Cleared Traditional

K222932 - INVOcell Intravaginal Culture System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K222932 · Invo Bioscience · Obstetrics & Gynecology device
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Jun 2023
Decision
269d
Days
Class 2
Risk

K222932 is an FDA 510(k) clearance for the INVOcell Intravaginal Culture System. Classified as Culture, Intravaginal, Assisted Reproduction (product code OYO), Class II - Special Controls.

Submitted by Invo Bioscience (Sarasota, US). The FDA issued a Cleared decision on June 22, 2023 after a review of 269 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6165 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Invo Bioscience devices

Submission Details

510(k) Number K222932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date June 22, 2023
Days to Decision 269 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 160d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OYO Culture, Intravaginal, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6165
Definition Intravaginal Culture Of Human Gametes And Embryos. To Hold And Maintain Gametes And Developing Embryos Over The Duration Of The Intravaginal Culture Period.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Avania, LLC
Wanda Carpinella

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05189405 Unknown Observational Industry-sponsored

3 Year Retrospective Analysis of IVF in Comparison With INVOcell

A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device

450
Patients (est.)
4
Sites
Condition studied Infertility
Eligibility Female only · 18 Years+
Sponsor INVO Bioscience, Inc. (industry)
Started 2021-10-12 → Primary completion 2022-02-28
Primary outcome
Embryo development
Secondary outcome
Maternal Adverse Events
View full study on ClinicalTrials.gov