(177 days)
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of AI/ML capabilities or related performance metrics.
No.
The device facilitates the introduction of diagnostic agents or therapeutic devices, but is not itself a therapeutic device.
No.
The device facilitates the introduction of diagnostic agents or therapeutic devices but is not itself described as performing diagnostic functions such as imaging or measuring physiological parameters for diagnosis.
No
The device description clearly describes a physical catheter with hardware components (coil, braid reinforcement, hydrophilic coating, radiopaque marker) and packaging. It is not solely software.
Based on the provided information, 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 the neuro and peripheral vasculature" to "facilitate introduction of diagnostic agents or therapeutic devices." This describes a device used within the body for access and delivery, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for navigation within blood vessels, with features like coil and braid reinforcement, hydrophilic coating, and a radiopaque marker for visualization under fluoroscopy. This aligns with an interventional or access device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
Therefore, the SOFIA EX Intracranial Support Catheter is a medical device used for accessing and navigating within the vasculature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The SOFIA™ EX Intracranial Support Catheter is a single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier Tyvek pouch and placed in a carton box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro and peripheral vasculature
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)
The following bench testing data were provided to evaluate the performance and support the substantial equivalence of the SOFIA™ EX Intracranial Support Catheter.
- Simulated Use and Physician Simulated Use: The simulated use of the device is evaluated in a tortuous anatomical benchtop model to assess tracking and hydrophilic coating lubricity of the device. Physician simulated use is conducted with the subject. Results: Device met acceptance criteria.
- Kink Resistance: Device is subjected to bending experienced in tortuous anatomy. Results: Device met acceptance criteria.
- Particulate Testing: The number and size of particulates generated during simulated use in a tortuous anatomical model were measured and results were compared with the predicate device. Results: Number of particulates generated are comparable to the predicate device.
No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes.
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.
SOFIA EX Intracranial Support Catheter (K182602)
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.
Benchmark Intracranial Access System (K212838)
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
September 14, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MicroVention, Inc. Miranda Beach Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656
Re: K230775
Trade/Device Name: SOFIA EX Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 15, 2023 Received: August 16, 2023
Dear Miranda Beach:
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,
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
2
Indications for Use
510(k) Number (if known) K230775
Device Name SOFIA EX Intracranial Support Catheter
Indications for Use (Describe)
The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries.
| 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
Image /page/3/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo features a stylized graphic of overlapping curved lines in shades of gray and blue on the left. To the right of the graphic is the text "MicroVention" in a blue sans-serif font, with "TERUMO" in a smaller, bolder blue font underneath.
510(k) Summary K230775
| 510(k) Owner | MicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656
Establishment Registration No: 3013556777 |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person | Miranda Beach
Regulatory Affairs Specialist
Email: Miranda.Beach@microvention.com |
| Date of Preparation | September 12, 2023 |
| Trade Name | SOFIATM EX Intracranial Support Catheter |
| Common Name | Catheter, Percutaneous, Neurovasculature |
| Classification | Class II, QJP, DQY |
| Regulation | 21 CFR 870.1250 |
| Predicate Device | SOFIA EX Intracranial Support Catheter (K182602) |
| Reference Device | Benchmark Intracranial Access System (K212838) |
Device Description
The SOFIA™ EX Intracranial Support Catheter is a single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier Tyvek pouch and placed in a carton box.
Indications for Use
The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries.
Comparison of Indications for Use and Technological Characteristics
The subject device is identical in its indication for use, technology, principle of operation, materials, sterilization method, and performance to the predicate device SOFIA™ EX Intracranial Support Catheter (K182602). The only difference between the subject and predicate devices are additional instructions added to the instructions for use (IFU) for the subject device
4
Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo consists of a circular graphic on the left, with the text "MicroVention" in blue to the right of the graphic. Below "MicroVention" is the word "TERUMO", also in blue. The circular graphic is made up of curved lines in shades of gray and blue.
related to radial access use. A comparison of the technological characteristics of the subject device and the predicate device is summarized in Table 1 below.
| | SOFIA™ EX Intracranial
Support Catheter (K182602) | SOFIA™ EX Intracranial
Support Catheter |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device | Subject Device |
| Indications for Use | The SOFIA EX Catheter is
indicated for general
intravascular use, including the
neuro and peripheral vasculature.
The SOFIA EX Catheter can be
used to facilitate introduction of
diagnostic agents or therapeutic
devices. The SOFIA EX Catheter
is not intended for use in
coronary arteries. | The SOFIA EX Intracranial
Support Catheter is indicated for
general intravascular use,
including the neuro and
peripheral vasculature. The
SOFIA EX Intracranial Support
Catheter can be used to facilitate
introduction of diagnostic agents
or therapeutic devices. The
SOFIA EX Intracranial Support
Catheter is not intended for use in
coronary arteries. |
| Device Classification | Class II
DQY
21 CFR 870.1250 | Class II
QJP, DQY
21 CFR 870.1250 |
| Catheter Body
Materials | Outer layer of polyolefin
elastomer, polyurethane
elastomer (Pellethane), polyether
block amide (Pebax) and
polyamide (Grilamid); inner layer
of stainless-steel braid, Nitinol
coil, and PTFE. | Same |
| Marker | Platinum/Iridium | Same |
| Hub | Nylon | Same |
| Strain Relief | Polyurethane | Same |
| Introducer | Pebax | Same |
| Catheter Size | 5F | Same |
| Inner Diameter (ID) | 0.058 in. | Same |
| | SOFIA™ EX Intracranial
Support Catheter (K182602) | SOFIA™ EX Intracranial
Support Catheter |
| | Predicate Device | Subject Device |
| Outer Diameter (OD) | 0.071 in. | Same |
| Effective Length | 105 cm, 115 cm. | 115 cm. |
| Coating | Hydrophilic Coating | Same |
| Tip Configuration | Straight | Same |
| Guidewire
Compatibility | $\leq$ 0.038 in. OD | Same |
| Accessories | Introducer Sheath | Same |
| Method of Supply | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging
Configuration | Catheter placed into a HDPE
dispenser tube. Dispenser tube
and introducer placed on a
polyethylene packaging card that
is inserted into a Tyvek pouch.
Pouch and IFU placed in
bleached sulfate carton box. | Same |
Table 1: Technological Characteristics Comparison
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Image /page/5/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a circular graphic on the left side, followed by the text "MicroVention" in a blue, sans-serif font. Below "MicroVention" is the word "TERUMO" in a smaller, bold, blue font. The overall design is clean and professional.
Performance Testing
The following bench testing data were provided to evaluate the performance and support the substantial equivalence of the SOFIA™ EX Intracranial Support Catheter.
| Test | Test Method Summary | Results |
|---|---|---|
| Simulated Use and | ||
| Physician Simulated Use | The simulated use of the | |
| device is evaluated in a | ||
| tortuous anatomical benchtop | ||
| model to assess tracking and | ||
| hydrophilic coating lubricity | ||
| of the device. |
Physician simulated use is
conducted with subject the | Device met acceptance
criteria. |
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Image /page/6/Picture/0 description: The image shows the logo for MicroVention TERUMO. The MicroVention part of the logo is in blue, with the word TERUMO in a smaller, bolder font below it. To the left of the text is a graphic of three overlapping circles in shades of gray and blue.
| Kink Resistance | Device is subjected to
bending experienced in
tortuous anatomy. | Device met acceptance
criteria. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Particulate Testing | The number and size of
particulates generated during
simulated use in a tortuous
anatomical model were
measured and results were
compared with the predicate
device. | Number of particulates
generated are comparable to
the predicate device. |
Biocompatibility
The subject device, SOFIA™ EX Intracranial Support Catheter is categorized as a limited exposure (≤ 24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1. The design and manufacturing of the subject device, SOFIA™ EX Intracranial Support Catheter use identical materials, processing, and sterilization method as the predicate device, SOFIA™ EX Intracranial Support Catheter (K182602) for which MicroVention has already successfully conducted biocompatibility testing per ISO 10993-1. Therefore, no additional biocompatibility testing is required.
Performance Data - Animal, Clinical
No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes.
Conclusions
The subject SOFIA™ EX Intracranial Support Catheter is substantially equivalent to the predicate device SOFIA™ EX Intracranial Support Catheter. The subject device has the same indications for use as the predicate device. The 510(k) Summary demonstrates that the subject device is substantially equivalent to the predicate device regarding operating principle, design, fundamental technology, and the device performs as intended. The changes to the instructions for use do not raise new questions of safety and effectiveness.