

Merit's Prelude® 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 _ x (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)

Division Sign Off

ardiovascular Devices

K082063 510(k) Number