(218 days)
Not Found
No
The device description and performance studies focus on mechanical and biocompatibility properties, with no mention of AI/ML terms or functionalities.
No
The device is described as a guidewire used to facilitate the introduction and placement of catheters and interventional devices, which are typically used for diagnosis or intervention, not for direct therapeutic treatment itself.
No
The device description clearly states its purpose: "To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures." This indicates it is a tool used during procedures, not a device that makes a diagnosis itself.
No
The device description clearly states it is a physical guidewire constructed from Nitinol and polymer, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures." This describes a device used within the body to aid in procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire used for navigation within the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This guidewire's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The Charlie guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Charlie Guidewire is a steerable guidewire that is compatible with .035" catheters and devices. Lengths are available from 70cm to 280cm. The guidewire is constructed from a Nitinol core wire with a polymer jacket. The jacket is coated with a hydrophilic polymer. The distal tip is atraumatic, and available in straight or various angled configurations. The main body is available in varying stiffness configurations. The device will be provided sterile and intended for one-time use. Product has a 2-year shelf life.
The Charlie Guidewire consists of a Nitinol core wire, an atraumatic distal tip, radiopaque polymer jacket, and a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 per applicable reference documents was completed comparing Charlie Guidewires to the predicates or to known standards for guidewire performance. This 510(k) includes the mechanical and functional bench testing that demonstrates the Charlie Guidewire performs as intended and is Substantially Equivalent to the predicates.
The biocompatibility of the Charlie Guidewires has been proven through applicable biocompatibility testing performed on finished, sterile devices. This 510(k) includes the results of the biocompatibility testing.
Performance Tests:
Resistance to flexure (flexing test)
Tip resistance to fracture (fracture test)
Radiopacity
Catheter compatibility
Coating adherence
Torque strength
Torque response
Coating lubricity
Tip stiffness
Tensile
Biocompatibility Testing:
Cytotoxicity
Sensitization
Irratation/Intracutaneous
Pyrogenicity
Systemic Injection
Thrombosis
PTT
Hemolysis
Compliant Activation
Coating/volatile residue
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.
Terumo - Radifocus Guidewire (K863168), Argon Medical - Guidewires (K841926), Abbott - Balance Middleweight Guidewire (K101011)
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
Guidepath
DEC 1 3 2012
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Guidepath Medical, Inc.
2621 Ridgepoint Dr. Suite 100
Austin, TX 78754
USA |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT | Mitchell Tatum
President, CEO
Tel: 512.638.2000
mitchell@guidepathmedical.com |
| DATE PREPARED | May 4th, 2012 |
| PRODUCT NAME | Charlie Guidewire |
| COMMON NAME | Guide Wire |
| CLASSFICATION
NAME | Wire, Guide Catheter |
| DEVICE
CLASSIFICATION | Class II per 21 CFR 870.1330 |
| PRODUCT CODE | DQX - Catheter Guide Wire |
| PREDICATE
DEVICE | Terumo - Radifocus Guidewire (K863168)
Argon Medical - Guidewires (K841926)
Abbott - Balance Middleweight Guidewire (K101011) |
DESCRIPTION OF THE DEVICE
The Charlie Guidewire is a steerable guidewire that is compatible with .035" catheters and devices. Lengths are available from 70cm to 280cm. The guidewire is constructed from a Nitinol core wire with a polymer jacket. The jacket is coated with a hydrophilic polymer. The distal tip is atraumatic, and available in straight or various angled configurations. The main body is available in varying stiffness configurations. The device will be provided sterile and intended for one-time use. Product has a 2-year shelf life.
INDICATIONS FOR USE
The Charlie guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
1
Guidepath
TECHNICAL CHARACTERISTICS
The Charlie Guidewire consists of a Nitinol core wire, an atraumatic distal tip, radiopaque polymer jacket, and a hydrophilic coating. The Charlie Guidewire is similar in dimensions and operating principles as the predicates. In addition, the materials used are similar to the predicates, and are commonly used materials in medical device applications. Comparison of the Charlie Guidewire and predicate devices show that the technological characteristics, such as the design, intended use, and performance data are substantially equivalent to the current marketed predicate devices.
PERFORMANCE DATA
Enclosed within this submission are performance data that demonstrate that the Guidepath Charlie Guidewire family meets all predetermined performance criteria. All components that are in contact with the patient have a known history of use in medical devices and are tested and proven to be biocompatible and acceptable for vascular use. Bench testing per applicable reference documents was completed comparing Charlie Guidewires to the predicates or to known standards for guidewire performance. This 510(k) includes the mechanical and functional bench testing that demonstrates the Charlie Guidewire performs as intended and is Substantially Equivalent to the predicates.
The biocompatibility of the Charlie Guidewires has been proven through applicable biocompatibility testing performed on finished, sterile devices. This 510(k) includes the results of the biocompatibility testing.
Performance Tests
Resistance to flexure (flexing test) Tip resistance to fracture (fracture test) Radiopacity Catheter compatibility Coating adherence Torque strength Torque response Coating lubricity Tip stiffness Tensile
Biocompatibility Testing Cytotoxicity Sensitization Irratation/Intracutaneous Pyrogenicity Systemic Injection Thrombosis PTT Hemolysis Compliant Activation Coating/volatile residue
SUMMARY/CONCLUSION
The Guidepath Charlie Guidewire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use. Performance test results demonstrate that any minor differences do not impact device performance as compared to the predicates and raise no new safety or efficacy concerns.
Guidepath Medical
510(k) Summary Page 2 of 2
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle's perimeter, with the eagle appearing to be in flight or taking off.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration . 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Guidepath Medical, Inc. % John Mitchell Tatum 2621 Ridgepoint Dr. Ste 100 Austin, TX 78754 US
DEC 1 3 2012
Re: K121398
Trade/Device Name: Charlie guidewire (regular), charlie guidewire (stiff) Regulation Number: 21 CFR 870.1330 Regulation Name: Charlie Guidewire Regulatory Class: Class II Product Code: DQX Dated: December 7, 2012 Received: December 11, 2012
Dear John Mitchell Tatum:
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
3
Page 2 - John Mitchell Tatum
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Guidepath
INDICATIONS FOR USE
510(k) Number (if known):
DEVICE NAME: Charlie Guidewires
INDICATIONS FOR USE: To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation
(Division sign-Off)
Division
Division of Cardiovascular Devices 510(k) Number
Guidepath Medical
Indications for Use Page 1 of 1