S-MAK XL

K190175 · Merit Medical Systems, Inc. · DRE · Apr 10, 2019 · Cardiovascular

Device Facts

• Record ID: K190175
• Device Name: S-MAK XL
• Applicant: Merit Medical Systems, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system.

Device Story

S-MAK XL is a vessel dilator/introducer sheath system used for percutaneous vascular access. It facilitates placement of larger diameter guide wires (up to 0.038") into the vasculature when a small needle stick is preferred. The device consists of a 4F coaxial introducer/dilator pair (30 cm length), a 21 gauge introducer needle, and a 0.018" Nitinol/Palladium guide wire. Used in clinical settings by healthcare professionals. The device allows for a minimally invasive approach to vascular access, reducing trauma compared to larger initial access methods.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included effective length, guide wire insertion, and catheter insertion. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility (ASTM hemolysis, complement activation, and thrombosis assessment). All tests met acceptance criteria.

Technological Characteristics

Coaxial introducer/dilator pair (4F, 30cm), 21G needle, 0.018" Nitinol/Palladium guide wire. Sterilized via ethylene oxide (ISO 11135:2014). Biocompatibility per ISO 10993-1:2009. Packaging per AAMI/ANSI/ISO 11607-1:2006. Shipping container testing per ASTM D4169-16.

Indications for Use

Indicated for percutaneous placement of up to a 0.038" guide wire or catheter into the vascular system in patients requiring vascular access.

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

• Merit MAK® (Mini Access Kit) (K091584)

Reference Devices

• Merit MAK® (Mini Access Kit) (K031691)
• VSI Micro-Introducer (K101604)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".

April 10, 2019

Merit Medical Systems, Inc. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K190175

Trade/Device Name: S-MAK XLTM Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: January 31, 2019 Received: February 1, 2019

Dear Mr. Thomas:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# 510(k) Summary

## K190175

S-MAK XL™

| 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>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>David Thomas<br>April 3, 2019<br>1721504 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | S-MAK XL™<br>Vessel Dilator/ Introducer Sheath<br>Vessel Dilator for Percutaneous Catheterization |
| Primary<br>Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Merit MAK® (Mini Access Kit)<br>Vessel Dilator for Percutaneous Catheterization<br>K091584<br>Merit Medical Systems, Inc. |
| Reference<br>Devices | 1. | K031691 - Merit MAK® (Mini Access Kit)<br>(Manufacturer by Merit Medical Systems, Inc.) |
| | 2. | K101604 – VSI Micro-Introducer<br>(Manufacturer by VSI Solutions, Inc.) |
| Classification | Class II<br>21 CFR § 870.1310<br>FDA Product Code: DRE<br>Review Panel: Cardiovascular | |
| Intended Use | The Merit S-MAK XL™ is intended for percutaneous placement of up to a<br>0.038" (.097mm) guide wire or catheter into the vascular system. | |
| Device<br>Description | The S-MAK XL TM utilizes a small diameter coaxial<br>introducer/dilator pair and guide wire for placement of larger<br>diameter guide wires into the vasculature system when a small<br>needle stick is preferred.<br>The S-MAK XL TM consists of the following components:<br>One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length)<br>One (1) 21 gauge Introducer Needle<br>One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire | |
| Comparison<br>to Predicate<br>Device | Design - The S-MAK XL TM will follow the same design as the<br>current 4F, 10cm predicate Merit MAK device except for the<br>increased length of 30cm for the Introducer/Dilator. Materials - All materials for the 30cm S-MAK XL TM will remain the<br>same as the predicate 4F, 10cm Merit MAK. Processes - Process parameters will remain the same, with<br>changes to the equipment as necessary to accommodate the | |

{3}------------------------------------------------

longer length.

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject S-MAK XL™ 4F 30cm was conducted based on the risk analysis and based on the requirements of the following international standards and guidance documents:

ISO 11135:2014, Sterilization of health care products - Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices.

ISO 11070:1998, Sterile, single use intravascular catheter introducer.

Performance Tests

ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process.

FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995

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.

{4}------------------------------------------------

AAMI/ANSI/ISO 11607-1:2006. Packaging for terminally sterilized medical devices - Part 1 - Requirements for materials, sterile barrier systems and packaging systems (Sterility)

ASTM D4169-16, Standards Practice for Performance Testing of Shipping Containers and Systems (Sterility)

ISO 2233 (2000), Packaging - Complete, filled transport packages and unit loads - conditions for testing

## Performance Testing-Bench

- Effective Length Introducer and dilator ●
- Guide wire insertion dilator ●
- Catheter insertion - introducer

Passing results were demonstrated on all tests above.

### Performance Tests cont.

Biocompatibility

- Cytotoxicity - Cytoxicity Study Using ISO Elation Method: MEM Extraction
- Sensitization - ISO Guinea Pig Maximization Test: Sodium Chloride and Sesame Oil Extraction
- Irritation - ISO Intracutaneous Study in Rabbits: Sodium Chloride and Sesame Oil Extraction
- . Acute Systemic Toxicity _ ISO Acute Systemic Toxicity Study in Mice: Sodium Chloride and Sesame Oil Extraction
- Pyrogenicity USP Rabbit Pyrogen Study, Material Mediated: . Nonpyrogenic 0.9% Sodium Chloride Extraction
- Hemocompatiblity
- ASTM Hemolysis Study Direct Contact and Extract O Method: Phosphate Buffered Saline Extraction
- Indirect Contact Complement Activation Assay o
- In-vitro Assessment of Introducer Thrombosis. O

Passing results were demonstrated on all tests above.

{5}------------------------------------------------

{6}------------------------------------------------

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190175

Device Name

S-MAK XLTM

Indications for Use (Describe)

The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular 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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."