(226 days)
No
The device description and performance studies focus on the mechanical and material properties of a guidewire, with no mention of AI or ML algorithms for image analysis, navigation, or any other function.
No.
The device is intended to facilitate the selective placement of diagnostic catheters and is not described as treating any condition or disease.
No
Explanation: The device is a guidewire intended to facilitate the selective placement of diagnostic catheters, not to perform diagnosis itself.
No
The device description clearly details a physical guidewire with various material components (stainless steel, Nitinol), a handle, and a torque accessory. It is a tangible medical device, not software.
Based on the provided information, the Drivewire 24 Guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use" to "facilitate the selective placement of diagnostic catheters." This describes a device used within the body for a procedural purpose (guiding other devices), not for testing samples outside the body.
- Device Description: The description details a physical guidewire with mechanical components designed for navigation within blood vessels. This aligns with an invasive medical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In summary, the Drivewire 24 Guidewire is an invasive medical device used to assist in medical procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 24 Guidewire is intended to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
The Drivewire 24 Guidewire is a 0.024" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only.
The Drivewire 24 Guidewire is comprised of a stainless steel hypotube that is cut along its length to provide flexibility and tip deflection ability through control of the handle, an inner Nitinol braided flexible coil, an inner core wire, and a handle. The inner core wire runs inside the hypotube from the distal end to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal section of the hypotube, forming a deflectable tip. The hypotube is marked with fluoro-safe markers to provide visual clues to the user to initiate fluoroscopy guided insertion.
In order to actuate the tip deflection in two directions, the Drivewire 24 Guidewire handle contains a tube assembly section. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. The handle assembly has neutral landmarks to identify the location where the tip is straight.
The Drivewire 24 Guidewire has a hydrophilic coating on its distal segment in order to reduce the friction of the guidewire while navigating.
The Drivewire 24 Guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to have patient contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General intravascular use, including the neuro and peripheral vasculature but not coronary arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Tests:
- Visual and Dimensional Verification: The overall guidewire length, diameter, and bend diameter, and coating length were measured. A visual inspection confirmed there was no damage to device. Results: Dimensional and visual inspection results meet acceptance criteria.
- Tip Flexibility: The force required to flex the distal tip was measured using a loading cell. Results: Tip flexibility was shown to be comparable to the predicate device.
- Tip Deflection Force: The force that the guidewire tip applies on the vessel wall was measured using a loading cell. Results: The force applied by the tip is equal to or less than the predicate device's.
- Simulated Use - Delivery and Retrieval Force: Forces for delivery and retrieval of the guidewire through simulated use vascular model were measured. Results: The delivery and retrieval forces were less than the predicate device's.
- Simulated Use - Performance and Compatibility: Guidewire performance and compatibility were assessed in a simulated use model. Results: All devices met acceptance criteria in demonstrating the intended use of the guidewire in challenging simulated use conditions.
- Usability Evaluation: Physicians evaluated the guidewire in clinically relevant simulated use models. Results: The device met the acceptance criteria.
- Torqueability: The ability of the guidewire to translate torque from the proximal end to the distal end was measured. Results: All devices met acceptance criteria in having the required initial rotation to the point when the tip starts to respond be equivalent to or less than the predicate device.
- Kink Resistance: Kink resistance was tested along the guidewire by wrapping the device around mandrels of smaller radii until failure. Results: All devices met acceptance criteria for kink resistance which represent clinical use scenarios.
- Fracture Test: The guidewire was wound around a cylinder and examined for fractures or other damage. Results: All devices met the acceptance criteria of having no fractures, loosening, or failures.
- Flexing Test: The distal portion of the guidewire was subjected to repeated bending and examined for damage. Results: All devices met the acceptance criteria of having no fractures, loosening, or failures.
- Tensile Force: The tensile strength of the guidewire joints was measured. Results: All joints met peak tensile force acceptance criteria established by delivery and retrieval force testing.
- Tip Mechanism Durability: In a simulated use model, the tip deflection mechanism was cycled to assess durability. Results: All devices met acceptance criteria of withstanding a predetermined number of handle actuations.
- Torque Strength: With the distal tip constrained, the number of turns to failure was measured. Results: All devices met the acceptance criteria of having the number of turns to failure be no less than a predetermined value.
- Torquer Performance: The torque device was tested for performance (functional, tensile and torque) with the guidewire. Results: All devices met acceptance criteria of having no damage to the handle or shaft, and equivalent or higher tensile force and measured torque force at slipping to predicate device.
- Particulate: Particulates were measured under simulated use conditions. Results: All devices have particulates equivalent or less than the predicate device.
- Lubricity: A pinch test using a pushability test system was performed on the device through cycles to measure the friction properties of the hydrophilic coating. Results: All devices met the acceptance criteria of having a maximal force and an average force comparable to the predicate device.
- Coating integrity: Visual inspection of hydrophilic coating following simulated use was performed. Results: All devices met the acceptance criteria of having no coating separation after simulated use testing.
- Radiopacity: Images were evaluated during the animal study. Results: All devices were visible under fluoroscopy.
- Corrosion: The device was tested according to Annex B of ISO 11070: 2014(E). Results: The test sample did not have evidence of corrosion.
Biocompatibility:
- Cytotoxicity: Cytotoxicity study using ISO Elution Method. Results: The test article extract showed no evidence of causing cell lysis or toxicity. The test met the requirements as the grade was less than a grade 2 (mild reactivity).
- Irritation (Intracutaneous Reactivity): ISO Intracutaneous Irritation Study using extracts. Results: The test article met the requirements, with no differences between each test article extract's overall mean score and the corresponding control extract's mean score.
- Sensitization: ISO Guinea Pig Maximization Sensitization Test. Results: Test articles showed no evidence of causing delayed dermal contact sensitization and were not considered sensitizers.
- Hemocompatibility – Hemolysis: ASTM Hemolysis Study - Extract and Direct Contact. Results: The test articles, both in direct and indirect contact with blood, were non-hemolytic.
- Hemocompatibility – Complement Activation: SC5b-9 Complement Activation Assay. Results: The test article was not considered a potential activator of the complement system.
- Pyrogenicity: USP Rabbit Pyrogen Study, Material Mediated. Results: The total rise of rabbit temperatures during the observation period was within acceptable USP limits. The test article was considered nonpyrogenic.
- Acute Systemic Toxicity: ISO Acute Systemic Toxicity in Mice. Results: There was no mortality or evidence of systemic toxicity from extracts injected into mice.
- In Vivo Thrombogenicity: In vivo thrombogenicity in a porcine model. Results: There was no evidence of thrombus formation.
Animal Study:
- Study Type: Acute, Good Laboratory Practices (GLP) study in domestic swine.
- Sample Size: Not explicitly stated as a number, but "Devices were navigated to the left and right renal arteries".
- Key Results: There was no evidence of thrombus on devices, in renal arteries or in downstream organs (kidney). The study results support the thromboresistance of the Drivewire as substantially equivalent to that of the Aristotle 24 Guidewire.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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July 11, 2024
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Rapid Medical Ltd. Ina Gutman RA/QA Director Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel
Re: K233791
Trade/Device Name: Drivewire 24 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: June 10, 2024 Received: June 10, 2024
Dear Ina Gutman:
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" (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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.
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).
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
2
Indications for Use
510(k) Number (if known) K233791
Device Name Drivewire 24 Guidewire
Indications for Use (Describe)
The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 24 Guidewire is intended to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.
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/0 description: The image shows the logo for Rapid Medical. The logo consists of a green graphic on the left and the words "Rapid Medical" in bold, dark gray font on the right. The graphic is a stylized representation of three curved lines, possibly suggesting movement or flow.
510(k) Summary K233791
Submission Sponsor
Rapid Medical Ltd. Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel Company Phone No.: +972-72-250-3331
Contacts:
Ina Gutman, RA/QA Director Email: ina.gutman@rapid-medical.com
Ronen Eckhouse, CEO Email: ronen@rapid-medical.com
Date Prepared
July 09, 2024
Device Identification
Trade/Proprietary Name: Drivewire 24 Guidewire Common/Usual Name: Drivewire 24 Guidewire Classification Name: Guide, Wire, Catheter, Neurovasculature Regulation Number: 21 CFR 870.1330 Product Codes: MOF, DQX Device Class: II Classification Panel: Neurology, Cardiovascular
Legally Marketed Predicate Device
Predicate Device: Aristotle 24 Guidewire (K192783)
Indications for Use Statement
The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
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Image /page/4/Picture/0 description: The image contains the logo for Rapid Medical. The logo features a stylized green graphic to the left of the company name. The text "Rapid Medical" is written in a bold, sans-serif font.
Device Description
The Drivewire 24 Guidewire is a 0.024" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only.
The Drivewire 24 Guidewire is comprised of a stainless steel hypotube that is cut along its length to provide flexibility and tip deflection ability through control of the handle, an inner Nitinol braided flexible coil, an inner core wire, and a handle. The inner core wire runs inside the hypotube from the distal end to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal section of the hypotube, forming a deflectable tip. The hypotube is marked with fluoro-safe markers to provide visual clues to the user to initiate fluoroscopy guided insertion.
In order to actuate the tip deflection in two directions, the Drivewire 24 Guidewire handle contains a tube assembly section. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. The handle assembly has neutral landmarks to identify the location where the tip is straight.
The Drivewire 24 Guidewire has a hydrophilic coating on its distal segment in order to reduce the friction of the guidewire while navigating.
The Drivewire 24 Guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to have patient contact.
Comparison of Technological Characteristics
The table below compares the indications for use, principles of operation, technological characteristics, and materials of the Drivewire 24 Guidewire with that of the predicate device (the Aristotle 24 Guidewire). The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The differences in technological characteristics of the Drivewire 24 Guidewire do not raise any new questions of safety or effectiveness.
| | Drivewire 24 Guidewire
(Subject device) | Aristotle 24 Guidewire
(Predicate device) | Columbus Guidewire
(Reference Device) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233791 | K192783 | K200374 |
| Regulation | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 |
| Product Code | MOF, DQX | MOF, DQX | MOF, DQX |
| | Drivewire 24 Guidewire
(Subject device) | Aristotle 24 Guidewire
(Predicate device) | Columbus Guidewire
(Reference Device) |
| Indications for
Use | The Drivewire 24
Guidewire is intended for
general intravascular use,
including the neuro and
peripheral vasculature. The
Drivewire 24 Guidewire is
intended to facilitate the
selective placement of
diagnostic or therapeutic
catheters. This device is not
intended for use in the
coronary arteries. | The Aristotle 24
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. | The Columbus Guidewire is
intended for general
intravascular use, including
the neuro and peripheral
vasculature. The Columbus
Guidewire is intended to
facilitate the selective
placement of diagnostic or
therapeutic catheters. This
device is not intended for
use in coronary arteries. |
| Anatomical
Location | General intravascular use,
including the neuro and
peripheral vasculature but
not coronary arteries. | General intravascular use,
including the neuro and
peripheral vasculature but
not coronary arteries. | General intravascular use,
including the neuro and
peripheral vasculature but
not coronary arteries. |
| Overall Length | 204 cm | 200 cm | 200 cm |
| Distal Diameter | 0.024" | 0.024" | 0.014" |
| Core Wire
Material | Nitinol | Stainless Steel | Nitinol |
| Proximal
Section Material | Stainless Steel | Nitinol | Stainless Steel |
| Radiopaque
Coil | Nitinol and Nitinol DFT 30%
tantalum | Platinum wire marker coil | Nitinol and Nitinol DFT
30% tantalum/ DFT 40%
Platinum |
| Distal Tip
Type and
Length | Steerable
1.6 cm | Shapeable
35 cm | Steerable
2 cm (Columbus LR
GWPP4464)
1.5 cm (Columbus LR
GWPP4463) |
| Hydrophilic
Coating | 42 cm | 46 cm | No coating |
| Sterilization | Sterile | Sterile | Sterile |
| Sterilization
Method | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Single Use | Yes | Yes | Yes |
| Packaging | Placed into a Dispenser | Placed into a Dispenser | Placed into a Dispenser |
| | hoop, Tyvek pouch, and
Carton box | hoop, Tyvek pouch, and
Carton box | hoop, Tyvek pouch, and
Carton box |
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Image /page/5/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left, followed by the words "Rapid Medical" in bold, dark gray font. The symbol appears to be three curved lines, stacked on top of each other, with the top line being the darkest shade of green and the bottom line being the lightest shade of green.
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Image /page/6/Picture/0 description: The image contains the logo for Rapid Medical. The logo consists of a stylized green graphic on the left, resembling three curved lines or paths. To the right of the graphic is the text "Rapid Medical" in a bold, sans-serif font. The word "Rapid" is in a lighter shade of gray, while "Medical" is in a darker, almost black, shade.
Non-Clinical Testing
In order to demonstrate safety and performance of the subject device and to support substantial equivalence to the predicate device, Rapid Medical Ltd. completed a number of non-clinical performance tests.
Bench Tests
The subject device passed all non-clinical performance bench testing in accordance with internal requirements, national standards and international standards as shown in the table below to support substantial equivalence of the device.
| Performance Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Visual and Dimensional Verification | The overall guidewire length, diameter, and bend diameter, and coating length were measured. A visual inspection confirmed there was no damage to device. | Dimensional and visual inspection results meet acceptance criteria. |
| Tip Flexibility | The force required to flex the distal tip was measured using a loading cell. | Tip flexibility was shown to be comparable to the predicate device. |
| Tip Deflection Force | The force that the guidewire tip applies on the vessel wall was measured using a loading cell. | The force applied by the tip is equal to or less than the predicate device's. |
| Simulated Use - Delivery and Retrieval Force | Forces for delivery and retrieval of the guidewire through simulated use vascular model were measured. | The delivery and retrieval forces were less than the predicate device's. |
| Simulated Use - Performance and Compatibility | Guidewire performance and compatibility were assessed in a simulated use model. | All devices met acceptance criteria in demonstrating the intended use of the guidewire in challenging simulated use conditions. |
| Usability Evaluation | Physicians evaluated the guidewire in clinically relevant simulated use models. | The device met the acceptance criteria. |
| Test | Test Method Summary | Results |
| Torqueability | The ability of the guidewire to translate torque from the proximal end to the distal end was measured. | All devices met acceptance criteria in having the required initial rotation to the point when the tip starts to respond be equivalent to or less than the predicate device. |
| Kink Resistance | Kink resistance was tested along the guidewire by wrapping the device around mandrels of smaller radii until failure. | All devices met acceptance criteria for kink resistance which represent clinical use scenarios. |
| Fracture Test | The guidewire was wound around a cylinder and examined for fractures or other damage. | All devices met the acceptance criteria of having no fractures, loosening, or failures. |
| Flexing Test | The distal portion of the guidewire was subjected to repeated bending and examined for damage. | All devices met the acceptance criteria of having no fractures, loosening, or failures. |
| Tensile Force | The tensile strength of the guidewire joints was measured. | All joints met peak tensile force acceptance criteria established by delivery and retrieval force testing. |
| Tip Mechanism | ||
| Durability | In a simulated use model, the tip deflection mechanism was cycled to assess durability. | All devices met acceptance criteria of withstanding a predetermined number of handle actuations. |
| Torque Strength | With the distal tip constrained, the number of turns to failure was measured. | All devices met the acceptance criteria of having the number of turns to failure be no less than a predetermined value. |
| Torquer | ||
| Performance | The torque device was tested for performance (functional, tensile and torque) with the guidewire. | All devices met acceptance criteria of having no damage to the handle or shaft, and equivalent or higher tensile force and measured torque force at slipping to predicate device. |
| Particulate | Particulates were measured under simulated use conditions. | All devices have particulates equivalent or less than the predicate device. |
| Lubricity | A pinch test using a pushability test system was performed on the device through cycles to measure the friction properties of the hydrophilic coating | All devices met the acceptance criteria of having a maximal force and an average force comparable to the predicate device. |
| Coating integrity | Visual inspection of hydrophilic coating following simulated use was performed. | All devices met the acceptance criteria of having no coating separation after simulated use testing. |
| Radiopacity | Images were evaluated during the animal study. | All devices were visible under fluoroscopy. |
| Corrosion | The device was tested according to Annex B of ISO 11070: 2014(E). | The test sample did not have evidence of corrosion. |
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Image /page/7/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left and the words "Rapid Medical" in bold, dark gray font on the right. The abstract symbol appears to be three curved lines that converge to a point.
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Image /page/8/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green graphic on the left and the words "Rapid Medical" in bold, dark gray font on the right. The graphic is made up of three curved lines that are stacked on top of each other.
Biocompatibility
Biocompatibility testing was completed for the Drivewire 24 Guidewire in accordance with ISO 10993 and consisted of the following tests:
| Test | Test Description | Results |
|---|---|---|
| Cytotoxicity | Cytotoxicity study | |
| using ISO Elution | ||
| Method | The test article extract showed no evidence | |
| of causing cell lysis or toxicity. The test met | ||
| the requirements as the grade was less than a | ||
| grade 2 (mild reactivity). | ||
| Irritation | ||
| (Intracutaneous | ||
| Reactivity) | ISO Intracutaneous | |
| Irritation Study using | ||
| extracts | The test article met the requirements, with | |
| no differences between each test article | ||
| extract's overall mean score and the | ||
| corresponding control extract's mean score. | ||
| Sensitization | ISO Guinea Pig | |
| Maximization | ||
| Sensitization Test | Test articles showed no evidence of causing | |
| delayed dermal contact sensitization and | ||
| were not considered sensitizers. | ||
| Hemocompatibility | ||
| – Hemolysis | ASTM Hemolysis Study |
- Extract and
Direct Contact | The test articles, both in direct and indirect
contact with blood, were non-hemolytic. |
| Hemocompatibility
– Complement
Activation | SC5b-9 Complement
Activation Assay | The test article was not considered a
potential activator of the complement
system. |
| Pyrogenicity | USP Rabbit Pyrogen
Study, Material Mediated | The total rise of rabbit temperatures during
the observation period was within
acceptable USP limits. The test article was
considered nonpyrogenic. |
| Acute Systemic
Toxicity | ISO Acute Systemic
Toxicity in Mice | There was no mortality or evidence of
systemic toxicity from extracts injected into
mice. |
| In Vivo
Thrombogenicity | In vivo thrombogenicity
in a porcine model | There was no evidence of thrombus
formation. |
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Image /page/9/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green graphic on the left and the words "Rapid Medical" in bold, black font on the right. The graphic is made up of three curved lines that start close together and then spread out.
All tests confirmed that the Drivewire 24 Guidewire met biological safety requirements per the ISO 10993 standard.
Animal Study
Rapid Medical Ltd. completed an acute, Good Laboratory Practices (GLP) study in domestic swine to support the substantial equivalence of the Drivewire to the predicate device. Devices were navigated to the left and right renal arteries and allowed dwell for 10 minutes, removed, examined for thrombus, scored, and photographed; this procedure was repeated three times for a total dwell time of 30 minutes. Activated clotting times were maintained within clinically relevant limits (250-350 seconds) throughout the procedure. After termination, the renal arteries, medulla, and capsule were examined. There was no evidence of thrombus on devices, in renal arteries or in downstream organs (kidney). Therefore, the study results support the thromboresistance of the Drivewire as substantially equivalent to that of the Aristotle 24 Guidewire.
Sterilization and Shelf Life
The device and its accessories underwent sterilization studies in accordance with ISO 11135: 2014/AC: 2014 ("Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices") requirements to demonstrate that the Ethylene Oxide (EtO) sterilization process will reliably sterilize the product loads to a sterility assurance level (SAL) of 100 or less, according to the overkill half cycle approach and relevant standards.
The Drivewire 24 Guidewire device and package met all shelf life and package integrity test acceptance criteria supporting a shelf-life of one (1) year.
Clinical Testing
No clinical studies were conducted, as substantial equivalence of the Drivewire 24 Guidewire to the predicate device is established through the non-clinical bench, biocompatibility, and animal testing.
Conclusion of Substantial Equivalence
The Drivewire 24 Guidewire has the same intended use and similar indications for use and technological characteristics compared to the predicate Aristotle 24 Guidewire. The differences do not raise new or different questions regarding the safety and effectiveness of the device. The non-clinical bench, biocompatibility, shelf-life, and animal testing with passing results discussed above further support the substantial equivalence of the Drivewire 24 Guidewire to the predicate device.