(202 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any AI/ML components or functionalities.
No.
The device facilitates the insertion and guidance of other devices but does not directly treat a disease or condition.
No
Explanation: The device description and intended use clearly state that the Q Catheter is used to facilitate the insertion and guidance of microcatheters, and for angiographic visualization. It does not mention any function related to diagnosing a disease or condition. The performance studies are entirely focused on device mechanical performance and safety, not diagnostic accuracy.
No
The device description clearly describes a physical catheter with a shaft, radiopaque markers, hydrophilic coating, and a stainless-steel control wire. The performance studies are bench tests related to the physical properties of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Q Catheter is a medical device used to facilitate the insertion and guidance of other catheters within the vascular system. It is a tool used within the body for procedural purposes, not for analyzing samples outside the body.
- Intended Use: The intended use clearly describes its function in guiding other devices within blood vessels.
- Device Description: The description details its physical characteristics and how it is used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Q Catheter is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Q 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The MIVI Q 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 catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q 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 catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vascular systems.
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)
Bench Testing:
- Test: Dimensional Verification, Test Method: Ensure device meets dimensional requirements., Results: Pass
- Test: Corrosion Resistance, Test Method: Any exposed metallic components must not show signs of corrosion., Results: Pass
- Test: Tensile Strength – Pin Vise, Test Method: Ensure adequate device tensile strength., Results: Pass
- Test: System Compatibility / Simulated Use, Test Method: Simulated use testing with “worst case” dimensional stack up., Results: Pass
Based on the test results, the Q catheter with the described wire modification is considered verified to perform to its design specifications.
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.
Not Found
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
§ 870.1250 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 6, 2020
MIVI Neurovascular Janel Hurtado Regulatory Affairs Director 6545 City West Parkway Eden Prairie, Minnesota 55344
Re: K192558
Device Name: MIVI O Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: March 12, 2020 Received: March 13, 2020
Dear Janel Hurtado:
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
1
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 (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 medical devices and radiation-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,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192558
Device Name MIVI Q Distal Access Catheter
Indications for Use (Describe)
The Q 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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3
510(K) SUMMARY
Date Prepared: November 8, 2019
| Table 1. General Information | |
|---|---|
| 510(k) Submitter | Contact |
| MIVI Neuroscience, Inc. | |
| 6545 City West Parkway | |
| Eden Prairie, MN 55344 | Randy LaBounty |
| Vice President Regulatory, Clinical and Quality | |
| Email: rlabounty@mivineuro.com | |
| Trade Name | MIVI Q Distal Access Catheter |
| Common Name | Distal access catheter |
| Classification | |
| Information | Percutaneous catheter; 21 CFR 870.1250 (Class II) |
| ProCode: QJP, DQY; Panel: Cardiovascular | |
| Predicate | |
| Device | MIVI Neuroscience, Inc. MIVI Mi-EXT Extension Catheter (now |
| branded as the MIVI Q Distal Access Catheter) (K163233) |
Device Description
The MIVI Q 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 catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q 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 catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.
Intended Use / Indications for Use
The Q 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 substantial equivalence of the subject and predicate devices.
| Feature | Subject Device
MIVI Q Distal Access Catheter | Currently Marketed
Predicate Device
MIVI Q Distal Access
Catheter | | |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 510(k) Holder &
Manufacturer | MIVI Neuroscience, Inc. | | | |
| Table 2. Comparison with Currently Marketed Predicate | | | | |
| Feature | Subject Device
MIVI Q Distal Access Catheter | Currently Marketed
Predicate Device
MIVI Q Distal Access Catheter | | |
| 510(k)# | K192558 | K163233 | | |
| Classification
Information | Percutaneous catheter
21 CFR 870.1250 (Class II)
ProCode: QJP, DQY | | | |
| Indications / Intended Use | 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. | | | |
| Principle of Operation | Used to endovascularly insert and guide microcatheters under
fluoroscopy during diagnostic and/or therapeutic procedures for
patients with 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 | | |
| | Radiopaque
Markers | Two (2) - Distal and Proximal | | |
| | Catheter
Coating | Hydrophilic | | |
| | Catheter Sizes | 3F, 4F, 5F, 6F | | |
| Total Length
(cm) | 3F | 148 | 163 | |
| | 4F | 135 | 150 | |
| | 5F | 130 | 145 | |
| | 6F | 130 | 145 | |
| Extensible Length | | Range | Fixed | |
| Extensible
Length (cm)
with:
90cm Guide | 3F | 40-42 | 42 | |
| | 4F | 27-29 | 29 | |
| | 5F | 22-24 | 24 | |
| | 6F | 22-24 | 24 | |
| Table 2. Comparison with Currently Marketed Predicate | | | | |
| Feature | | | Subject Device
MIVI Q Distal Access Catheter | Currently Marketed
Predicate Device
MIVI Q Distal Access
Catheter |
| | 95cm Guide | 3F | 35-37 | 42 |
| | | 4F | 22-24 | 29 |
| | | 5F | 17-19 | 24 |
| | | 6F | 17-19 | 24 |
| Control Wire Length | | | 104 cm | 119 cm |
| | Pin Vise Shape | | Looped shape
(Pin vise not removable) | Straight shape
(Pin vise can be removed) |
| | Guidewire
Compatibility
(cm) | 3F | 0.018" | |
| | | 4F | 0.035" | |
| | | 5F | | |
| | | 6F | | |
| Catheter Biomaterials | | | Patient contacting materials are identical between the subject and
currently marketed predicate. | |
| Accessories / Packaging / Sterilization / Shelf Life / Labeling | | | | |
| | Provided Accessories | | | None |
| Required Accessories
(not provided) | | | 8F guide catheter / 6F guide sheath
with rotating hemostasis valve with Y adapter and stopcock. | 8F guide catheter / 6F
guide sheath
Y adapter with rotating
hemostasis valve (lengths
between 6-8 cm) |
| Package Configuration | | | Catheter inserted in a plastic tube, mounted on an insert card, and
sealed in a pouch. Sealed pouch packaged in carton along with
Instructions for Use. | |
| Sterile & Non-
pyrogenic? | | | Yes | |
| Sterilization Method | | | Ethylene Oxide (EO) | |
| Shelf Life | | | 3 years | |
| Labeling | | | Proposed IFU | Current IFU |
4
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5
6
Non-Clinical Performance Testing
Bench Testing
| Table 3. Design Verification Testing | ||
|---|---|---|
| Test | Test Method | Results |
| Dimensional Verification | Ensure device meets dimensional requirements. | Pass |
| Corrosion Resistance | Any exposed metallic components must not show signs of corrosion. | Pass |
| Tensile Strength – Pin Vise | Ensure adequate device tensile strength. | Pass |
| System Compatibility / Simulated Use | Simulated use testing with “worst case” dimensional stack up. | Pass |
Based on the test results, the Q catheter with the described wire modification is considered verified to perform to its design specifications.
Biocompatibility
The MIVI Q Distal Access Catheter patient contacting materials are the same materials used in the currently marketed predicate MIVI Q Catheter K163233 with an identical biocontact. There is no change to colorants between the subject and predicate devices.
Sterilization
The MIVI Q Distal Access Catheter packaging configuration and packaged device density are the same for the predicate K163233 and subject device. No additional testing or validation is required for the subject device to be adopted into the existing sterilization cycles.
Shelf Life and Expiration Dating
The modified Q catheter will be labeled with an expiration date of 3 years from the date of sterilization, which is the same as the predicate K163233. The change to the length and distal feature of the control (push) wire does not introduce any new materials and does not impact the shelf life of the product.
Substantial Equivalence Summary and Conclusion
The modified MIVI Q Distal Access Catheter has identical indications, principle of operation, and a similar design to the currently marketed MIVI Q catheter predicate device. Based on the predicate comparison, risk assessment, and device testing results, the modified MIVI Q catheter has been shown to be appropriate for its intended use and is therefore considered substantially equivalent to the predicate device. The modified Q catheter raises no new questions of safety or effectiveness compared to the predicate device and is therefore substantially equivalent.