(154 days)
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guidewire used to introduce and position other devices, not to treat a condition itself.
No
Explanation: The device is described as a guidewire used to introduce and position other devices, not to diagnose a condition.
No
The device description clearly details the physical components of a guidewire, including materials like stainless steel, Nitinol, and PTFE, and describes its construction and physical attributes. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used within the body during a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical components of a guidewire designed for navigation within blood vessels. This aligns with an interventional device, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
74DQX
Device Description
The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires (Reference 510(k);s K970376, K041624).
OUTSIDE DIAMETER: .014" LENGTHS: 185cm - 300 cm TIPS: Straight
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)
In order to demonstrate equivalence of the Trailrunner™ Guidewires, LRM performed testing to established requirements. Test pieces were tested according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices.
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.
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.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
072965
Image /page/0/Picture/1 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized symbol to the left of the words "Lake Region". The word "Medical" is located below and to the right of "Lake Region".
PRODUCT: TRAILRUNNER™ GUIDEWIRES MISSION DATE: SEPTEMBER 10, 2009 SUBMISSION TYPE: TRADITIONAL
FEB 2 6 2010
510(k) SUMMARY SECTION 5.0:
5:1 MANUFACTURER / REGISTRATION INFORMATION
| Lake Region Medical | Contact Person: | Karen Mortensen |
|---|---|---|
| 340 Lake Hazeltine Drive | Title: | Manager, Regulatory Affairs |
| Chaska, MN 55318-1029 USA | Telephone: | (952) 448-5111, Extension 6727 |
| FDA REGISTRATION NUMBER: 2126666 | Fax: | (952) 448-3441 |
5.2 TRADE NAME (PROPRIETATY NAME)
Lake Region Medical (LRM) produces Guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors.
5.3 . DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES
These devices are commonly known as Guides, Guidewires, or spring Guidewires. The current classification names and product codes are Wire, Guide, Catheter (74DQX).
CLASS OF DEVICE 5.4
This type of Guidewire was originally listed as a Class II device by the Neurology (84HAD), the Cardiovascular (74DQX) and the Radiology (74JAJ) Review Panels, respectively.
IDENTIFICATION OF PREDICATE DEVICE(s) 5.5
| 510(k) NUMBER | MANUFACTURER | DEVICE NAME |
|---|---|---|
| K983033 | GUIDANT | High Torque BMW Guidewire |
ડ.૯ DEVICE DESCRIPTION
The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)
OUTSIDE DIAMETER: .014" LENGTHS: 185cm - 300 cm
TIPS: Straight
TECHNOLOGICAL CHARACTERSTICS 5.7
The design specifications are substantially equivalent High Torque BMW Guidewire. Both have a bi-metal core comprised of stainless steel and Nitinol connected by a hypotube. Both designs have a platinum distal coil and a stainless steel coil and both designs have ribbon wires inserted into the inside diameter of the coils. Component joining methods are similar and both are partially coated with hydrophilic coating and contain proximal depth markings on the core.
1
O Lake Re
PRODUCT: TRAILRUNNER™ GUIDEWIRES SUBMISSION DATE: SEPTEMBER 10, 2009 SUBMISSION TYPE: TRADITIONAL
510(k) SUMMARY SECTION 5.0:
COMPLIANCE WITH APPLICABLE STANDARDS 5.8
LRM has determined that no mandatory standards, performance standards or special controls have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.
INTENDED USE STATEMENT 5.9
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
5.10 COMPARISON
A comparison table to display the similarities and differences of the proposed Trailrunner™ Guidewire to the previously cleared High Torque BMW Guidewires (K983033), to which equivalency is claimed is included in this section.
The table below illustrates the design for the Trailrunner™ Guidewire iterations and the comparison to the predicate devices:
| TRAILRUNNER™ GUIDEWIRES | |
|---|---|
| PREDICATE DEVICE | |
| CLEARED UNDER K983033 | PROPOSED DEVICE |
| TRAILRUNNER™ GUIDEWIRE PRODUCT LINE | |
| CORE | |
| Proximal - PTFE Coated Stainless Steel | Proximal - PTFE Coated Stainless Steel |
| Distal - Nitinol | Distal - Nitinol |
| COIL | |
| Proximal - Stainless Steel | |
| (longer length than proposed device) | Proximal - Stainless Steel |
| (shorter length than predicate device) | |
| Distal - Platinum Alloy | Distal - Platinum Alloy |
| ADDITIONAL COATINGS | |
| Hydrophilic | Hydrophilic |
| JOINING AGENTS | |
| End joints - Solder | End joints - Solder |
| Hypotube - Adhesive | Hypotube - Adhesive |
| GUIDEWIRE LENGTHS | |
| 190 cm and 300 cm | 185 cm and 300 cm |
| DEPTH MARKINGS | |
| Ablated from PTFE | White PTFE |
| GUIDEWIRE DIAMETER | |
| .014" | .014" |
| STERILIZATION METHOD | |
| Gamma | ETO |
2
C Lake Region
PRODUCT: TRAILRUNNER™ GUIDEWIRES SUBMISSION DATE: SEPTEMBER 10, 2009 SUBMISSION TYPE: TRADITIONAL
510(k) SUMMARY SECTION 5.0:
5.11 QUALIFICATION TESTING CONTRACT
NON-CLINICAL TESTS
In order to demonstrate equivalence of the Trailrunner™ Guidewires, LRM performed testing to established requirements. Test pieces were tested according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices.
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Trailrunner™ devices and has been found to be acceptable.
・
SUBSTANTIAL EQUIVALENCE DATA 5.12
Lake Region believes the Trailrunner™ Guidewire is substantially equivalent to the High Torque BMW Guidewire cleared under K983033. All non-clinical test results support the claim of substantial equivalence.
.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB 2 6 2010
Lake Region Medical c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313
Rc: K092965
Trade Name: Trailrunner™ Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: February 5, 2010 Received: February 16, 2010
Dear Mr. Job:
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
4
Page 2 -- Mr. Mark Job
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Diana R. Vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Lake Region
Medical..
PRODUCT: TRAILRUNNER™ GUIDEWIRES SUBMISSION DATE: SEPTEMBER 10, 2009 SUBMISSION TYPE: TRADITIONAL
INDICATIONS FOR USE
510(k) NUMBER (if KNOWN): KO92965
DEVICE NAME: TRAILRUNNER™ Guidewires
INDICATIONS FOR USE:
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
PRESCRIPTION USE X (Part 21 CFR 801 Subpart D) AND/OR
OVER-THE-COUNTER USE (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of
Duna E. V. L. Viner
vascular Devices
510(k) Number_