(209 days)
No
The device description and performance studies focus on the mechanical properties and clinical outcomes of physical catheters, with no mention of AI or ML algorithms for image analysis, decision support, or other functions.
Yes.
The Turnpike catheters are intended to "subselectively infuse/ deliver diagnostic and therapeutic agents," indicating a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section for all listed catheters (Turnpike, GuideLiner V3, and TrapLiner) explicitly states their purpose is to "facilitate placement and exchange of guidewires," "subselectively infuse/deliver diagnostic and therapeutic agents," "facilitate placement of interventional devices," and "assist in crossing de novo coronary chronic total occlusions (CTO)." While they can deliver diagnostic agents, their primary mentioned uses are interventional and facilitative rather than solely for diagnosis. There is no mention of the device itself performing a diagnostic function (e.g., providing images, measurements, or other diagnostic information).
No
The device description clearly details physical catheter components made of polymers, braid, coil, stainless steel, and nylon, indicating it is a hardware device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used within the human body to access and manipulate the coronary and peripheral vasculature. This involves physical interaction with the patient's anatomy.
- Device Description: The device descriptions detail physical catheters designed for insertion into blood vessels.
- Clinical Tests: The performance studies involve clinical trials on human subjects undergoing procedures, not laboratory testing of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
These devices are clearly invasive medical devices used for interventional procedures, not IVDs.
N/A
Intended Use / Indications for Use
Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
Turnpike catheters: The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.
GuideLiner V3 catheters: The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
TrapLiner catheters: The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and Peripheral Vasculature
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)
A prospective, multi-center, single-arm study of 150 subjects was performed to evaluate the safety and effectiveness of Vascular Solutions' specialized guidewires, microcatheters, and guide extensions in patients undergoing CTO-PCI. The objective of the study was to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO PCI in which at least one study guidewire and one Turnpike catheter were used.
Primary Endpoint: Procedure success through discharge or 24 hours post-procedure, whichever came first. Procedure success was defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access, and absence of in-hospital MACE (cardiac death, target lesion revascularization, or post-procedural MI defined as CK-MB ≥ 3x ULN). The study primary endpoint result was 75.3% (113/150), meeting the predetermined performance goal. Angiographic Visualization of any guidewire distal/proximal to CTO in the true vessel lumen was 94.7% (142/150), and Absence of in-hospital MACE was 80.7% (121/150).
Secondary Endpoints:
- Frequency of successful recanalization: 140 (93.3%)
- Frequency of MACE through discharge or 24 hours post-procedure (In-Hospital): 29 (19.3%)
- Frequency of MACE at 30 days post-procedure: 0 (0.0%)
- Frequency of clinically significant perforation: 16 (10.7%)
- Procedure Success by Crossing Technique: Antegrade 69 (85.2%) (69/81), Retrograde 1 (50.0%) (1/2), Combined Antegrade and Retrograde 43 (64.2%) (43/67)
- Technical success: 140 (93.3%)
No new safety or effectiveness issues were raised during the study. The results demonstrate that the subject catheters are suitable for their intended use to assisting in crossing de novo coronary chronic total occlusions (CTO).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K171933, Asahi Corsair Pro microcatheter (Asahi Intecc Co., LTD)
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.
K191560, Turnpike catheter (Vascular Solutions LLC), K172090, GuideLiner V3 catheter (Vascular Solutions LLC), K161901, TrapLiner catheter (Vascular Solutions LLC)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 9, 2022
Vascular Solutions LLC Rebecca Astrup Sr. Regulatory Product Specialist 6464 Sycamore Court N Maple Grove. Minnesota 55369
Re: K212211
Trade/Device Name: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 14, 2021 Received: July 15, 2021
Dear Rebecca Astrup:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212211
Device Name
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; GuideLiner V3 Catheter; TrapLiner Catheter
Indications for Use (Describe)
Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
| 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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3
Image /page/3/Picture/1 description: The image is a logo for Vascular Solutions. The logo features a tan square with a black, abstract design above it that resembles a series of descending blocks. Below the square, the words "Vascular" and "Solutions" are written in a stylized font, with "Vascular" in a larger, bolder typeface than "Solutions."
510(k) Summary
[As required by 21 CFR 807.92] Date Prepared: February 9, 2022
510(k) Number: K212211
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Becky Astrup Sr. Regulatory Product Specialist Tel: 763-762-2601 Fax: 763-251-0363
General Information
| Trade Name | Turnpike catheter
Turnpike Spiral catheter
Turnpike LP catheter
Turnpike Gold catheter
GuideLiner V3 catheter
TrapLiner catheter |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 870.1250, DQY, Percutaneous catheter, Class II |
| Predicate Device | K171933, Asahi Corsair Pro microcatheter (Asahi Intecc Co., LTD) |
| Reference Devices | K191560, Turnpike catheter (Vascular Solutions LLC)
K172090, GuideLiner V3 catheter (Vascular Solutions LLC)
K161901, TrapLiner catheter (Vascular Solutions LLC) |
4
Device Description
Turnpike catheters:
The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.
GuideLiner V3 catheters:
The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
TrapLiner catheters:
The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.
Intended Use
All devices are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. The indications for use are as follows.
Turnpike catheters:
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheters:
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/ or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
5
TrapLiner catheters:
The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Technological Characteristics Comparison
The Turnpike Catheter, GuideLiner V3 Catheter, TrapLiner Catheter, and Corsair Pro Microcatheter have the same intended use. The Turnpike Catheter, GuideLiner V3 Catheter, TrapLiner Catheter, and Corsair Pro Microcatheter are both manufactured with a polymer layers and include a coil segment with a radiopaque tip and a lumen compatible with 0.014" guidewires.
The tables below compare the technological characteristics of each subject device with the predicate device. The Turnpike, GuideLiner V3, and TrapLiner catheters are substantially equivalent to the predicate device with respect to indications for use and technological characteristics. Furthermore, the Turnpike, GuideLiner V3, and TrapLiner catheters are identical in design and technological characteristics to each reference device.
| | Subject Device
Turnpike Catheter | Predicate Device
Asahi Corsair Pro microcatheter
(K171933) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | 21 CFR 870.1250 Percutaneous Catheter | |
| Product Code | | DQY |
| Intended Use/Indications | The Turnpike catheters are intended
to be used to access discrete regions
of the coronary and/or peripheral
vasculature. They may be used to
facilitate placement and exchange of
guidewires, to subselectively
infuse/deliver diagnostic and
therapeutic agents, and to assist in
crossing de novo coronary chronic | This product is intended to provide
support to facilitate the placement
of guidewires in the coronary and
peripheral vasculatures, and can be
used to exchange one guidewire for
another.
This product is also intended to
assist in the delivery of contrast
media into the coronary, peripheral,
and abdominal vasculatures, and to
assist in crossing de novo coronary |
| | total occlusions (CTO). | chronic total occlusions (CTO).
This device should not be used in
the neurovasculature. |
| Device Description | Single lumen guidewire support catheter with radiopaque tip | |
| Anatomical Location | Coronary and Peripheral Vasculature | |
| Guidewire Compatibility | $ ≤ $ 0.014" | |
| Guide Catheter
Compatibility | $ ≥ $ 5F | |
| Working Length | 135 cm, 150 cm | |
| Coating Length | 60 cm | |
| Proximal Shaft OD | 0.038" | 0.037" |
| Distal Shaft OD | 0.029" – 0.038" | 0.034" |
6
| | Subject Device
Turnpike Catheter | Predicate Device
Asahi Corsair Pro microcatheter
(K171933) |
|---------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Distal Tip OD | 0.021" – 0.028" | 0.017" |
| Materials | Materials compatible with ISO 10993, commonly used for the manufacture of medical devices. | |
| Sterilization | Ethylene Oxide, SAL 10-6 | |
| | Subject Device
GuideLiner V3 Catheter | Predicate Device |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Asahi Corsair Pro microcatheter
(K171933) |
| Product Classification | | 21 CFR 870.1250 Percutaneous Catheter |
| Product Code | | DQY |
| Intended Use/Indications | GuideLiner catheters are intended
to be used in conjunction with
guide catheters to access discrete
regions of the coronary and/ or
peripheral vasculature, to facilitate
placement of interventional
devices, and to assist in crossing
de novo coronary chronic total
occlusions (CTO). | This product is intended to provide
support to facilitate the placement of
guidewires in the coronary and
peripheral vasculatures, and can be
used to exchange one guidewire for
another.
This product is also intended to assist
in the delivery of contrast media into
the coronary, peripheral, and
abdominal vasculatures, and to assist
in crossing de novo coronary chronic
total occlusions (CTO).
This device should not be used in the
neurovasculature. |
| Device Description | Single lumen rapid exchange
catheter with radiopaque tip | Single lumen guidewire support
catheter with radiopaque tip |
| Anatomical Location | Coronary and Peripheral Vasculature | |
| Guidewire Compatibility | | ≤0.014" |
| Guide Catheter
Compatibility | 5 Fr: ID ≥0.056" (1.42 mm)
5.5 Fr: ID ≥0.066" (1.68 mm)
6 Fr: ID ≥0.070" (1.78 mm)
7 Fr: ID ≥0.078" (1.98 mm)
8 Fr: ID ≥0.088" (2.24 mm) | ≥5F |
| Working Length | 150 cm | 135 cm, 150 cm |
| Coating Length | 25 cm | 60 cm |
| Shaft ID | 0.046" – 0.071" | 0.018" (0.45 mm) |
| Shaft OD | 0.053" – 0.085" | Proximal: 0.037"
Distal: 0.034" |
| Materials | Materials compatible with ISO 10993, commonly used for the manufacture
of medical devices. | |
| Sterilization | Ethylene Oxide, SAL 10-6 | |
7
| | Subject Device
TrapLiner Catheter | Predicate Device
Asahi Corsair Pro microcatheter
(K171933) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | 21 CFR 870.1250 Percutaneous Catheter | |
| Product Code | DQY | |
| Intended Use/Indications | The TrapLiner catheter is intended
for use in conjunction with guide
catheters to access discrete regions
of the coronary and/or peripheral
vasculature, to facilitate placement
of interventional devices, to
facilitate the exchange of an
interventional device while
maintaining the position of a
guidewire within the vasculature,
and to assist in crossing de novo
coronary chronic total occlusions
(CTO). | This product is intended to provide
support to facilitate the placement of
guidewires in the coronary and
peripheral vasculatures, and can be
used to exchange one guidewire for
another.
This product is also intended to
assist in the delivery of contrast
media into the coronary, peripheral,
and abdominal vasculatures, and to
assist in crossing de novo coronary
chronic total occlusions (CTO).
This device should not be used in the
neurovasculature. |
| Device Description | Rapid-exchange guide extension
catheter with trapping balloon | Single lumen guidewire support
catheter with radiopaque tip |
| Anatomical Location | Coronary and Peripheral Vasculature | |
| Guidewire Compatibility | ≤ 0.014" | |
| Guide Catheter
Compatibility | 6 Fr: ID ≥0.070" (1.78 mm)
7 Fr: ID ≥0.078" (1.98 mm)
8 Fr: ID ≥0.088" (2.24 mm) | ≥5F |
| Working Length | 150 cm | 135 cm, 150 cm |
| Coating Length | 11.5 cm | 60 cm |
| Materials | Materials compatible with ISO 10993, commonly used for the manufacture
of medical devices. | |
| Sterilization | Ethylene Oxide, SAL 10-6 | |
Questions related to clinical performance have been evaluated for the subject devices through design verification and validation testing, including an IDE clinical study.
Performance Data
No physical changes have been made to the subject devices compared to the reference devices; therefore, comparisons of bench, biocompatibility, packaging, and sterilization testing are not necessary. Clinical testing has been performed to evaluate the technological differences when comparing the subject devices to the predicate device for the CTO indication.
Clinical Tests:
A prospective, multi-center, single-arm study of 150 subjects was performed to evaluate the safety and effectiveness of Vascular Solutions' specialized guidewires, microcatheters, and guide extensions in patients undergoing CTO-PCI. The objective of the study was to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO PCI in which at least one study guidewire and one Turnpike catheter were used.
8
Device Use
A total of 566 study-guidewires (55% of the total number of guidewires used; used in all 150 subjects) and 457 non-study guidewires (45% of the total; used on 112 subjects) were used in the CTO-PCI Study. A detailed breakdown of study device wire use is provided in the following table.
| Guidewire Device Usage | |
|---|---|
| Guidewire | Number (%) of Subjects with Device Used |
| Spectre | 129 (86.0%) |
| Raider | 102 (68.0%) |
| Warrior | 35 (23.3%) |
| Bandit | 68 (45.3%) |
| R350 | 39 (26.0%) |
At least one Turnpike catheter and one study guidewire were used in all cases, and a GuideLiner catheter or TrapLiner catheter was used in all cases where a guide extension was required (64% of cases). A breakdown of Turnpike catheter use by model is provided in the following table.
| Turnpike Catheter Device Usage | |||
|---|---|---|---|
| Catheter | Number (%) of Subjects with Device Used | ||
| Turnpike | 33 (22.0%) | ||
| Turnpike Spiral | 94 (62.7%) | ||
| Turnpike Gold | 1 (0.7%) | ||
| Turnpike LP | 85 (56.7%) |
Study device procedural technique is provided in the following table.
| Procedural Technique – n (%) | |
|---|---|
| Wire escalation | 86 (57.3%) |
| Dissection/re-entry | 23 (15.3%) |
| Wire externalization | 21 (14.0%) |
| Safety | 15 (10.0%) |
| Stabilization and/or support | 7 (4.7%) |
| Delivery | 5 (3.3%) |
| Reverse CART | 4 (2.7%) |
| Crossing | 2 (1.3%) |
| Not specified | 2 (1.3%) |
| CTO RCA and RPL | 1 (0.7%) |
| Donor vessel | 1 (0.7%) |
| Knuckled | 1 (0.7%) |
| Workhorse | 1 (0.7%) |
9
Primary Endpoint
The primary endpoint for the study was defined as procedure success through discharge or 24 hours postprocedure, whichever came first. Procedure success was defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access, and absence of in-hospital MACE (cardiac death, target lesion revascularization, or post-procedural MI defined as CK-MB ≥ 3x ULN).
Summary of Primary Endpoint Analysis
The study primary endpoint result (75.3%) met the predetermined performance goal.
| Category | Study Results
% (n/N) |
|------------------------------------------------------------------------------------------------|--------------------------|
| Overall Primary Endpoint Met
Components of Primary Endpoint | 75.3% (113/150) |
| Angiographic Visualization of any guidewire distal/proximal to
CTO in the true vessel lumen | 94.7% (142/150) |
| Absence of in-hospital MACE | 80.7% (121/150) |
Secondary Endpoint
The secondary endpoints include:
- . Frequency of successful recanalization (defined as angiographic confirmation of crossing CTO and restoring blood flow to the affected area).
- . Frequency of MACE through discharge or 24 hours post-procedure, whichever comes first (inhospital follow-up), and at 30 days post-procedure (MACE components are also reported separately).
- . Frequency of clinically significant perforation (defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy).
- Procedural success according to crossing technique. ●
- Technical success.
10
| Parameter | Study Results
% (n/N) |
|-----------------------------------------|--------------------------|
| Successful recanalization | 140 (93.3%) |
| MACE | 29 (19.3%) |
| In-Hospital | 29 (19.3%) |
| 30-Day | 0 (0.0%) |
| Clinically Significant Perforations | 16 (10.7%) |
| Procedure Success by Crossing Technique | |
| Antegrade | 69 (85.2%) (69/81) |
| Retrograde | 1 (50.0%) (1/2) |
| Combined Antegrade and Retrograde | 43 (64.2%) (43/67) |
| Technical Success | 140 (93.3%) |
Summary of Secondary Endpoint Analysis
MACE includes all MIs defined as CK-MB ≥ 3x ULN.
In a multicenter, prospective registration trial, procedural success was achieved in a high lesion complexity patient population (e.g. 94.7% severely calcified lesions) using contemporary technique and application of dedicated CTO guidewires, microcatheters and guide catheter extensions. No new safety or effectiveness issues were raised during the study. These results demonstrate that the subject catheters are suitable for their intended use to assisting in crossing de novo coronary chronic total occlusions (CTO). The clinical data raised no new questions of safety and effectiveness compared to the predicate devices, supporting that the subject catheters with the expanded indication are substantially equivalent to the predicate devices.
Conclusion
The Turnpike Catheter, GuideLiner V3 Catheter, and TrapLiner Catheter are substantially equivalent to the predicate device.