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510(k) Data Aggregation
(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): |
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(252 days)
The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intra Vaginal Culture (IVF/IVC) and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device and the INVOcell Holding Block. The INVOcell Culture Device is not indicated for incubation periods exceeding 72h.
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 72 hours.
The INVOcell Holding Block is indicated for use with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures.
The INVOcell Intravaginal Culture System is comprised of three parts: the INVOcell Intravaginal Culture Device, the INVOcell Retention Device, and the INVOcell Holding Block. All devices are designed to be utilized together.
INVOcell Intravaginal Culture Device: a single-use plastic container that serves to house and protect the gametes and/or embryos during intravaginal culture. It is provided sterile. The culture device consists of two components: the inner chamber and the outer shell.
INVOcell Retention Device: aids in the retention of the INVOcell Intravaginal Culture Device during incubation in the vagina. It is a single-use device that is provided nonsterile. The device is a cup-shaped silicone piece that includes to allow flow of vaginal secretions. The device comes in four sizes (65, 70, 75, and 80 mm). It is accompanied by a fitting kit, which is utilized to determine the appropriate diameter of the INVOcell Retention Device to ensure appropriate retention, and is intended to be reprocessed.
INVOcell Holding Block: designed to hold and maintain temperature of the inner vessel of the INVOcell Intravaginal Culture Device during loading and retrieval procedures. The block does this passively by serving as a heat sink. Prior to use, the block is preheated to body temperature. The block then can be utilized to hold the Intravaginal Culture Device inner vessel, and will maintain appropriate temperature for short periods of time. The block is solid stainless steel, with a conical hole in the top for the inner vessel. The block also includes a glass window on the side, to allow viewing of the embryos in the inner vessel during retrieval.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Key Takeaways:
- Device: INVOcell Intravaginal Culture System, comprising the INVOcell Culture Device, INVOcell Retention Device, and INVOcell Holding Block.
- Purpose: Intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization (IVF) or intravaginal culture (IVC) procedures.
- Approval Basis: FDA De Novo classification. This means there was no existing predicate device, so the manufacturer had to demonstrate safety and effectiveness.
- Study Types: Primarily non-clinical bench studies and two clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text has an excellent table summarizing the non-clinical/bench studies, their purpose, methods, acceptance criteria, and results. I will reproduce key parts of that table and also synthesize clinical performance criteria from the "Special Controls" section.
Acceptance Criteria and Reported Device Performance for INVOcell Intravaginal Culture System
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance and Results |
|---|---|---|---|
| Non-Clinical/Bench Studies | |||
| Sterilization, Cleaning, Disinfection | Sterilization (Culture Device) | Sterility Assurance Level (SAL) shall be 10^-6 | Passed |
| Reprocessing (Holding Block) | >6-log10 reduction in microorganism counts | Passed | |
| Biocompatibility | Cytotoxicity | Not explicitly stated (implied: non-cytotoxic) | Grade 0 (non-cytotoxic) |
| Rabbit Muscle Implantation | Not explicitly stated (implied: no significant toxic effects) | No significant difference from negative control (no signs of toxic response) | |
| Vaginal Irritation | Not explicitly stated (implied: no irritation) | No signs of macroscopic or microscopic irritation from polar and non-polar extracts | |
| Sensitization | Not explicitly stated (implied: no sensitization) | No signs of sensitization from polar and non-polar extracts | |
| Acute Systemic Toxicity | Not explicitly stated (implied: no systemic toxicity) | No evidence of mortality or systemic toxicity from test material extracts | |
| Bench Testing | Volumetric Capacity | Inner vessel volume shall meet specification, and no bubbles or air pockets shall be formed during filling | Passed. No bubbles or air pockets were observed. |
| Fluid Contact Surface Finish | No surface imperfections ≥ 50 microns shall be observed | Passed | |
| Illumination and Optical Properties | Not explicitly stated (implied: ability to observe embryos) | No obscured views, 89% of samples scored 5/5, 11% were 4/5. | |
| Temperature Maintenance | Media inside inner vessel shall maintain a temperature of >34°C for >10 minutes | Passed; Block maintains temperature of inner vessel (>34°C) for 12 minutes. | |
| pH Maintenance | pH shall remain within ±0.2 of controls (legally marketed ART labware) | Passed | |
| Seal Integrity | Culture media within the inner vessel shall remain sterile during incubation and extraction | Passed; 30/30 samples maintained culture media sterility during incubation and extraction. | |
| Mouse Embryo Assay (Embryo compat.) | >80% embryos shall reach expanded blastocyst stage | Passed; >90% of embryos reached expanded blastocyst stage. | |
| Endotoxin Testing | The endotoxin level shall be 80% of embryos shall reach the blastocyst stage | Passed, >90% reached blastocyst stage. | |
| pH maintenance (end of shelf) | pH shall remain within ±0.2 of the control | Passed | |
| Clarity of vessel wall (end of shelf) | Ability to identify and count embryos accurately | Passed | |
| Seal integrity (end of shelf) | Culture media within the inner vessel shall remain sterile during incubation and extraction (worst-case scenario) | Passed; 30/30 samples maintained culture media sterility during incubation and extraction. | |
| Clinical Performance Testing (from Special Controls) | |||
| Performance Characteristics | Comfort and retention of device | Demonstrated retention and minimal discomfort (implied based on study results) | Study 2: Retention for 72hr in 25/29 subjects (100% with Retention Device). Majority reported minimal discomfort. |
| Adverse vaginal tissue reactions | Demonstrated absence of significant reactions (implied based on study results) | Study 2: No reports of erythema, ulceration, or lesions. | |
| Maximum number of gametes/embryos | Indicated for up to 7 oocytes/embryos (based on clinical data supporting this limit) | Majority of clinical data |
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