Prelude SNAP Splittable Hydrophilic Sheath Introducer

K152381 · Merit Medical Systems, Inc. · DYB · Oct 30, 2015 · Cardiovascular

Device Facts

• Record ID: K152381
• Device Name: Prelude SNAP Splittable Hydrophilic Sheath Introducer
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Device Story

Splittable hemostatic introducer system; facilitates introduction of pacing leads and catheters into heart/coronary venous system. System includes hydrophilic-coated splittable sheath, dilator, 18g introducer needle, guide wire, and syringe. Sheath features hemostasis valve to minimize blood loss/air ingress; side-port and three-way stopcock allow aspiration, infusion, sampling, and pressure monitoring. Used in hospitals/healthcare facilities by clinicians. Device provides access path for leads/catheters; splittable design allows removal of sheath while leaving lead/catheter in place. Benefits include reduced blood loss and controlled access during cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included sheath insertion, outer/inner diameter verification, peel force, simulated use (kink/flexibility), coating lubricity/durability, particulate testing, and biocompatibility (cytotoxicity).

Technological Characteristics

Polymer sheath/dilator; stainless steel needle/guide wire. Hydrophilic coating. Available in 13cm and 25cm lengths; 6F-12.5F diameters. Includes hemostasis valve, side-port, and three-way stopcock. Sterilized via ethylene oxide. Complies with ISO 11070, ISO 11135-1, ISO 10993-1/7, AAMI/ANSI ST72, and ISO 11607-1.

Indications for Use

Indicated for patients requiring the introduction of pacing leads and catheters into the heart and coronary venous system.

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 SNAP™ Splittable Sheath Introducer (K143255)

Submission Summary (Full Text)

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

October 30, 2015

Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K152381

Trade/Device Name: Prelude SNAPTM Splittable Hydrophilic Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 30, 2015 Received: October 1, 2015

Dear Alina Stubbs:

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 of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

M.A. Hillebrand

for

for 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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### K152381

Prelude SNAP™ Splittable Hydrophilic Sheath Introducer Premarket Notification 510(k)

Merit Medical Systems, Inc.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

| | 510(k) Number (if known) |
|--|--------------------------|
| | K152231 |

K152381

Device Name

Prelude SNAPTM Hydrophilic Splittable Sheath Introducer

Indications for Use (Describe)

For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| | | FOR FDA USE ONLY | |
|--|--|------------------|--|
|--|--|------------------|--|

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

Page 1 of 1

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#### K152381 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>65 Great Valley Parkway<br>Malvern, PA 19335<br>[phone]<br>[phone]<br>Alina Stubbs<br>October 27, 2015<br>2529252 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Prelude SNAP™ Splittable Hydrophilic Sheath<br>Introducer<br>Sheath Introducer<br>Introducer, Catheter (21 CFR §870.1340) |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Prelude SNAP™ Splittable Sheath Introducer<br>Introducer, Catheter (21 CFR §870.1340)<br>K143255 - Prelude SNAP™ Splittable Sheath<br>Introducer<br>Merit Medical Systems, Inc. |
| Classification | | Class II<br>21 CFR § 870.1340<br>FDA Product Code: DYB<br>Review Panel: Cardiovascular |
| Intended Use | | Prelude SNAP™ Splittable Hydrophilic Sheath Introducer is indicated<br>"For the introduction of various types of pacing leads and catheters to<br>the heart and coronary venous system". |

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| | Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer is a splittable<br>hemostatic introducer system that is intended for the introduction of<br>various types of pacing leads and catheters. The Prelude SNAP™™<br>Splittable Hydrophilic Sheath Introducer system consists of a splittable<br>sheath introducer lubricated with hydrophilic coating, dilator, 18g<br>introducer needle, guide wire, and a syringe. The device is provided<br>sterile and intended for single use only. It is for use in hospitals or<br>healthcare facilities. | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device<br>Description | The splittable sheath introducer contains a hemostasis valve to<br>minimize blood loss and air ingress during use. The introducer is<br>available with a side-port and three-way stopcock that provides means<br>for air or blood aspiration, fluid infusion, blood sampling, and pressure<br>monitoring. The splittable sheath introducer is available in two lengths:<br>13cm and 25cm. The dilator is designed to conform to the inner<br>diameter of the introducer and has a tapered tip. | |
| | The materials of construction are primarily polymers with the exception<br>of the guide wire and needle cannula which are stainless steel. | |

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Summary of the technological characteristics of the modified device compared to the predicate device:

| | Technical Characteristics | Predicate Device<br>(K143255) | Subject Device |
|--|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| | Device Dimensions (nominal) | | |
| | Sheath introducer inner diameter (French) | 6F through 12.5F | 6F through 12.5F |
| | Sheath introducer length (cm) | 13 & 25 cm | 13 & 25 cm |
| | Sheath Introducer sideport and stopcock | Available with and without sideport and stopcock. | Available with sideport and stopcock only. |
| | Dilator outer diameter (French) | 6F through 12.5F | 6F through 12.5F |
| | Dilator length (in) | 13 cm: 8.34"<br>and<br>25 cm: 13.09" | 13 cm: 8.34"<br>and<br>25 cm: 13.09" |
| | Dilator tip ID (in) | 0.039" | 0.039" |
| | Introducer needle length (cm) | 7 cm | 7 cm |
| | Introducer needle outer diameter (gage) | 18 g | 18 g |
| | Guide wire length & diameter (in. x cm) | 13 cm: 0.038" x 50 cm J-Tip<br>and<br>25 cm: 0.038" x 80 cm J-Tip | 13 cm: 0.038" x 50 cm J-Tip<br>and<br>25 cm: 0.038" x 80 cm J-Tip |
| | Syringe volume (cc) | 12 cc or 10 cc | 12 cc or 10 cc |
| | Device Materials | | |
| | Sheath Lubricant | Silicone Dispersion | Hydrophilic Coating |
| | All other materials of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer are identical to the predicate device. | | |

Note: All dimensions are nominal.

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The Prelude SNAP™ Splittable Hydrophilic Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer:

- Risk Analysis
- Requirements/Specification Reviews ●
- Design Reviews ●
- Performance Testing-Bench ●
- Introducer Sheath Insertion O
- O Introducer Sheath Outer Diameter (O.D.)
- Introducer Sheath Tip Inner Diameter (I.D.) o
- Introducer Sheath Peel Force o
- Simulated Use Introducer Insertion (Kink and O Flexibility)
- Introducer Sheath Coating Length O
- Introducer Sheath Coating Adherence o
- Introducer Sheath Coating Lubricity/Durability O
- Particulate Testing O
- Sterilization Validation
- Biocompatibility Testing .
- o Cytotoxicity

Safety & Performance Tests

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| Safety &<br>Performance<br>Tests<br>(continued) | No performance standards have been established under section 514 of<br>the Food, Drug and Cosmetic Act for this device. When applicable,<br>performance testing of the Prelude SNAP™ Splittable Hydrophilic<br>Sheath Introducer was conducted based on the risk analysis and based<br>on the requirements of the following international standards:<br>ISO 11070:1998E Sterile single-use intravascular catheter<br>introducers ISO 11135-1: 2007, Sterilization of health care products -<br>Ethylene oxide - Part 1: Requirements for development,<br>validation and routine control of a sterilization process for<br>medical devices AAMI TIR28:2009, Product adoption and process equivalence<br>for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices<br>Part-1: Evaluation and Testing within a risk management<br>process, ISO 10993-7: 2008, Biological Evaluation of Medical Devices<br>Part-7 Ethylene Oxide Sterilization Residuals USP 37-NF 32 <85>, United States Pharmacopeia 37, National<br>Formulary 32, 2014 <85> Bacterial Endotoxins Test USP 37-NF 32 <151>, United States Pharmacopeia 37,<br>National Formulary 32, <151> Pyrogen Test. 2014 AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods,<br>routine monitoring, and alternatives to batch testing ASTM D4169-09, Standard Practice for Performance Testing of<br>Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical<br>devices - Part 1: Requirements for materials, sterile barrier<br>systems and packaging systems ISO 14971:2012, Medical devices - Application of risk<br>management to medical devices The results of the testing demonstrated that the subject Prelude<br>SNAP™ Splittable Hydrophilic Sheath Introducer met the<br>predetermined acceptance criteria of the device. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance<br>testing, the subject Prelude SNAP™ Splittable Hydrophilic Sheath<br>Introducer meets the requirements that are considered essential for its<br>intended use and is substantially equivalent to the predicate device, the<br>Prelude SNAP™ Splittable Sheath Introducer - K143255, manufactured<br>by Merit Medical Systems, Inc. |