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.

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.

AI/ML Overview

The information provided does not describe an AI/ML device but rather a medical guidewire. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable here.

This document, K233791, is a 510(k) premarket notification for the Drivewire 24 Guidewire, a physical medical device. The submission demonstrates substantial equivalence to a predicate device (Aristotle 24 Guidewire) through non-clinical testing.

Here's an analysis of the provided information, framed to address the prompt's questions where applicable, but explicitly noting the absence of AI/ML-specific details:

1. A table of acceptance criteria and the reported device performance

The document provides a table of "Non-Clinical Testing" which outlines various bench tests, their methods, and results indicating they met acceptance criteria. While specific numerical acceptance criteria are not always stated, the results confirm successful performance.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Visual and Dimensional Verification	Meet specified overall length, diameter, bend diameter, coating length; no damage.	Dimensional and visual inspection results meet acceptance criteria.
Tip Flexibility	Comparable to predicate device.	Tip flexibility was shown to be comparable to the predicate device.
Tip Deflection Force	Less than or equal to the predicate device's force.	The force applied by the tip is equal to or less than the predicate device's.
Simulated Use - Delivery & Retrieval Force	Less than the predicate device's force.	The delivery and retrieval forces were less than the predicate device's.
Simulated Use - Performance & Compatibility	Demonstrate intended use in challenging simulated conditions.	All devices met acceptance criteria in demonstrating the intended use of the guidewire in challenging simulated use conditions.
Usability Evaluation	Meet acceptance criteria (as determined by physicians).	The device met the acceptance criteria.
Torqueability	Required initial rotation to tip response equivalent to or less than predicate device.	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	Withstand clinical use scenarios without kinking.	All devices met acceptance criteria for kink resistance which represent clinical use scenarios.
Fracture Test	No fractures, loosening, or failures when wound around a cylinder.	All devices met the acceptance criteria of having no fractures, loosening, or failures.
Flexing Test	No fractures, loosening, or failures after repeated bending.	All devices met the acceptance criteria of having no fractures, loosening, or failures.
Tensile Force	Meet peak tensile force criteria established by delivery and retrieval force testing.	All joints met peak tensile force acceptance criteria established by delivery and retrieval force testing.
Tip Mechanism Durability	Withstand a predetermined number of handle actuations.	All devices met acceptance criteria of withstanding a predetermined number of handle actuations.
Torque Strength	Number of turns to failure no less than a predetermined value.	All devices met the acceptance criteria of having the number of turns to failure be no less than a predetermined value.
Torquer Performance	No damage to handle or shaft; equivalent or higher tensile force and measured torque force at slipping to predicate device.	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 equivalent to or less than the predicate device.	All devices have particulates equivalent or less than the predicate device.
Lubricity	Maximal and average force comparable to the predicate device.	All devices met the acceptance criteria of having a maximal force and an average force comparable to the predicate device.
Coating Integrity	No coating separation after simulated use testing.	All devices met the acceptance criteria of having no coating separation after simulated use testing.
Radiopacity	Visible under fluoroscopy.	All devices were visible under fluoroscopy.
Corrosion	No evidence of corrosion.	The test sample did not have evidence of corrosion.
Biocompatibility Tests (Cytotoxicity, Irritation, Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic Toxicity, Thrombogenicity)	Meet ISO 10993 standards and specific test requirements.	All tests confirmed that the Drivewire 24 Guidewire met biological safety requirements per the ISO 10993 standard, with specific positive results for each test (e.g., no toxicity, no irritation, not sensitizers, non-hemolytic, not complement activator, nonpyrogenic, no systemic toxicity, no thrombus formation).
Sterilization	Achieve SAL of 10^-6 or less by EtO.	Demonstrate that the Ethylene Oxide (EtO) sterilization process will reliably sterilize the product loads to a sterility assurance level (SAL) of 10^-6 or less, according to the overkill half cycle approach and relevant standards.
Shelf Life and Package Integrity	Meet acceptance criteria for 1 year shelf-life.	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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Bench Tests: The specific number of devices tested for each bench test is not explicitly stated, but the results refer to "All devices," implying a sufficient sample was used to statistically validate the findings against acceptance criteria. Data provenance for bench tests is typically from the manufacturer's internal labs.
Biocompatibility Tests: The description mentions "test article extract" or "test articles," indicating samples of the device or its materials were used according to ISO 10993 standards.
Animal Study: The study was conducted in "domestic swine." The number of animals or devices used per animal is not specified but is implicitly sufficient for a GLP study.

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 question is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert ground truth for interpretation. The "Usability Evaluation" mentioned that "Physicians evaluated the guidewire in clinically relevant simulated use models," implying expert input, but details on their number or qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML diagnostic study requiring expert adjudication of results.

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. No MRMC study was performed as this is a physical medical device. The efficacy is demonstrated through non-clinical testing and comparison to a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a physical device like a guidewire, the "ground truth" is established through physical and material science measurements, functional performance testing against defined engineering specifications, and biological safety testing against established international standards (e.g., ISO 10993). In the animal study, the "ground truth" for thrombogenicity was the direct examination of devices, renal arteries, and downstream organs for thrombus absence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML model was involved.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K233791

Device Name Drivewire 24 Guidewire

Indications for Use (Describe)

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 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 forUse	The Drivewire 24Guidewire is intended forgeneral intravascular use,including the neuro andperipheral vasculature. TheDrivewire 24 Guidewire isintended to facilitate theselective placement ofdiagnostic or therapeuticcatheters. This device is notintended for use in thecoronary arteries.	The Aristotle 24Guidewire is intended forgeneral vascular usewithin the neuro andperipheral vasculatures tointroduce and positioncatheters and otherinterventional devices.The guidewire is notintended for use in thecoronary vasculature.	The Columbus Guidewire isintended for generalintravascular use, includingthe neuro and peripheralvasculature. The ColumbusGuidewire is intended tofacilitate the selectiveplacement of diagnostic ortherapeutic catheters. Thisdevice is not intended foruse in coronary arteries.
AnatomicalLocation	General intravascular use,including the neuro andperipheral vasculature butnot coronary arteries.	General intravascular use,including the neuro andperipheral vasculature butnot coronary arteries.	General intravascular use,including the neuro andperipheral vasculature butnot coronary arteries.
Overall Length	204 cm	200 cm	200 cm
Distal Diameter	0.024"	0.024"	0.014"
Core WireMaterial	Nitinol	Stainless Steel	Nitinol
ProximalSection Material	Stainless Steel	Nitinol	Stainless Steel
RadiopaqueCoil	Nitinol and Nitinol DFT 30%tantalum	Platinum wire marker coil	Nitinol and Nitinol DFT30% tantalum/ DFT 40%Platinum
Distal TipType andLength	Steerable1.6 cm	Shapeable35 cm	Steerable2 cm (Columbus LRGWPP4464)1.5 cm (Columbus LRGWPP4463)
HydrophilicCoating	42 cm	46 cm	No coating
Sterilization	Sterile	Sterile	Sterile
SterilizationMethod	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, andCarton box	hoop, Tyvek pouch, andCarton box	hoop, Tyvek pouch, andCarton 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 MechanismDurability	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.
TorquerPerformance	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 studyusing ISO ElutionMethod	The test article extract showed no evidenceof causing cell lysis or toxicity. The test metthe requirements as the grade was less than agrade 2 (mild reactivity).
Irritation(IntracutaneousReactivity)	ISO IntracutaneousIrritation Study usingextracts	The test article met the requirements, withno differences between each test articleextract's overall mean score and thecorresponding control extract's mean score.
Sensitization	ISO Guinea PigMaximizationSensitization Test	Test articles showed no evidence of causingdelayed dermal contact sensitization andwere not considered sensitizers.
Hemocompatibility– Hemolysis	ASTM Hemolysis Study- Extract andDirect Contact	The test articles, both in direct and indirectcontact with blood, were non-hemolytic.
Hemocompatibility– ComplementActivation	SC5b-9 ComplementActivation Assay	The test article was not considered apotential activator of the complementsystem.
Pyrogenicity	USP Rabbit PyrogenStudy, Material Mediated	The total rise of rabbit temperatures duringthe observation period was withinacceptable USP limits. The test article wasconsidered nonpyrogenic.
Acute SystemicToxicity	ISO Acute SystemicToxicity in Mice	There was no mortality or evidence ofsystemic toxicity from extracts injected intomice.
In VivoThrombogenicity	In vivo thrombogenicityin a porcine model	There was no evidence of thrombusformation.

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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.

Regulation Number and Section

§ 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.