(29 days)
Not Found
No
The device description focuses on the physical construction and materials of a guidewire, and there is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests evaluating physical properties.
No.
The Charter™ Guidewire is intended for use in the coronary and peripheral vasculature for guidance, not for treating a condition or disease.
No
Explanation: The Charter™ Guidewire is an invasive medical device used for navigating through the vasculature to deliver other devices or for diagnostic purposes (like angiography guidance), but it does not perform any diagnostic function itself. Its purpose is mechanical support and guidance, not data collection or analysis for diagnosis. The mention of "greater visibility on x-ray equipment" is for visual guidance during a procedure, not for diagnostic image output from the guidewire itself.
No
The device description clearly details a physical guidewire made of stainless steel, platinum tungsten, and polymer tubing, 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 coronary and peripheral vasculature, which are parts of the circulatory system within the body.
- Device Description: The device is a guidewire, a physical tool used to navigate within blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are designed for testing samples in a laboratory or similar setting.
The device is a medical device used in vivo (within the living body) for interventional procedures.
N/A
Intended Use / Indications for Use
The Charter(TM) Guidewires are intended for use in the coronary and peripheral vasculature.
Contraindications:
The Charter(TM) Guidewire is not intended for use in the cerebral vasculature.
Patients judged not acceptable for percutaneous intervention (PCI)
Product codes
DQX
Device Description
The Charter(TM) Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.
The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body.
Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray equipment
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)
In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the new Charter Guidewires models and the existing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing devices in the range. The introduction of these new models raise no new issues of safety and effectiveness such that the proposed new Charter Guidewire models are considered substantially equivalent to the predicate devices.
In vitro bench tests were carried out to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". The following bench tests were performed:
. Tensile Strength
. Torque Strength
. Outer Diameter measurement
. Torque Response
. Catheter Compatibility
. Coating Adherence/Coating Integrity
. Tip Stiffness
. Particulate Residue
The results from these performance evaluations demonstrated that the Charter Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate 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.
0
K122856 page 1 of 2
ОСТ
Image /page/0/Picture/1 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized swirl above the words "Lake Region" in a bold, sans-serif font. Below "Lake Region" is the word "Medical" in a smaller font.
Charter 510(k) Application
510(k) Summary as required by 21 CFR 807.92(c)
| Device Name | Charter™ Guidewire | |||
|---|---|---|---|---|
| Submitters | Brivant Ltd, | |||
| name/contact | Parkmore West Business Park, | |||
| details | Galway, | |||
| Ireland | ||||
| Contact Details: | ||||
| Kenneth Walsh | ||||
| Senior QA/RA Supervisor | ||||
| Tel: +353 91 385391 | ||||
| Fax: +353 91 766598 | ||||
| Summary | 31st August 2012 | |||
| Preparation Date | ||||
| Device Name & | Trade Name: | Charter™ Guidewire | ||
| Classification | Common Name: | Guidewire | ||
| Classification Name: | Catheter, Guidewire | |||
| Device Classification: | Class II, 21 CFR §870.1330 | |||
| Product Code: | DQX | |||
| Intended Use | Intended Use: | |||
| The Charter™ Guidewires are intended for use in the coronary and peripheral | ||||
| vasculature. | ||||
| Contraindications: | ||||
| The Charter™ Guidewire is not intended for use in the cerebral vasculature. | ||||
| Patients judged not acceptable for percutaneous intervention (PCI) | ||||
| Device Description | The Charter™ Guidewire is a disposable medical device designed for single use | |||
| only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or | ||||
| 0.018" diameter stainless steel core wire, one end of which is reduced in | ||||
| diameter over a 43cm approx. segment in a progressive fashion through a | ||||
| centreless grinding operation. The profile of this reduced section affords the | ||||
| product a reduced area of stiffness and can be varied to produce various levels | ||||
| of support. | ||||
| The distal part of the reduced section is covered with a 3cm, 0.010" platinum | ||||
| tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm | ||||
| approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing | ||||
| is applied over the tapered distal end of the wire and ground to form a constant | ||||
| outer diameter, OD, equivalent in diameter to the main core body. | ||||
| Coatings are placed on the device to improve the lubricity and ease in its | ||||
| advancement through the guide catheter and the blood vessel | ||||
| Predicate Devices | Manufacturer | 510k | Date | |
| Charter Guidewire | K103377 | 18th May 2011 | ||
| Principle of | The Charter™ Guidewire is operated manually by a manual process |
1
Charter 510(k) Application Operation The Charter™ wire has the following differences from the originally approved Comparison of Technological devices. Introduction of a 0.016" diameter range. Characteristics Introduction of a "soft" version tip providing models with greater distal flexibility. Introduction of 300cm length models. In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the new Charter™ Guidewires models and the existing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing devices in the range. The introduction of these new models raise no new issues of safety and effectiveness such that the proposed new Charter™ Guidewire models are considered substantially equivalent to the predicate devices. In vitro bench tests were carried out to demonstrate equivalence with reference Performance Testing (nonto the FDAs guidance document "Coronary and Cerebrovascular Guidewire clinical) Guidance, Jan 1995". The following bench tests were performed: . Tensile Strength Torque Strength Outer Diameter measurement Torque Response Catheter Compatibility Coating Adherence/Coating Integrity Tip Stiffness Particulate Residue The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device. Conclusions Based on safety and performance testing, technological characteristics and the indications for use for the device, the proposed new Charter™ Guidewire models has been demonstrated to be appropriate for its intended use and is considered
to be substantially equivalent to the original
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 17 2012
Brivant Ltd. Lake Region Medical International Research & Development Centre c/o Kenneth Walsh Parkmore West Business Park Galway Ireland
Re: K122856
Trade/Device Name: Charter Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX
Dear Mr. Walsh:
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
3
Page 2 - Mr. Kenneth Walsh
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Tu A. Sillel
$\mathscr{R}$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for Lake Region Healthcare. The logo features a stylized image of a lake with a sun or star above it. Below the image is the text "Lake Region" in a bold, sans-serif font. Below that is the word "Healthcare" in a smaller font.
Indications for Use Statement
510{k) Number (if known):
Device Name:
CHARTER™ GUIDEWIRE
and peripheral vasculature.
Indications for Use:
Contraindications:
The Charter Guidewire is not intended.for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PCI).
Charter™ Guidewires are intended for use in the coronary
MZKilleh
iovascular Devices
510(k) Number K112286