(23 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device itself is not a therapeutic device but is used for the "controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels." It is a delivery system for therapeutic agents, not a therapeutic agent itself.
No
Explanation: The device is a microcatheter used for the infusion of materials, including diagnostic materials, into vessels. However, it is not described as performing any diagnostic function itself, such as imaging or measuring a physiological parameter to diagnose a condition. It is a tool for delivering diagnostic substances.
No
The device description clearly details a physical catheter with various lengths, tip configurations, a hub, a hydrophilic coating, and a radiopaque marker. It also mentions included syringes. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use, including peripheral and coronary vasculature" and for the "controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels." This describes a device used within the body for direct intervention or delivery, not for testing samples outside the body.
- Device Description: The description details a physical catheter with features like working length, tip configurations, coatings, and radiopaque markers. These are characteristics of an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples.
Therefore, the Maestro Microcatheter is an invasive medical device used for procedures within the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Maestro Microcatheter is available in working length sizes 110cm, 130cm, 150cm, 165cm and 175cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the catheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Maestro Microcatheter is offered with two 3ml syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature. The catheter should not be used in the cerebral vessels.
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-Bench:
- Effective Length Analysis
- Soft Flexible Transition Length
- Proximal Shaft OD
- Proximal Hub ID
- Coating Length
- Freedom from Liquid Leakage (Pressure Test)
- Freedom from Air Leakage
- Peak Tensile Force
Design Validation:
- Torque Strength
- Hoop Removal
- Soft Distal Section
- Distal Tip
- Straightener
- Guidewire Compatibility
- Pushability
- Catheter Compatibility
- Trackability
- Torsion
- Reposition Guidewire
- Negative Pressure
- Delivery of Coil
The results of the testing demonstrated that the subject "longer length" Maestro Microcatheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
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March 30, 2023
Merit Medical System, Inc. Garry Courtney Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K230636
Trade/Device Name: Maestro Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: February 6, 2023 Received: March 7, 2023
Dear Garry Courtney:
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 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
1
devices or postmarketing safety reporting (21 CFR 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 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 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).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Lydia S. Glaw -S". The date of the signature is March 30, 2023, and the time is 15:22:51 -04'00'.
Lydia Glaw Assistant Director 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
2
Indications for Use
510(k) Number (if known) K230636
Device Name Maestro Microcatheter
Indications for Use (Describe)
The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
| 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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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
(801) 208-4583
Garry A. Courtney
03/03/2023
1721504 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Maestro Microcatheter
Microcatheter
Continuous Flush Catheter
2
KRA
870.1210
Cardiovascular |
| Predicate Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Maestro Microcatheter
Continuous Flush Catheter
K172081
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall |
| Reference Device | | Merit Medical Maestro Microcatheter – K082613 |
4
| Device
Description | The Maestro Microcatheter is available in working length sizes 110cm,
130cm, 150cm, 165cm and 175cm lengths. The distal tip of the
microcatheter is offered in straight or pre-shaped 45 degree and swan
neck configurations. The proximal end of the catheter consists of a
molded winged hub with a tapered strain relief. The outer surface of
the distal 80cm of the microcatheter shaft is coated with a hydrophilic
coating designed to facilitate the introduction of the catheter into the
vasculature. The microcatheter incorporates a radiopaque marker at
the distal tip to facilitate fluoroscopic visualization.
The Maestro Microcatheter is offered with two 3ml syringes. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | There is no change in the Indications for Use Statement from the
predicate to the subject device.
The Microcatheter is intended for general intravascular use, including
peripheral and coronary vasculature. Once the subselective region has
been accessed, the microcatheter can be used for the controlled and
selective infusion of diagnostic, embolic or therapeutic materials into
vessels. The catheter should not be used in the cerebral vessels. |
5
The design and technological characteristics of the subject "longer length" Maestro Microcatheters are substantially equivalent to those of the predicate Maestro Microcatheter. The subject device has the same basic design as the predicate device. The main difference between the subject and the predicate devices is in the working length of the microcatheter – where longer length catheters (165cm and 175cm) are made available to address clinical needs. The comparison between the subject and the predicate devices is based on the following:
- Same intended use ●
- Same indications for use
- Similar material types that meet ISO 10993 biocompatibility requirements
- Same design ●
- Same sterilization methods ●
- Same fundamental technology/principle of operation
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Maestro Microcatheters was conducted based on the risk analysis and based on the requirements of the following international standard:
- ISO 10555-1:2013, Intravascular Catheters Sterile and single-● use catheters - Part 1: General requirements
- ISO 10993-1:2009, Biological Evaluation of Medical Devices . Part 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1. 1995
Comparison to Predicate Device
6
The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:
Performance Testing-Bench
- Effective Length Analysis •
- Soft Flexible Transition Length .
- Proximal Shaft OD .
- Proximal Hub ID .
- . Coating Length
- Freedom from Liquid Leakage (Pressure Test) .
- Freedom from Air Leakage .
- Peak Tensile Force .
| Safety &
Performance
| Tests cont. | Design Validation | |
|---|---|---|
| • Torque Strength | ||
| • Hoop Removal | ||
| • Soft Distal Section | ||
| • Distal Tip | ||
| • Straightener | ||
| • Guidewire Compatibility | ||
| • Pushability | ||
| • Catheter Compatibility | ||
| • Trackability | ||
| • Torsion | ||
| • Reposition Guidewire | ||
| • Negative Pressure | ||
| • Delivery of Coil | ||
| The results of the testing demonstrated that the subject "longer length" Maestro Microcatheters met the predetermined acceptance criteria applicable to the safety and efficacy of the device. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the indications for use, design, safety and performance testing, the subject "longer length" Maestro Microcatheters meet the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Maestro Microcatheter, K172081, manufactured by Merit Medical Systems, Inc.. |