(124 days)
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.
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).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Socrates™ 38 Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that all tests either "Pass" or that the "subject device met all acceptance criteria." The acceptance criteria are implicitly defined by the test methods referenced (e.g., ISO standards, comparison to predicate).
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018; same design, components, materials, and manufacturing process as referenced device (K223913). | Pass |
| Functional Testing | ||
| Tensile and Elongation | Meet requirements of ISO-10555-1:2014 for peak tensile force and elongation. | Pass |
| Tip Stiffness | Meet defined cantilever bending stiffness requirements. | Pass |
| Kink Radius | Meet minimum kink radius requirements. | Pass |
| Liquid Leak and Static Burst | Meet requirements of ISO-10555-1:2014. | Pass |
| Dynamic Flow | Meet requirements of ISO-10555-1:2014 for dynamic flow rate. | Pass |
| Agent Compatibility | Maintain functionality after exposure to contrast media and saline. | Pass |
| Torque Turns to Failure | Comparable performance to predicate device in an anatomical model. | Pass |
| Visual and Dimensional Inspections | Meet requirements of ISO-10555-1:2014 and engineering drawings. | Pass |
| Flexural Fatigue | No damage after multiple flex cycles. | Pass |
| Air Ingress and Negative Collapse | Meet requirements for air ingress per ISO-10555-1:2014 and maintain lumen integrity under vacuum. | Pass |
| Model and Compatibility Testing | Successful performance with ancillary devices in a tortuous neurovasculature model. | Pass |
| Hub Luer Design Verification | Meet requirements of ISO-80369-7. | Pass |
| Usability and Radiopacity Validation | Physicians' positive evaluation of performance characteristics and radiopacity. | Pass |
| Lubricity and Durability | Maintain frictional force and coating integrity after simulated use. | Pass |
| Corrosion Resistance | Meet requirements of ISO-10555-1:2014. | Pass |
| Particulate Characterization | Comparable particle count to predicate device after simulated use. | Pass |
| Model and Product Compatibility Evaluation | Successful advancement through neurovascular model with ancillary devices, comparable to predicate. | Pass |
| Delivery and Retrieval Testing | Meet force requirements for delivery and retrieval in a tortuous pathway. | Pass |
| Coating Integrity | Maintain hydrophilic coating integrity after simulated use. | Pass |
| Sterilization, Shelf-Life, Residuals | Meet all acceptance criteria for shelf-life, packaging integrity, sterilization (EO, ECH residuals), and bacterial endotoxin levels. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the individual functional tests. It only states that "performance testing was conducted." The data provenance is non-clinical performance data, primarily from laboratory testing. It does not mention country of origin for the data, nor whether it's retrospective or prospective, as these are non-clinical studies. Many tests were "leveraged" from a previous submission (K223913) for a similar device, implying consistency in design and testing methodologies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
For the "Usability and Radiopacity Validation" test, it states "Physicians evaluated various performance characteristics...in a human cadaver."
- Number of experts: Not specified (plural "Physicians" implies more than one).
- Qualifications of experts: "Physicians" (likely interventional neuroradiologists or neurosurgeons given the device's indications) are mentioned, but specific qualifications (e.g., years of experience, subspecialty) are not provided.
- This specific test involved evaluation in a "human cadaver," which serves as a realistic test environment.
For all other functional tests, the "ground truth" (acceptance criteria) was established by engineering specifications, relevant ISO standards, and comparisons to the predicate device, not by expert consensus on a test set in the traditional sense of a clinical or image-based study.
4. Adjudication Method for the Test Set
For the "Usability and Radiopacity Validation" involving physicians, an adjudication method is not specified. For the other non-clinical functional tests, adjudication is not applicable as the results are quantitative measures against pre-defined engineering or standard-based acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Therefore, no clinical study was conducted." The device being reviewed is a physical medical device (catheter), not an AI or software device that would typically undergo MRMC studies to evaluate human-in-the-loop performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is a physical catheter, not an algorithm or software. Therefore, the concept of "algorithm only without human-in-the-loop performance" does not apply.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through:
- Engineering specifications and design requirements: For dimensional, mechanical, and functional aspects.
- International Standards (ISO): Such as ISO 10555-1:2014 for catheters and ISO 80369-7 for luer connectors, which define test methods and performance requirements.
- Comparison to a legally marketed predicate device: Many tests established performance relative to the "Modified HD Guide Catheter (K133177)" or "Socrates Aspiration System (K223913)."
- Expert Observational Consensus: For the "Usability and Radiopacity Validation" test, physicians' evaluations (though specific methodology is not detailed).
- Leveraged Data: Much of the data was leveraged from the previous K223913 submission, indicating that the design, components, and manufacturing processes are sufficiently similar to pre-validate certain aspects.
8. The Sample Size for the Training Set
This question is not applicable. The Socrates™ 38 Catheter is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms, as no algorithm is being developed or trained.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above. There is no training set for this physical medical device.
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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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2
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 1 (888) 385-9016 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 DeviceSocrates 38Catheter | Predicate DeviceModified HD GuideCatheter (K133177) | Reference Device(comparisons vs subject) The SocratesAspiration System (K223913) | Comparison analysis (subject device vs predicate device) |
|---|---|---|---|---|
| Indications for Use | The Socrates™ 38Catheter isindicated for use infacilitating theinsertion andguidance of anappropriatemicrocatheter ordiagnostic agentsinto a selected bloodvessel in theperipheral or neurovasculature. TheSocrates™ 38Catheter is notintended for use inthe coronaryvasculature. | The modified HDguide catheter isindicated for use infacilitating theinsertion andguidance of anocclusion catheter,infusion catheter orother appropriatemicrocatheter into aselected bloodvessel in theperipheral,coronary, andneuro vascularsystems. It mayalso be used as adiagnosticangiographiccatheter and as aconduit for retrievaldevices | As part of theSocrates AspirationSystem, the Socrates38Aspiration Catheterwith acompatible suctionpump is indicated foruse in therevascularization ofpatients with acuteischemic strokesecondary tointracranial largevessel occlusivedisease (within theinternal carotid,middle cerebral -M1 and M2segments, basilar,and vertebralarteries) within 8 | Different |
| hours of symptomonset. Patients whoare ineligible forintravenous tissueplasminogenactivator (IV t-PA)or who fail IV t-PAtherapy arecandidates fortreatment. | ||||
| As part of theSocrates AspirationSystem, the SocratesAspiration Tubingis indicated toconnect the Socrates38 AspirationCatheter to acompatible suctionpump. | ||||
| Intended Use | Vascular access | Vascular access | Revascularization ofpatients with acuteischemic stroke. | Same |
| Catheter Materials | HubPolycarbonateStrain ReliefStainless SteelCatheter ShaftPEBAX,Polyurethane,Nitinol, and PTFERadiopaque MarkerTantalum | HubPEBAXStrain ReliefPolyolefinCatheter ShaftPEBAX, StainlessSteel, Acrylic andPTFERadiopaque MarkerPlatinum/ Iridium | Same | Different |
| CatheterDimensions | Outer DiameterProximal: 0.053"Distal: 0.053"Inner DiameterProximal: 0.038"Distal: 0.038"Effective Lengths115 cm, 127cm, and156 cm | Outer Diameter:Proximal: 0.051"Distal: 0.051"Inner DiameterProximal: 0.038"Distal: 0.038"Effective Lengths105-136 cm | Same | Different |
| Hydrophilic Coating length | Hydrophilic Coating length | |||
| 90 cm | Unknown | |||
| Coating | Hydrophilic | Hydrophilic | Same | Same |
| Tip Shape | Straight | Straight | Same | Same |
| RadiopaqueMarkers | 1 distally locatedradiopaque marker | 1 distally locatedradiopaque marker | Same | Same |
| Condition Supplied | Sterile, Single Use | Sterile, Single Use | Same | Same |
| SterilizationMethod | Ethylene Oxide(EO) | Ethylene Oxide(EO) | Same | Same |
| PackagedAccessories | Rotating HemostasisValve (RHV) | Rotating HemostasisValve (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 aftersimulated use in a tortuous path model with comparison tothe predicate. | Pass |
| Model and Product CompatibilityEvaluation | Catheters were advanced through a representativeneurovascular anatomical model with the use ofinterfacing ancillary devices and compared with thepredicate device. | Pass |
| Delivery and Retrieval Testing | Measured the forces required to deliver and retrieve thecatheter in a tortuous pathway with ancillary devices. | Pass |
| Coating Integrity | Hydrophilic coating of catheter was inspected before andafter simulated use in a tortuous path model withinterfacing 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.
§ 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).