(35 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML.
No
The device is described as introducing and positioning catheters and interventional devices, which are diagnostic or procedural tools, not therapeutic in themselves.
No
The device description and intended use indicate that it is a guidewire used to introduce and position other devices, not to diagnose a condition.
No
The device description clearly details physical components like a Nitinol or Stainless Steel core, Palladium coil, and PTFE coating, indicating 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 for a medical procedure, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a physical guidewire used for navigation within blood vessels. This aligns 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 diagnostics.
Therefore, this device is a medical device used for interventional procedures, not an IVD.
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)
74HAP, 74DQX, 74JAJ
Device Description
Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetraflyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm
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)
NON-CLINICAL TESTS THE FIRE FOR THE FOR SHOW FOR WARRET WE WARRE WE WAR In order to demonstrate equivalence of the Mandrel Guidewire iterations, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, 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.
BIOGOMPATIBILITY TESTING COUNTY CONTROLLER OF THE CONNECT CONSULTION Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable.
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.
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
§ 870.1330 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
SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS
January 18, 2007
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
COMPANY NAME, ADDRESS AND TELEPHONE NUMBER
Lake Region Manufacturing, Inc. d/b/a Lake Region Medical (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318 (952) 448-5111 Telephone: (952) 448-3441 Fax: Contact Person: Deep Pal Regulatory Affairs Specialist
ESTABLISHMENT REGISTRATION NUMBER
2126666
DEVICE TRADE NAME/PROPRIETARY NAME
Mandrel Guidewire Or M-Wires
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 Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ).
GLASSIFICATION OF DEVICES OF CHICLES OF CHARACT CHEAR OF The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels, respectively.
APPLICABILITY OF PERFORMANCE STANDARDS
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical 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.
DEVICE DESCRIPTION
Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetraflyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters:
Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm
1
SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS (continued...)
TECHNOLOGICAL CHARACTERSTICS
The design specifications are substantially similar to the existing Mandrel Guidewires. Material used for the coil of the Guidewire will be Palladium.
QUALITY SYSTEM CONTROLS
DESIGN CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
MATERIAL/SUPPLIER/PRODUCT/PROCESS CONTROLS = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = LRM has formal quality systems in place to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.
QUALIFICATION TESTING
NON-CLINICAL TESTS THE FIRE FOR THE FOR SHOW FOR WARRET WE WARRE WE WAR In order to demonstrate equivalence of the Mandrel Guidewire iterations, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, 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.
BIOGOMPATIBILITY TESTING COUNTY CONTROLLER OF THE CONNECT CONSULTION Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable.
SUBSTANTIAL EQUIVALENCE DATA
Lake Region believes the Mandrel Guidewire iterations are substantially equivalent to the predicate devices cleared under 510(k) K011084. All non-clinical test results support the claim of substantial equivalence to the predicate devices.
INTENDED USE STATEMENT
Mandrel Guidewires are intended for use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. NOTE: The modification of this device does not alter its intended use.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
FEB 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lake Region Manufacturing, Inc. DBA Lake Region Medical c/o Mr. Deep Pal Regulatory Affairs Specialist 340 Lake Hazeltine Drive Chaska, MN 55318
Re: K080144
Mandrel Guidewires Regulation Number: 21 CFR §870.1330 Regulation Name: Vascular clamp Regulatory Class: II Product Code: DQX Dated: January 18, 2008 Received: January 22, 2008
Dear Mr. Pal:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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, de necs that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , necess , sisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de ho ho ho hadditional 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.
3
Page 2 - Mr. Deep Pal
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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dmna R. Vorhner
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
080 510(k) Number (if known):
Device Name: Mandrel 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 × (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)
uma R. Vuchner
(Division Sign-Off)
Page 1 of
Division of Cardiovascular Devices
510(k) Number_
9-1