(68 days)
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.
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
The provided text describes the 510(k) summary for the S-MAK XL™ device. Based on the information available, a study was conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on performance and biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantified table format for each test. Instead, it lists the types of performance and biocompatibility tests conducted and states that "Passing results were demonstrated on all tests above." We can infer the acceptance criterion for each test was a "passing result" according to the specified international standards and guidance documents.
| Category | Test Performed | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|---|
| Performance - Bench | Effective Length Introducer and dilator | Passing result per standard | Demonstrated Passing Results |
| Guide wire insertion dilator | Passing result per standard | Demonstrated Passing Results | |
| Catheter insertion - introducer | Passing result per standard | Demonstrated Passing Results | |
| Biocompatibility | Cytotoxicity - Cytoxicity Study Using ISO Elation Method: MEM Extraction | Passing result per ISO 10993-5:2009 | Demonstrated Passing Results |
| Sensitization - ISO Guinea Pig Maximization Test: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-10:2010 | Demonstrated Passing Results | |
| Irritation - ISO Intracutaneous Study in Rabbits: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-10:2010 | Demonstrated Passing Results | |
| Acute Systemic Toxicity - ISO Acute Systemic Toxicity Study in Mice: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-11 (implied) | Demonstrated Passing Results | |
| Pyrogenicity - USP Rabbit Pyrogen Study, Material Mediated: Nonpyrogenic 0.9% Sodium Chloride Extraction | Passing result per USP | Demonstrated Passing Results | |
| Hemocompatibility - ASTM Hemolysis Study Direct Contact and Extract O Method: Phosphate Buffered Saline Extraction | Passing result per ASTM | Demonstrated Passing Results | |
| Hemocompatibility - Indirect Contact Complement Activation Assay | Passing result per standard | Demonstrated Passing Results | |
| Hemocompatibility - In-vitro Assessment of Introducer Thrombosis | Passing result per standard | Demonstrated Passing Results | |
| Sterilization & Packaging | ISO 11135:2014, Sterilization of health care products - Ethylene oxide | Compliance | Implied Compliance |
| ISO 11070:1998, Sterile, single use intravascular catheter introducer | Compliance | Implied Compliance | |
| ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7 Ethylene Oxide sterilization residuals | Compliance | Implied Compliance | |
| AAMI/ANSI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices | Compliance | Implied Compliance | |
| ASTM D4169-16, Standards Practice for Performance Testing of Shipping Containers and Systems | Compliance | Implied Compliance | |
| ISO 2233 (2000), Packaging - Complete, filled transport packages and unit loads | Compliance | Implied Compliance |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each performance and biocompatibility test set. The provenance of the data is implied to be from laboratory testing conducted according to the listed international standards (e.g., ISO, ASTM, USP). There is no information about the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing performed for the S-MAK XL™. The tests are primarily physical, chemical, and biological evaluations, not requiring expert human interpretation to establish a ground truth in the way medical imaging or diagnostic studies might. The "ground truth" is inherently defined by the technical specifications and standards (e.g., a device either passes a tensile strength test or it doesn't).
4. Adjudication method for the test set
Not applicable. The tests are objective and based on established international standards, not requiring adjudication by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The S-MAK XL™ is a medical device (vessel dilator/introducer sheath), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The S-MAK XL™ is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests and biocompatibility tests is based on adherence to the specified international standards and guidance documents (e.g., ISO, ASTM, USP). For instance, for cytotoxicity, the ground truth is whether the device extract causes a cytotoxic effect within defined parameters. For physical performance, the ground truth is whether the device meets its design specifications (e.g., correct length, ability to insert guide wire).
8. The sample size for the training set
Not applicable. As a physical medical device, the S-MAK XL™ does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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
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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
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510(k) Summary
K190175
S-MAK XL™
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4956(801) 253-6982David ThomasApril 3, 20191721504 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | S-MAK XL™Vessel Dilator/ Introducer SheathVessel Dilator for Percutaneous Catheterization |
| PrimaryPredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Merit MAK® (Mini Access Kit)Vessel Dilator for Percutaneous CatheterizationK091584Merit Medical Systems, Inc. |
| ReferenceDevices | 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 II21 CFR § 870.1310FDA Product Code: DREReview Panel: Cardiovascular | |
| Intended Use | The Merit S-MAK XL™ is intended for percutaneous placement of up to a0.038" (.097mm) guide wire or catheter into the vascular system. | |
| DeviceDescription | The S-MAK XL TM utilizes a small diameter coaxialintroducer/dilator pair and guide wire for placement of largerdiameter guide wires into the vasculature system when a smallneedle 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 NeedleOne (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire | |
| Comparisonto PredicateDevice | Design - The S-MAK XL TM will follow the same design as thecurrent 4F, 10cm predicate Merit MAK device except for theincreased length of 30cm for the Introducer/Dilator. Materials - All materials for the 30cm S-MAK XL TM will remain thesame as the predicate 4F, 10cm Merit MAK. Processes - Process parameters will remain the same, withchanges to the equipment as necessary to accommodate the |
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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.
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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.
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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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§ 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).