(415 days)
The zIVF-AIRe Photo Catalytic Air Purification System models are designed to improve indoor air quality. The manufacturer's models QA-20, SP-20, and SP-20C for residential and general office use were re-engineered for use in IVF laboratories, in Reproductive, Endocrinology, and Andrology laboratories, as well as for general hospital use.
zIVF-AIRe Photo-Catalytic Air Purification System
The provided text is a 510(k) clearance letter for the ZIVF-AIRe Photo-Catalytic Air Purification System, Model 100C. This document primarily focuses on the regulatory clearance process and does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that for regulatory purposes, the FDA has determined the device is as safe and effective as a previously cleared device. However, this letter does not provide details on specific performance acceptance criteria or a study to demonstrate its performance.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's technical specifications, performance metrics, and the results of testing conducted to support its claims.
Based on the provided text, I can only state the following:
- Acceptance Criteria and Reported Device Performance: Not available in this document. The letter indicates "substantially equivalent," implying it meets the performance characteristics of predicate devices, but no specific metrics are mentioned.
- Sample Size (Test Set) and Data Provenance: Not available in this document.
- Number and Qualifications of Experts for Ground Truth: Not available in this document.
- Adjudication Method: Not available in this document.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not available in this document. This typically applies to diagnostic or interpretative devices, not air purification systems.
- Standalone Performance Study: Not available in this document.
- Type of Ground Truth Used: Not available in this document.
- Sample Size for Training Set: Not available in this document.
- How Ground Truth for Training Set was Established: Not available in this document.
The document indicates the device is an "Air Purification System" designed to "improve indoor air quality" in settings like IVF laboratories. Performance studies for such devices typically involve measuring the reduction of specific airborne contaminants (e.g., volatile organic compounds, particulates) under controlled conditions, with acceptance criteria defined by industry standards or established benchmarks for air quality in sensitive environments. However, these specific details are not present in this 510(k) clearance letter.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.