(136 days)
Not Found
No
The document describes a physical catheter and associated tools for facilitating insertion and guidance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a distal access catheter used to facilitate the insertion and guidance of microcatheters. It does not actively treat or diagnose a disease itself, but rather assists in procedures.
No
The device is a catheter used for facilitating the insertion and guidance of microcatheters. Its function is to provide access to blood vessels, not to diagnose medical conditions by identifying diseases or injuries. While it uses "angiographic visualization," this is for guiding the catheter, not for diagnosis by the catheter itself.
No
The device description clearly outlines physical components like a catheter, radiopaque markers, hydrophilic coating, stainless-steel control wire, docking station, and pin vise. The performance studies also focus on bench testing of these physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to facilitate the insertion and guidance of other catheters into blood vessels. This is a surgical/interventional device, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a physical catheter designed for insertion into the vascular system, not a reagent, instrument, or kit used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MIVI 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.
Product codes
QJP, DQY
Device Description
The MIVI Q Distal Access Catheter (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 Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral, coronary and neuro vascular systems (selected blood vessel in)
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)
Non-Clinical Performance Testing:
Bench Testing:
- Dimensional Verification: The device must meet dimensional specifications. Result: Pass.
- System Introduction (Simulated Use): The device must function as intended. Result: Pass.
- Liquid Leakage under Pressure: The device must hold a hydrostatic pressure. Result: Pass.
- Tensile Strength: Tensile strength pull force minimum must be met. Result: Pass.
Biocompatibility:
- Cytotoxicity: Extracted with MEM with 10% FBS at 37 °C for 24 hours and administered on mouse fibroblast L929 cells. Result: PASS.
- Irritation or Intracutaneous Reactivity: Extracted with 0.9% NaCl and cottonseed oil (CSO) at 37 °C for 72 hours and intracutaneously injected in rabbits. Result: PASS.
- Sensitization: Extracts: 0.9% NaCl, CSO for 72 hours at 37 °C. Result: PASS.
- Acute Systemic Toxicity: Extracted with 0.9% NaCl and CSO at 37 °C for 72 hours and injected in mice. Result: PASS.
- Pyrogenicity (Material-mediated): Extracted with 0.9% NaCl at 37 °C for 72 hours and injected intravenously in rabbits. Result: PASS.
- Hemolysis: Extracted from PBS at 37 °C for 24 hours, administered on rabbit blood; or directly contacting rabbit blood in vitro. Result: PASS.
- Unactivated Partial Thromboplastin Time: Human plasma was exposed to the test article at a ratio of 6 cm2/ml for 15 minutes at 37 °C. Result: PASS.
- Complement Activation: Human plasma was exposed to the test article at a ratio of 6 cm2/mL for 90 mins at 37 °C, in triplicate. Result: PASS.
Sterilization: Confirmatory testing on the final packaging configuration was completed and met specification.
Shelf Life and Expiration Dating: The bench testing described above was performed to support the shelflife of the modified device.
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
§ 870.1250 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 shows the date December 16, 2021. The month is spelled out, followed by the day and year. The text is in a simple, sans-serif font and is left-aligned.
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MIVI Neuroscience, Inc. Janel Hurtado Director of Regulatory 6545 City West Parkway Eden Prairie, Minnesota 55344
Re: K212402
Trade/Device Name: MIVI Q Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 11, 2021 Received: November 17, 2021
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
1
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, 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
2
Indications for Use
510(k) Number (if known) K212402
Device Name MIVI Q Distal Access Catheter
Indications for Use (Describe)
The MIVI 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)
X 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 K212402
[as required by 21 CFR $807.92(c)]
Date Prepared: December 14, 2021
| 510(k) Submitter | Contact | |
|---|---|---|
| MIVI Neuroscience, Inc. | ||
| 6545 City West Parkway | ||
| Eden Prairie, MN 55344 | ||
| (952) 944-3834 | Janel Hurtado | |
| Regulatory Affairs Director | ||
| Email: jhurtado@mivineuro.com | ||
| (952) 944-3834 | ||
| General Information | ||
| Trade Name | MIVI Q Distal Access Catheter | |
| Common Name | Distal access catheter | |
| Classification | ||
| Information | Device Classification: Class II | |
| Common Name: Percutaneous catheter | ||
| Regulation Number: 21 CFR 870.1250 | ||
| Product Code: QJP; Panel: Neurology | ||
| Product Code: DQY; Panel: Cardiovascular | ||
| Predicate Device | MIVI Q Distal Access Catheter (K192558; April 6, 2020) |
Device Description
The MIVI Q Distal Access Catheter (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 Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
Intended Use / Indications for Use
The MIVI 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.
Substantial Equivalence Comparison
The MIVI Q Distal Access Catheter (pre-loaded with Docking Station) has identical indications, principle of operation, and similar design as the currently marketed predicate catheters.
| Table 1: Comparison with Currently Marketed Predicate | |||
|---|---|---|---|
| Feature | Subject Device | ||
| MIVI Q Distal Access Catheter | Predicate Device | ||
| MIVI Q Distal Access Catheter | |||
| 510(k) Holder & | |||
| Manufacturer | MIVI Neuroscience, Inc. | MIVI Neuroscience, Inc. | |
| 510(k)# | K212402 | K192558 | |
| Table 1: Comparison with Currently Marketed Predicate | |||
| Feature | Subject Device | ||
| MIVI Q Distal Access Catheter | Predicate Device | ||
| MIVI Q Distal Access Catheter | |||
| Classification | |||
| Information | Percutaneous catheter | ||
| 21 CFR 870.1250 (Class II) | |||
| ProCode: QJP, DQY | |||
| Indications / Intended Use / Principle of Operation | |||
| Indications for Use | The MIVI 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 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. | |||
| 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 | ||
| Docking Station assembly | |||
| Tip | Straight | ||
| Radiopaque | |||
| Markers | Two (2) - Distal and Proximal | ||
| Catheter | |||
| Coating | Hydrophilic | ||
| Catheter Sizes | 3F, 4F, 5F, 6F | ||
| 3F | 154 | 148 | |
| 4F | 141 | 135 | |
| Total Length | |||
| (cm) | 5F | 136 | 130 |
| 6F | 136 | 130 | |
| Extensible Length | |||
| 3F | 40-42 | ||
| 4F | 27-29 | ||
| Extensible length (cm) with: | |||
| 90 cm Guide | 5F | 22-24 | |
| 6F | 22-24 | ||
| 3F | 35-37 | ||
| 4F | 22-24 | ||
| 95 cm Guide | 5F | 17-19 | |
| 6F | 17-19 | ||
| Control Wire | |||
| Length | 108 | 104 | |
| Table 1: Comparison with Currently Marketed Predicate | |||
| Feature | Subject Device | ||
| MIVI Q Distal Access Catheter | Predicate Device | ||
| MIVI Q Distal Access Catheter | |||
| Pin Vise Shape | Looped shape (Pin Vise not removable) | ||
| 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 and accessories. | |||
| Accessories / Packaging / Sterilization / Shelf Life | |||
| Provided Accessories | 9F Rotating Hemostasis Valve Y-Connector | None | |
| Required Accessories | |||
| (not provided) | 8F guide catheter / 6F guide sheath 90-95 cm in length | ||
| 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 |
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P a g e | 2
5
Page | 3
The technological differences between the modified MIVI Q Distal Access Catheter and the currently marketed predicate do not raise new questions of safety and effectiveness.
Non-Clinical Performance Testing
Bench Testing
Bench testing was completed to assess the performance of the subject device, as shown in the following table.
| Test | Test Summary | Result |
|---|---|---|
| Dimensional | ||
| Verification | The device must meet dimensional specifications. | Pass |
| System Introduction (Simulated | ||
| Use) | The device must function as intended. | Pass |
| Liquid Leakage under Pressure | The device must hold a hydrostatic pressure. | Pass |
| Tensile Strength | Tensile strength pull force minimum must be met. | Pass |
6
Page | 4
Biocompatibility
Biocompatibility testing was completed to assess the subject device, as shown in the following table.
| Test | Test Summary | Result |
|---|---|---|
| Cytotoxicity | Extracted with MEM with 10% FBS at 37 °C for 24 | |
| hours and administered on mouse fibroblast L929 cells. | PASS | |
| Irritation or Intracutaneous | ||
| Reactivity | Extracted with 0.9% NaCl and cottonseed oil (CSO) at | |
| 37 °C for 72 hours and intracutaneously injected in | ||
| rabbits. | PASS | |
| Sensitization | Extracts: 0.9% NaCl, CSO for 72 hours at 37 °C. | PASS |
| Acute Systemic Toxicity | Extracted with 0.9% NaCl and CSO at 37 °C for 72 | |
| hours and injected in mice. | PASS | |
| Pyrogenicity (Material- | ||
| mediated) | Extracted with 0.9% NaCl at 37 °C for 72 hours and | |
| injected intravenously in rabbits. | PASS | |
| Hemolysis | Extracted from PBS at 37 °C for 24 hours, administered | |
| on rabbit blood; or directly contacting rabbit blood in | ||
| vitro. | PASS | |
| Unactivated Partial | ||
| Thromboplastin Time | Human plasma was exposed to the test article at a ratio of | |
| 6 cm2/ml for 15 minutes at 37 °C. | PASS | |
| Complement Activation | Human plasma was exposed to the test article at a | |
| ratio of 6 cm2/mL for 90 mins at 37 °C, in triplicate. | PASS |
Sterilization
The sterilization method is unchanged. Confirmatory testing on the final packaging configuration was completed and met specification.
Shelf Life and Expiration Dating
The labeled shelf life of the modified device is the same as that of the predicate, 3 years from the date of sterilization. The bench testing described above was performed to support the shelflife of the modified device.
Conclusion
The modified MIVI Q Distal Access Catheter has identical indications, principle of operation, and similar design as the currently marketed MIVI Q Catheter predicate device. The technological differences between the modified Q Catheter and the currently marketed predicate do not raise new questions of safety and effectiveness. Based on the predicate comparison, risk assessment, and device testing results, the modified MIVI Q Distal Access Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the predicate device.