ELECTRODE/EXTENSION CABLES, MODELS ATAR by Oscor Inc.

The provided text is a 510(k) clearance letter from the FDA for Electrode/Extension Cables. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device's AI or algorithmic component.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This document is a regulatory approval letter, not a study report.

Summary

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2007

Oscor Inc. C/O Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 DeSoto Boulevard Palm Harbor, FL 34683

Re: K070926/S001

Trade/Device Name: Electrode/Extension Cables, Model series ATAR Regulation Number: 21 CFR, 890.1175 Regulation Name: Electrode Cable Regulatory Class: Class II Product Code: IKD Dated: May 7, 2007 Received: May 9, 2007

Dear Ms. Doskocil:

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 such 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.

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Page 2 – Ms. Mila Doskocil

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to

proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfimmmafr

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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Attachment 2

Indications for Use Statement

510k Number (if known) -

Device Name: Electrode/Extension Cables, Models ATAR™

Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

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NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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Division Sign-Off

vision Sign-Off COS Division of Cardlov; 510(k) Number

Regulation Number and Section

§ 890.1175 Electrode cable.

(a)
Identification. An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.(b)
Classification. Class II (special controls). The special controls consist of:(1) The performance standard under part 898 of this chapter, and
(2) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 890.9.