(169 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a micro access system for vascular procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is an access system intended for percutaneous placement of a guidewire, which facilitates access to the vascular system; it does not provide any therapeutic effect itself.
No
The device is intended for percutaneous placement of a guidewire into the vascular system, which is a procedural/interventional function, not a diagnostic one.
No
The device description explicitly details physical components like needles, guidewires, introducer-dilator pairs, and mentions performance studies related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system." This describes a procedure for accessing the vascular system, not for performing diagnostic tests on samples taken from the body.
- Device Description: The device components (introducer-dilator pair, needle, guidewire) are all tools used for accessing and navigating within the vascular system. They are not designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the device (length, diameter, insertion force, pushability, tensile strength, etc.) and its biocompatibility. These are typical tests for devices that are inserted into the body, not for IVDs which are evaluated based on their analytical performance (sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the Merit Micro Ace™ Gold Advanced Micro Access System is a medical device used for accessing the vascular system, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
DRE
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the subject Micro Ace™ Gold was conducted based on the risk analysis and based on the requirements of the following international standards:
- ISO 10555-1:2013, Intravascular Catheters – Sterile and single-use catheters - Part 1: General requirements.
- EN ISO 11070 2014/A1:2018, Sterile Single-Use Intravascular Catheter Introducers.
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices.
- ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices.
The appropriate tests were performed for the classification: Externally Communicating Device with Circulating Blood Contact for a Limited Duration (≤ 24 hours).
The tests listed below were performed to demonstrate that the modified device meets product specification criteria, and to demonstrate there were no unacceptable risks associated with the changes made to the device.
Tests were performed on both 4F and 5F Micro Ace™ Gold products, and on sterile devices (following ethylene oxide processing) and aged devices. All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize.
All tested samples met pre-established performance criteria and were deemed 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
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).
1
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'
2
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
3
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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4
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(385) 534-0632
Niloufar Samimi
11/25/2024
1721504 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Micro Ace™ Gold Advanced Micro Access
System
Percutaneous Catheterization System
Dilator, Vessel, for Percutaneous
Catheterization
2
DRE
870.1310
Cardiovascular |
| Predicate Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Merit Micro Ace™ Advanced Micro Access
System
Dilator, Vessel, for Percutaneous
Catheterization
K232609
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall. |
5
| Device
Description | 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. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | There is no change in the Indications for Use Statement from the
predicate to the subject device.
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. |
6
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 ●
7
| Safety &
Performance:
Verification &
Validation | No performance standards have been established under Section 514
of the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject Micro Ace™ Gold was conducted based on the
risk analysis - and based on the requirements of the following
international standard: |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. ISO 10555-1:2013, Intravascular Catheters – Sterile and single-use
catheters - Part 1: General requirements. |
| | 2. EN ISO 11070 2014/A1:2018, Sterile Single-Use Intravascular
Catheter Introducers. |
| 3. ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing within a risk management process, and FDA
guidance Required Biocompatibility Training and Toxicology Profiles
for Evaluation of Medical Devices.
The appropriate tests were performed for the classification:
Externally Communicating Device with Circulating Blood Contact for a
Limited Duration (≤ 24 hours). | |
| 4. ISO 14971:2019, Medical Devices – Application of Risk Management
to Medical Devices. | |
| The tests listed below were performed to demonstrate that the
modified device meets product specification criteria, and to
demonstrate there were no unacceptable risks associated with the
changes made to the device. | |
| The tests were performed on both 4F and 5F Micro Ace™ Gold
products. Further, the testing was performed on sterile devices
(following ethylene oxide processing) and aged devices. All samples
were manufactured in accordance with existing and validated
processes, and when sterile, are representative of product that Merit
Medical intends to commercialize. | |
| All tested samples met pre-established performance criteria and were
deemed 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 | |
8
- 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.