MODIFICATION TO:APEX MEDICAL IF-4100

• K Number: K013813
• Device Name: MODIFICATION TO:APEX MEDICAL IF-4100
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2001-12-14 ( 28 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

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:

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

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

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).