The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a coronary guidewire, which is a medical device. It does not contain information about an AI/ML device or a study proving its performance against specific acceptance criteria in the context of AI/ML.

Therefore, many of the requested fields cannot be filled.

However, I can extract information related to the device's performance testing in a general sense:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Substantial Equivalence	Demonstrated to be substantially equivalent to the predicate device (Galeo Guidewire)
Predetermined Acceptance Criteria	Met all pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness
Risk Assessment	Risks associated with use found acceptable when evaluated by FMEA (Failure Mode and Effects Analysis)
Bench Testing	Performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance, including assessments of performance data
Biocompatibility Testing	Performed on patient-contacting materials in accordance with ISO 10993-1

The study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is a series of "Performance Testing" and "Biocompatibility Testing" as described in the 510(k) summary. These are bench tests and material compatibility tests, not clinical studies involving human patients or AI/ML evaluation.

Regarding the specific AI/ML related questions, the information is NOT available in the provided text:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is not an AI/ML device study. The performance testing refers to bench tests and biocompatibility tests.
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. "Ground truth" in the context of expert consensus is for diagnostic AI/ML devices. This device is a physical guidewire validated through engineering and biocompatibility tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance would be the objective measurements from bench testing (e.g., tensile strength, torque transmission, guidewire trackability) and the results of biocompatibility assessments against established standards.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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Concert Medical, LLC January 20, 2009

510(k) Premarket Notification (Traditional) Conductor Coronary Guidewire

Section 5 - 510(k) Summary

General Information

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

Concert Medical, LLC SEP 2 5 2009 77 Accord Park Drive Norwell, MA 02061 (781) 871-7882 (781) 871-6657 Nancy Martin, VP of Operations & Regulatory Affairs

Subject Device Name: Trade Name: Common/Usual Name: Classification Name:

Conductor Coronary Guidewire Conductor Coronary Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II

Predicate Device Name; Trade Name: Common/Usual Name: Classification Name:

Premarket Notification:

Galeo Guidewire Galeo Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II K001736 (Galeo Hydro Guidewire), SE date August 2, 2000 K982272 (Galeo Guidewire), SE date January 8, 1999

Device Description

Indications for Use

For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

Performance Testing

Performance data demonstrated that the Concert Medical Conductor guidewire is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.

Bench tests performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance included assessments of performance data. Biocompatibility testing was performed on the patient-contacting materials present in the Conductor guidewire in accordance with ISO 10993-1.

Conclusion

The Concert Medical Conductor coronary guidewire meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Conductor guidewire is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Concert Medical, LLC C/O Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

SEP 2 5 2009

Re: K090193

Trade/Device Name: Conductor Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DQX Dated: September 14, 2009 Received: September 16, 2009

Dear Ms. Papineau:

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.

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 - Ms. Pamela Papineau

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duna R. Palmer

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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Concert Medical, LLC January 20, 2009

Section 4 - Indications for Use Statement

510(k) Number (if known):

K090193

Device Name:

Conductor Coronary Guidewire

Indications for Use:

For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

vina D. Jackson

(Division Sign-Off) Division Ci Cardiovascular Devices

510(k) Number_K090193

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.