(164 days)
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).
The GuideLiner Coast catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in four sizes - 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner Coast 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, hydrophilic coated 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.
This device is a GuideLiner Coast catheter, intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, facilitate placement of interventional devices, and assist in crossing de novo coronary chronic total occlusions (CTO).
The submission focuses on establishing substantial equivalence to a predicate device (K212211, GuideLiner V3 catheter and TrapLiner catheter) by evaluating technological differences, specifically a new hydrophilic coating material, a reduction in coating length, and cosmetic changes to the hub. The information provided does not describe a clinical study involving human patients or the use of AI. Instead, it relies on a series of bench tests and biocompatibility tests. Therefore, many of the requested sections regarding clinical study design, ground truth, and AI performance are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Deliverability | Device samples passed |
| Hydrophilic Coating Evaluation | Device samples passed |
| Tensile Strength | Device samples passed |
| Hub Markings | Device samples passed |
| Biocompatibility (Cytotoxicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Sensitization) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Irritation) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Systemic Toxicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Material Mediated Pyrogenicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Hemolysis) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Complement Activation) | Device samples passed (in accordance with ISO 10993-1) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each bench test. The term "device samples" is used. The data provenance is from bench testing, meaning it's laboratory-generated data, not patient data from a specific country, and is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench tests is typically established by engineering specifications, material science standards, and established test methodologies, not by expert medical opinion.
4. Adjudication Method for the Test Set
Not applicable. As this is bench testing, there is no adjudication process involving multiple human evaluators of test results in the way described for clinical data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This submission does not involve an AI device or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The ground truth for the performance tests (Deliverability, Hydrophilic Coating Evaluation, Tensile Strength, Hub Markings) is based on engineering specifications and established test methods for medical devices.
The ground truth for biocompatibility tests is based on ISO 10993-1 standards for biological evaluation of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device, so there is no training set or associated ground truth establishment process.
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August 18, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vascular Solutions LLC Steph Pahl Regulatory Product Specialist 6464 Sycamore Court N Maple Grove, Minnesota 55369
Re: K220647
Trade/Device Name: GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: March 4, 2022 Received: March 7, 2022
Dear Steph Pahl:
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 aw are 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
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220647
Device Name GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
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, to facilitate placement of interventional devices, 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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Image /page/3/Picture/1 description: The image shows the logo for Vascular Solutions. The logo features a tan square with a series of black squares above it that decrease in size as they move upwards, creating a visual effect resembling a plume or rising column. Below the square is the text "Vascular SOLUTIONS" with the word "Vascular" in a larger, bold font and "SOLUTIONS" in a smaller, regular font.
510(k) Summary [As required by 21 CFR 807.92] Date Prepared: August 18, 2022 510(k) Number: K220647
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Steph Pahl Sr. Regulatory Product Specialist Tel: 763-762-2641 Fax: 763-251-0363
| General Information | |
|---|---|
| Trade Name | GuideLiner Coast catheter |
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 870.1250, DQY, Percutaneous catheter, Class II |
| Predicate Device | K212211, GuideLiner V3 catheter and TrapLinercatheter (Vascular Solutions) |
Device Description
The GuideLiner Coast catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in four sizes - 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner Coast 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, hydrophilic coated 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.
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Intended Use
The subject device is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. The indications for use are as follows.
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).
Technological Characteristics Comparison
The key technological differences between the GuideLiner Coast catheter and the predicate device are the introduction of a new hydrophilic coating material, a reduction in coating length, and the colors of the hub resin and hot stamp foil ink.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate device have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the GuideLiner Coast catheter.
Bench Tests:
The device performance was verified through the following tests:
- . Deliverability
- Hydrophilic Coating Evaluation
- Tensile Strength
- Hub Markings ●
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemolysis ●
- Complement Activation
Conclusions
The differences between the GuideLiner Coast catheter and the predicate GuideLiner V3 catheter have been evaluated through bench data. The bench data raised no new questions of safety and effectiveness compared to the predicate device, supporting that the GuideLiner Coast catheter is substantially equivalent to the predicate device.
§ 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).