MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R

• K Number: K013988
• Device Name: MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
• Manufacturer: MILLIPORE CORP.
• Date Cleared: 2002-04-04 ( 121 days)
• Product Code: BSN
• Regulation Number: 868.5130
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Device Description

Millex- GP Sterilizing Filter Unit

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria for device performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text.

The document primarily focuses on:

• Device Name: Millex- GP Sterilizing Filter Unit
• Regulation Number/Name: 868.5130, Anesthesia Conduction Filter
• Regulatory Class: II
• Product Code: BSN
• Indications for Use: Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
• FDA's finding: Substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 868.5130 Anesthesia conduction filter.

(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).