(101 days)
No
The device description and performance studies focus on the mechanical and material properties of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and intended use state that it is used to facilitate placement of interventional devices, which are then used to treat. The GuideLiner catheter itself does not directly treat a condition.
No
The device is intended to facilitate the placement of interventional devices and access discrete regions of the vasculature. It does not perform any diagnostic function.
No
The device description clearly details a physical catheter with specific dimensions, materials (stainless steel, polymer, platinum-iridium), and physical components (pushwire shaft, guide extension segment, marker bands, positioning marks). The performance studies also focus on physical characteristics and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices." This describes a device used within the body for procedural assistance, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the GuideLiner V3 catheter is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Product codes
DQY
Device Description
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, 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 semi-circular polymer that meets the proximal end of the full-round guide extension segment. The GuideLiner V3 catheter has two platinumiridium marker bands; the distal marker band is located at the distal tip and the proximal marker band is located near the collar. The GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm (double mark) from the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and performance tests to provide evidence of substantial equivalence for the GuideLiner V3 catheter. The GuideLiner V3 catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Kink Radius
- Bend Diameter
- Extension into Anatomy
- Silicone Coating
- Radiopacity
- Contrast Delivery
- Interventional Device Delivery
- Shaft Tensile
- Hub Tensile
- Torque Strength
- Distal Shaft Length
- Half-Pipe Length
- Working Length
- Guide Catheter Compatibility
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- Thrombogenicity
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the GuideLiner V3 catheter is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
GuideLiner V2 Catheter - K112082
Reference Device(s)
TrapLiner Catheter – K161901
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 20, 2017
Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K172090
Trade/Device Name: GuideLiner V3 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 21, 2017 Received: September 22, 2017
Dear Beka Vite:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name GuideLiner V3 Catheter
Indications for Use (Describe)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
| Type of Use (Select one or both, as applicable) |
|---|
| Registration (ID: 01-077-001-0-0000) |
| One-Time Event (ID: 01-077-001-1-0000) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92] Date Prepared: September 19, 2017 510(k) Number: K172090
Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| Vascular Solutions, Inc. | Beka Vite |
| 6464 Sycamore Court North | Sr. Regulatory Product Specialist |
| Minneapolis, MN 55369 USA | Tel: 763-657-5732 |
| Establishment Registration # 2134812 | Fax: 763-656-4253 |
General Information
| Trade Name | GuideLiner V3 Catheter |
|---|---|
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 820.1250 |
| Predicate Device | GuideLiner V2 Catheter - K112082 |
| Reference Device | TrapLiner Catheter – K161901 |
Device Description
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, 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 semi-circular polymer that meets the proximal end of the full-round guide extension segment. The GuideLiner V3 catheter has two platinumiridium marker bands; the distal marker band is located at the distal tip and the proximal marker band is located near the collar. The GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm (double mark) from the distal tip.
Intended Use
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
4
Technological Characteristics Comparison
The key technological difference between the GuideLiner V3 catheter and the predicate device is the addition of the semi-circular polymer transition from the pushrod to the full-round guide extension segment. An additional 5F configuration is also included.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and performance tests to provide evidence of substantial equivalence for the GuideLiner V3 catheter. The GuideLiner V3 catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Kink Radius
- . Bend Diameter
- . Extension into Anatomy
- Silicone Coating
- Radiopacity
- Contrast Delivery
- . Interventional Device Delivery
- Shaft Tensile
- Hub Tensile
- Torque Strength
- Distal Shaft Length
- Half-Pipe Length
- Working Length
- Guide Catheter Compatibility
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- . Sensitization
- . Irritation
- Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- Thrombogenicity
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the GuideLiner V3 catheter is substantially equivalent to the predicate device.