(31 days)
Not Found
No
The description focuses on the physical composition and intended use of a guidewire, with no mention of AI or ML technologies.
No
The device is a guidewire intended to facilitate the introduction and placement of interventional devices, not to provide a therapeutic effect itself.
No
The guidewires are intended to facilitate the introduction and placement of interventional devices, not to diagnose a condition.
No
The device description clearly details a physical guidewire made of stainless steel, indicating it is a hardware medical 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 clearly states that the guidewires are used to "facilitate the introduction and placement of interventional devices within the chambers of the heart". This describes a device used in vivo (within the living body) for a procedural purpose.
- Device Description: The description details a physical guidewire made of stainless steel and PTFE, designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
Therefore, this device is an interventional medical device used within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve. The following table shows the characteristics of the product family:
| Outside Diameter: | 0.035" |
|---|---|
| Overall Length: | 260cm to 300cm |
| Tip Shape: | Double-Curve |
| Tip Sizes: | Extra Small - Large |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart
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)
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
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:
- Dimensional
- FDA Tensile Strength
- FDA Tip Flexibility
- FDA Catheter Compatibility
- Packaging Study
- Tip Shape Retention
- Particulate
- ISO Visual
- ISO Fracture
- ISO Flex
- ISO Corrosion Resistance
- Linear Stiffness
BIOCOMPATIBILITY TESTING
There were no changes to materials used in the design or manufacture of the Pre-Formed guidewire family; therefore, no additional biocompatibility tests were completed.
ANIMAL STUDY
A GLP Animal study was completed to evaluate safety and performance of the guidewire compared to the currently marketed device. The study shows the guidewires are substantially equivalent to the 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three human profiles incorporated into the design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
Lake Region Medical Mathew Pexa Sr. Regulatory Specialist 340 Lake Hazeltine Dr. Chaska, Minnesota 55318
Re: K151244
Trade/Device Name: Pre-Formed Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: May 8, 2015 Received: May 11, 2015
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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.
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 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. 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 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 yours,
M.A. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized heart shape in red and gray, followed by the words "Lake Region" in a simple, sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller, lighter font.
INDICATIONS FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): K151244
DEVICE NAME: Pre-Formed Guidewire
INDICATIONS FOR USE:
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
PRESCRIPTION
USE
AND/OR
OVER-THE-COUNTER 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)
PAGE 1 of ।
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Image /page/3/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a geometric shape on the left, which is a combination of red and gray triangles forming a heart-like shape. To the right of the geometric shape is the text "Lake Region" in a clean, sans-serif font, with the "i" in "Region" having a red square dot. Below "Lake Region" and slightly offset to the right is the word "MEDICAL" in a smaller, lighter font.
510(k) SUMMARY
May 8, 2015
This summary is being included in the 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: | Sr. Regulatory Specialist | ||
| 2.2 | DEVICE TRADE NAME / PROPRIETARY NAME |
Pre-Formed Guidewires
2.3 DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES 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.
| 2.5 | IDENTIFICATION OF PREDICATE DEVICE(s) |
|---|---|
| ----- | --------------------------------------- |
Pre-Formed Guidewires (Lake Region Medical) K130798
DEVICE DESCRIPTION 2.6
The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve. The following table shows the characteristics of the product family:
| Outside Diameter: | 0.035" |
|---|---|
| Overall Length: | 260cm to 300cm |
| Tip Shape: | Double-Curve |
| Tip Sizes: | Extra Small - Large |
| 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, ISO 11138.
2.8 INTENDED USE STATEMENT
Pre-Formed Guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures.
NOTE: This modification does not alter its intended use.
2.9 CONTRAINDICATIONS
This wire is not intended for use in the cerebrovasculature or coronary arteries.
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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a geometric shape on the left, which is a combination of red and gray squares forming a heart-like shape. To the right of the shape, the words "Lake Region" are written in a simple, sans-serif font, with the word "MEDICAL" in smaller letters below.
2.10 TECHNOLOGICAL CHARACTERISTICS
The design specifications are substantially equivalent to the existing Pre-Formed Guidewires
QUALITY SYSTEM CONTROL 2.11
DESIGN CONTROLS
LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.30. 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:
- Dimensional -
- -FDA Tensile Strength
- -FDA Tip Flexibility
- -FDA Catheter Compatibility
- -Packaging Study
- -Tip Shape Retention
- -Particulate
- ISO Visual "
- -ISO Fracture
- -ISO Flex
- -ISO Corrosion Resistance
- -Linear Stiffness
BIOCOMPATIBILITY TESTING
There were no changes to materials used in the design or manufacture of the Pre-Formed guidewire family; therefore, no additional biocompatibility tests were completed.
ANIMAL STUDY
A GLP Animal study was completed to evaluate safety and performance of the guidewire compared to the currently marketed device. The study shows the guidewires are substantially equivalent to the legally marketed device.
2.13 CHANGES FROM PREDICATE DEVICE
- Additional tip shape, Extra Small -
- -Distal core grind diameter minimum made larger
2.14 SUBSTANTIAL EQUIVALENCE DATA
The changes included in this 510(k) for the Pre-Formed guidewire family do 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.