(68 days)
No
The device description and performance studies focus on mechanical components and standard medical device testing, with no mention of AI/ML capabilities or data processing.
No.
The device is intended for percutaneous placement of guide wires or catheters into the vascular system, acting as an introducer for other medical devices, rather than directly providing a therapeutic effect itself.
No
The device is described as an introducer system for percutaneous placement of guide wires or catheters into the vascular system, which is a procedural/interventional use, not diagnostic.
No
The device description explicitly lists physical components such as introducers, dilators, a needle, and a guide wire, and the performance studies describe bench testing and biocompatibility testing of these physical components.
Based on the provided information, the Merit S-MAK XL™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system." This describes a device used for a medical procedure performed directly on a patient, not for testing samples taken from the body.
- Device Description: The components listed (introducer/dilator pair, needle, guide wire) are all instruments used for accessing and navigating within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Merit S-MAK XL™ is an invasive medical device used in vivo (within the body) for procedural access.
N/A
Intended Use / Indications for 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.
Product codes
DRE
Device Description
The S-MAK XL TM utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred.
The S-MAK XL TM consists of the following components:
One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length)
One (1) 21 gauge Introducer Needle
One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
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 Tests (Bench):
- Effective Length Introducer and dilator
- Guide wire insertion dilator
- Catheter insertion - introducer
Passing results were demonstrated on all tests above.
Biocompatibility Tests:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-4956
(801) 253-6982
David Thomas
April 3, 2019
1721504 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | S-MAK XL™
Vessel Dilator/ Introducer Sheath
Vessel Dilator for Percutaneous Catheterization |
| Primary
Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Merit MAK® (Mini Access Kit)
Vessel Dilator for Percutaneous Catheterization
K091584
Merit Medical Systems, Inc. |
| Reference
Devices | 1. | K031691 - Merit MAK® (Mini Access Kit)
(Manufacturer by Merit Medical Systems, Inc.) |
| | 2. | K101604 – VSI Micro-Introducer
(Manufacturer by VSI Solutions, Inc.) |
| Classification | Class II
21 CFR § 870.1310
FDA Product Code: DRE
Review Panel: Cardiovascular | |
| 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
Description | The S-MAK XL TM utilizes a small diameter coaxial
introducer/dilator pair and guide wire for placement of larger
diameter guide wires into the vasculature system when a small
needle stick is preferred.
The S-MAK XL TM consists of the following components:
One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length)
One (1) 21 gauge Introducer Needle
One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire | |
| Comparison
to Predicate
Device | Design - The S-MAK XL TM will follow the same design as the
current 4F, 10cm predicate Merit MAK device except for the
increased length of 30cm for the Introducer/Dilator. Materials - All materials for the 30cm S-MAK XL TM will remain the
same as the predicate 4F, 10cm Merit MAK. Processes - Process parameters will remain the same, with
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) |
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