(236 days)
The ORIGIO® Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's) and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.
The Origio Gas Line Filter combines a High Efficiency Particulate Air (HEPA) Filter Media and an Activated Carbon Media Filter which is impregnated with Potassium Permanganate (KMNO4). The 1.5", 0.5um Glass Fiber HEPA Media is designed to remove particulates from the supply gas, №2, СО₂ or TriGas (N₂, CO₂ and O₂ ) blend which is commonly used in IVF Incubators and other IVF work stations. The 3.5" Potassium Permanganate – Impregnated Activated Carbon Fiber Felt Media is designed to remove Volatile Organic Compounds (VOC's) from the supply gas provided to the IVF Incubator/Work Station.
The HEPA Filter Media and the Activated Carbon Filter Media are encased in a polypropylene outer shell creating a capsule for the filtration of the medical supply gas. The Origio Gas Line Filter is designed to be installed between the supply gas and the IVF Incubator/Work station utilizing the integrated ¼" male and ¼" female quick- connections. Quick disconnect "intake and output fittings" and clamps are provided along with a magnetic holding bracket for easy installation on to the supply gas line. The Origio Gas Line Filter is provided non-sterile and is individually vacuum packed in a double poly bag.
The Origio Gas Line Filter combines a HEPA filter and an activated carbon media filter impregnated with Potassium Permanganate (KMNO4) to reduce volatile organic compounds (VOCs) and particulate contaminants from supply gas lines to IVF incubators and workstations.
The study presented to establish substantial equivalence for the Origio Gas Line Filter focuses on performance testing to demonstrate its structural integrity, filtration efficiency, and VOC reduction capabilities.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| HEPA Filtration Efficiency | Must capture a minimum of 99.97% of particulate contaminants at 0.3 microns in size. |
| VOC Removal Efficiency | Not explicitly stated as a numerical criterion for the predicate, but implied as a key function based on the predicate's description. |
| Mouse Embryo Assay (MEA) Toxicity | No negative impact on mouse embryo development. |
| Structural Integrity | Not explicitly specified as numerical acceptance criteria, but tested. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. For particle filtration and VOC removal, "new filters, aged filters and filters that were challenged with a simulated particle load" were tested, and "filters which had already been in service in IVF laboratories for 6 months." The exact number of filters in each category is not given.
- Data Provenance: The studies were conducted by the manufacturer, Origio Inc. The data is prospective, testing the performance of the Origio Gas Line Filter. The country of origin of the data is not specified but is implicitly associated with the applicant, Origio Inc. (Charlottesville, VA, USA).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The device is a filter for gas lines, and its performance is evaluated through objective physical and chemical measurements (filtration efficiency, VOC removal) and biological assays (Mouse Embryo Assay), not through human expert assessment of images or clinical outcomes that require "ground truth" to be established by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable as the testing does not involve subjective assessments requiring adjudication. The tests employ objective laboratory methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Origio Gas Line Filter is a physical filtration device, not a diagnostic tool requiring human interpretation.
6. Standalone Performance Study
- Standalone Performance Study: Yes, standalone performance studies were done. The tests described (particle filtration efficiency, VOC removal efficiency, structural integrity, and Mouse Embryo Assay) evaluated the performance of the Origio Gas Line Filter itself, without human intervention in its filtering function. The "human-in-the-loop" aspect is not relevant for this type of device.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for performance was established through:
- Objective Measurement Standards: Industry standard test methods for particle filtration (to meet HEPA/ULPA requirements), validated chemical analysis methods for VOC concentration, and standard biological assays (Mouse Embryo Assay).
- Simulated Conditions: Simulated particle loads and VOC challenge gas concentrations were based on published literature of typical IVF laboratory environments.
- Real-world Use Data: VOC efficiency testing also used filters that had been in service in IVF laboratories for 6 months.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. This device is a physical filter, not an AI or machine learning algorithm that requires a "training set" of data.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 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.