(357 days)
The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.
The medical device described, the Q Distal Access Catheter, is not an AI/ML powered device, therefore, the requested information regarding AI/ML related aspects (such as effect size, standalone performance, training set details, and expert qualifications for ground truth) is not applicable. The provided text details the non-clinical performance testing for a physical medical catheter.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Q Distal Access Catheter are derived from various non-clinical performance tests, including bench testing and biocompatibility testing. The "Results" column from the provided tables serves as the reported device performance, indicating that the device "Pass"ed each criterion.
| Test Category | Specific Test | Acceptance Criterion (Test Method Summary) | Reported Device Performance (Result) |
|---|---|---|---|
| Bench Testing | Label Integrity | Device labels were evaluated to ensure labels are intact and legible after environmental conditioning, distribution simulation and aging. | Pass |
| Bubble Leak | Device packaging was evaluated to detect gross leaks in packaging. | Pass | |
| Pouch Seal Strength | Pouch was evaluated for the mechanical strength of the seal. | Pass | |
| Coating Particulate | The number and size of particles generated during simulated use were measured. | Pass | |
| Dimensional Verification | Dimensional specifications were verified to ensure device meets all the requirements. | Pass | |
| Tip Inspection | Catheter tip was evaluated to ensure the complete retrieval of tip during its removal. | Pass | |
| Surface Integrity | Device visually inspected to ensure surface is free of defects that can cause tissue trauma. | Pass | |
| Heat Shrink Inspection | To ensure heat shrink identifier remains intact and legible after environmental conditioning, distribution simulation and aging. | Pass | |
| Coating Uniformity | To evaluate the devices for uniform coating. | Pass | |
| Simulate Use/Compatibility | The catheter performance was evaluated when used in conjunction with other devices used in standard procedures without sustaining damage or kinks and without causing damage to the other devices. | Pass | |
| Coating Adhesion | To visually categorize the integrity of coating on the device. | Pass | |
| Push/Track | To ensure device is able to be tracked without kink under normal conditions in tortuous anatomy. | Pass | |
| Kink Resistance | The distal shaft of the device was evaluated for kink resistance when subjected to a bend radius of 1.0 cm. | Pass | |
| Liquid Leak Under Pressure | To ensure device does not exhibit leakage of liquid under a minimum pressure of 44 psi for a minimum of 30 seconds. | Pass | |
| Static Burst | To ensure device withstands a minimum pressure of 100 psi prior to burst. | Pass | |
| Tensile Strength - Push Wire | To ensure device meets the required tensile strength between the push wire and catheter body: 15 N pull force minimum. | Pass | |
| Tensile Strength - Distal Section | To ensure device meets the required tensile strength of the distal section of the shaft: 5N pull force minimum. | Pass | |
| Biocompatibility | Cytotoxicity | Biological reactivity Grade 0 on the test article after 48 hrs. incubation with mouse fibroblast. The response on the positive and negative control article extracts confirmed the suitability of the tests. The test article (TA) is considered non-cytotoxic. | Pass |
| Hemolysis (Direct and Indirect) | The test article in direct contact with blood had a hemolytic index of 0.3%, and the test article extract had a hemolytic index of 0.2%. Both the test article in direct contact with blood and the test article extract were non-hemolytic. | Pass | |
| Sterilization | Ethylene Oxide (EO) Residuals | In accordance with ISO 10993-7. | Pass (Implied by Conclusion) |
| Limulus Amoebocyte Lysate (LAL) | In accordance with USP 24 chapter 85 and FDA guidance. | Pass (Implied by Conclusion) | |
| Bioburden Testing | In accordance with relevant standards (not explicitly listed but implied alongside EO residuals and LAL). | Pass (Implied by Conclusion) | |
| Shelf-life | Shelf-life Verification (3 years) | The device will be labeled with an expiration date of 3 years from the date of sterilization. | Pass (Implied by Conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific bench or biocompatibility test. The evaluation involved "design verification testing" and "additional biocompatibility testing." The provenance of the data is from internal testing conducted by MIVI Neuroscience, Inc., as part of their 510(k) submission. This is considered retrospective for the purpose of the submission, as the tests were performed to demonstrate compliance of an already designed and manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the Q Distal Access Catheter is a physical medical device, not an AI/ML powered device that relies on expert interpretation for "ground truth" establishment in its performance evaluation. The "ground truth" in this context refers to established engineering specifications, material science standards, and biocompatibility guidelines.
4. Adjudication Method for the Test Set
This question is not applicable for a physical medical device. The "adjudication method" concept is typically used for subjective assessments in clinical or AI/ML studies where human interpretation of ambiguous data is involved. For engineering and scientific testing of a physical device, results are typically objective and determined by established protocols and measurement techniques.
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
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not have a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Q Distal Access Catheter's performance evaluation is based on a combination of:
- Design Specifications: Predefined engineering requirements and dimensional tolerances for the catheter.
- Established Industry Standards: Such as ISO 11135:2014 for sterilization, ISO 10993-7 for biocompatibility residuals, ASTM F756 for hemolysis, and USP 24 chapter 85 for bacterial endotoxins.
- Visual and Mechanical Inspection Criteria: Standardized methods to assess physical integrity, coating uniformity, and functional performance.
- Physiological Response Criteria: For biocompatibility, established thresholds for cytotoxicity and hemolysis.
8. The Sample Size for the Training Set
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.
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September 19, 2023
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MIVI Neuroscience, Inc. Srija Reddy Bandari Regulatory Affairs Specialist 6545 City West Parkway Eden Prairie, Minnesota 55344
Re: K222948
Trade/Device Name: Q Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 18, 2023 Received: August 21, 2023
Dear Srija Reddy Bandari:
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
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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 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 (OS) 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K222948
Device Name Q Distal Access Catheter
Indications for Use (Describe)
The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
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 K222948
Date Prepared: 09-18-2023
| Table 1. General Information | |
|---|---|
| 510(k) Submitter | Contact |
| MIVI Neuroscience, Inc.6545 City West ParkwayEden Prairie, MN 55344 | Srija Reddy BandariRegulatory Affairs SpecialistEmail: sbandari@mivineuro.comPhone: (612) 447-2897Fax: (952)-944-3488 |
| Trade Name | Q Distal Access Catheter |
| Common Name | Q Distal Access Catheter |
| Classification Information | Percutaneous catheter; 21 CFR 870.1250 (Class II)ProCode: QJP, DQYPanel: Cardiovascular |
| Predicate Device | MIVI Q Distal Access Catheter (K192558) |
Device Description
The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.
Intended Use / Indications for Use
The O Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Substantial Equivalence Comparison
Table 2 compares the intended use and technological characteristics of the subject and predicate devices.
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| Table 2: Comparison with Currently Marketed Predicate | |||
|---|---|---|---|
| Feature | Subject DeviceQ Distal Access Catheter | Currently Marketed PredicateDeviceMIVI Q Distal Access Catheter | |
| 510(k) Holder &Manufacturer | MIVI Neuroscience, Inc. | MIVI Neuroscience, Inc. | |
| 510(k)# | K222948 | K192558 | |
| ClassificationInformation | Percutaneous catheter21 CFR 870.1250 (Class II)ProCode: QJP, DQY; Panel: Cardiovascular | ||
| Indications / Intended Use / Principle of Operation | |||
| Indications /Intended Use | Indicated for use with compatible guide catheters in facilitating theinsertion and guidance of microcatheters into a selected blood vessel inthe peripheral, coronary and neuro vascular systems. | ||
| Principle ofOperation | Used to endovascularly insert and guide microcatheters underfluoroscopy during diagnostic and/ or therapeutic procedures for patientswith arterial disease or damage. | ||
| Design Information | |||
| Configuration | Distal | Single-lumen, variable stiffness, braided (5F, 6F) / coiled (3F, 4F) | |
| Proximal | Control (push) wire through a guide catheter luer fitting | ||
| Tip | Straight | ||
| RadiopaqueMarkers | Two (2)- Distal and Proximal | ||
| CatheterCoating | Hydrophilic | ||
| Catheter Sizes | 3F, 4F, 5F, 6F | ||
| CatheterLengths | 3F | 148 cm | 148 cm |
| 4F | 135 cm and 145 cm | 135 cm | |
| 5F | 130 cm and 140 cm | 130 cm | |
| Table 2: Comparison with Currently Marketed Predicate | |||
| Feature | Subject DeviceQ Distal Access Catheter | Currently Marketed Predicate DeviceMIVI Q Distal Access Catheter | |
| 6F130 cm and 135 cm | 130 cm | ||
| GuidewireCompatibility(cm) | 3F0.018" | ||
| 4F | |||
| 5F0.035" | |||
| 6F | |||
| Guide Catheter /SheathCompatibility (ID) | 0.088"- 0.091" | 0.088"- 0.090" | |
| Guide Catheter/Sheath LengthRange (cm) | 90-100 | 90-95 | |
| CatheterBiomaterials | Patient contacting materials are identical between the subject and currently marketed predicate. | ||
| Accessories / Packaging / Sterilization / Shelf Life / Labeling | |||
| ProvidedAccessories | Syringe (5 mL)Flush tool (4F/5F) | None | |
| RequiredAccessories (notprovided) | Compatible Y adapter withrotating hemostasis valve (lengthsbetween 6-8 cm) | Same | |
| PackageConfiguration | Catheter inserted in a plastic tube,placed in PETG tray with lid, andsealed in new Tyvek pouch withimproved chevron. Sealed pouchpackaged in labeled carton withInstructions for Use. | Catheter inserted in a plastic tube,mounted on an insert card, andsealed in a pouch. Sealed pouchpackaged in carton box along withInstructions for Use. | |
| Sterile & Non-pyrogenic? | Yes | ||
| SterilizationMethod | Ethylene Oxide (sustainable) | Ethylene Oxide | |
| Shelf Life | 3 years |
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Non-Clinical Performance Testing
Bench Testing
The modified Q Distal Access Catheter has been evaluated through design verification testing, which confirmed the device met the design specifications as summarized in Table 3 below.
| Table 3: Design Verification Testing | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Label Integrity | Device labels were evaluated to ensure labels are intact andlegible after environmental conditioning, distribution simulationand aging. | Pass | |
| Bubble Leak | Device packaging was evaluated to detect gross leaks inpackaging. | Pass | |
| Pouch SealStrength | Pouch was evaluated for the mechanical strength of the seal. | Pass | |
| CoatingParticulate | The number and size of particles generated during simulated usewere measured. | Pass | |
| DimensionalVerification | Dimensional specifications were verified to ensure device meetsall the requirements. | Pass | |
| Tip Inspection | Catheter tip was evaluated to ensure the complete retrieval of tipduring its removal. | Pass | |
| Surface Integrity | Device visually inspected to ensure surface is free of defectsthat can cause tissue trauma. | Pass | |
| Heat shrinkInspection | To ensure heat shrink identifier remains intact and legible afterenvironmental conditioning, distribution simulation and aging. | Pass | |
| CoatingUniformity | To evaluate the devices for uniform coating. | Pass | |
| Simulate Use/Compatibility | The catheter performance was evaluated when used inconjunction with other devices used in standard procedureswithout sustaining damage or kinks and without causingdamage to the other devices. | Pass | |
| CoatingAdhesion | To visually categorize the integrity of coating on the device. | Pass | |
| Push/Track | To ensure device is able to be tracked without kink under normal conditions in tortuous anatomy. | Pass | |
| Kink Resistance | The distal shaft of the device was evaluated for kink resistance when subjected to a bend radius of 1.0 cm. | Pass | |
| Liquid Leak Under Pressure | To ensure device does not exhibit leakage of liquid under a minimum pressure of 44 psi for a minimum of 30 seconds. | Pass | |
| Static Burst | To ensure device withstands a minimum pressure of 100 psi prior to burst. | Pass | |
| Tensile Strength - Push Wire | To ensure device meets the required tensile strength between the push wire and catheter body: 15 N pull force minimum. | Pass | |
| Tensile Strength - Distal Section | To ensure device meets the required tensile strength of the distal section of the shaft: 5N pull force minimum. | Pass |
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Biocompatibility
The Q Distal Access Catheter patient contacting materials are the same materials used in the currently marketed predicate MIVI Q Distal Access Catheter K192558 with the same patient contact classification. A summary of the additional biocompatibility testing conducted to support the device modifications is included in Table 4 below.
| Table 4: Summary of Biocompatibility Testing | |||
|---|---|---|---|
| Test | Test Method | Conclusion | Result |
| Cytotoxicity | Extracted with MEM with10% FBS at 37°Cfor 24 hours andadministered on mousefibroblast L929 cells. | Biological reactivity Grade 0 on thetest article after 48 hrs. incubationwith mouse fibroblast. The responseon the positive and negative controlarticle extracts confirmed thesuitability of the tests. The test article(TA) is considered non-cytotoxic. | Pass |
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| Hemolysis(Direct and Indirect) | ASTM F756, StandardPractice for Assessment ofHemolytic Properties ofMaterials. | The test article in direct contact withblood had a hemolytic index of 0.3%,and the test article extract had ahemolytic index of 0.2%. Both the testarticle in direct contact with blood andthe test article extract were non-hemolytic. | Pass |
|---|---|---|---|
| ------------------------------------ | -------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
Sterilization
The modified O Distal Access Catheter in the new packaging is sterilized using Sustainable Ethylene Oxide (EO) sterilization process. Sterilization was performed in accordance with ISO 11135:2014 to qualify the reduced EO sterilization process developed by Steris AST which is an optimized cycle using less EO sterilant while still achieving the 10 ° sterility assurance level (SAL) as an acceptable means of sterilization.
The EO residual, limulus amoebocyte lysate (LAL), and bioburden testing were performed in accordance with standards listed below:
- ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide ● Sterilization Residuals.
- The USP 24 chapter 85 "Bacterial Endotoxins Test" and FDA guidance, "Pyrogen and ● Endotoxins Testing: Questions and Answers, " June 2012.
Shelf-life
The modified O Distal Access Catheter will be labelled with an expiration date of 3 years from the date of sterilization, which is same as for the predicate device K192558.
Conclusions
The modified Q Distal Access Catheter has the same indications for use, principle of operation, and design concept as the currently marketed MIVI Q Distal Access Catheter predicate device. The technological differences between the subject device and the currently marketed predicate device include the catheter dimensions, increased compatibility range with the guide catheter/sheath, addition of the syringe and flush tool accessory components to the packaging configuration, packaging, sterilization, and product labeling updates. The subject device has been evaluated through risk analysis and testing. The differences do not raise new questions of safety or effectiveness. The testing verified the device met the design specifications. Based on the predicate comparison, risk assessment, and device testing information provided in this 510(k) submission, the subject device has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).