(252 days)
No
The summary describes a mechanical aspiration catheter and its accessories, with no mention of AI or ML in its function, design, or testing.
Yes
The device is described as an aspiration catheter intended for use in the revascularization of patients with acute ischemic stroke to remove thrombus/embolus from the neurovasculature, which directly treats a medical condition.
No.
The device is an aspiration catheter designed to remove thrombus/embolus; it does not diagnose medical conditions.
No
The device description clearly details a physical catheter, tubing kit, and accessories, indicating it is a hardware medical device, not software-only.
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 the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed directly on the patient's body to treat a medical condition.
- Device Description: The description details a physical catheter designed to be introduced into the neurovasculature to remove thrombus/embolus. This is a medical device used for a procedure, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical/interventional.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
Product codes
NRY
Device Description
The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
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. Conclusion: Device performs as intended and demonstrates equivalency to its predicate devices under simulated use conditions.
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. Conclusion: Device met established dimensional and physical specifications and is substantially equivalent to the predicate device.
Kink Resistance: No kinks when wrapped around 0.030 and 0.040-inch pin gauges. No kinks noted during simulated use testing. Conclusion: Device resistant to kinking around small radii turns, same as predicate device.
Durability/Lubricity of Hydrophilic Coating: Test article achieved a rating of >= 3 during simulated use testing for coating durability and lubricity. Conclusion: Device tracks easily with no coating cracking or separation.
Catheter Stiffness: Device stiffness equivalent to predicate and competitive devices. Conclusion: Device tracks in tortuous anatomy while advancing to target site.
Catheter Flexural Fatigue: No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. Conclusion: Device integrity suitable for intended clinical use.
Force at Break (Shaft and hub): Catheter force at break >= 15N for shaft section and hub/catheter junction. Conclusion: Tensile strength test results meet acceptance criteria and equivalent to predicate and competitive devices.
Force at Break (After tip shaping): Catheter force at break >= 15N for distal section assessed pre- and post-tip shaping. Conclusion: Device meets acceptance criteria and no difference between pre- and post- force at break.
Static Burst Pressure: No damage of pressurized catheter at 46 psi. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: Device met labeled maximum infusion pressure of 300 psi.
Catheter Collapse: Test articles were pressurized for a duration of 6 minutes and no observation of catheter collapse. Conclusion: No observation of device collapse, equivalent to predicate device.
Vacuum Pressure: Vacuum pressure testing of catheter at distal tip was compared to vacuum pressure of source. No difference detected. Conclusion: No difference was measured between device and predicate.
Torque Response: Catheter torque response was assessed in vascular model and met acceptance criteria. Conclusion: Equivalent or better than predicate.
Torque Strength: Catheter was torqued and did not break. Conclusion: Met acceptance criteria.
Advance/Retract: Catheter was subjected to advance/retraction test in a vascular model and was equivalent or better than predicate. Conclusion: Met acceptance criteria.
Radiopacity: Marker band was detectable under fluoroscopy. Conclusion: Marker band is visible under fluoroscopy.
Corrosion Resistance: Met ISO 10555-1. Conclusion: Catheter is corrosion resistant.
Particulate Testing: Met USP criteria. Conclusion: Catheter does not generate particulate.
Animal Study: The SOFIA Plus Aspiration Catheter was evaluated in a comparative animal study that was conducted to evaluate its aspiration performance and its safe use in a swine model. Histopathological evaluations of the affected vasculature using the device were also performed as part of the study.
Key Metrics
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
June 11, 2018
MicroVention, Inc. Naomi Gong Associate Director, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K173200
Trade/Device Name: SOFIA Plus Aspiration Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 27, 2018 Received: May 1, 2018
Dear Naomi 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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for 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) K173200
Device Name SOFIA Plus Aspiration Catheter
Indications for Use (Describe)
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
| 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 - K173200
Pursuant to Section 12, Part (a)(i)(3)(A) of the Safe Medical Devices Act of 1990, MicroVention, Inc. is providing this summary of substantial equivalence for the SOFIA™ Plus Aspiration Catheter (21 CFR 807.92).
Applicant Name and Address
MicroVention, Inc. 1311 Valencia Avenue Tustin, California 92780 USA
Contact Information
Naomi Gong Associate Director, Regulatory Affairs Tel: (714) 247-8055 naomi.gong(@microvention.com
Date of Preparation of the 510(k) Summary
June 5. 2018
Device Trade or Proprietary Name
SOFIA Plus Aspiration Catheter
Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Regulation Name(s): | Percutaneous Catheter |
| Regulation Number(s): | 21 CFR 870.1250 |
| Product Code: | NRY (Catheter, Thrombus Retriever) |
Predicate Device
Penumbra Reperfusion Catheter ACE64 and ACE68 (K152541)
Indications for Use
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Description
The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.
4
Technological Characteristics Comparison Table
| | Penumbra Reperfusion Catheter
ACE 64/68
(K152541 predicate device) | | SOFIA Plus Aspiration Catheter
(subject device) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | The Penumbra System is intended for use
in the revascularization of patients with
acute ischemic stroke secondary to
intracranial large vessel occlusive disease
(within the internal carotid, middle
cerebral - M1 and M2 segments, basilar,
and vertebral arteries) within 8 hours of
symptom onset. | | SAME:
The SOFIA Plus Aspiration Catheter with the
Gomco 405 Aspiration Pump and
MicroVention Tubing Kit is intended for use in
the revascularization of patients with acute
ischemic stroke secondary to intracranial large
vessel occlusive disease (within the internal
carotid, middle cerebral - M1 and M2
segments, basilar, and vertebral arteries) within
8 hours of symptom onset. Patients who are
ineligible for intravenous tissue plasminogen
activator (IV t-PA) or who fail IV t-PA therapy
are candidates for treatment. |
| Material | | | |
| Catheter body | Outer layer of polyurethane elastomer
(Tecoflex and Pellethane), polyether block
amide (Pebax) and polyamide (Vestimid);
inner layer of stainless steel and/or NiTi
coil | | 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 |
| Marker band | Pt/Ir | | Pt/Ir |
| Hub | Nylon (Grilamid) | | Nylon |
| Strain relief | Nylon (Grilamid)/SS304 | | Polyurethane |
| Introducer | PTFE | | Pebax |
| Shaping mandrel | Stainless Steel | | Stainless steel |
| ID | ACE64:
Prox = 0.068 in. Min
Distal = 0.064 in. Min | ACE68:
0.068 in. Min | 0.070 in. |
| OD | ACE64:
Prox = 0.084 in. Max
Distal = 0.080 in. Max | ACE68:
0.084 in. Max | Prox: 0.083 in.
Distal: 0.082 in. |
| Effective Length | 115 - 132 cm | | 125 - 131 cm |
| Coating | Hydrophilic coating (SRDX Harmony) | | Hydrophilic coating (Hydak®) |
| Tip Configuration | Steam shapeable by user | | Steam shapeable by user |
| Accessories | Peelable sheath, rotating hemostatic valve,
shaping mandrel | | Introducer sheath and shaping mandrel |
| Method of Supply | Sterile and single use | | Sterile and single use |
| Sterilization Method | Ethylene oxide | | Ethylene oxide |
| Packaging
Configuration | Polyester/polyethylene/Tyvek® pouch,
Polyethylene hoop, polyethylene card,
paperboard carton. | | Polyester/polyethylene/Tyvek® pouch,
Polyethylene tube, polyethylene card, paperboar
carton. |
| Components | | | |
| Aspiration Pump | Penumbra Aspiration Pump
Vacuum of -25 in Hg | | Gomco 405 Aspiration Pump |
| Aspiration Tubing | 112 inch length
Tubing ID = 0.110 inch | | Same |
5
Summary of Pre-Clinical Testing
Included in this section are summary descriptions of the non-clinical testing which substantiates the performance of the subject device, the SOFIA Plus Aspiration Catheter:
| Biocompatibility | Results | Conclusions |
|---|---|---|
| Cytotoxcitiy (ISO 10993-5) |
- MEM elution assay | Cell culture treated with test article
exhibited slight reactivity (Grade 1) | Non-cytotoxic
PASSED |
| 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
PASSED |
| 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
PASSED |
| 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
PASSED |
| 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
PASSED |
| Hemocompatibility - Complement
Activation Assay (ISO 10993-4) | C3a and SC5b-9 levels 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 |
| Catheter Collapse | Test articles were pressurized for a duration of
6 minutes and no observation of catheter
collapse | No observation of device
collapse, equivalent to
predicate device |
| Vacuum Pressure | Vacuum pressure testing of catheter at distal
tip was compared to vacuum pressure of
source. No difference detected. | No difference was measured
between device and predicate |
| Torque Response | Catheter torque response was assessed in
vascular model and met acceptance criteria. | Equivalent or better than
predicate |
| Torque Strength | Catheter was torqued and did not break | Met acceptance criteria |
| Advance/Retract | Catheter was subjected to advance/retraction
test in a vascular model and was equivalent or
better than predicate | Met acceptance criteria |
| Radiopacity | Marker band was detectable under
fluoroscopy | Marker band is visible under
fluoroscopy |
| Corrosion Resistance | Met ISO 10555-1 | Catheter is corrosion resistant |
| Particulate Testing | Met USP criteria | Catheter does not generate
particulate |
6
7
Animal Study:
The SOFIA Plus Aspiration Catheter was evaluated in a comparative animal study that was conducted to evaluate its aspiration performance and its safe use in a swine model. Histopathological evaluations of the affected vasculature using the device were also performed as part of the study.
Summary of Clinical Data:
Not applicable
Summary of Substantial Equivalence
The data presented in this submission demonstrate the technological similarity and performance equivalency of the SOFIA Plus Aspiration Catheter when compared with the predicate device, the Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).
The devices:
- . Have the same intended use and indications for use,
- Have the same mode of action,
- Use the same operating principle, ●
- Incorporate the same basic design, materials, dimensional and physical characteristics, and
- Are packaged and sterilized using same methods, with similar shelf-life. .
In summary, the SOFIA Plus Aspiration Catheter described in this substantially equivalent to its predicate device, Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).