FRAG COMMANDER

• K Number: K973749
• Device Name: FRAG COMMANDER
• Manufacturer: SCIERAN TECHNOLOGIES, INC.
• Date Cleared: 1997-12-08 ( 68 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

For use in fragmentation and aspiration of the human lens

Device Description

Frag Commander™ Phacofragmentation Device

AI/ML Overview

This document, a 510(k) clearance letter, does not contain any information about acceptance criteria or a study proving device performance.

The letter from the FDA to Scieran Technologies for the "Frag Commander" device (K973749) indicates that the device has been found substantially equivalent to a legally marketed predicate device. This substantial equivalence determination means that the FDA believes the new device is as safe and effective as a device already on the market.

However, the letter only certifies the regulatory clearance and does not provide details about:

• Acceptance Criteria: What specific performance metrics were required for the device.
• Study Data: Any clinical or non-clinical study results demonstrating the device meets performance thresholds.
• Sample Sizes, Ground Truth, Expert Qualifications, Adjudication, MRMC studies, Standalone performance, or Training set details.

These types of details would typically be found in the 510(k) submission itself, which is not provided in the input. The provided text is solely the FDA's decision letter.

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.