(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance 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 provide therapy itself.
No
The device, PREDICTE™ III GUIDEWIRE, is intended for use in angiographic procedures to introduce and position catheters and interventional devices. Its description details its physical components and materials. There is no mention of it being used to detect, diagnose, or monitor a disease or condition. The performance studies focus on bench testing and biocompatibility, not diagnostic accuracy.
No
The device description clearly describes a physical guidewire made of Nitinol or Stainless Steel with a coil, 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 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 within the body for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details the physical components of a guidewire used in interventional procedures (core wire, coil, markers). This aligns with a medical device used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This guidewire's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
PREDICATE™ III GUIDEWIRE 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)
DOX
Device Description
The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The Guidewire family is bound by the following parameters:
Core Material: Stainless Steel or Nitinol
Coil Material: Stainless Steel
Coil Length: Full length
Joining Agents: Weld
Tip Type: Straight, Shaped
Tip Flexibilities: Various
Overall Lengths: 30cm to 500cm
Outside Diameters: 0.018" to 0.038"
Sterilization Method: ETO
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 was performed to establish requirements for the guidewire. 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, Guidewire Pull Test, Camber Resistance, Visual Inspection, Wire Fracture Test, Corrosion, Wire Flex Test, ISO Strength of Union, and Particulate Residue Test.
Biocompatibility testing was performed per the design input summary requirements to show that the addition of full length coil to the device does not affect the biocompatibility of the device and the device is still in compliance with pre-defined acceptance criteria. A biocompatibility risk assessment determined the following biocompatibility tests are required: Cytotoxicity, Hemolysis, and Chemical Characterization.
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.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Drive Chaska, MN 55318
Re: K142393
Trade/Device Name: Predicate III Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: October 28, 2014 Received: October 30, 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 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
1
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 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/Resourcesfor You/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 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,
Melissa A. Torres -S
For Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): K142393
device name: PREDICATE™ III GUIDEWIRE
INDICATIONS FOR USE:
PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
| 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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e Region
PRODUCT: PREDICATE™ III GUIDEWIRE – Vascular Use JBMISSION DATE: August 260, 2014 SUBMISSION TYPE: SPECIAL 510(k)
510(k) SUMMARY
November 25, 2014
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: | Sze Yuen Tan | |
| FDA REGISTRATION NUMBER: 2126666 | Title: | Regulatory Intern | |
| 2.2 | DEVICE TRADE NAME / PROPRIETARY NAME |
PREDICATE™ III GUIDEWIRE
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)
K140485 Mandrel Guidewires (Lake Region Medical)
2.6 DEVICE DESCRIPTION
The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The Guidewire family is bound by the following parameters:
| Core Material | Stainless Steel or Nitinol |
|---|---|
| Coil Material | Stainless Steel |
| Coil Length | Full length |
| Joining Agents | Weld |
| Tip Type | Straight, Shaped |
| Tip Flexibilities | Various |
| Overall Lengths | 30cm to 500cm |
| Outside Diameters | 0.018" to 0.038" |
| Sterilization Method | ETO |
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
PREDICATE™ III 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.
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2.11
PRODUCT: PREDICATE™ III GUIDEWIRE – Vascular Use BMISSION DATE: August 260, 2014 SUBMISSION TYPE: SPECIAL 510(k)
2.9 CONTRAINDICATIONS
There are no contraindications listed.
2.10 TECHNOLOGICAL CHARACTERISTICS
The design specifications are substantially equivalent to the existing Mandrel Guidewires.
QUALITY SYSTEM CONTROL
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
- Guidewire Pull Test
- Camber Resistance
- Visual Inspection
- Wire Fracture Test ●
- · Corrosion
- Wire Flex Test
- ISO Strength of Union
- Particulate Residue Test
- BIOCOMPATIBILITY TESTING
Biocompatibility testing per the design input summary requirements show the addition of full length coil to the device does not affect the biocompatibility of the device and 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
-
Chemical Characterization
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2.13 CHANGES FROM PREDICATE DEVICE
- Include a Stainless Steel Coil only option as opposed to Stainless Steel, Platinum/Tungsten, -Palladium, and Tungsten
- -Weld as a joining option as opposed to options for Braze, Solder, Epoxy and Weld
- -Full length coil as opposed to 2cm to 30cm distal tip coil
- -Min. Diameter goes to 0.018" as opposed to 0.014"
- -Max. Diameter goes to 0.035" as opposed to 0.038"
- -No coating options as opposed to PTFE coating
2.14 SUBSTANTIAL EQUIVALENCE DATA
The changes included in this 510(k) for 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.