(269 days)
Not Found
No
The device description and performance studies focus on the physical components and clinical outcomes of an intravaginal culture system, with no mention of AI or ML capabilities.
Yes
The device is used in In Vitro Fertilization/Intravaginal Culture (IVF/IVC) procedures, which are medical treatments aimed at achieving pregnancy. It directly participates in the process of culturing gametes and embryos, thereby addressing a medical condition (infertility) and facilitating a physiological process (reproduction).
No
Explanation: The device is indicated for 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. It facilitates the culture process rather than diagnosing a condition.
No
The device description clearly outlines physical components (Culture Device, Retention Device, Inner Vessel, Outer Rigid Shell, silicone O-ring, silicone retention device) made of materials like polystyrene and silicone, indicating it is a hardware-based medical device.
Based on the provided information, the INVOcell Intravaginal Culture System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- INVOcell's Function: The INVOcell system is a container and retention device used to hold and culture human gametes and embryos outside the body during the process of In Vitro Fertilization (IVF) and Intra-Cytoplasmic Sperm Injection (ICSI). It facilitates the fertilization and early development of embryos.
- Lack of Diagnostic Purpose: The device itself does not analyze or test a specimen to provide diagnostic information about a patient's health or condition. Its purpose is to provide a controlled environment for biological processes to occur.
While the process of IVF/ICSI involves laboratory procedures and the evaluation of embryos, the INVOcell device is a tool used within that process, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
The INVOcell Intravaginal Culture System consists of the following components:
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.
Product codes (comma separated list FDA assigned to the subject device)
OYO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1: INVOcell Culture System Comfort and Retention
- Study Type: Single center, open label trial to evaluate Comfort and Retention of the INVOcell Intravaginal Culture System during 120 hours of intravaginal incubation.
- Sample Size: 29 subjects
- Key Results:
- No reports of INVOcell Culture Device expulsion.
- One subject reported the system was felt to be dislodged and successfully readjusted, resulting in an overall retention rate of 96%.
- No clinically relevant vaginal findings (e.g., lesions, ulcerations, erythema, or bleeding) identified after device wearing for 120 hours, demonstrating safety for longer duration.
Study #2: Retrospective Analysis of the INVOcell Culture System (IVC) in Comparison with traditional IVF and ICSI for 5 Day Incubation
- Study Type: Multicenter, retrospective cohort study comparing safety and effectiveness of the INVOcell Culture System (IVC/IVF and IVC/ICSI) to traditional IVF and ICSI procedures for 5 Day incubation.
- Sample Size: 240 fresh embryo transfers in the INVOcell arm (IVC/IVF and IVC/ICSI) and 685 fresh embryo transfers in the traditional IVF and ICSI arm.
- Data source: Data collected from four fertility clinics in the U.S. for the 3-year period of January 2017 to December 2019.
- Key Results:
- Effectiveness:
- Day 5 embryo development is more advanced, and clinical pregnancy and live birth rates are higher for day 5 incubation in the INVOcell device for both IVF and ICSI cohorts compared to day 3 INVOcell.
- While INVOcell ICSI produced lower rates of embryos developed to the blastocyst stage than traditional ICSI, the rates for IVC/IVF and traditional IVF were similar.
- The rates of embryo transfer, clinical pregnancy, implantation, miscarriage, live birth, and pre-term birth using the IVC/ICSI methods were similar to day 5 traditional IVF and ICSI methods.
- The data supports that embryos suitable for transfer can be formed by incubation in the INVOcell device with 120h incubation and use of the revised device loading methods.
- Safety:
- The type of maternal and offspring adverse events experienced in both cohorts were similar.
- 2 birth defects reported in 2 subjects in the IVC cohort (out of 104 births with known outcomes) and 9 birth defects in 9 subjects in the traditional IVF and ICSI cohort (out of 273 births with known outcomes).
- The data supports that incubation in the INVOcell device with 120h incubation and use of the revised device loading methods did not result in increased adverse events or outcomes.
- Effectiveness:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Overall retention rate of 96% (Study 1).
- One-cell Mouse Embryo Assay (MEA): ≥80% embryos developed to expanded blastocyst at 120h (Non-clinical testing).
- Clinical pregnancy rates are higher for day 5 incubation in the INVOcell device for both IVF and ICSI cohorts (Study 2).
- Live birth rates are higher for day 5 incubation in the INVOcell device for both IVF and ICSI cohorts (Study 2).
- Rates of embryo transfer, implantation, miscarriage, and pre-term birth using the IVC/ICSI methods were similar to the day 5 traditional IVF and ICSI methods (Study 2).
- Birth defects reported: 2 in IVC cohort (out of 104 births with known outcomes); 9 in traditional IVF and ICSI cohort (out of 273 births with known outcomes) (Study 2).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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June 22, 2023
INVO Bioscience, Inc. % Wanda Carpinella Regulatory Affairs Consultant Avania, LLC 100 Crowley Drive, Suite 100 Marlborough, MA 01760
Re: K222932
Trade/Device Name: INVOcell Intravaginal Culture System Regulation Number: 21 CFR§ 884.6165 Regulation Name: Intravaginal Culture System Regulatory Class: II Product Code: OYO Dated: May 18, 2023 Received: May 19, 2023
Dear Wanda Carpinella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -S
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222932
Device Name INVOcell Intravaginal Culture System
Indications for Use (Describe) The INVOcell Intravaginal Culture System consists of the following components:
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K222932
INVOcell® Intravaginal Culture System
| I. | Submitter | INVO Bioscience, Inc.
5582 Broadcast Court
Sarasota, FL 34240 |
|-----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person | Steven Shum
CEO INVO Bioscience, Inc.
5582 Broadcast Court
Sarasota, FL 34240
Tel: 978-878-9505
Email: sshum@invobio.com |
| | Date Prepared | June 20, 2023 |
| II. | Device | |
| | Trade name | INVOcell Intravaginal Culture System |
| | Common name | Intravaginal Culture System |
| | Regulatory Name | Intravaginal Culture System |
Classification Name: 21 CFR 884.6165 Product Code(s): OYO (Culture, Intravaginal, Assisted Reproduction) Regulatory Class: =
III. Predicate Device
INVOcell Intravaginal Culture System (DEN150008) from INVO Bioscience, Inc.
The predicate device has not been subject to a design-related recall.
IV. Description of the Device
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.
4
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.
V. Indications for Use
The INVOcell Intravaginal Culture System consists of the following components:
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/IVC) 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.
VI. Substantial Equivalence Comparison:
A comparison of the intended use and technological features of the subject and predicate devices are described in the table below:
| | K222932
Subject Device | DEN150008
Predicate Device | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The INVOcell Intravaginal Culture System consists of the following components:
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/IVC) 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 | The INVOcell Intravaginal Culture System consists of the following components:
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/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 | The indications for use statements for the subject and predicate devices are not identical; however, the intended uses of the subject and predicate devices are the same. |
| | | | |
| | indicated for use exceeding 120h. | INVOcell Retention Device is not indicated for use exceeding 72h.
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. | |
| Components | Inner chamber, outside rigid shell, retention device | Inner chamber, outside rigid shell, retention device, holding block | Different: The subject device does not include a holding block. Differences in components do not raise different questions of safety and effectiveness (S&E). |
| Fully
Assembled
Dimensions | 1.8" length x 1.1" diameter | 1.8" length x 1.1" diameter | Same |
| Sterilization | Gamma sterilized | Gamma sterilized | Same |
| Endotoxin
(LAL) |