Socrates 38 Catheter

K242301 · Scientia Vascular, Inc. · QJP · Dec 4, 2024 · Cardiovascular

Device Facts

• Record ID: K242301
• Device Name: Socrates 38 Catheter
• Applicant: Scientia Vascular, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Dec 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Socrates™ 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates™ 38 Catheter is not intended for use in the coronary vasculature.

Device Story

Socrates™ 38 Catheter is a single-lumen, variable-stiffness, open-ended catheter; used for vascular access in neuro and peripheral vasculature. Device tracks through guide catheters using steerable guidewires and microcatheters. Construction includes nitinol, polymers (PEBAX, polyurethane), PTFE, and internal lubricious liner; distal exterior features hydrophilic coating; single radiopaque tantalum tip marker for fluoroscopic visualization. Proximal end includes clear luer lock hub and stainless-steel strain relief. Supplied sterile for single use; packaged with rotating hemostasis valve (RHV). Operated by physicians in clinical settings to facilitate navigation of diagnostic or therapeutic devices. Output is physical access to target vessels; aids clinical decision-making by enabling delivery of diagnostic agents or microcatheters to specific anatomical sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including tensile/elongation, tip stiffness, kink radius, liquid leak/burst, dynamic flow, torque, flexural fatigue, air ingress, and simulated use in tortuous anatomical models. Biocompatibility, sterilization, and shelf-life data leveraged from reference device K223913.

Technological Characteristics

Single-lumen, variable-stiffness catheter. Materials: PEBAX, polyurethane, nitinol, PTFE, polycarbonate hub, stainless steel strain relief, tantalum marker. Hydrophilic coating. Dimensions: 0.053" OD, 0.038" ID; lengths 115-156 cm. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993-1 (biocompatibility), ISO 10555-1 (catheter performance), ISO 80369-7 (luer design).

Indications for Use

Indicated for facilitating insertion and guidance of microcatheters or diagnostic agents into peripheral or neuro vasculature. Not for use in coronary vasculature.

Regulatory Classification

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.

Predicate Devices

• Modified HD Guide Catheter (K133177)

Reference Devices

• Socrates Aspiration System (K223913)

Submission Summary (Full Text)

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December 4, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Scientia Vascular, Inc Thomas Lippert Regulatory Affairs Specialist 2460 South 3270 West West Valley City, UT 84119

Re: K242301

Trade/Device Name: Socrates™ 38 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 1, 2024 Received: November 1, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Michael Mcknight -S

for 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) K242301

Device Name Socrates™ 38 Catheter

Indications for Use (Describe)

The Socrates™ 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates™ 38 Catheter is not intended for use in the coronary vasculature.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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K242301 Scientia Vascular Inc. Traditional 510(k) Socrates™ 38 Catheter

Image /page/4/Picture/1 description: The image shows the logo for Scientia. The logo features a stylized, teal-colored symbol resembling an interconnected chain or a stylized letter 'S' above the word "SCIENTIA" in a futuristic, gray font. The overall design is clean and modern.

510(K) SUMMARY K242301 (Per 21 CFR 807.92)

### SCIENTIA VASCULAR INC Socrates 38 Catheter

Submitter Name and Address Scientia Vascular, Inc. 2460 South 3270 West West Valley City, UT 84119

Contact Person Thomas Lippert Regulatory Affairs Specialist Phone: [phone] Email: regulatory(@scientiavascular.com

Date Prepared 4 December 2024

#### SUBJECT DEVICE

| Trade Name: | So |
|-------------------------|-----|
| Common Name: | Car |
| Classification Name: | Per |
| Regulation: | 21 |
| Primary Product Code: | QJ |
| Secondary Product Code: | DQ |
| Review Panel: | Ne |
| Device Class: | Cla |

crates™ 38 Catheter theter, percutaneous, neurovasculature rcutaneous catheter CFR 870.1250 P )Y urology ass II device per 21 CFR 870.1250

PREDICATE DEVICE Trade Name: Modified HD Guide Catheter Predicate 510(k) Number: K133177

REFERENCE DEVICE Trade Name: Socrates Aspiration System Predicate 510(k) Number: K223913 Device Models: Socrates™ 38 Aspiration Catheter

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#### DEVICE DESCRIPTION

Scientia Vascular's Socrates™ 38 Catheter is a single lumen, variable stiffness, open-ended catheter designed to track through a guide catheter using a steerable guidewire and microcatheter. 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).

#### INTENDED USE

The Socrates™ 38 Catheter is intended to provide access to the neuro and peripheral vasculatures.

#### INDICATIONS FOR USE

The Socrates [1] 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates TM 38 Catheter is not intended for use in the coronary vasculature.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Socrates™ 38 Catheter are compared to those of the predicate device, the Modified HD Guide Catheter below. Differences are indicated in bold.

| Characteristic | Subject Device<br>Socrates 38<br>Catheter | Predicate Device<br>Modified HD Guide<br>Catheter (K133177) | Reference Device<br>(comparisons vs subject) The Socrates<br>Aspiration System (K223913) | Comparison analysis (subject device vs predicate device) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Indications for Use | The Socrates™ 38<br>Catheter is<br>indicated for use in<br>facilitating the<br>insertion and<br>guidance of an<br>appropriate<br>microcatheter or<br>diagnostic agents<br>into a selected blood<br>vessel in the<br>peripheral or neuro<br>vasculature. The<br>Socrates™ 38<br>Catheter is not<br>intended for use in<br>the coronary<br>vasculature. | The modified HD<br>guide catheter is<br>indicated for use in<br>facilitating the<br>insertion and<br>guidance of an<br>occlusion catheter,<br>infusion catheter or<br>other appropriate<br>microcatheter into a<br>selected blood<br>vessel in the<br>peripheral,<br>coronary, and<br>neuro vascular<br>systems. It may<br>also be used as a<br>diagnostic<br>angiographic<br>catheter and as a<br>conduit for retrieval<br>devices | As part of the<br>Socrates Aspiration<br>System, the Socrates<br>38<br>Aspiration Catheter<br>with a<br>compatible suction<br>pump is indicated for<br>use in the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to<br>intracranial large<br>vessel occlusive<br>disease (within the<br>internal carotid,<br>middle cerebral -<br>M1 and M2<br>segments, basilar,<br>and vertebral<br>arteries) within 8 | Different |
| | | | hours of symptom<br>onset. Patients who<br>are ineligible for<br>intravenous tissue<br>plasminogen<br>activator (IV t-PA)<br>or who fail IV t-PA<br>therapy are<br>candidates for<br>treatment. | |
| | | | As part of the<br>Socrates Aspiration<br>System, the Socrates<br>Aspiration Tubing<br>is indicated to<br>connect the Socrates<br>38 Aspiration<br>Catheter to a<br>compatible suction<br>pump. | |
| Intended Use | Vascular access | Vascular access | Revascularization of<br>patients with acute<br>ischemic stroke. | Same |
| Catheter Materials | Hub<br>Polycarbonate<br>Strain Relief<br>Stainless Steel<br>Catheter Shaft<br>PEBAX,<br>Polyurethane,<br>Nitinol, and PTFE<br>Radiopaque Marker<br>Tantalum | Hub<br>PEBAX<br>Strain Relief<br>Polyolefin<br>Catheter Shaft<br>PEBAX, Stainless<br>Steel, Acrylic and<br>PTFE<br>Radiopaque Marker<br>Platinum/ Iridium | Same | Different |
| Catheter<br>Dimensions | Outer Diameter<br>Proximal: 0.053"<br>Distal: 0.053"<br>Inner Diameter<br>Proximal: 0.038"<br>Distal: 0.038"<br>Effective Lengths<br>115 cm, 127cm, and<br>156 cm | Outer Diameter:<br>Proximal: 0.051"<br>Distal: 0.051"<br>Inner Diameter<br>Proximal: 0.038"<br>Distal: 0.038"<br>Effective Lengths<br>105-136 cm | Same | Different |
| | Hydrophilic Coating length | Hydrophilic Coating length | | |
| | 90 cm | Unknown | | |
| Coating | Hydrophilic | Hydrophilic | Same | Same |
| Tip Shape | Straight | Straight | Same | Same |
| Radiopaque<br>Markers | 1 distally located<br>radiopaque marker | 1 distally located<br>radiopaque marker | Same | Same |
| Condition Supplied | Sterile, Single Use | Sterile, Single Use | Same | Same |
| Sterilization<br>Method | Ethylene Oxide<br>(EO) | Ethylene Oxide<br>(EO) | Same | Same |
| Packaged<br>Accessories | Rotating Hemostasis<br>Valve (RHV) | Rotating Hemostasis<br>Valve (RHV) | Same | Same |

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When compared with the predicate device, the subject Socrates™ 38 Catheter has the technological characteristic differences shown in the table above. These differences do not raise new questions of safety and effectiveness for the subject device. To evaluate the effects of these characteristic differences on safety and effectiveness, performance testing was conducted.

#### NON-CLINICAL PERFORMANCE DATA

The following non-clinical performance data were provided in support of the substantial equivalence determination:

- Biocompatibility ●
- Functional Testing
- Sterilization, Shelf Life, and Residuals

#### Performance Data - Biocompatibility

Performance data demonstrating the biocompatibility of the subject Socrates™ 38 Catheter per ISO 10993-1:2018 are leveraged from evaluations supporting the reference Socrates™ 38 Aspiration Catheter (K223913), which has the same design, components, materials, and manufacturing process as the subject device. No further required biocompatibility assessments were identifed.

#### Performance Data - Functional Testing

Non-clinical functional testing was leveraged and conducted in support of the substantial equivalence determination.

| Test | Test Method Summary | Results |
|------------------------------|--------------------------------------------------------------------------------------------------|---------|
| Tensile and Elongation | Reference ISO-10555-1:2014. Peak tensile force and elongation measured by displacement at break. | Pass |
| Tip Stiffness | The cantilever bending stiffness of the catheter tip was measured. | Pass |
| Kink Radius | Minimum kink radius was measured by wrapping the catheter around mandrels of varying size. | Pass |
| Liquid Leak and Static Burst | Per ISO-10555-1:2014. | Pass |

The following functional tests were leveraged for the Socrates™ 38 Catheter from K223913:

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| Test | Test Method Summary | Results |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dynamic Flow | Reference ISO-10555-1:2014. Dynamic flow rate was characterized. | Pass |
| Agent Compatibility | Compatibility was measured by functionally testing catheters following exposure to contrast media and saline. | Pass |
| Torque Turns to Failure | Torque turns to failure were evaluated in an anatomical model and compared with the predicate. | Pass |
| Visual and Dimensional Inspections | Test per ISO-10555-1:2014. Dimensional inspection per engineering drawings. | Pass |
| Flexural Fatigue | The catheter was flexed for multiple cycles and inspected for damage. | Pass |
| Air Ingress and Negative Collapse | Air ingress through catheter hub per ISO-10555-1:2014. Negative collapse measures catheter lumen integrity while the catheter is subjected to a worst- case vacuum pressure. | Pass |
| Model and Compatibility Testing | An anatomical model designed to simulate the tortuous neurovasculature was used for performance with ancillary devices. | Pass |
| Hub Luer Design Verification | Test per ISO-80369-7 | Pass |
| Usability and Radiopacity Validation | Physicians evaluated various performance characteristics of the subject and predicate catheter, including radiopacity in a human cadaver. | Pass |
| Lubricity and Durability | 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 |
| Corrosion Resistance | Per ISO-10555-1:2014 | Pass |

The following functional tests were conducted for the Socrates™ 38 Catheter:

| Test | Test Method Summary | Results |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Particulate Characterization | Particulates of various size ranges were counted after<br>simulated use in a tortuous path model with comparison to<br>the predicate. | Pass |
| Model and Product Compatibility<br>Evaluation | Catheters were advanced through a representative<br>neurovascular anatomical model with the use of<br>interfacing ancillary devices and compared with the<br>predicate device. | Pass |
| Delivery and Retrieval Testing | Measured the forces required to deliver and retrieve the<br>catheter in a tortuous pathway with ancillary devices. | Pass |
| Coating Integrity | Hydrophilic coating of catheter was inspected before and<br>after simulated use in a tortuous path model with<br>interfacing ancillary devices. | Pass |

#### Performance Data - Sterilization, Shelf-Life, and Residuals

Additionally, testing evaluating subject device and packaging for shelf-life, packaging integrity and sterilization including EO, ECH residuals, and bacterial endotoxin levels was leveraged from K223913. The subject device met all acceptance criteria.

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K242301 Scientia Vascular Inc. Traditional 510(k) Socrates™ 38 Catheter

The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Socrates™ 38 Catheter. Therefore, no clinical study was conducted.

#### CONCLUSION

The subject device, Socrates™ 38 Catheter, 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 non-clinical performance testing. The resulting data demonstrate that the subject device is substantially equivalent to the predicate.