(29 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data-driven performance metrics.
No.
The device is a guidewire used to introduce and position catheters and interventional devices, facilitating diagnostic or interventional procedures, but it does not treat a disease or condition itself.
No
Explanation: The device is a guidewire intended for introducing and positioning catheters and interventional devices, which are therapeutic or interventional actions, not diagnostic ones.
No
The device description clearly describes a physical guidewire made of materials like Nitinol, Stainless Steel, and various metals for the coil, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details the physical components of a guidewire used in vascular procedures, such as a core wire, coating, coil, and markers. This aligns with an interventional medical device, not an IVD.
- 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.
Therefore, the Mandrel guidewire is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Mandrel guidewires are intended 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)
DQX
Device Description
The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters:
Lengths: 20cm to 500cm
Outside Diameter: 0.014" To 0.35"
Tips: Straight or shaped with various flexibilities
Coil Length: 2cm to 30cm
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)
Bench testing and biocompatibility testing were performed.
Bench tests included visual, radiopacity, lubricity, J-Memory Test, Body Stiffness, Adhesion / Durability, Guidewire Pull test, Torque Strength, Torque Control, Dimensional, Linear Stiffness, Lateral Stiffness, Particulate Test, ISO Strength of Union, ISO Flex Test, ISO Corrosion Resistance Test, ISO Fracture Test, Hydrodurability.
Biocompatibility tests included cytotoxicity and hemolysis.
The results demonstrated compliance with design input summary and showed the device is at least as safe and effective as the current legally marketed device.
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.
K011084, K022759, K033758, K080144
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
Lake Region
SECTION 2.0 - 510(k) SUMMARY
September 24, 2014
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
| 2.1 | MANUFACTURER / REGISTRATION INFORMATION | |
|---|---|---|
| Lake Region Medical | Telephone: | 952-448-5111 |
| 340 Lake Hazeltine Dr. | Fax: | 952-448-3441 |
| Chaska, Mn 55318 | Contact Person: | Mathew Pexa, |
| FDA REGISTRATION NUMBER: 2126666 | Title: | Regulatory Specialist II |
2.2 DEVICE TRADE NAME / PROPRIETARY NAME
Mandrel Guidewires or M-Wires
DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES 2.3
- CATHETER GUIDEWIRE (DQX)
2.4 CLASS OF DEVICE
These devices are commonly known as guides, guidewires, or spring guidewires. The current classification name and product code is Catheter Guidewire (DQX) and is considered a Class II device per 21 CFR Part 870.1330.
- IDENTIFICATION OF PREDICATE DEVICE(s) 2.5
| K011084 | Mandrel Guidewires (Lake Region Medical) |
|---|---|
| K022759 | Mandrel Guidewires (Lake Region Medical) |
DEVICE DESCRIPTION 2.6
The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters:
| Lengths: | 20cm to 500cm |
|---|---|
| Outside Diameter: | 0.014" To 0.35" |
| Tips: | Straight or shaped with various flexibilities |
| Coil Length: | 2cm to 30cm |
2.7 COMPLIANCE WITH APPLICABLE STANDARDS
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 or by any subsequent regulatory action. However, the following standards are referenced within this filing: ISO 10993, ISO 11070, ISO 11135.
INTENDED USE STATEMENT 2.8
Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. NOTE: This modification does not alter its intended use.
2.9 CONTRAINDICATIONS
There are no contraindications listed.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Dr. Chaska, MN 55318
Re: K140485
Trade/Device Name: Mandrel Guidewire with Tungsten Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: February 11, 2014 Received: February 26, 2014
Dear Mr. Pexa,
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 four d 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 or any 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
2
Page 2 - Mathew Pexa
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
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
3
് Lal
PRODUCT: MANDREL GUIDEWIRE FAMILY w/ TUNGSTEN - Vascular Use SUBMISSION DATE: February 11, 2014 SUBMISSION TYPE: SPECIAL 510(k)
INDICATIONS FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Mandrel Guidewire
INDICATIONS FOR USE:
Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
| PRESCRIPTION | X | AND/OR | OVER-THE-COUNTER |
|---|---|---|---|
| USE | USE | ||
| (Part 21 CFR 801 Subpart D) | (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)
Bram D. Zuckerman -S 2014.03.27 16:48:58 -04'00'
PAGE 1 of
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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red circular design on the left, followed by the words "Lake Region" in a bold, serif font. Below "Region" is the word "Medical" in a smaller font size. The logo is clean and professional, suggesting a healthcare organization.
TECHNOLOGICAL CHARACTERISTICS 2.10
The design specifications are substantially equivalent to the existing Mandrel Guidewires. Material used for the coil of the guidewire will include the addition material option of Tungsten.
2.11 QUALITY SYSTEM CONTROL
DESIGN CONTROLS
LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.33. Risk analysis was completed by means of a Failure Mode and Effects Analysis and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
MATERIALS / SUPPLIER / PRODUCT / PROCESS CONTROLS
LRM has formal quality systems in placed to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse effect on safety or 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.
2.12 QUALIFICATION TESTING
The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device.
BENCH TESTING
In order to demonstrate equivalence of the guidewire, Lake Region Medical performed bench testing to establish requirements. Test devices were manufactured and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. The devices were then subjected to the following test methods to show the devices comply with the design input summary:
- Visual
- Radiopacity
- Lubricity
- J-Memory Test
- Body Stiffness
- Adhesion / Durability
- Guidewire Pull test
- · Torque Strength • Torque Control
- Dimensional • Linear Stiffness
- Lateral Stiffness
- Particulate Test
- ISO Strength of Union
- ISO Flex Test
- ISO Corrosion Resistance Test
- · ISO Fracture Test
- · Hydrodurability
- BIOCOMPATIBILITY TESTING
Biocompatibility testing per the design input summary requirements show the addition of Tungsten to the device does not affect the biocompatibility of the device is still in compliance with pre-defined acceptance criteria outlined in the product Design Input Summary. A biocompatibility risk assessment determined the following biocompatibility tests are required:
- · Cytotoxicity · Hemolysis
2.13 SUBSTANTIAL EQUIVALENCE DATA
The addition of Tungsten to the Mandrel guidewire family does not change the indications for use of the Mandrel guidewires and is not a change to the fundamental scientific technology. The information summarized above shows the device will perform as well as the previously marketed device.