(154 days)
No
The device description focuses on the physical components and materials of a guidewire, with no mention of software, algorithms, or any capabilities that would suggest AI/ML. The performance studies are standard for a physical medical device.
No
This device is a guidewire designed to facilitate the introduction and placement of other interventional devices. It does not exert a therapeutic effect itself on the body.
No
The "Intended Use / Indications for Use" states that the guidewire is "intended to facilitate the introduction and placement of interventional devices." This function is for facilitating treatments, not for diagnosing conditions.
No
The device description clearly details a physical guidewire made of stainless steel components, 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 body) for a procedural purpose.
- Device Description: The description details the physical components and materials of a guidewire, which is a medical device used during procedures.
- 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 diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for procedural purposes.
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
DQX
Device Description
The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of 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 core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.
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
Comparison bench and animal tests were completed on the Boston Scientific Amplatz SuperStiff guidewire with 510(k) number K930622 to determine substantial equivalence.
Bench testing: Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. Test methods were developed using FDA Coronary and Cerebrovascular Guidewire guidance and ISO 11070:1998. Applicable bench tests performed at baseline and aging include: Dimensional, FDA Device Compatibility, FDA Tensile Strength, FDA Tip Flexibility, FDA Coating Adherence/Integrity, FDA Catheter Compatibility, Packaging Study, Particulate, ISO Visual, ISO Fracture, ISO Flex, ISO Corrosion Resistance, ISO Strength of Union, ISO Radiopacity, Body Stiffness.
Biocompatibility testing: Per ISO 10993 series. Tests include: Cytotoxicity, Kligman Maximization Test, Irritation / Intracutaneous Reactivity, Complement Activation Assay, Rabbit Pyrogen, Hemolysis, Thrombogenicity, Lee and White Coagulation, Unactivated Thromboplastin Time Assay, Acute Systemic Toxicity Test, Partial Thromboplastin Time Assay, USP Physicochemical Test, Inhibition and Enhancement.
Animal Studies: A GLP Animal Study was completed to evaluate customer feedback, performance and safety of the Guidewire compared to the currently marketed device. The studies show the guidewires are substantially equivalent to the legally marketed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo for Lake Region Medical. The logo features a circular graphic to the left of the text "Lake Region". Below the word "Region" is the word "Medical" in a smaller font size. The logo is simple and professional.
PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)
SECTION 5.0: 510(k) SUMMARY
| 5.1 | MANUFACTURER / REGISTRATION INFORMATION | |
|---|---|---|
| Lake Region Medical | ||
| 340 Lake Hazeltine Drive | ||
| Chaska, MN 55318-1029 USA | ||
| FDA REGISTRATION NUMBER: 2126666 | Contact Person: Mathew Pexa | |
| Title: Regulatory Specialist II | ||
| Telephone: 952-641-8511 | ||
| Fax: 952-448-3441 |
5.2 TRADE NAME (PROPRIETATY NAME)
Pre-Formed Guidewire
DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAME 5.3
CATHETER GUIDEWIRE (DQX)
CLASS OF DEVICE 5.4
This type of Guidewire was originally listed as a Class II device by the Cardiovascular (DQX) review panel.
| 5.5 IDENTIFICATION OF PREDICATE DEVICE(s) ==================================================================================================================================== | ||
|---|---|---|
| 510(k) NUMBER MANUFACTURER | DEVICE NAME | |
| K930622 | Boston Scientific | Amplatz SuperStiff Guidewire |
5.6 DEVICE DESCRIPTION
The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of 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 core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.
| OUTSIDE DIAMETER: | 0.035" |
|---|---|
| LENGTHS: | 260cm - 300cm |
| TIP SHAPE: | Double-curve |
| TIP SIZES: | Small - Large |
COMPLIANCE WITH APPLICABLE STANDARDS 5.7
The guidewire is in compliance with ISO 10993-1, ISO 10993-4, ISO 10993-7, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 15223-1, EN 980, ISO 11135-1, and ISO 11070.
AUG 2 3 2013
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PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)
K130798 Page 2 of 3
SECTION 5.0: 510(k) SUMMARY
5.8 INTENDED USE STATEMENT
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.
5.8 CONTRAINDICATIONS
This wire is not intended for use in the cerebrovasculature or coronary arteries.
59 COMPARISON
Comparison bench and animal tests were completed on the Boston Scientific Amplatz SuperStiff guidewire with 510(k) number K930622 to determine substantial equivalence.
5.10 OUALIFICATION TESTING
The conclusions drawn from bench testing, biocompatibility, and a GLP animal study demonstrate the device is as safe, as effective and performs at least as safely and effectively as the legally marketed device.
BENCH TESTING
In order to demonstrate equivalence of the guidewire, Lake Region Medical performed testing to establish requirements. Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. Test methods were developed using FDA Coronary and Cerebrovascular Guidewire guidance and ISO 11070:1998. The following table lists the applicable bench tests performed at baseline and aging include:
- Dimensional .
- . FDA Device Compatibility
- FDA Tensile Strength .
- . FDA Tip Flexibility
- . FDA Coating Adherence/Integrity
- FDA Catheter Compatibility .
- . Packaging Study
- Particulate .
- . ISO Visual
- . ISO Fracture
- ISO Flex .
- . ISO Corrosion Resistance
- ISO Strength of Union .
- . ISO Radiopacity
- Body Stiffness
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Pre-Formed guidewires and has been found to be acceptable.
- Cytotoxicity .
- . Kligman Maximization Test
- Irritation / Intracutaneous Reactivity .
- Complement Activation Assay
- Rabbit Pyrogen 0
- Hemolysis
- Thrombogenicity
- . Lee and White Coagulation
- . Unactivated Thromboplastin Time Assay
- Acute Systemic Toxicity Test .
- Partial Thromboplastin Time Assay .
- USP Physicochemical Test .
- . Inhibition and Enhancement
ANIMAL STUDIES
A GLP Animal Study was completed to evaluate customer feedback, performance and safety of the Guidewire compared to the currently marketed device. The studies show the guidewires are substantially equivalent to the legally marketed device.
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Lake Reg
PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)
SUBSTANTIAL EQUIVALENCE DATA 5.11
The Pre-Formed guidewires are substantially equivalent to the Amplatz SuperStiff Guidewire manufactured by Boston Scientific cleared under 510(k) number K930622.
The guidewire has similar technological characteristics to the predicate device. The technological differences between the proposed device and the predicate device are:
- Larger Proximal Core Diameter .
- -Longer Distal Grind
- . Lack of intermediate joint
- -Stainless steel weld (as opposed to Solder)
- Double Curve on distal tip -
- -Lack of moveable core
The data generated by accepted test methods and comparisons to the predicate device show that the Pre-Formed guidewire is substantially equivalent to the predicate device and the technological differences listed above do not pose any new issues of safety or effectiveness.
The Pre-Formed guidewires are substantially equivalent to the Amplatz SuperStiff Guidewire cleared under 510(k) K930622. All test results support the claim of substantial equivalence.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 23, 2013
Lake Region Medical C/O Mr. Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Drive Chaska, MN 55318-1029
Rc: K130798
Trade/Device Name: Pre-Formed Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: August 14, 2013 Received: August 14, 2013
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 docs 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 (sec above) into cither 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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements us set
4
Page 2 - Mr. Mathew Pexa
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" (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 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,
M.A. Hillen
for
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K130798
DEVICE NAME: PRE-FORMED GUIDEWIRES
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 within transcatheter aortic valve procedures.
This guidewire is not intended for use in the cerebrovasculature or coronary arteries.
PRESCRIPTION X
USE
AND/OR
OVER-THE-COUNTER USE (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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M.A. Zillmann