(265 days)
As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated 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.
As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.
The Scientia Vascular Socrates Aspiration System is composed of two components: the Socrates 38 Aspiration Catheter, designed to aid in accessing vasculature, and the Socrates Aspiration Tubing, designed to connect the aspiration catheter to a compatible suction pump and control flow between them. When used with a compatible vacuum pump, these components facilitate the aspiration and removal of thrombus from the neurovasculature. Both components are supplied sterile for single use only.
The Socrates 38 Aspiration Catheter is a single lumen, variable stiffness catheter designed to be advanced over a steerable guidewire. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with Luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).
The Socrates Aspiration Tubing is designed to connect the Socrates 38 Aspiration Catheter to a compatible vacuum pump and control flow between them. The aspiration tubing consists of tubing attached to a suction connector on one end and a male Luer lock on the other with an intermediate on/off fluid flow control device and is supplied sterile and for single use only.
The provided FDA 510(k) summary for the Socrates Aspiration System does not contain information related to an AI/ML-enabled device or its performance criteria specific to AI/ML applications. The document describes a medical device for revascularization in acute ischemic stroke and its non-clinical performance data (biocompatibility, functional testing, and an animal study) to support substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves an AI-enabled device meets those criteria based on the provided text. The document clearly states:
- "The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Socrates Aspiration System. Therefore, no clinical study was conducted."
- There is no mention of an AI/ML component, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
If you have a document pertaining to an AI/ML medical device, please provide that.
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September 20, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Scientia Vascular, Inc. Thomas Lippert Regulatory Affairs Associate 3487 West 2100 South Suite 100 West Valley City, Utah 84119
Re: K223913
Trade/Device Name: Socrates Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 22, 2023 Received: August 23, 2023
Dear Thomas Lippert:
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
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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 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 -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
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Indications for Use
510(k) Number (if known) K223913
Device Name Socrates™ Aspiration System
Indications for Use (Describe)
As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated 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.
As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.
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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Scientia Vascular, Inc Traditional 510(k) Socrates™ Aspiration System
Image /page/3/Picture/2 description: The image contains a logo with a stylized blue design at the top, followed by the word "SCIENTIA" in a stylized font. Below the word, there is the text "510(k) SUMMARY K223913" and then "(Per 21 CFR 807.92)". The text appears to be related to a regulatory submission or summary document.
SCIENTIA VASCULAR, INC Socrates™ Aspiration System
SUBMITTER
Submitter Name and Address Scientia Vascular, Inc. 3487 West 2100 South Suite 100 West Valley City, UT 84119
Contact Person Thomas Lippert Regulatory Affairs Associate Phone: 1 (888) 385-9016 Email: regulatory(@scientiavascular.com
Date Prepared September 20, 2023
DEVICE
| Trade Name: | Socrates Aspiration System |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | NRY |
| Review Panel: | Neurology |
| Device Class: | II |
PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Trade Name: | Penumbra System® MAX |
| Predicate 510(k) Number: | K113163 |
| Device Models: | Reperfusion Catheters 3MAX and 4MAX |
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DEVICE DESCRIPTION
The Scientia Vascular Socrates Aspiration System is composed of two components: the Socrates 38 Aspiration Catheter, designed to aid in accessing vasculature, and the Socrates Aspiration Tubing, designed to connect the aspiration catheter to a compatible suction pump and control flow between them. When used with a compatible vacuum pump, these components facilitate the aspiration and removal of thrombus from the neurovasculature. Both components are supplied sterile for single use only.
The Socrates 38 Aspiration Catheter is a single lumen, variable stiffness catheter designed to be advanced over a steerable guidewire. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with Luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).
The Socrates Aspiration Tubing is designed to connect the Socrates 38 Aspiration Catheter to a compatible vacuum pump and control flow between them. The aspiration tubing consists of tubing attached to a suction connector on one end and a male Luer lock on the other with an intermediate on/off fluid flow control device and is supplied sterile and for single use only.
INTENDED USE
The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke.
INDICATIONS FOR USE
As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated 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.
As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Socrates Aspiration System are compared to those of the predicate device, the Penumbra System® MAX (K113163) in Table 1, below.
| Table 1. Comparison between Subject & Predicate Device Technological Characteristics | |||
|---|---|---|---|
| Note: Differences are bolded | |||
| Characteristic | Subject DeviceSocrates Aspiration System(K223913) | Predicate DevicePenumbra System® MAX(K113163)Reperfusion Catheter 3MAXunless otherwise noted | ComparisonAnalysis |
| Indications forUse | As part of the SocratesAspiration System, theSocrates 38 AspirationCatheter with a compatible suction pump is indicated foruse in the revascularization ofpatients with acute ischemicstroke secondary to intracraniallarge vessel occlusive disease( within the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.As part of the SocratesAspiration System, the SocratesAspiration Tubing is indicatedto connect the Socrates 38Aspiration Catheter to acompatible suction pump . | The Penumbra System is intendedfor use in the revascularization ofpatients with acute ischemicstroke secondary to intracraniallarge vessel occlusive disease (inthe internal carotid, middlecerebral - M1 and M2 segments,basilar, and vertebral arteries)within 8 hours of symptom onset. | The differencesreflect that thesubject devicedoes not include asuction pump andthe more currentwording regardingIV t-PA therapy. |
| Intended Use | Revascularization of patientswith acute ischemic stroke. | Revascularization of patients withacute ischemic stroke. | Same |
| CatheterMaterials | HubPolycarbonate | HubPolycarbonate | The differenceshave beenevaluated via non-clinical testing. |
| Strain ReliefStainless Steel | Strain ReliefStainless Steel | ||
| Catheter ShaftPEBAX, Polyurethane, Nitinol,and PTFE | Catheter ShaftPolyether Block Amide (PEBAX),Urethane, Nylon, StainlessSteel/Nitinol, and PTFE | ||
| Radiopaque MarkerTantalum | Radiopaque MarkerPlatinum/Iridium | ||
| CatheterDimensions | Outer DiameterProximal: 0.053"Distal: 0.053"Inner DiameterProximal: 0.038" | ||
| Distal: 0.038" | Proximal: 0.064"Distal: 0.041"Effective Lengths (3MAX)153 cmHydrophilic Coating length | ||
| Effective Lengths115 cm and 156 cmHydrophilic Coating length90 cm | 95 cmEffective Lengths (4MAX)139 cmHydrophilic Coating lengthUnknown | ||
| Coating | Hydrophilic | Hydrophilic | Same |
| Tip Shape | Straight | Straight | Same |
| RadiopaqueMarkers | 1 Distally Located RadiopaqueMarker | 1 Distally Located RadiopaqueMarker | Same |
| ConditionSupplied | Sterile, Single Use | Sterile, Single Use | Same |
| SterilizationMethod | Ethylene Oxide (EO) | EO | Same |
| PackagedAccessories | Rotating Hemostasis Valve(RHV) | RHV and Shaping Mandrel | Similar |
| AspirationTubing SetFeatures | Length: 100 in (254 cm)Inner Diameter (ID): 0.110 inVacuum control: Clamp | Length: 112 in.ID: 0.110 inVacuum control: Flow Switch | The differenceshave beenevaluated via non-clinical testing. |
| Aspiration PumpFeatures | Pressure: -20 inHg to -29inHg | Pressure: -20 inHg to -29inHg | Same |
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The subject device, Socrates Aspiration System, has technological characteristic differences as shown in Table 1 above when compared to the predicate device. These differences do not raise new questions of safety and effectiveness for the subject device. Evaluation of the risks for the subject device in the form of failure modes and effect analysis (FMEA) was conducted along with testing of the subject device to demonstrate the substantial equivalence to the predicate.
NON-CLINICAL PERFORMANCE DATA
The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Biocompatibility ●
- Functional Testing ●
- . Animal Study
Biocompatibility Testing
The biocompatibility evaluation of the subject device, Socrates Aspiration System, was performed in accordance with ISO 10993-1: 2018, and is summarized in Table 2 below.
| Table 2. Summary of Subject Device Biocompatibility Testing Performed | ||
|---|---|---|
| Test | Test Summary | Conclusion of Testing |
| Socrates 38 Aspiration Catheter | ||
| Cytotoxicity(MEM Elution) | Cell culture was observed forcytotoxic reactivity. | Non-cytotoxic |
| Sensitization | The study animals with subjectdevice were observed for dermalsensitization. | No sensitization reaction. |
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Functional Testing
Following a risk assessment per ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices, the functional testing summarized in Table 3 was performed in accordance with the following standards:
- ISO 10555-1:2013 (corrected 2014) Intravascular catheters Sterile and single-. use catheters - Part 1: General requirements,
- . ISO 80369-7:2016 Small bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications,
- ISO 80369-20:2015 Small bore connectors for liquids and gases in healthcare ● applications - Common test methods,
- AAMI TIR 42: 2021 Evaluation of Particulates Associated with Vascular Medical ● Devices.
As well as the FDA Guidance Documents:
- Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings -● Labeling Considerations (October 2019),
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and ● Associated Delivery Systems (April 2010).
| Table 3. Summary of Subject Device Functional TestingSocrates 38 Aspiration Catheter | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Visual & Dimensional | Test per ISO-10555-1:2014.Dimensional inspection perengineering drawings. | Pass |
| Dynamic Flow | Reference ISO-10555-1:2014.Dynamic flow rate wascharacterized. | Pass |
| Liquid Leak / Static Burst | Test Per ISO-10555-1:2014. | Pass |
| Torque - Turns to Failure | Torque - turns to failure wereevaluated in an anatomical modelwith comparison to the predicate. | Pass |
| Simulated Clot Retrievaland CompatibilityTesting (System) | An anatomical model designed tosimulate the tortuousneurovasculature was used forperformance (including simulatedthrombectomy) testing with theaspiration system (tubing andRHV) attached to a vacuum pump. | Pass |
| Tensile/Elongation | Reference ISO-10555-1:2014.Peak tensile force andelongation measured bydisplacement at break. | Pass |
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| Socrates – Aspiration System | ||
|---|---|---|
| Flexural Fatigue | The catheter was flexed for multiple cycles and inspected for damage. | Pass |
| Particulate | Particulates of various size ranges were counted after simulated use in a tortuous path model with comparison to the predicate. | Pass |
| Coating Integrity | Frictional force of the coated catheter portion was determined after simulated use in a tortuous path model. Coating integrity was visually inspected pre- and post-simulated use. | Pass |
| Suction Flow Rate (System) | Measured the suction flow rate at maximum pressure while the catheter is connected to the aspiration tubing. | Pass |
| Tip Stiffness | Measured the cantilever bending stiffness of the catheter tip. | Pass |
| Delivery and Retrieval | Measured the forces required to deliver and retrieve the catheter in a tortuous pathway with ancillary devices. | Pass |
| Air Ingress/Negative Collapse | Test per ISO-10555-1:2014 for air ingress through the catheter hub. Negative collapse testing checks for catheter lumen integrity while being subjected to a worst-case vacuum pressure. | Pass |
| Kink Radius | The catheter is wrapped around mandrels of descending sizes to determine minimum kink radius. | Pass |
| Hub Luer Design Verification | Test per ISO-80369-7. | Pass |
| Corrosion Resistance | Test Per ISO-10555-1:2014. | Pass |
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| Compatibility with Agents | The catheters were inspected and functionally tested post exposure to agents (contrast media and saline) used during test procedures. | Pass |
|---|---|---|
| Usability and Radiopacity Validation | Physicians evaluated subject and predicate catheters for various performance characteristics, including radiopacity, in a human cadaver. | Pass |
| Socrates Aspiration Tubing | ||
| Visual & Dimensional | Visual and dimensional inspection per engineering drawing. | Pass |
| Vacuum Drop | The aspiration tubing was evaluated for ability to hold a vacuum over a specified time period. | Pass |
| Leakage | The ability of the clamp to prevent leakage after a specified number of cycles was evaluated. | Pass |
| Negative Collapse (Degree of Collapse) | Test per ISO 10079-4. | Pass |
| Joint Tensile | Peak tensile force measured at break. | Pass |
| Simulated Clot Retrieval and Compatibility Testing (System) | An anatomical model designed to simulate the tortuous neurovasculature was used for performance (including simulated thrombectomy) testing with the aspiration system (tubing and RHV) attached to a vacuum pump. | Pass |
| Suction Flow Rate (System) | Measured the suction flow rate at maximum pressure while the catheter is connected to the aspiration tubing. | Pass |
Additionally, the subject device and packaging were evaluated for the proposed shelf-life, packaging integrity and sterilization including ethylene oxide (EO), ethylene chlorohydrin (ECH) residuals, and bacterial endotoxin levels.
Animal Study
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The safety and effectiveness of the Socrates Aspiration System was evaluated in a comparative animal study conducted under Good Laboratory Practices (GLP) in a porcine model against a control (the Penumbra System with the ACE 68 Reperfusion Catheter). Assessments included aspiration of experimental soft and firm clots and application of maximum vacuum with the device in a wedged position against the vessel wall. Both the subject and control systems were evaluated at subacute (3 day) and chronic (30 day) time points. Clot aspiration and wedge assessment results were comparable between the test and control systems. Angiographic and histological evaluations concluded the systems were comparable at all time points.
CLINICAL PERFORMANCE DATA
The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Socrates Aspiration System. Therefore, no clinical study was conducted.
CONCLUSION
The subject device, Socrates Aspiration System, has the same intended use and similar indications for use as the predicate device. The differences in technological characteristics do not raise new questions of safety or effectiveness and have been evaluated through testing and the resulting data demonstrate that the subject device, Socrates Aspiration System, is substantially equivalent to the predicate.
§ 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).