(43 days)
Not Found
No
The summary describes a physical catheter device and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device description states it is used to "facilitate introduction of diagnostic and therapeutic agents", which means it delivers other substances, not that it is therapeutic itself.
No
The device is described as facilitating the introduction of diagnostic and therapeutic agents, indicating it is a tool for delivery rather than performing a diagnostic function itself.
No
The device description clearly outlines physical components like a catheter, introducer sheath, and shaping mandrel, and the performance studies include extensive bench testing on physical attributes and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general intravascular use, including the neuro and peripheral vasculature." This describes a device used within the body for diagnostic and therapeutic purposes, not a device used to examine specimens outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter designed for navigation through the vasculature, which is consistent with an in-vivo device.
- Performance Studies: The performance studies focus on aspects like biocompatibility, mechanical properties (kink resistance, torque strength, etc.), and flow rate, all of which are relevant to a device used internally. There are no studies related to analyzing biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is a catheter used for accessing and delivering agents within the patient's blood vessels.
N/A
Intended Use / Indications for Use
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
Product codes
DQY, DQO
Device Description
The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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
Bench Testing:
- Simulated Use: Test articles achieved a rating >= 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/ guidewire removal, removal/ aspiration of clot, mechanical clot retriever and stent delivery with no particles. Device performs as intended under simulated use conditions.
- Equipment Interface: Test articles compatible with 0.035-inch guidewire, 7F or larger guide catheter/guiding sheath, common RHVs using insertion tool, stopcocks and = 3 during simulated use testing for coating durability and lubricity. Device tracks easily with no coating cracking or separation.
- Catheter Stiffness: Device stiffness equivalent to predicate and competitive devices. Device tracks in tortuous anatomy while advancing to target site.
- Torque Strength: No catheter breakage after 50 rotations. Device torque strength same as predicate device.
- Catheter Flexural Fatigue: No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. Device integrity suitable for intended clinical use.
- Surface Contamination: Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm2, embedded particulates. Distal tip smooth and tapered. Device integrity suitable for intended clinical use.
- Force at Break (Distal and Hub): PTFE inner layer not delaminated. Catheter force at break >= 3.37 lbf for distal section and hub/catheter junction. Tensile strength test results equivalent to predicate and competitive devices.
- Flow Rate: Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices. Device meets specified requirements for delivery of diagnostic agents.
- Static Burst Pressure: No damage of pressurized catheter at 46 psi. Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
- Fluid Leakage at > 46 psi: No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
- Air Leakage: No air leakage at hub into syringe for 15 seconds. Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
- Dynamic Burst: Test articles did not burst at or below 300 psi. Device met labeled maximum infusion pressure of 300 psi.
- Particulate Test: Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume. Device met specifications for maximum allowable particles.
Biocompatibility (Prior test data from predicate device):
- Cytotoxicity (ISO 10993-5) - MEM elution assay: Cell culture treated with test article exhibited slight reactivity (Grade 1). Non-cytotoxic.
- Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization: Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). Weak allergic potential or sensitizing capacity.
- Sensitization/Irritation (ISO 10993-10) - Intracutaneous reactivity: Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. Non-irritant.
- Hemocompatibility – Rabbit Blood Direct and Indirect Contact (ISO 10993-4): The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). Non-hemolytic.
- Hemocompatibility – Unactivated Partial Thromboplastin Time Assay Direct Contact (ISO 10993-4): No statistically significant difference found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. No effect on coagulation.
- Hemocompatibility - Complement Activation Assay (ISO 10993-4): C3a and SC5b-9 levels
§ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
Microvention, Inc. Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Ave Tustin, California 92780
Re: K150366
Trade/Device Name: Sofia 6F PLUS/Distal Access Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DQO Dated: February 11, 2015 Received: February 12, 2015
Dear Ms. Gong:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150366
Device Name SOFIA PLUS/Distal Access Catheter
Indications for Use (Describe)
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It 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
| 510(k) Summary | |
|---|---|
| Trade Name: | SOFIA™ PLUS Catheter |
| SOFIA™ Distal Access Catheter | |
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Naomi Gong |
| Date: | 2015 February 11 |
| Predicate Device: | SOFIA Distal Access Catheter (K142014/K131482) |
Device Description:
The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
Indications For Use:
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
| | SOFIA Distal Access Catheter
(predicate) | SOFIA PLUS/Distal Access
Catheter |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Intended Use | Intended for general intravascular use, including the neuro and peripheral vasculature.
It can be used to facilitate the introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries. | Same |
| Material
Catheter Body | Outer layer of polyurethane elastomer (Polyblend and Pellethane), polyether block amide (Pebax) and polyamide (Grilamid); inner layer of stainless steel braid/coil, PTFE and polyolefin elastomer | Same |
| Marker | Platinum/Iridium | |
| Hub | Nylon | |
| Strain Relief | Polyurethane | |
| Introducer | Pebax | |
| Shaping Mandrel | Stainless steel | |
| Catheter size | 5 F | 6F |
| ID | 0.055 inch (1.4 mm) | 0.070 inch (1.78 mm) |
| OD | 0.068 inch (1.7 mm) | 0.0825 inch (2.1 mm) |
| Effective Length | 115-125 cm | 115-135 cm |
Technological Comparison:
4
| | SOFIA Distal Access Catheter
(predicate) | SOFIA PLUS/Distal Access
Catheter |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Coating | Hydrophilic coating
(Hydak® - same) | Same |
| Tip Configuration | Steam shapeable by user | Same |
| Guidewire Compatibility | 0.035 inch | Same |
| Accessories | Introducer sheath and shaping mandrel | 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, introducer and shaping mandrel
placed on a polyethylene packaging card that is
inserted into a Tyvek® pouch. Pouch and IFU
placed in bleached sulfate carton box. | Same |
Verification and Test Summary:
| Bench Testing | ||
|---|---|---|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating ≥ 3 for | |
| preparation/ease of assembly, introducer | ||
| sheath interaction, introducer peel away, | ||
| tracking with guidewire/microcatheter, | ||
| microcatheter/guidewire lockup, lubricity | ||
| and durability of hydrophilic coating, | ||
| microcatheter/ guidewire removal, | ||
| removal/ aspiration of clot, mechanical | ||
| clot retriever and stent delivery with no | ||
| particles | Device performs as intended | |
| under simulated use | ||
| conditions | ||
| Equipment Interface | Test articles compatible with 0.035-inch | |
| guidewire, 7F or larger guide | ||
| catheter/guiding sheath, common RHVs | ||
| using insertion tool, stopcocks and ≤ | ||
| 0.027-inch microcatheters | Device compatible with | |
| recommended accessories | ||
| commonly used in | ||
| intravascular procedures | ||
| Dimensional and Physical Attributes | Test articles met the specified dimensional | |
| requirements for catheter OD, catheter ID, | ||
| overall working length, length of distal | ||
| section, length of distal tip to marker band | ||
| and total length of hub/strain relief | Device met established | |
| dimensional and physical | ||
| specifications | ||
| Kink Resistance | No kinks at 1 cm, 4 cm, 12 cm and 25 cm | |
| from distal tip when wrapped around | ||
| 0.025, 0.030, 0.040-inch pin gauges | ||
| No kinks noted during simulated use | ||
| testing | Device resistant to kinking | |
| around small radii turns | ||
| Tip Shapeability | Tip angle of test article equivalent to | |
| competitive devices after steam shaping | ||
| using mandrel with an angle of | ||
| approximately 90° | Shapeability of distal tip after | |
| steam shaping – for reference | ||
| Radio Detectability | Distal marker band visible under | |
| fluoroscopy | ||
| (Prior test data from predicate device) | Device radiopacity equivalent | |
| to or better than predicate and | ||
| competitive devices | ||
| Gauging (ISO 594-2) | Gauging pin and hub align in limit planes | |
| (Prior test data from predicate device) | Device hub meets the | |
| requirements of ISO 594-2 | ||
| Bench Testing | ||
| Test | Results | Conclusions |
| Separation Force (ISO 594-2) | Mating parts separation force greater than 25 N (Prior test data from predicate device) | Device hub meets the requirements of ISO 594-2 |
| Unscrewing Torque (ISO 594-2) | Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds (Prior test data from predicate device) | Device hub meets the requirements of ISO 594-2 |
| Stress Cracking (ISO 594-2) | No stress cracks on test article hub (Prior test data from predicate device) | Device hub meets the requirements of ISO 594-2 |
| Ease of Assembly (ISO 594-2) | Components fit together securely with no resistance observed between test article luer and reference fitting (Prior test data from predicate device) | Device hub meets the requirements of ISO 594-2 |
| Resistance to Overriding (ISO 594-2) | Test article luer does not override reference fitting threads (Prior test data from predicate device) | Device hub meets the requirements of ISO 594-2 |
| Durability/Lubricity of Hydrophilic Coating | Test article achieved a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity. | Device tracks easily with no coating cracking or separation |
| Catheter Stiffness | Device stiffness equivalent to predicate and competitive devices | Device tracks in tortuous anatomy while advancing to target site |
| Torque Strength | No catheter breakage after 50 rotations | Device torque strength same as predicate device |
| Catheter Flexural Fatigue | No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing | Device integrity suitable for intended clinical use |
| Surface Contamination | Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm2, embedded particulates | |
| Distal tip smooth and tapered | Device integrity suitable for intended clinical use | |
| Force at Break (Distal and Hub) | PTFE inner layer not delaminated | |
| Catheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction | Tensile strength test results equivalent to predicate and competitive devices | |
| Flow Rate | Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices | Device meets specified requirements for delivery of diagnostic agents |
| Static Burst Pressure | No damage of pressurized catheter at 46 psi | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 |
| Fluid Leakage at > 46 psi | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 |
| Air Leakage | No air leakage at hub into syringe for 15 seconds | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 |
| Dynamic Burst | Test articles did not burst at or below 300 psi | Device met labeled maximum infusion pressure of 300 psi |
| Particulate Test | Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume | Device met specifications for maximum allowable particles |
5
6
| Note: Biocompatibility was prior test data from predicate device. | |||||
|---|---|---|---|---|---|
| Biocompatibility | Result | Conclusions |
|---|---|---|
| Cytotoxicity (ISO 10993-5) |
- MEM elution assay | Cell culture treated with test article
exhibited slight reactivity (Grade 1) | Non-cytotoxic |
| Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization | Extracts of the test article elicited no
reaction at the challenge (0%
sensitization) following the induction
phase (Grade 1). | Weak allergic potential
or sensitizing capacity |
| Sensitization/Irritation (ISO 10993-10) - Intracutaneous reactivity | Extracts of the test article did not
show a significantly greater
biological reaction than the sites
injected with the control article | Non-irritant |
| Hemocompatibility – Rabbit Blood Direct and
Indirect Contact (ISO 10993-4) | The hemolysis index was 0.13%
(direct contact) and 0.0% (indirect
contact) | Non-hemolytic |
| Hemocompatibility – Unactivated Partial
Thromboplastin Time Assay Direct Contact (ISO
10993-4) | No statistically significant difference
found between the Unactivated
Partial Thromboplastin Time (UPTT)
of the plasma exposed to the test
article and that of the plasma exposed
to either the negative control or the
untreated control | No effect on
coagulation |
| Hemocompatibility - Complement Activation
Assay (ISO 10993-4) | C3a and SC5b-9 levels ≤ negative
and untreated controls | No effect on
complement activation |
| Hemocompatibility - Thrombogenicity Study in
Dogs (ISO 10993-4) | Minimal thrombosis observed with a
Grade 0 in two out of two test sites
and two out of two control sites | No significant
thrombosis |
| Systemic Toxicity - Systemic Injection Test
(ISO 10993-11) | Extracts of test article did not induce
a significantly greater biological
reaction than the control extracts
when injected in Swiss Albino mice | No toxic effects |
| Systemic Toxicity - Rabbit Pyrogen Test (ISO
10993-11) | The temperature increases
(maximum) was 0.03°C from
baseline | Non-pyrogenic |
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA PLUS/Distal Access Catheter when compared with the predicate device, SOFIA Distal Access Catheter (K142014/K131482).
The devices,
- " Have the same intended use,
- Use the same operating principle, ■
- Incorporate the same basic design,
- . Are packaged and sterilized using same methods.
In summary, the SOFIA PLUS/Distal Access Catheter described in this submission is substantially equivalent to the predicate device.