The RVT CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.

Device Description

The RVT CTO Device is a sterile, disposable, steerable 0.018" OD Guidewire with an Active Tip for penetrating chronic total occlusions and is used with a sterile, disposable, battery-operated Control Unit during a single patient procedure.

The RVT CTO System consists of four (4) components: the RVT CTO Device, Control Unit, Shaping Tool, and the RVT Extension Wire.

RVT CTO Device (Guidewire Assembly, Torquer, Motor Housing with integrated Connector Cable) - The RVT CTO Device consists of a distal 0.018" Guidewire Assembly and a Motor Housing with Connector Cable. The RVT CTO Device is 165 cm in working length and is hydrophilically coated. The RVT CTO Device has a shapeable Distal Tip and the cone-shaped portion of the Active Tip is diamond coated. The distal 3 cm is radiopaque to facilitate visualization under fluoroscopy.
Control Unit - Pressing the Activation Button allows current to flow from the battery in the Control Unit to the DC Motor within the Motor Housing. Mechanical energy (via rotational torque) is generated and transferred from the DC Motor to the Nitinol Driveshaft located within the stationary hollow Outer Shaft. The Driveshaft turns the Active Tip at the very distal end of the Guidewire Assembly at approximately 13,000 revolutions per minute (RPM) under "no load" conditions. The hollow Outer Shaft remains stationary while the Active Tip rotates independently. In the Active Mode, the RVT Guidewire creates a pathway through the lesion via mechanical rotation. In the "Passive Mode" the operator steers the Guidewire Assembly to seek a path of least resistance through the lesion consistent with standard quidewires.
Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
RVT Extension Wire Attachment of the RVT Extension Wire to the RVT CTO Device creates an extended guidewire that can be used to exchange a catheter without removing the RVT CTO Device from the artery.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the RVT CTO Device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Freedom from clinical perforation of the index lesion to 30 days (Primary Safety Endpoint)	0.0% clinical perforations at time of intervention with RVT CTO Device; 1 (1.2%) patient experienced clinical perforation from a cutting balloon (deemed unlikely related to RVT CTO Device).
Advancement of the RVT CTO Device through the CTO and subsequent distal guide wire positioning (Primary Clinical Efficacy Endpoint)	Achieved in 65 out of 85 cases (76.5%).
Facilitation of crossing the CTO with any guide wire (Primary Performance / Technical Success Endpoint)	Achieved in 68 of 85 patients (80%).
Safety and effectiveness in facilitating crossing of CTOs in patients with PAD where conventional guidewires have failed.	Demonstrated that the device is safe and effective; did not increase perforation rate beyond that of conventional guidewires.
Does not raise new questions of safety or effectiveness when compared to predicate devices.	Evidence from non-clinical testing and the ReOPEN study indicates no new safety/effectiveness concerns.

Note: The document explicitly states that the "studies were similar in design, both were prospective clinical studies of 85 patients... The inclusion/exclusion criteria were the same between the two studies as were the study endpoints and results" when comparing the Re-OPEN study to the FlowCardio predicate. This implies that the acceptance criteria for the RVT CTO Device were largely based on demonstrating equivalent (or superior) performance to the predicate device using similar endpoints.

Study Details

Sample sizes used for the test set and the data provenance:
- Sample Size: 85 patients.
- Data Provenance: Prospective, multi-center, single-arm study (Re-OPEN Study) conducted in Europe between January and December 2009.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that "All SAEs (Serious Adverse Events) were adjudicated by an independent CEC" (Clinical Events Committee). It also mentions the CEC reviewed all AEs in aggregate.
- Number of Experts: Not explicitly stated, but implies a committee (more than one).
- Qualifications: Not explicitly stated beyond "independent CEC."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- "All SAEs (Serious Adverse Events) were adjudicated by an independent CEC." This implies a form of consensus or expert review, but the specific "x+y" method is not detailed.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (guidewire) and not an AI/software product, so this type of study is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical guidewire used by a human operator, making an "algorithm-only" study irrelevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primary Safety Endpoint: Clinical events (e.g., clinical perforation) adjudicated by an independent Clinical Events Committee (CEC).
- Primary Clinical Efficacy Endpoint: Angiographic assessment (advancement of device and distal guidewire positioning).
- Primary Performance (Technical Success) Endpoint: Angiographic assessment (facilitation of crossing the CTO with any guidewire).
- Occlusion Confirmation: "occlusions treated under this protocol were all confirmed to be 100% CTOs that had been in existence for 30 days or greater" likely through angiographic or imaging means.
The sample size for the training set:
- This device is a physical medical device, not a machine learning algorithm, so there is no "training set" in the conventional sense. The "training" comes from the device's design, engineering, and manufacturing processes, which are validated through non-clinical bench testing and animal studies.
How the ground truth for the training set was established:
- Not applicable as there is no machine learning training set. Ground truth for the development and validation of the physical device and its components was established through various engineering specifications, bench test standards, and animal model results. E.g., "Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the RVT CTO Device meet the established specifications necessary for consistent performance during its intended use."

Summary

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Chronic Total Occlusion Device

510(k) Summary

JAN 1 8 2011

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name, Address, Phone and Fax Number of Applicant

ReVascular Therapeutics, Inc. 766 Palomar Avenue Sunnyvale, CA 94085 Phone: (408) 617-0770 Fax: (408) 481-9045

B. Contact Person

Nancy Lincé, RAC Regulatory Affairs Consultant (650) 759-6186

C. Date Prepared June 4, 2010

D. Device Name

Trade Name:	RVT CTO Device
Common Name:	Guidewire
Classification Name:	21 CFR §870.1330; Wire, Guide, Catheter
Product Code:	DQX

E. Device Description

The RVT CTO System consists of four (4) components: the RVT CTO Device, Control Unit, Shaping Tool, and the RVT Extension Wire.

1. RVT CTO Device (Guidewire Assembly, Torquer, Motor Housing with integrated Connector Cable) - The RVT CTO Device consists of a distal 0.018" Guidewire Assembly and a Motor Housing with Connector Cable. The RVT CTO Device is 165 cm in working length and is hydrophilically coated. The RVT CTO Device has a shapeable Distal Tip and the cone-shaped portion of the Active Tip is diamond coated. The distal 3 cm is radiopaque to facilitate visualization under fluoroscopy.

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Materials used in construction with patient contact: Nitinol. Gold Plated a. Stainless Steel, Platinum Tungsten, Hydrophilic Coating, Tin, Silver, Nickel, Natural Diamonds
1. Control Unit - Pressing the Activation Button allows current to flow from the battery in the Control Unit to the DC Motor within the Motor Housing. Mechanical energy (via rotational torque) is generated and transferred from the DC Motor to the Nitinol Driveshaft located within the stationary hollow Outer Shaft. The Driveshaft turns the Active Tip at the very distal end of the Guidewire Assembly at approximately 13,000 revolutions per minute (RPM) under "no load" conditions. The hollow Outer Shaft remains stationary while the Active Tip rotates independently. In the Active Mode, the RVT Guidewire creates a pathway through the lesion via mechanical rotation. In the "Passive Mode" the operator steers the Guidewire Assembly to seek a path of least resistance through the lesion consistent with standard quidewires.
- a. Materials used in construction with patient contact: none
1. Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
- a. Materials used in construction with patient contact: none
1. RVT Extension Wire Attachment of the RVT Extension Wire to the RVT CTO Device creates an extended guidewire that can be used to exchange a catheter without removing the RVT CTO Device from the artery.
- a. Materials used in construction with patient contact: none

F. Intended Use

The RVT CTO Device is indicated to facilitate the intra-luminal placement of conventional quidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The RVT CTO Device is only intended for use with the RVT Control Unit.

The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.

G. Predicate Device Comparison

The RVT CTO Device is substantially equivalent to the FlowCardia CROSSER (K072776, K091119) and Baylis Medical RF Tunneler (K051670). The devices have similar components with respect to materials, technological characteristics, intended use, and procedural steps as presented in the following table.

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ReVascular Therapeutics

FEATURE	FlowCardiaCROSSER System	BaylisPowerWire RFGuidewire(formerly RFTunneler Wire)	ReVascular TherapeuticsRVT CTO Device
510(k)ReferenceNumber	K072776 and K091119	K051670	K101599
Indications forUse	The CROSSER System isindicated to facilitate theintra-luminal placement ofconventional guidewiresbeyond peripheral arterychronic total occlusions. Thedevice is contraindicated foruse in carotid arteries.	The RF TunnelerWire is intended tocreate a channel intotally occludedperipheral vessels3mm or greater.	The RVT CTO Device isindicated to facilitate theintra-luminal placement ofconventional guidewiresbeyond peripheral arterychronic total occlusions.The device iscontraindicated for use incarotid arteries.
Design Features	The FlowCardia Systemconsists of reusableelectronics (Generator andTransducer) and the singleuse CROSSER Catheter.The CROSSER Catheter isconnected to the electronicsby attaching the proximalhub of the CROSSER to thedistal end of the Transducer.The Generator converts ACline power into highfrequency current. Thiscurrent is then delivered topiezoelectric crystalscontained within thetransducer resulting incrystal expansion andcontraction. The Transducerhorn amplifies the rapidcrystal expansion andcontraction propagating highfrequency mechanicalvibration down a Nitinol corewire to the tip of theCROSSER Catheter. Thisvibrational energy providesmechanical impact whichaids in the recanalization of	The RF TunnelerWire consists of acore wiresurrounded with apolymer insulation.The wire connectsto a RF generatorat the proximal endvia a connectorcable, and has anactive tip at thedistal end todelivery RF energy.	The RVT CTO Device hasa Nitinol Outer Shaft andan internal Driveshaftconnected to an externaldistal Active Tip. Activerotational energy isdelivered to the distalActive Tip via by theinternal Nitinol Driveshaft.The proximal end of theinternal Nitinol Driveshaft isconnected to an externalMotor Housing and aControl Unit.
FEATURE	FlowCardiaCROSSER System	Baylis PowerWire RFGuidewire(formerly RFTunnelor Wire)	Revascular TherapeuticsRVT-CTO Device
MainComponents	• Core Wire• Catheter• Transducer• Reusable AC PoweredGenerator• Footswitch	• Nitinol Corew/InsulatingPolymer Coating• ProximalConnector Cable• PatientGrounding Pad• Reusable RFGenerator and FootSwitch	• Driveshaft with ActiveTip• Outer Shaft Assembly• Motor Housing• Control Unit• Shaping Tool• Extension Wire
Energy Type	Mechanical Energy	Radio FrequencyEnergy	Mechanical Energy
Power Level	20,000 cycles per second	10 - 25 Watts	13,000 revolutions perminute
Mechanism ofAction	High frequency currentconverted into vibrationalenergy delivered at the distaltip	RF energydelivered at thedistal tip	Rotational energydelivered at the distal tip
Shaft Size(s)(OD)	0.043" and 0.061"	0.035"	0.018"
Tip Diameter(OD)	0.043" and 0.061"	0.028"	0.017"
Tip Attributes	Steerable	Steerable, straight,and angled	Steerable, shapeable
WorkingLength(s)	146 cm and 125 cm	250 cm	165 cm
Radiopacity	Yes	Yes	Yes
GuidewireExchangePossible	Yes	Yes	Yes
SterilizationMethod	Gamma	Ethylene Oxide	Ethylene Oxide
Pyrogen Free	Yes	Yes	Yes
Single Use Only	Yes	Yes	Yes
Meetsapplicable IEC60601-1 Testing	Yes	Yes	Yes

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ReVascular Therapeutics

Traditional 510(k) Notification Chronic Total Occlusion Device

The subject and predicate systems provide "active" energy to power the distal Tip of the device through the occlusion. The ReVascular Therapeutics (RVT) CTO Device and its predicates are designed to cross Chronic Total Occlusions (CTO's) in the periphery by providing a means of energy at the distal tip. All the devices are similar in that they convert an external electrical energy source to energy at the device tip. The ReVascular Therapeutics CTO Device and the FlowCardia CTO Device (CROSSER) are designed to cross CTO's in the periphery by providing a means of

Appendix B, Page 4 of 7

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mechanical energy at the distal tip and the Baylis PowerWire RF Guidewire System provides radio frequency energy to power the guidewire through the occlusion. Like the PowerWire System, the RVT System uses a guidewire-based platform, while the Crosser is catheter-based. All devices focus energy at the active tip to create channels in the target occlusion. Both the RVT and Baylis devices may be used as standard guidewire systems when used in their "passive" modes.

H. Summary of Performance Data

The RVT CTO Device performance characteristics were evaluated in the following invitro bench and in-vivo animal studies:

Dimensional Verification .
. Torqueability
◆ Torque Strength
. Active Tip Rotation
. Tip Stiffness
Catheter Compatibility
Flexibility/Trackability ●
Device Advancement .
Friction: Static and Dynamic ●
t Tip Temperature
Tensile Testing .
Electrical Safety and ● Electromagnetic Testing
· Tip Shaping
· Coating Adhesion Integrity
· Support Catheter Removal and Advancement Over Extension
· Coil Integrity
· Packaging Testing
· Shipping Testing
· Sterility Testing
· Shelf Life Testing
· Evaluation of safety and performance of the RVT CTO Device in the porcine model
· Biocompatibility

Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the RVT CTO Device meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the RVT CTO Device does not raise new questions of safety or effectiveness when compared to the predicate devices.

l. Summary of Clinical Data

The RVT CTO Device was the subject of an investigational study, the Re-OPEN Study, a prospective, multi-center, single-arm (non-randomized) study conducted to evaluate the device in the treatment of infrainguinal target vessel occlusions classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion was visible.

The purpose of the study was to demonstrate that the RVT CTO Device can safely and effectively facilitate the crossing of chronic total infrainguinal artery occlusions

Appendix B, Page 5 of 7 .

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following demonstration of resistance to crossing with conventional guidewire techniques or prior failed treatment attempt. In addition, this study was intended to evaluate the impact of successfully crossing a CTO and allowing subsequent treatment using interventional methods rather than bypass surgery or medical management alone.

A total of 85 patients were enrolled across 3 medical centers in Europe between January and December 2009. The population in this study was composed of patients who presented with Peripheral Artery Disease who met all eligibility criteria and exhibited any of the following conditions: ABI of less than 1.0, abnormal duplex ultrasound, claudication, leg numbness or weakness, leg rest pain, leg skin color changes or non-healing ulcers of the legs or feet, or previously documented lower extremity artery occlusions. Each patient must have had a prior failed attempt or a concurrent and reasonable attempt (at least 5 minutes) during the procedure to demonstrate resistance to conventional guidewire crossing. The occlusions treated under this protocol were all confirmed to be 100% CTOs that had been in existence for 30 days or greater.

The Primary Safety Endpoint was defined as freedom from clinical perforation (any perforation requiring treatment) of the index lesion to 30 days. There were no (0.0%) clinical perforations reported at time of intervention with use of the RVT CTO Device and only 1 (1.2%) patient experienced a clinical perforation as a result of a cutting balloon and was successfully treated with stent placement. No further clinical sequelae were reported. This event was considered by the Clinical Events Committee (CEC) to be unlikely related to the RVT CTO Device with a definite relation to the procedure and a probable relation to a preexisting condition.

All SAEs (Serious Adverse Events) were adjudicated by an independent CEC. In addition, the CEC reviewed all AEs in aggregate to ensure that there were no trends or AEs occurring in greater severily or degree of incidence than anticipated for this patient population. There were no AEs reported that were considered unanticipated in nature, severity or degree of incidence.

The Primary Clinical Efficacy Endpoint, defined as advancement of the RVT CTO Device through the CTO and subsequent distal guide wire positioning was achieved in 65 out of 85 cases (76.5%). This allowed subsequent positioning of conventional guide wire(s) distal to the vessel occlusion,

The Primary Performance (Technical Success) Endpoint, defined as facilitation of crossing the CTO with any guide wire was achieved in 68 of 85 patients (80%).

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In conclusion, the ReOPEN Study provides strong evidence that the RVT CTO Device is safe and effective at facilitating crossing of Chronic Total Occlusions (CTOs) in patients with Peripheral Vascular Disease (PAD) where conventional guidewires have failed. The results demonstrated that the RVT CTO device was able to successfully facilitate crossing in the majority of cases where a conventional guidewire was unsuccessful and use of the RVT CTO did not increase the rate of perforations beyond the rate seen with use of a conventional quidewire.

In addition to the non-clinical testing and descriptive comparisons, the data from the ReOPEN study provide further evidence that use of the RVT CTO Device does not raise new questions of safety or effectiveness when compared to the predicate devices.

J. Summary of Data

Non-clinical testing of the subject device has shown that the RVT CTO Device meets the functional, performance, and design requirements derived from a variety of design inputs; including specifications resulting from examination of the predicate devices, external standards and clinician input. In addition to the non-clinical testing and descriptive comparisons, the data from the ReOPEN study provide further evidence that use of the RVT CTO device does not raise new questions of safety or effectiveness when compared to the predicate devices, as demonstrated by a comparison of the investigational study results reported for the FlowCardio predicate and the subject device. The studies were similar in design, both were prospective clinical studies of 85 patients designed to assess the safety and efficacy of the devices in the treatment of infrainguinal target vessel occlusions classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion was visible and following demonstration of resistance to crossing with conventional guidewire techniques. The inclusion/exclusion criteria were the same between the two studies as were the study endpoints and results.

The RVT CTO Device is substantially equivalent to the predicate device for intended use, physical characteristics, anatomical sites, performance, safety characteristics, and labeling. The RVT CTO Device incorporates similar design features, procedural steps, and performance characteristics when compared to the predicate devices. Safety and performance testing, combined with the technical equivalency assessment and clinical study results, demonstrate that the RVT CTO Device performs as intended and does not raise any new issues of safety and effectiveness when compared with the predicate devices.

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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping profiles, creating a sense of depth and movement. The overall design is simple and conveys a sense of authority and professionalism.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ReVascular Therapies Ms. Nancy Lincé 766 Palomar Avenue Sunnyvale, CA 94085

SEP 1 8 2013

Re: K101599

Trade/Device Name: ReVascular Therapies Chronic Total Occlusion (RVT CTO) Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: January 7, 2011 Received: January 10, 2011

Dear Ms. Lincé:

This letter corrects our substantially equivalent letter of January 18, 2011.

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Z.M.Z

Ar Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K101599

Device Name: RVT CTO Device

Indications for Use:

The RVT Extension Wire is designed to extend the RVT CTO Device so that a catheter can be exchanged for another catheter.

Prescription Use	X
------------------	---

OR (per 21 CFR 801.109) Over-The-Counter Use_

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

vision of Cardiovascular Devices

510(k) Number

ー

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).