To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

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.

AI/ML Overview

The provided document describes a medical device, the Charlie Guidewire, and its clearance through the 510(k) pathway. However, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document states that "performance data that demonstrate that the Guidepath Charlie Guidewire family meets all predetermined performance criteria" and "Bench testing per applicable reference documents was completed comparing Charlie Guidewires to the predicates or to known standards for guidewire performance." It lists various performance tests conducted. However, the specific acceptance criteria (i.e., the numerical thresholds or qualitative standards for passing each test) and the actual results obtained for the Charlie Guidewire are not explicitly presented.

Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about the training set. This information is typically found in detailed study reports or technical specifications, which are not part of this 510(k) summary.

Based on the provided text, here is what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance:

Performance Test	Acceptance Criteria	Reported Device Performance
Resistance to flexure	Not Specified	Not Specified
Tip resistance to fracture	Not Specified	Not Specified
Radiopacity	Not Specified	Not Specified
Catheter compatibility	Not Specified	Not Specified
Coating adherence	Not Specified	Not Specified
Torque strength	Not Specified	Not Specified
Torque response	Not Specified	Not Specified
Coating lubricity	Not Specified	Not Specified
Tip stiffness	Not Specified	Not Specified
Tensile	Not Specified	Not Specified
Cytotoxicity	Not Specified	Biocompatible
Sensitization	Not Specified	Biocompatible
Irritation/Intracutaneous	Not Specified	Biocompatible
Pyrogenicity	Not Specified	Biocompatible
Systemic Injection	Not Specified	Biocompatible
Thrombosis	Not Specified	Biocompatible
PTT	Not Specified	Biocompatible
Hemolysis	Not Specified	Biocompatible
Complement Activation	Not Specified	Biocompatible
Coating/Volatile Residue	Not Specified	Biocompatible

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not specified. The document mentions "bench testing" and "applicable biocompatibility testing performed on finished, sterile devices" but does not detail sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not specified. This device is a guidewire, and the performance tests described are mechanical and biocompatibility tests, not diagnostic imaging or clinical evaluation requiring expert ground truth establishment in the typical sense (e.g., for AI algorithms). The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties and biological interactions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This typically refers to the resolution of disagreements among experts in a clinical study. The tests described are laboratory/bench tests and biocompatibility tests, which have objective endpoints according to defined protocols, not requiring expert adjudication in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This type of study is for diagnostic or interpretative AI devices that assist human readers. The Charlie Guidewire is a physical medical device (guidewire), not an AI algorithm for image interpretation or diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Charlie Guidewire is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the mechanical and functional tests: The "ground truth" would be established by known standards for guidewire performance and comparison to predicate devices using objective measurements and established protocols.
For biocompatibility tests: The "ground truth" would be established by adherence to internationally recognized standards for biocompatibility testing (e.g., ISO 10993 series) which determine if materials are acceptable for medical device use based on cellular, systemic, and local responses.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As stated above, this is a physical medical device, not an AI algorithm.

Summary

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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 100Austin, TX 78754USA
CONTACT	Mitchell TatumPresident, CEOTel: 512.638.2000mitchell@guidepathmedical.com
DATE PREPARED	May 4th, 2012
PRODUCT NAME	Charlie Guidewire
COMMON NAME	Guide Wire
CLASSFICATIONNAME	Wire, Guide Catheter
DEVICECLASSIFICATION	Class II per 21 CFR 870.1330
PRODUCT CODE	DQX - Catheter Guide Wire
PREDICATEDEVICE	Terumo - Radifocus Guidewire (K863168)Argon Medical - Guidewires (K841926)Abbott - Balance Middleweight Guidewire (K101011)

DESCRIPTION OF THE DEVICE

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.

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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

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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

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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

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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

Regulation Number and Section

§ 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.