(225 days)
Not Found
No
The device description focuses on mechanical rotation and manual steering, with no mention of AI, ML, or automated decision-making based on data analysis.
No.
The device facilitates the placement of guidewires to cross chronic total occlusions, which is a procedural aim, not a treatment or therapy for the underlying condition itself.
No
The device is used to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions by creating a pathway through the lesion via mechanical rotation. It is an interventional device, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a guidewire, control unit, shaping tool, and extension wire. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions." This describes a device used within the body for a therapeutic or interventional procedure.
- Device Description: The description details a guidewire with an active tip, a control unit, and other components used for mechanical rotation to create a pathway through a lesion in vivo.
- Anatomical Site: The device is used in "peripheral artery, infrainguinal artery," which are locations within the human body.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, not for analyzing samples in vitro.
- Performance Studies: The studies described involve in-vitro bench testing, in-vivo animal studies, and a clinical study in human patients, all focused on the device's performance within the body.
- Key Metrics: The key metrics (freedom from clinical perforation, advancement through the CTO, facilitation of crossing) are all related to the device's performance during an interventional procedure in vivo.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device clearly operates within the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
Materials used in construction with patient contact: Nitinol. Gold Plated a. Stainless Steel, Platinum Tungsten, Hydrophilic Coating, Tin, Silver, Nickel, Natural Diamonds
2. 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
3. Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
a. Materials used in construction with patient contact: none
4. 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral artery
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)
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.
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 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 severity 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%).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Safety Endpoint: 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.
Primary Clinical Efficacy Endpoint: 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%).
Primary Performance (Technical Success) Endpoint: facilitation of crossing the CTO with any guide wire was achieved in 68 of 85 patients (80%).
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.
Not Found
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
§ 870.1250 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).
0
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 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.
1
- Materials used in construction with patient contact: Nitinol. Gold Plated a. Stainless Steel, Platinum Tungsten, Hydrophilic Coating, Tin, Silver, Nickel, Natural Diamonds
-
- 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
-
- Shaping Tool used to shape the tip of the RVT CTO Device, if desired.
- a. Materials used in construction with patient contact: none
-
- 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.
2
ReVascular Therapeutics
·
| FEATURE | FlowCardia
CROSSER System | Baylis
PowerWire RF
Guidewire
(formerly RF
Tunneler Wire) | ReVascular Therapeutics
RVT CTO Device |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Reference
Number | K072776 and K091119 | K051670 | K101599 |
| Indications for
Use | The CROSSER System 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 RF Tunneler
Wire is intended to
create a channel in
totally occluded
peripheral vessels
3mm or greater. | 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. |
| Design Features | The FlowCardia System
consists of reusable
electronics (Generator and
Transducer) and the single
use CROSSER Catheter.
The CROSSER Catheter is
connected to the electronics
by attaching the proximal
hub of the CROSSER to the
distal end of the Transducer.
The Generator converts AC
line power into high
frequency current. This
current is then delivered to
piezoelectric crystals
contained within the
transducer resulting in
crystal expansion and
contraction. The Transducer
horn amplifies the rapid
crystal expansion and
contraction propagating high
frequency mechanical
vibration down a Nitinol core
wire to the tip of the
CROSSER Catheter. This
vibrational energy provides
mechanical impact which
aids in the recanalization of | The RF Tunneler
Wire consists of a
core wire
surrounded with a
polymer insulation.
The wire connects
to a RF generator
at the proximal end
via a connector
cable, and has an
active tip at the
distal end to
delivery RF energy. | The RVT CTO Device has
a Nitinol Outer Shaft and
an internal Driveshaft
connected to an external
distal Active Tip. Active
rotational energy is
delivered to the distal
Active Tip via by the
internal Nitinol Driveshaft.
The proximal end of the
internal Nitinol Driveshaft is
connected to an external
Motor Housing and a
Control Unit. |
| FEATURE | FlowCardia
CROSSER System | Baylis PowerWire RF
Guidewire
(formerly RF
Tunnelor Wire) | Revascular Therapeutics
RVT-CTO Device |
| Main
Components | • Core Wire
• Catheter
• Transducer
• Reusable AC Powered
Generator
• Footswitch | • Nitinol Core
w/Insulating
Polymer Coating
• Proximal
Connector Cable
• Patient
Grounding Pad
• Reusable RF
Generator and Foot
Switch | • Driveshaft with Active
Tip
• Outer Shaft Assembly
• Motor Housing
• Control Unit
• Shaping Tool
• Extension Wire |
| Energy Type | Mechanical Energy | Radio Frequency
Energy | Mechanical Energy |
| Power Level | 20,000 cycles per second | 10 - 25 Watts | 13,000 revolutions per
minute |
| Mechanism of
Action | High frequency current
converted into vibrational
energy delivered at the distal
tip | RF energy
delivered at the
distal tip | Rotational energy
delivered 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 |
| Working
Length(s) | 146 cm and 125 cm | 250 cm | 165 cm |
| Radiopacity | Yes | Yes | Yes |
| Guidewire
Exchange
Possible | Yes | Yes | Yes |
| Sterilization
Method | Gamma | Ethylene Oxide | Ethylene Oxide |
| Pyrogen Free | Yes | Yes | Yes |
| Single Use Only | Yes | Yes | Yes |
| Meets
applicable IEC
60601-1 Testing | Yes | Yes | Yes |
·
3
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
4
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 .
5
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%).
6
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.
7
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
8
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
9
Indications for Use Statement
510(k) Number (if known): K101599
Device Name: RVT CTO Device
Indications for Use:
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.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR (per 21 CFR 801.109) Over-The-Counter Use_
|--|
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