(23 days)
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.
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.
This document is a 510(k) premarket notification for the Maestro Microcatheter and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing conducted to support this claim, but it does not detail a study involving AI or human readers, or provide specific acceptance criteria and reported device performance in the manner typically seen for AI/CADe devices.
Therefore, many of the requested sections about AI/CADe study design cannot be answered from the provided text.
Here is the information that can be extracted or inferred from the document regarding acceptance criteria and performance, as appropriate for a medical device cleared via 510(k) demonstrating equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance for each specific test in numerical detail as would be expected for an AI system's metrics (e.g., sensitivity, specificity, AUC). Instead, it broadly states that the conducted tests met "predetermined acceptance criteria."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Meet predetermined acceptance criteria applicable to the safety and efficacy of the device. | 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. |
| Compliance with ISO 10555-1:2013 | (Implied compliance, as this standard guided testing) |
| Compliance with ISO 10993-1:2009 & FDA guidance for biocompatibility | (Implied compliance, as this standard and guidance guided testing) |
| No unacceptable risks associated with changes (device length) | Demonstrated through various performance (bench) and design validation tests. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes bench and design validation testing, not a clinical study involving a "test set" of patient data. Therefore, the concepts of sample size for a test set, data provenance, and retrospective/prospective do not apply in the context of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as this is bench and design validation testing for a physical medical device, not a diagnostic AI system requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reason stated above.
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. This submission is for a microcatheter, not an AI or CADe device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench and design validation tests, the "ground truth" implicitly refers to physical measurements, engineering specifications, and established limits defined by relevant standards (e.g., ISO 10555-1) and internal product requirements. The tests assessed characteristics like effective length, tensile force, leakage, pushability, trackability, etc., against predefined pass/fail criteria.
8. The sample size for the training set
Not applicable. No training set is involved for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
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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
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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
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4583Garry A. Courtney03/03/20231721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Maestro MicrocatheterMicrocatheterContinuous Flush Catheter2KRA870.1210Cardiovascular |
| Predicate Device | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Maestro MicrocatheterContinuous Flush CatheterK172081Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall |
| Reference Device | Merit Medical Maestro Microcatheter – K082613 |
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| DeviceDescription | The Maestro Microcatheter is available in working length sizes 110cm,130cm, 150cm, 165cm and 175cm lengths. The distal tip of themicrocatheter is offered in straight or pre-shaped 45 degree and swanneck configurations. The proximal end of the catheter consists of amolded winged hub with a tapered strain relief. The outer surface ofthe distal 80cm of the microcatheter shaft is coated with a hydrophiliccoating designed to facilitate the introduction of the catheter into thevasculature. The microcatheter incorporates a radiopaque marker atthe distal tip to facilitate fluoroscopic visualization.The Maestro Microcatheter is offered with two 3ml syringes. |
|---|---|
| Indications forUse | There is no change in the Indications for Use Statement from thepredicate to the subject device.The Microcatheter is intended for general intravascular use, includingperipheral and coronary vasculature. Once the subselective region hasbeen accessed, the microcatheter can be used for the controlled andselective infusion of diagnostic, embolic or therapeutic materials intovessels. The catheter should not be used in the cerebral vessels. |
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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
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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 &PerformanceTests 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 ofSubstantialEquivalence | 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.. |
§ 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).