MODIFICATION TO:APEX MEDICAL IF-4100 by APEX MEDICAL CORP.

I am sorry, but the provided text from the 510(k) K013813 letter does not contain the detailed information necessary to answer your request. The document is an FDA clearance letter for a medical device (Apex Medical IF 4100) and primarily focuses on its substantial equivalence to a predicate device for marketing purposes.

It lacks specifics on:

Acceptance criteria and reported device performance: While the indications for use are mentioned, no performance metrics or acceptance criteria are listed.
Study details: There is no description of any clinical or performance studies, including sample sizes, data provenance, expert qualifications, or ground truth establishment.
MRMC comparative effectiveness study or standalone performance: These types of studies are not mentioned.

Therefore, I cannot extract the requested information from this document.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2001

Daniel Lee General Manager ApexMedical Corp. 10th Fl., No.31, Lane 169, Kang Ning Street., His-Chih Chen, Taipei Hsien, Taiwan, R.O.C.

Re: 510(k) Number K013813 Trade/Device Name: Apex Medical IF 4100 Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous Electrodes and Interferential Stimulator Regulatory Class: Class II and Unclassified Product Code: GXY and LIH Dated: November 12, 2001 Received: November 16, 2001

Dear Mr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard cate of the Medical Device Amendments, or to conninered phor to May 20, 1978, are onceance with the provisions of the Federal Food, Drug, de vices mat have been recure approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, mercere, mantel of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elaboried (so a controls. Existing major regulations affecting your device can may or subject to back additions, 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drines and regulations administered by other Federal agencies. You must or uny I 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 form in the quarty by roovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manieung of substantial equivalence of your device to a legally prematics notification. The PDF interessification 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 and If you desire specific acrice for your sovices diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0671. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1857 - 1252 - 1252 - 12 - 12 - 4639. Also, please note the your devices, proads of Misbranding by reference to premarket notification" (21CFR Part 807.97). It guiation entities, "Thisoranang onesponsibilities under the Act may be obtained from the Outler general miormation on Journational 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/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : _K013813 Device Name : Apex Medical IF 4100

Indications For Use:

IF4100 is intended to be used in symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Over-The-Counter-Use

(Optional Format 1-2-96)

Susan Walk

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013813

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).