(182 days)
Not Found
No
The device description focuses on the physical components and materials of a guidewire, and there is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on bench tests and biocompatibility, not algorithmic performance.
No
The device, a guidewire, is intended for use in navigating bodily vessels to facilitate the placement of other medical devices, which is a diagnostic or procedural support function, not a direct therapeutic intervention.
No
The device is a guidewire used for navigation in blood vessels during interventional procedures, not for diagnosing conditions. While it is visible on X-ray, this is for guidance during a procedure, not for generating a diagnostic image.
No
The device description clearly outlines 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 body, not for examining specimens derived from the human body.
- Device Description: The device is a guidewire, a physical tool used to navigate within blood vessels. It does not perform any diagnostic tests on biological samples.
- Function: The description focuses on the physical properties and function of the guidewire for guiding other devices within the body.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze blood, tissue, or any other biological sample for diagnostic purposes.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This guidewire is a therapeutic/interventional device used within the body.
N/A
Intended Use / Indications for 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)
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Navilyst Medical Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm or 180cm, 0.014" 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
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)
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 Flexibility
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.
Biological Safety of the device has been established through biocompatibility testing carried out in compliance with ISO 10993-1 under VP-0427.
The following biocompatibility tests were performed:
Test Description: Cytotoxicity Study, Test Method: Qualitative Evaluation – Dye Exclusion & Microscopial Evaluation
Test Description: Cytotoxicity Study, Test Method: Quantitative Evaluation - MTT or XTT Assay
Test Description: Irritation Test, Test Method: Intracutaneous Injection (ISO10993-10)
Test Description: Acute Systemic Toxicity Test, Test Method: Systemic Injection ISO10993-11
Test Description: Acute Systemic Toxicity Test, Test Method: ISO-Rabbit-Pyrogen
Test Description: Haemocompatibility Test, Test Method: Haematology: Haemolysis - rabbit blood- Direct (Complete ASTM Method)
Test Description: Haemocompatibility Test, Test Method: Haematology: In-vitro Haemocompatiblity Assay
Test Description: Haemocompatibility Test, Test Method: Coagulation: The Prothrombin Time Assay (PT)
Test Description: Haemocompatibility Test, Test Method: Coagulation: The Unactivated Partial Thromboplastin Time Assay (UPTT)
Test Description: Haemocompatibility Test, Test Method: Thrombosis: In Vivo Thrombogenicity in Dogs
Test Description: Haemocompatibility Test, Test Method: Complement Activation
Test Description: Haemocompatibility Test, Test Method: Lee& White Coagulation Assay
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
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K103377
Navilyst Charter 510(k) Application
510(k) Summary
as required by 21 CFR 807.92(c)
| Device Name | Charter™ Guidewire | ||
|---|---|---|---|
| Submitters | |||
| name/contact | |||
| details | Brivant Ltd, | ||
| Parkmore West Business Park, | |||
| Galway, | |||
| Ireland |
Contact Details:
Tomas Furey
Operations Manager,
Tel: +353 91 385037
Fax: +353 91 766598 | | |
| Summary
Preparation Date | 10th November 2010 | | |
| Device Name &
Classification | Trade Name: Charter™ Guidewire
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 Navilyst Medical Guidewire is a disposable medical device designed for
single use only. It consists of a PTFE coated 140cm or 180cm, 0.014" 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 |
| | Brivant Ltd, Brivant Guidewire | K060551 | 07 Jun 2006 |
| | Brivant Ltd, Streamer Guidewire | K083094 | 07 July 2009 |
| | Brivant Ltd, Courier Guidewire | K073082 | 09 Jan 2008 |
| Principle of
Operation | The Charter™ Guidewire is operated manually by a manual process | | |
| Comparison of
Technological
Characteristics | The Charter™ wire has minor differences in construction to the approved Brivant
Guidewire. These include Same diameter range as predicate devices Same basic construction technology as the predicate devices. Different polymer and hydrophilic coating materials to the predicate devices providing improved radiopacity. Slightly shorter overall length than predicate devices. Minor differences in profiles of the distal tip area of the guidewire changes to meet customer performance requirements. These changes are within ranges of the predicate devices. | | |
| | In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the Charter™ Guidewires (in its various configurations) and the predicate devices.
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 predicate devices. The differences in construction between the Charter™ wire and the predicate devices raise no new issues of safety and effectiveness such that the Charter™ Guidewire is considered substantially equivalent to the predicate devices. | | |
| Performance
Testing (non-clinical) | 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 Flexibility 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. | | |
| | Biological Safety of the device has been established through biocompatibility testing carried out in compliance with ISO 10993-1 under VP-0427
The following biocompatibility tests were performed | | |
| | Test Description | Test Method | |
| | Cytotoxicity Study | Qualitative Evaluation – Dye Exclusion &
Microscopial Evaluation | |
| | Cytotoxicity Study | Quantitative Evaluation - MTT or XTT Assay | |
| | Irritation Test | Intracutaneous Injection (ISO10993-10) | |
| | Acute Systemic Toxicity Test | Systemic Injection
ISO10993-11 | |
| | Acute Systemic Toxicity Test | ISO-Rabbit-Pyrogen | |
| | Haemocompatibility Test | Haematology: Haemolysis - rabbit blood- Direct
(Complete ASTM Method) | |
| | Haemocompatibility Test | Haematology:
In-vitro Haemocompatiblity Assay | |
| | Haemocompatibility Test | Coagulation: The Prothrombin Time Assay (PT) | |
| | Haemocompatibility Test | Coagulation: The Unactivated Partial
Thromboplastin Time Assay (UPTT) | |
| | Haemocompatibility Test | Thrombosis: In Vivo Thrombogenicity in Dogs | |
| | Haemocompatibility Test | Complement Activation | |
| | Haemocompatibility Test | Lee& White Coagulation Assay | |
| Conclusions | Based on safety and performance testing, technological characteristics and the | | |
| | indications for use for the device, the Charter™ Guidewire has been | | |
| | demonstrated to be appropriate for its intended use and is considered to be
substantially equivalent to the predicate devices. | | |
1
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Navilyst Charter 510(k) Application
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:
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Brivant, LTD. c/o Mr. Tomas Furey Operations Manager Parkmore West Business Park Galway Ireland
MAY 18 2011
Re: K103377
Trade/Device Name: Charter Guidewire Model 45-281, 45-282, 45-283 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter, Guidewire Regulatory Class: Class II Product Code: DQX Dated: April 14, 2011 Received: April 18, 2011
Dear Mr. Furey:
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
4
Page 2 - Mr. Tomas Furey
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/CDRH0ffices/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,
C. Tom Zuckerman, M.D.
Bram Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K103377 510(k) Number (if known):
Charter Guidewire Device Name:
Indications For Use: 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).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(K) number K103377