DISPOSABLE TORQUE DEVICE by COEUR, INC.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Coeur, Inc. Disposable Torque Device." It's a regulatory approval document and does not contain the information requested in your prompt.

The prompt asks for details about a study proving a device meets acceptance criteria, including:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for the test set.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This FDA letter simply states that the device is "substantially equivalent" to legally marketed predicate devices and is approved for marketing. It does not provide any of the study design, acceptance criteria, or performance data that would be found in a clinical or validation study report.

Therefore, I cannot extract the requested information from the provided text.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 20 2012

Coeur, Inc. Ms. Debra Manning VP, Quality and Regulatory Affairs 100 Physicians Way Lebanon, TN 37090

Re: K113498

Trade/Device Name: Coeur, Inc. Disposable Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 8, 2012 Received: June 11, 2012

Dear Ms. Manning:

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.

{1}------------------------------------------------

Page 2 – Ms. Debra Manning

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc acrised that I Dri broom that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I odetar statues and reguirements, 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 de rice-related daverse overse) { regulation (21 CFR Part 820); and if applicable, the electronic forth in and quand by browisions (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 the Conter 101 Dovietts and 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 Tou may 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,

cm. S. Hillen

for

C. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Coeur, Inc. Disposable Torque Device

Indications For Use:

to facilitate manipulation of a guide wire during a vascular procedure

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

s. Hillier

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_ku13498

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.