(269 days)
The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-Cytoplasmic Sperm Injection Fertilization/ Intravaginal Culture (ICSI/VC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device. The INVOcell Culture Device is not indicated for incubation periods exceeding 120h.
The INVOcell Retention Device is indicated for use with the INVOcell Culture Device to aid in retention of the INVOcell Culture Device in the vaginal cavity during the incubation period. The INVOcell Retention Device is not indicated for use exceeding 120h.
The INVOcell Intravaginal Culture System consists of the INVOcell Culture Device and the INVOcell Retention Device.
The INVOcell Culture Device is a radiation sterilized, single-use polystyrene container that holds and maintains the gametes and/or embryos during intravaginal culture for a maximum duration of 120 hours. The INVOcell Culture Device consists of three components: Inner Vessel, Outer Rigid Shell, and Retention Device.
The Inner Vessel holds the culture medium along with the gametes and /or embryos. It has a rotating valve at its top, which allows for access to the chamber when loading and retrieving gametes/embryos and provides a seal during incubation. At the bottom of the Inner Vessel, there is a physical stop to limit the penetration depth of the retrieval catheter into the Inner Vessel to protect embryos during retrieval.
The Outer Rigid Shell that is made of polystyrene, protects the Inner Vessel from the vaginal environment when the device is in use. The Inner Vessel fits into the bottom portion of the Outer Rigid Shell and is sealed in position by the top portion of the Outer Rigid Shell cap with a silicone O-ring, which provides a liquid-tight seal to prevent contamination of the Inner Vessel.
The Retention Device aids in the retention of the INVOcell Culture Device during incubation in the vaginal cavity for a maximum duration of 120 hours. The Retention Device is single-use and provided non-sterile. It is a 70 mm diameter cup-shaped silicone retention device that includes holes to allow flow of vaginal secretions during use.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the INVOcell Intravaginal Culture System.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The information for "acceptance criteria" and "reported device performance" is primarily found in the "Summary of Non-Clinical Performance Testing" and "Summary of Clinical Performance Testing" sections, as well as the comparison table in Section VI.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA): ≥80% embryos developed to expanded blastocyst at 120h (1-Cell MEA per 2021 FDA guidance) | Met: ≥80% embryos developed to expanded blastocyst at 120h (Confirmed in "Shelf-Life Testing" section; implicitly met for the clinical efficacy as well) |
| Seal Integrity Testing: No contamination inside and outside the vessel after 120h of incubation. | Met: No contamination inside and outside the vessel after 120h of incubation. |
| pH Stability: pH of test medium in device remained within the specified range after 120h of incubation. | Met: pH of test medium in device remained within the specified range after 120h of incubation. |
| Vessel Wall Optical Clarity: No obscured views after 120h of incubation. | Met: No obscured views after 120h of incubation. |
| Sterilization Validation: Gamma irradiation to achieve sterility. | Met: The gamma irradiation sterilization methods for the predicate device (ISO 11137:2006) are being relied on. |
| Packaging Integrity Testing: Qualify 6-year expiration date (bubble leak testing per ASTM F2096, seal strength testing per ASTM F88). | Met: Packaging integrity tested after accelerated aging to support 6-year expiration date. |
| Endotoxin (LAL): |
§ 884.6165 Intravaginal culture system.
(a)
Identification. An intravaginal culture system is a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate the following:
(i) Comfort and retention of the intravaginal culture device;
(ii) Adverse vaginal tissue reactions associated with intravaginal culture;
(iii) Maximum number of gametes and/or embryos that can be placed in a device; and
(iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes.
(2) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage;
(ii) Endotoxin testing on gamete and embryo-contacting components of the device;
(iii) Cleaning and disinfection validation of reusable device components;
(iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation period and subsequent embryo extraction; and
(v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Shelf life testing must demonstrate that the device maintains its performance characteristics and the packaging of device components labeled as sterile maintain integrity and sterility for the duration of the shelf life.
(6) Labeling for the device must include:
(i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events;
(ii) Validated methods and instructions for reprocessing of reusable components;
(iii) The maximum number of gametes or embryos that can be loaded into the device;
(iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture; and
(v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk (
e.g., antibiotics) and to support continued embryonic development over the intravaginal culture period.(7) Patient labeling must be provided and must include:
(i) Relevant warnings, precautions, and adverse effects and complications;
(ii) Information on how to use the device;
(iii) The risks and benefits associated with the use of the device; and
(iv) A summary of the principal clinical device effectiveness results.