(167 days)
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The provided text describes a medical device, the Aristotle Colossus Guidewire, and its clearance process with the FDA. It details a comparison to a predicate device and reports on non-clinical performance tests. However, the document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth by experts for such a study. It specifically focuses on the physical and functional characteristics of a guidewire.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of an AI/human-in-the-loop performance evaluation. The document describes a traditional medical device clearance process based on material properties, functional performance, and biocompatibility.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what is present:
Information NOT present in the document which your request asks for:
- A table of acceptance criteria and reported device performance related to AI/human reader performance.
- Sample size used for a test set in the context of AI/human reader performance.
- Data provenance (country of origin, retrospective/prospective) for AI/human reader performance data.
- Number of experts used to establish ground truth for an AI/human reader test set or their qualifications.
- Adjudication method for an AI/human reader test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size of human readers with/without AI).
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data) in the context of AI interpretation.
- Sample size for a training set (for an AI model).
- How ground truth for a training set was established (for an AI model).
Information that IS present in the document (but is for a physical medical device, not an AI/Software as a Medical Device):
The document describes the acceptance criteria and performance study for the Aristotle Colossus Guidewire, which is a physical medical device (a guidewire for vascular procedures). The studies described are non-clinical (laboratory and simulated use) to demonstrate the device's physical and biological safety and effectiveness.
1. Acceptance criteria and reported device performance (for the physical guidewire):
The document states: "Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents."
The "Table 3: Summary of Subject Device Functional Testing" lists the tests performed and consistently reports: "The Aristotle Colossus Guidewires met test acceptance criteria."
Here's a summary of the stated "acceptance criteria" through the lens of successful test outcomes for the physical guidewire:
| Acceptance Criteria (Implied by Test Name) | Reported Device Performance (Always "Met Acceptance Criteria") |
|---|---|
| Biocompatibility: | |
| Non-cytotoxic | Non-cytotoxic |
| Non-hemolytic | Non-hemolytic |
| No effect on Partial Thromboplastin Time | No effect on the PTT. The two samples are considered similar. |
| Similar or lower Complement Activation | Similar or lower potential to activate the complement system when compared to the predicate. |
| Similar Thrombogenic risk potential | Thrombogenic risk potential similar to the predicate. |
| Functional Testing: | |
| Dimensional conformance | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Sufficient Tensile Strength | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Resistance to Fracture and Flexing | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Acceptable Torqueability and Torque Strength | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Appropriate Tip Flexibility | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Tip Shape Retention | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Acceptable Coating Lubricity and Durability | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Coating Integrity | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Low Particulate Generation | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Performance in Simulated Use Model | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Favorable Usability Evaluation by Physicians | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Sterilization & Shelf Life: | |
| Sterilization assurance levels (SAL) of at least 10^-6 | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Acceptable EO and ECH residuals | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Acceptable bacterial endotoxin levels | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Packaging integrity maintained through shelf-life | Not explicitly stated 'met', but implied by final conclusion for clearance and new 1-year shelf life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively for each test, but it refers to the physical guidewires tested. Standard engineering and biocompatibility testing typically involves a specific number of units per lot or batch, but these numbers are not detailed in this summary.
- Data Provenance: The studies are non-clinical performance tests conducted in a laboratory setting, likely by or for the manufacturer, Scientia Vascular, Inc. (West Valley City, Utah). They are simulations or bench tests rather than data derived from patients. The studies are prospective in the sense that they were designed and executed to evaluate this specific device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable in the context of this device's testing. The "Usability Evaluation" involved "Physicians [who] evaluated subject and predicate guidewires for various performance characteristics in a human cadaver." The number and specific qualifications of these physicians are not provided. This is a usability assessment, not an expert panel for establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical device, and the "usability evaluation" doesn't describe a ground truth adjudication process in the manner seen for diagnostic AI.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a guidewire, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a guidewire, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by engineering specifications, material science standards, and in vitro/ex vivo (cadaver) performance. For biocompatibility, it's established via standardized biological assays. There is no "ground truth" in the clinical diagnostic sense with expert consensus or pathology involved.
8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
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January 26, 2023
Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Scientia Vascular, Inc. Max Alfonso Regulatory Affairs Specialist 3487 West 2100 South, Suite 100 West Valley City, Utah 84119
Re: K222437
Trade/Device Name: Aristotle Colossus Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 28, 2022 Received: December 29, 2022
Dear Max Alfonso:
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
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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) 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 (OS) 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)
Device Name Aristotle Colossus Guidewire
Indications for Use (Describe)
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire 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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Image /page/3/Picture/1 description: The image features the logo for Scientia. The logo consists of a stylized, teal-colored symbol resembling an abstract "S" or a linked chain, positioned above the word "SCIENTIA" in a gray, futuristic-looking font. The symbol is made up of two parallel lines that curve and overlap, creating a sense of connection or flow.
510(k) SUMMARY (Per 21 CFR 807.92)
SCIENTIA VASCULAR, INC. Aristotle Colossus Guidewire
Submitter Name and Address: Scientia Vascular, Inc. 3487 West 2100 South Suite 100 West Valley City, UT 84119
Contact Person: Max Alfonso Regulatory Affairs Specialist Phone: 1 (888) 385-9016 Email: regulatory(@scientiavascular.com
Date Prepared: January 26, 2023
| Trade Name: | Aristotle Colossus Guidewire |
|---|---|
| Common Name: | Guidewire |
| Classification Name: | Guide, Wire, Catheter, Neurovasculature per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Secondary Product Code: | DQX |
| Review Panel: | Neurology |
| Device Class: | Class II device per 21 CFR 870.1330 |
| Predicate Device: | Aristotle 24 Guidewire (K192783) |
| Reference Device: | ASAHI Neurovascular Guide Wire ASAHI CHIKAI Black 18 (K141751) |
DEVICE DESCRIPTION
Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the
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guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.
INTENDED USE
The Aristotle Colossus Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.
INDICATIONS FOR USE
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Aristotle Colossus Guidewire has the:
- Same indications for use. ●
- Same intended use,
- Same operating principle. ●
- Same basic guidewire design, ●
- Same materials, and ●
- Same packaging materials and sterilization process,
as the predicate device.
Shown in the table below is the comparison of technological characteristics for the Aristotle Colossus Guidewire to those of the predicate device, Aristotle 24 Guidewire (K192783), and the reference device, ASAHI Neurovascular Guide Wire ASAHI CHIKAI Black 18 (K141751).
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| Table 1: Comparison between Subject & Predicate/Reference Device Technological CharacteristicsNote: Differences between subject and predicate devices are bolded | |||
|---|---|---|---|
| Description | Subject DeviceAristotle Colossus Guidewire | Predicate DeviceAristotle 24 Guidewire (K192783) | Reference DeviceASAHI Neurovascular Guide Wire ASAHICHIKAI Black 18 (K141751) |
| Indicationsfor Use | The Aristotle Colossus Guidewire isintended for general vascular use withinthe neuro and peripheral vasculatures tointroduce and position catheters andother interventional devices. Theguidewire is not intended for use in thecoronary vasculature. | The Aristotle 24 Guidewire is intendedfor general vascular use within the neuroand peripheral vasculatures to introduceand position catheters and otherinterventional devices. The guidewire isnot intended for use in the coronaryvasculature. | This guide wire is intended to be used in theneuro vasculature to facilitate the placementand exchange of therapeutic devices such ascerebral catheters during intravasculartherapy. This guide wire is intended for useonly in the neuro vasculature. |
| Intended Use | The Aristotle Colossus Guidewire isintended for use by a physician to helpintroduce and position catheters or otherinterventional devices within the neuroand peripheral vasculature. | The Aristotle 24 Guidewire is intendedfor use by a physician to help introduceand position catheters or otherinterventional devices within the neuroand peripheral vasculature. | This guide wire is intended to be used in theneuro vasculature to facilitate the placementand exchange of therapeutic devices such ascerebral catheters during intravasculartherapy. This guide wire is intended for useonly in the neuro vasculature. |
| WireDiameter | 0.035" (0.88 mm) | 0.024" (0.61 mm) | 0.018" (0.45 mm) |
| DeviceLength | 150 cm to 300 cm | 200 cm | 200 cm |
| Flex Length | 35 cm | 35 cm | 34 cm |
| Tip Type andShape | Straight, shapeable | Straight, shapeable | Round Curve |
| Flexibility | Standard | Support, Standard, Soft | Standard |
| Wire Material | Core wire: Stainless-steel | Core wire: Stainless-steel | Core wire: Stainless-steel |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Distal End: Hydrophilic |
| Table 1: Comparison between Subject & Predicate/Reference Device Technological CharacteristicsNote: Differences between subject and predicate devices are bolded | |||
| Description | Subject DeviceAristotle Colossus Guidewire | Predicate DeviceAristotle 24 Guidewire (K192783) | Reference DeviceASAHI Neurovascular Guide Wire ASAHICHIKAI Black 18 (K141751) |
| Distal Coated Length: 46 cm | Distal Coated Length: 46 cm | Distal Coated Length: 170 cm | |
| Proximal End: PTFE | Proximal End: PTFE | Proximal End: None | |
| Accessories | Shaping mandrel, guidewire introducer,torque device | Shaping mandrel, guidewire introducer,torque device | Shaping mandrel, guidewire introducer,torque device |
| PackagingConfiguration | Tyvek pouch, carton, shipper box | Tyvek pouch, carton, shipper box | Tyvek pouch, carton, shipper box |
| SterilizationMethod | 100% Ethylene Oxide (EO) | 100% EO | 100% EO |
| Shelf Life | 1 year | 3 years | 3 years |
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The subject device has the following technological characteristic differences when compared to the predicate device: wire diameter, device length and shelf life. The changes in technological characteristics do not result in new materials used or raise new or different questions of safety and effectiveness, nor do the changes result in introduction of new risks for the subject device.
NON-CLINICAL PERFORMANCE TESTS
Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents.
Biocompatibility
The biocompatibility evaluation for the subject device, Aristotle Colossus Guidewire, identified as an externally communicating device with circulating blood contact for a limited duration (≤ 24 hours), was performed in accordance with ISO 10993-1: 2018. The materials used in the manufacture of the subject device Aristotle Colossus Guidewire are identical to those used in the manufacturing of the predicate device Aristotle 24 Guidewire, also manufactured by Scientia Vascular, Inc. (K192783). Therefore, some testing is adopted from K192783. The following are the biocompatibility tests performed on the Aristotle Colossus Guidewire:
| Name of Test | Test Summary | Conclusion of Testing |
|---|---|---|
| Cytotoxicity: MEMElution | Cell culture was observed for cytotoxicreactivity. | Non-cytotoxic. |
| Direct Contact and ExtractMethod Hemolysis Test | The difference between the hemolyticindexes of the subject device and thenegative control was evaluated. | Non-hemolytic. |
| Partial Thromboplastin Time(PTT) Test | The clotting time was observed for boththe subject device and the predicate. | No effect on the PTT. The twosamples are considered similar. |
| Complement Activation ofSC5b-9 | Comparison of the subject device SC5b-9value to the predicate device for allexposure times was performed. | The subject device had similar orlower potential to activate thecomplement system when comparedto the predicate. |
| Hemocompatibility In- vitroBlood Loop | The catheters are placed in an in- vitroblood loop for three runs.The thrombus score for the subjectdevice and predicate device is observed. | Thrombogenic risk potential similar tothe predicate. |
Functional Testing
Performance testing on the subject device was performed after conducting a risk assessment in accordance with ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices. Functional testing was performed in accordance with the following standards:
- ISO 11070-2014 Sterile Single-use Intravascular Introducers, Dilators, and Guidewires; .
- AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices; ● as well as the FDA Guidance Documents:
- Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recommended ● Labeling (October 2019):
- Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings Labeling ●
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Considerations (October 2019).
Table 3 summarizes the testing performed to demonstrate substantial equivalence of the subject device to the predicate device.
| Table 3: Summary of Subject Device Functional Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| DimensionalVerification | Tests per ISO 11070:Dimensional inspection per engineeringdrawings. | The Aristotle ColossusGuidewires met testacceptance criteria. |
| Tensile Strength | Tensile testing per ISO 11070. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Fracture andFlexing | Fracture and Flexing tests per ISO 11070. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Torqueability andTorque Strength | Measurement of torque response (averageinput to output lag) in an anatomical model.Torque turns to failure in an anatomicalmodel. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Tip Flexibility | Measure force to deflect guidewire tips at 5mm, 10 mm, and 20 mm test lengths. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Tip Shape,Retention | Guidewires must be shapeable and mustretain shaped angle after simulated use. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Coating Lubricityand Durability | Frictional force of coated guidewires wasdetermined after simulated use in a tortuouspath. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Coating Integrity | Coating uniformity and integrity werevisually examined on dyed samples aftersimulated use in a tortuous path. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Particulate | Particulates of various size ranges countedafter simulated use in a tortuous path. | The Aristotle ColossusGuidewires met testacceptance criteria |
| Simulated UseModel Testing andProductCompatibility | Anatomical model designed to simulate thetortuous anatomy of the neurovasculature wasused for simulated use testing and productcompatibility. | The Aristotle ColossusGuidewires met testacceptance criteria |
| UsabilityEvaluation | Physicians evaluated subject and predicateguidewires for various performancecharacteristics in a human cadaver. | The Aristotle ColossusGuidewires met testacceptance criteria |
Sterilization
The Aristotle Colossus Guidewire was evaluated for shelf-life testing, packaging integrity, and sterilization including testing to ensure sterilization assurance levels (SAL) of at least 10°, and testing for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels.
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CONCLUSION
The subject device, Aristotle Colossus Guidewire, has the same intended use, same indications for use, and the same fundamental design, materials, and device features as the predicate device. The differences in technological characteristics have been evaluated through testing and risk evaluation, and do not raise new or different questions of safety and effectiveness, supporting that the subject device is substantially equivalent to the predicate, Aristotle 24 Guidewire.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.