(169 days)
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.
However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.
Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.
The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.
Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance (for a physical medical device):
The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implicit via test type) | Test Performed | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Dilator Effective length | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Dilator Outer Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Inner Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Mechanical Properties | Insertion Force | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Pushability and Kink Test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Shaft Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hub Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Bend | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Fracture | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Material/Surface Characteristics | Particulate test | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Lubricity test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Biocompatibility | Cytotoxicity | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Sensitization | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Irritation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Acute Systematic Toxicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Pyrogenicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hemolysis | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Partial Thromboplastin Time | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Heparinized Blood Platelet and Leukocyte Count | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Complement Activation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Extract Particulates | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Design Validation | Clinician feedback assessment | Not specified, but implied satisfactory as part of overall acceptability statement. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
- Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of AI/SaMD ground truth establishment.
- For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.
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 type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI/SaMD performance, which is not the subject of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.
8. The sample size for the training set:
- Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this document does not describe an AI algorithm or its training set.
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January 15, 2025
Merit Medical Systems, Inc. Niloufar Samimi Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K242229
Trade/Device Name: Micro Ace Gold Advanced Micro Access System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: November 25, 2024 Received: November 26, 2024
Dear Niloufar Samimi:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Digitally signed by Sincerely,Finn E. Finn E. Donaldson -S Donaldson -S Date: 2025.01.15 11:14:59 -05'00'
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Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242229
Device Name
Micro Ace Gold Advanced Micro Access System
Indications for Use (Describe)
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(385) 534-0632Niloufar Samimi11/25/20241721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Micro Ace™ Gold Advanced Micro AccessSystemPercutaneous Catheterization SystemDilator, Vessel, for PercutaneousCatheterization2DRE870.1310Cardiovascular |
| Predicate Device | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Merit Micro Ace™ Advanced Micro AccessSystemDilator, Vessel, for PercutaneousCatheterizationK232609Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall. |
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| DeviceDescription | The Merit Micro Ace™ Gold Advanced Micro Access System(hereafter referred to as Micro Ace™ Gold) provides access to thevascular system and facilitates the placement of a 0.035" (0.89mm)or 0.038" (0.97mm) guide wires. The system is available in 4 Frenchand 5 French sizes – and includes the coaxial introducer-dilator pair,a 21 gauge needle and a 0.018” (0.46mm) guide wire.The introducer-dilator assembly that is included in each kit is 10 cmeffective length. The system will be offered with optional guidewires:Some catalog codes will include a nitinol wire with platinumguidewire tips; Some catalog codes will be offered with a stainless steel wirewith platinum guidewire tips. |
|---|---|
| Indications forUse | There is no change in the Indications for Use Statement from thepredicate to the subject device.The Merit Micro Ace™ Gold Advanced Micro Access System isintended for percutaneous placement of a 0.035" (0.89mm) or 0.038"(0.97mm) guidewire into the vascular system. |
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The design and technological characteristics of the subject modified Micro Ace™ Gold are substantially equivalent to those of the predicate Micro Ace™ Advanced Micro Access System. The subject device has the same basic design as the predicate device. The differences between the predicate Micro Ace™ Advanced Micro Access System device and the subject/modified Micro Ace™ Gold device are as follows:
- The dilator material was changed from HDPE to PEEK . vellow.
- Addition of silicone coating lubricant to the shaft and tip of . the introducer, to reduce insertion force.
- Dilator hub material was changed from HDPE to nylon. .
Comparison to Predicate Device
The comparison between the subject and the predicate devices is based on the following:
- Same intended use ●
- Same indications for use ●
- . Same sterilization methods
- Same packaging scheme .
- Same fundamental technology/principles of operation
- Similar material types (all meet ISO 10993 biocompatibility . requirements)
- Equivalent design ●
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| Safety &Performance:Verification &Validation | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Micro Ace™ Gold was conducted based on therisk analysis - and based on the requirements of the followinginternational standard: |
|---|---|
| 1. ISO 10555-1:2013, Intravascular Catheters – Sterile and single-usecatheters - Part 1: General requirements. | |
| 2. EN ISO 11070 2014/A1:2018, Sterile Single-Use IntravascularCatheter Introducers. | |
| 3. ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1:Evaluation and Testing within a risk management process, and FDAguidance Required Biocompatibility Training and Toxicology Profilesfor Evaluation of Medical Devices.The appropriate tests were performed for the classification:Externally Communicating Device with Circulating Blood Contact for aLimited Duration (≤ 24 hours). | |
| 4. ISO 14971:2019, Medical Devices – Application of Risk Managementto Medical Devices. | |
| The tests listed below were performed to demonstrate that themodified device meets product specification criteria, and todemonstrate there were no unacceptable risks associated with thechanges made to the device. | |
| The tests were performed on both 4F and 5F Micro Ace™ Goldproducts. Further, the testing was performed on sterile devices(following ethylene oxide processing) and aged devices. All sampleswere manufactured in accordance with existing and validatedprocesses, and when sterile, are representative of product that MeritMedical intends to commercialize. | |
| All tested samples met pre-established performance criteria and weredeemed acceptable. | |
| Design Verification Studies• Dilator Effective length• Dilator Outer Diameter• Dilator Tip Inner Diameter• Insertion Force• Pushability and Kink Test• Shaft Tensile• Hub Tensile• Dilator Tip Bend• Dilator Tip Fracture |
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- Particulate test ●
- . Lubricity test
Design Validation Studies
-
Clinician feedback following assessment of design changes. .
Biocompatibility Studies -
. Cytotoxicity
-
Sensitization
-
Irritation
-
Acute Systematic Toxicity
-
Pyrogenicity ●
-
Hemolysis
-
Partial Thromboplastin Time .
-
Heparinized Blood Platelet and Leukocyte Count
-
Complement Activation
-
Extract Particulates ●
Summary of Substantial Equivalence
Based on the indications for use, design, materials, safety and performance testing (verification and validation), and materials, the subject Micro Ace™ Gold Advanced Micro Access System is deemed to be substantially equivalent to the predicate device, the Micro Ace™ Advanced Micro Access System, K232609. Both the subject device and the predicate device are legally manufactured by Merit Medical Systems, Inc.
§ 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).