P3 UNIVERSAL PHACO HANDPIECE

• K Number: K972253
• Device Name: P3 UNIVERSAL PHACO HANDPIECE
• Manufacturer: ODYSSEY TECHNOLOGIES, INC.
• Date Cleared: 1997-07-29 ( 43 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

Device Description

Odyssey Technologies P3 Universal Handpiece

AI/ML Overview

The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. The documents are an FDA 510(k) clearance letter for the "Odyssey Technologies P3 Universal Handpiece," which is used in cataract surgery.

Specifically, the letter from the FDA to Mr. Glenn A. Dunki-Jacobs of Odyssey Technologies states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory clearance based on equivalence, not necessarily on a performance study with acceptance criteria.

The information requested in the prompt, such as acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in these documents.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.