(129 days)
The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.
The Merit MAK® (Mini Access Kit) 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 Merit MAK® consists of the following components:
One (1) 4F or 5F Coaxial Introducer/Dilator Pair
One (1) 21 gauge Introducer Needle
One (1) 0.018" (0.46mm) Guide Wire
Two new versions of guide wires will be offered:
Stainless Steel Wire with Palladium Tip
Nitinol Wire with Palladium Tip
The provided text describes a 510(k) premarket notification for the Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire. However, it does not include detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications in the way one would describe a study proving a device meets acceptance criteria for an AI/CADe device.
The document focuses on demonstrating substantial equivalence to a predicate device (the Merit MAK with platinum tip guide wire [K031691]) through comparison of technological characteristics and safety/performance tests. It explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, a "battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device."
Without the specific "battery of tests" and their corresponding acceptance criteria, it's impossible to create the requested table and answer many of the questions. The document is for a medical device (guide wire, dilator/introducer sheath), not an AI/CADe device, thus many of the questions regarding AI-specific studies (MRMC, standalone algorithm, training set, etc.) are not applicable.
Therefore, this response will highlight the information that is available and explicitly state what is not found in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table specifying distinct acceptance criteria for each test and the corresponding quantitative performance of the Merit MAK with Palladium Tip Guide Wire. It generally states that a "battery of tests was performed...and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device," but the specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance
Not explicitly stated for any specific test. The document refers to "a battery of tests" but does not quantify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to the type of device and study described. This device is a physical medical instrument, and its evaluation relies on engineering, biocompatibility, and functional tests, not interpretation of images by experts for ground truth establishment.
4. Adjudication method for the test set
Not applicable, as there's no clinical trial or expert review described for establishing ground truth in the context of an AI/CADe device.
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
No. This is not an AI/CADe device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/CADe device.
7. The type of ground truth used
Not explicitly defined in the context of expert consensus, pathology, or outcomes data. For a physical medical device like this, "ground truth" would relate to validated engineering specifications, material properties, and functional performance benchmarks (e.g., tensile strength, lubricity, flexural properties, biocompatibility), which are assessed through laboratory testing rather than medical "ground truth" as typically understood for diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe device.
Summary of Study (as described in the document):
The study performed was a series of safety and performance tests to demonstrate substantial equivalence of the Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire to a predicate device (Merit MAK with platinum tip guide wire, K031691). The basis for acceptance criteria was "protocols based on the requirements of industry standards and guidances." The specific tests and their detailed results validating these criteria are not included in the provided text. The overall conclusion was that the device "meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device."
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Merit Medical Systems, Inc. Section 5 Merit MAK with Palladium Tip Guide Wire 510(k) Summary Traditional Premarket Notification 510(k) 1091584 . ب . 2. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Section 5 OCT 2 9 2009 510(k) Summary Submitter Name: Merit Medical Systems, Inc. 1600 West Merit Parkway Address: South Jordan, UT 84095 General Telephone Number: (801) 208-4789 Provisions Fax Number: (801) 253-6919 Contact Person: Susan Christensen May 28, 2009 Date of Preparation: Registration Number: 1721504 Trade Name: Merit MAK® (Mini Access Kit) Subject Common/Usual Name:Vessel Dilator/Introducer Sheath Device Classification Name: Vessel Dilator for Percutaneous Catheterization Trade Name: Merit® MAK (Mini Access Kit) Vessel Dilator for Percutaneous Classification Name: Predicate Catheterization Device Premarket Notification: K031691 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR § 870.1310, 74 DRE Classification Division of Cardiovascular Devices The Merit MAK (Mini Access Kit) is intended for percutaneous Intended Use placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.
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| The Merit MAK® (Mini Access Kit) 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. | |
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| DeviceDescription | The Merit MAK® consists of the following components:One (1) 4F or 5F Coaxial Introducer/Dilator PairOne (1) 21 gauge Introducer NeedleOne (1) 0.018" (0.46mm) Guide WireTwo new versions of guide wires will be offered:Stainless Steel Wire with Palladium TipNitinol Wire with Palladium Tip |
| TechnologicalCharacteristics | Technological characteristics of the subject Merit MAK® withpalladium tip guide wire are substantially equivalent to those of thepredicate, the currently marketed Merit MAK with platinum tip guidewire [K031691]. |
| Safety &PerformanceTests | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. However, abattery of tests was performed according to protocols based on therequirements of industry standards and guidances and were shownto meet the acceptance criteria that were determined to demonstratethe safety and efficacy of the device. |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety, and performancetesting, the subject Merit MAK® with palladium tip guide wire meetsthe requirements that are considered essential for its intended useand is substantially equivalent to the predicate device, the currentlymarketed Merit MAK with platinum tip guide wire manufactured byMerit Medical Systems, Inc. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. c/o Ms. Susan Christensen Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, UT 84095
OCT 2 9 2009
Re: K091584
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Trade/Device Name: Merit MAK® (Mini Access Kit) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II (two) Product Code: DRE Dated: September 30, 2009 Received: October 1, 2009
Dear Ms. Christensen:
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. Drue, 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.
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.
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Page 2 - Ms. Susan Christensen
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kc
Bram b. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4
Indications for Use Statement
510(k) Number (if known):
Device Name: Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire
Indications for Use:
The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. L. Cox
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K091584
§ 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).