(225 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML.
No
The device is a guidewire, which is an accessory used to facilitate the placement of other therapeutic devices (e.g., catheters for angioplasty or stent placement) but does not directly provide therapy itself.
No
Explanation: The device is a guidewire, which is used for navigation and support in the vasculature, not for diagnosing conditions. While it is visible on x-ray equipment, this radiopacity serves to guide the procedure, not to produce diagnostic images.
No
The device description clearly outlines a physical guidewire made of stainless steel with coatings and a spring 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 is "for use in the peripheral vasculature." This describes a device used within the body for a medical procedure, not a test performed on a sample taken from the body.
- Device Description: The description details a physical guidewire used for navigation within blood vessels. This is consistent with an interventional medical device, not a diagnostic test.
- 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.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.
Contraindications:
ENROUTE 0.014" Guidewire is not intended for use in:
● The cerebral or coronary vasculature.
● Patients judged not acceptable for percutaneous intervention.
Product codes
DQX
Device Description
The ENROUTE .014” guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The very distal tip section is flattened to further reduce stiffness and enable the tip to be shaped.
The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in straight configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
In vitro bench tests were utilized to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
The following bench tests support the proposed product:
- Tensile Strength
- Torque Strength
- Dimensional measurements (Overall length)
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Stiffness/Flexibility
- Radiopacity
- Biocompatibility
- Shelf Life
The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices.
Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
Conclusions: Based on safety and performance testing, technological characteristics and the indications for use for the device, the ENROUTE 0.014" Guidewire has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Lake Region Medical Mr. Michael Dunning QA/RA Manager Parkmore West Business Park Galway G07001 Ireland
Re: K160643
Trade/Device Name: ENROUTE 0.014" Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 7, 2016 Received: September 9, 2016
Dear Mr. Dunning:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160643
Device Name ENROUTE 0.014" Guidewire
Indications for Use (Describe) The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.
Contraindications:
ENROUTE 0.014" Guidewire is not intended for use in:
- The cerebral or coronary vasculature
- Patients judged not acceptable for percutaneous intervention
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary – ENROUTE 0.014” Guidewire |
|---|
| K160643 - Traditional 510(k) |
| Device Name | ENROUTE 0.014" Guidewire | ||
|---|---|---|---|
| Submitters name | Brivant Ltd T/A Lake Region Medical International Research & | ||
| Development Centre, | |||
| Parkmore West Business Park, | |||
| Co. Galway, | |||
| Ireland. | |||
| Application | |||
| Correspondent | Michael Dunning | ||
| QA/RA Manager | |||
| Brivant Ltd T/A Lake Region Medical International Research & | |||
| Development Centre | |||
| Tel: +353 91 385391 | |||
| Fax: +353 91 766598 | |||
| Summary | |||
| Preparation Date | 7th September 2016 | ||
| Device Name & | |||
| Classification | Trade Name: | ENROUTE 0.014" Guidewire | |
| Common Name: | Guidewire | ||
| Classification Name: | Catheter, Guidewire | ||
| Device Classification: | Class II, 21 CFR §870.1330 | ||
| Product Code: | DQX | ||
| Intended Use | Intended Use: | The ENROUTE 0.014" Guidewire is intended for use in the peripheral | |
| vasculature. | |||
| Contraindications: | |||
| ENROUTE 0.014" Guidewire is not intended for use in: | |||
| ● The cerebral or coronary vasculature. | |||
| ● Patients judged not acceptable for percutaneous intervention. | |||
| Device Description | The ENROUTE .014” guidewire is a disposable medical device designed for | ||
| single use only. It consists of a 95cm PTFE coated 0.014" diameter | |||
| stainless steel core wire, one end of which is reduced in diameter over | |||
| approximately 9.5cm in a progressive fashion through a centreless | |||
| grinding operation. The profile of this reduced section affords the product | |||
| an area of reduced stiffness. The very distal tip section is flattened to | |||
| further reduce stiffness and enable the tip to be shaped. |
The distal section is covered with a 5cm platinum tungsten spring coil. This
provides for greater visibility on x-ray equipment (radiopacity). A
hydrophilic coating is applied to the distal section to enhance lubricity. The
product is available in straight configuration | | |
4
| Predicate Device | Manufacturer | 510k | Date |
|---|---|---|---|
| Brivant Guidewire (Rapidwire Plus variant – | |||
| previously known as SLK) | K060551 | 06/07/2006 | |
| Nitrex Nitinol Guidewire | K040345 | 03/02/2004 | |
| Principle of Operation | The ENROUTE 0.014" guidewire is operated manually by a manual process | ||
| Comparison of Technological Characteristics | The key technological and performance similarities examined between the | ||
| approved devices and the proposed ENROUTE 0.014" Guidewire device | |||
| are as follows: |
- Indications for use - The Indications for use for the proposed
device is a subset of indications for use of the predicate device as
proposed device, ENROUTE 0.014" is for peripheral vasculature
only - Contraindications – The contraindications for use are very similar
to that of the predicate device Nitrex Nitinol Guidewire. The
ENROUTE 0.014" device has an additional contraindication to the
predicate Rapidwire Plus against use in the Coronary Vasculature. - Fundamental scientific technology, including design - identical to
the predicate devices - Operating principle - identical to the predicate devices
- Packaging materials - identical to the predicate device Rapidwire
Plus - Sterility assurance level and method of sterilization - identical to
the predicate devices - The length of the device is within the length range of the predicate
device; Nitrex Nitinol Guidewire - The diameter of the proposed device is within the diameter range
of the predicate devices (0.014") - The proposed device and that of the Rapidwire Plus device are
identical in that they are constructed with a stainless steel core
which is reduced in diameter at the distal end to provide flexibility - The proposed device has equivalent tip stiffness characteristics to
that the Rapidwire Plus device - The proposed device has an identical hydrophilic coating to that of
the Rapidwire Plus device at the distal tip - All devices have a PTFE coating on the guidewire shaft
- The proposed device and that of the Rapidwire Plus device have
equivalent torque response properties | | |
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- Compatible with equivalent interventional devices
| Performance
Testing (non-
clinical) | In vitro bench tests were utilized to demonstrate equivalence with
reference to the FDAs guidance document "Coronary and Cerebrovascular
Guidewire Guidance, Jan 1995". |
| ------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The following bench tests support the proposed product:
| Test | Leveraged from
Predicate
510(k) Data | ENROUTE 0.014"
510(k) data |
|----------------------------------------|--------------------------------------------|-------------------------------|
| Tensile Strength | X | |
| Torque Strength | | X |
| Dimensional measurements | X | X
(Overall length) |
| Torque Response | | X |
| Catheter Compatibility | | X |
| Coating Adherence/Coating
Integrity | X | |
| Particulate Testing | X | |
| Tip Stiffness/Flexibility | X | |
| Radiopacity | | X |
| Biocompatibility | X | |
| Shelf Life | X | |
The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices.
Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.