Prelude SNAP Splittable Sheath Introducer

K143255 · Merit Medical Systems, Inc. · DYB · Apr 9, 2015 · Cardiovascular

Device Facts

• Record ID: K143255
• Device Name: Prelude SNAP Splittable Sheath Introducer
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 9, 2015
• Decision: SESE
• Submission Type: Traditional
• 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

Prelude SNAP Splittable Sheath Introducer is a sterile, single-use hemostatic introducer system used in hospitals/healthcare facilities. It facilitates the introduction of pacing leads and catheters into the heart and coronary venous system. The system includes a splittable sheath (with or without side-port), dilator, 18g introducer needle, guide wire, and syringe. The hemostasis valve minimizes blood loss and air ingress. Side-port models allow for aspiration, fluid infusion, blood sampling, and pressure monitoring. Physicians use the device to gain vascular access; the sheath is split and removed after lead/catheter placement. The device benefits patients by providing a controlled, low-leakage access point for cardiac interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensional verification, functional testing (hub break force, peel force, joint strength, hemostasis, leakage), and simulated use testing. Biocompatibility testing was conducted per ISO 10993 standards, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, and hemocompatibility.

Technological Characteristics

Materials: Polymers (sheath/dilator), stainless steel (guide wire/needle). Dimensions: 6F-12.5F inner diameter, 13cm/25cm lengths. Features: Hemostasis valve, optional side-port with three-way stopcock. Sterilization: Ethylene oxide. Standards: ISO 11070, ISO 594-2, ISO 11135-1, ISO 10993 series, USP <85>, ASTM D4169, ISO 11607-1, ISO 14971.

Indications for Use

Indicated for the introduction of various types of pacing leads and catheters to the heart and coronary venous system in patients requiring such procedures.

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

• ClassicSheath Splittable Hemostatic Introducer System (K934901)

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

April 9, 2015

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

Re: K143255

> Trade/Device Name: Prelude Snap Splittable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 3, 2015 Received: April 6, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Fernande Aguel Fernando Aguel -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K143255

Device Name

Prelude SNAPTM 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Attachment 1

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#### K143255 510(k) Summary

| General<br>Provisions | Correspondent 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 19355<br>[phone]<br>[phone]<br>Alina Stubbs<br>April 3, 2015<br>2529252 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Prelude SNAPTM Splittable 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: | ClassicSheathTM Splittable Hemostatic<br>Introducer System<br>Introducer, Catheter (21 CFR §870.1340)<br>K934901 – Tear-Away Sheath Introducer<br>Set With Integral Hemostasis Valve<br>Merit Medical Systems, Inc.<br>65 Great Valley Parkway<br>Malvern, PA 19355<br>(formerly operating as<br>Thomas Medical Products, Inc.) |
| Classification | Class II<br>21 CFR §870.1340<br>FDA Product Code: DYB<br>Review Panel: Cardiovascular | |
| Intended Use | Prelude SNAPTM Splittable Sheath Introducer is indicated "For the<br>introduction of various types of pacing leads and catheters to the<br>heart and coronary venous system". | |

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Prelude SNAP™ Splittable Sheath Introducer is a splittable hemostatic introducer system that is intended for the introduction of various types of pacing leads and catheters. The Prelude SNAP™ Splittable Sheath Introducer system consists of a splittable sheath introducer (with or without side-port), dilator, 18g introducer needle, guide wire, and a syringe. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities.

The splittable sheath introducer contains a hemostasis valve to Device minimize blood loss and air ingress during use. The introducer is Description available with or without a side-port with three-way stopcock that provides means for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The splittable sheath introducer is available in two lengths: 13cm and 25cm. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip.

> The materials of construction are primarily polymers with the exception of the guide wire and needle cannula which are stainless steel.

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| | Technical<br>Characteristics | Predicate Device<br>(K934901) | Subject Device |
|----------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Dimensions (nominal) | | |
| | Sheath introducer inner<br>diameter (French) | 6F through 12.5F | 6F through 12.5F |
| | Sheath introducer length<br>(cm) | 13 & 25 cm | 13 & 25 cm |
| | Dilator outer diameter<br>(French) | 6F through 12.5F | 6F through 12.5F |
| | Dilator length (in) | 13 cm: 8.95"<br>and<br>25 cm: 13.67" | 13 cm: 8.34"<br>and<br>25 cm: 13.09" |
| | Dilator tip ID (in) | 0.038" | 0.039" |
| Comparison to<br>Predicate | Introducer needle length<br>(cm) | 7 cm | 7 cm |
| | Introducer needle outer<br>diameter (gage) | 18 g | 18 g |
| | Guide wire length &<br>diameter (in. x cm) | 13 cm: 0.038" x<br>45 cm J-Tip<br>and<br>25 cm: 0.038" x<br>80 cm J-Tip | 13 cm: 0.038" x<br>50 cm J-Tip<br>and<br>25 cm: 0.038" x<br>80 cm J-Tip |
| | Syringe volume (cc) | 12 cc | 12 cc or 10 cc |
| | Device Materials | The materials of<br>construction are<br>primarily<br>polymers with the<br>exception of the<br>guide wire and<br>needle cannula,<br>which are<br>stainless steel. | The materials of<br>construction are<br>primarily polymers<br>with the exception<br>of the guide wire<br>and needle<br>cannula, which<br>are stainless<br>steel. |

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

Note: All dimensions are nominal.

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The Prelude SNAP™ Splittable 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 Sheath Introducer:

- Risk Analysis
- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to:
- o Dimensional Tests
- Introducer tube outer diameter (OD) l
- I Introducer tip inner diameter (ID)
- 트 Introducer free length
- Dilator tube outer diameter (OD) ■
- l Dilator tip inner diameter (ID)
- Dilator protrusion from introducer when l assembled
- o Functional Tests
- Introducer hub break force .
- . Introducer peel
- Introducer side-port pull force l
- Introducer tube to hub joint strength
- l Dilator tube to hub joint strength
- o Simulated Use Test
- Introducer hemostasis ■
- I Device insertion through introducer valve
- I Introducer valve hemostasis (liquid leakage)
- l Introducer liquid leakage
- l Introducer insertion
- l Dilator to introducer engagement
- Dilator luer functionality
- . Dilator liquid leakage
- Visual Tests o
- Introducer pad printing ■
- l Introducer soft touch pad attachment
- . Sterilization validation

.

- Biocompatibility Testing
- o Cytotoxicity
- Sensitization O
- Irritation O
- Acute System Toxicity O
- Pyrogenicity O
- Genotoxicity O
- Hemocompatibility O

Safety & Performance Tests

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| | No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. Performance testing of the Prelude SNAP™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards: |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| International<br>Standards | ISO 11070: 1998(E), Sterile, single-use intravascular catheter introducers ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings ISO 11135-1: 2007, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, ISO 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006 ISO 10993-5: 2009, Biological Evaluation of Medical Devices Part-5 Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part-10 Tests for Irritation and Skin Sensitization ISO 10993-11: 2006, Biological Evaluation of Medical Devices Part-11 Tests for Systemic Toxicity ISO 10993-17: 2002, Biological evaluation of medical devices – Part 17: Methods for the establishment of allowable limits for leachable substances USP 37-NF 32 <85>: 2014, United States Pharmacopeia 37, National Formulary 32, 2014 <85> Bacterial Endotoxins Test ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14971:2012, Medical devices - Application of risk |

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Merit Medical Systems, Inc. considers the Prelude SNAP™ Splittable Sheath Introducer substantially equivalent to the currently marketed Summary of predicate device (ClassicSheath™ Splittable Hemostatic Introducer Substantial System - K934901). This assessment is based upon analysis of Equivalence similar technological characteristics, bench testing, and indications for use.