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

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This document is a 510(k) clearance letter from the FDA for a medical device called "Millex®- HV, VV, GV Syringe Filter Unit." It is an approval for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is a premarket notification process that demonstrates a new device is as safe and effective as a legally marketed device (predicate device). It primarily focuses on comparing the new device to an existing one. It does not typically include detailed performance study results, acceptance criteria, or ground truth establishment in the way that would be seen for a new, novel device requiring a PMA (Premarket Approval) or for AI/ML-driven devices.

Therefore, I cannot provide the requested information from this document. The document confirms that the device is intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications, and that it has been deemed substantially equivalent to a predicate device.

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

Millex- GP Sterilizing Filter Unit

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.

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

Millex - MP Sterilizing Filter Unit

I am sorry, but based on the provided document excerpts, there is no information available regarding acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the "Millex® - MP Filter Unit," which primarily addresses the substantial equivalence of the device to a predicate device for its intended use.

The letter and the enclosed "Indications for Use Statement" do not contain details about:

• Specific performance metrics or acceptance criteria for the filter.
• Any performance study results (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
• Details about training sets or their ground truth establishment.

The document states the device's indications for use: "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." The FDA's clearance is based on its determination of substantial equivalence, which implies that the device performs as intended and is as safe and effective as a legally marketed predicate device, but the specific data proving this from a primary study are not included in these excerpts.

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