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510(k) Data Aggregation
(91 days)
Rejoni, Inc.
The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes.
When used for HSG. the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency.
The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.
The Rejoni Intrauterine Catheter is a sterile, single-lumen uterine catheter intended for delivering contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. It can also be used for evaluation of tubal patency during HSG.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Performance - Mechanical | In accordance with device performance specifications | Pass |
| Performance - Functional | In accordance with device performance specifications | Pass | |
| Dimensional Verification | Met design specifications | Pass | |
| Visual Assessment | Met design specifications | Pass | |
| Tensile Testing (luer to inner shaft; acorn to outer shaft) | Met design specifications | Pass | |
| Kink Testing | Met design specifications | Pass | |
| Leak Testing | Met design specifications | Pass | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Pass |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing | Pass | |
| Intracutaneous Reactivity (ISO 10993-10:2021) | Non-irritating | Pass | |
| Sterility | Sterility Assurance Level (SAL) | 10$^{-6}$ | 10$^{-6}$ (validated) |
| Sterilization Process Validation | Conforms to ISO 11137-1, -2, -3 | Validated | |
| Shelf Life | Device performance over shelf life | Maintains performance as per mechanical testing | Pass |
| Sterile barrier integrity over shelf life | Maintains sterile barrier | Pass | |
| Package integrity after accelerated aging (ASTM 1980-16) | No gross leaks, adequate seal strength, visual integrity | Pass | |
| Package integrity after simulated shipping (ISTA-3A:2018, ASTM D4169-16) | No gross leaks, adequate seal strength, visual integrity | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were used for tensile testing, biocompatibility, etc.). However, it indicates these were pre-clinical tests (lab-based) rather than clinical studies with patient data. Therefore, data provenance such as country of origin of data or retrospective/prospective characteristics is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The described studies are pre-clinical performance and safety tests (mechanical, biocompatibility, sterility, shelf life) rather than studies that require expert-established ground truth on diagnostic accuracy, for example. The "ground truth" for these tests is defined by established industry standards (ISO, ASTM) and the device's own design specifications.
4. Adjudication Method:
Not applicable. As noted above, these are pre-clinical tests following defined protocols and standards, not studies requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a physical catheter, not an AI-assisted diagnostic tool requiring evaluation of human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) study was not done. This device is a manual instrument and does not involve an algorithm.
7. Type of Ground Truth Used:
The ground truth for these tests is implicitly or explicitly defined by:
- Design Specifications: For mechanical and functional performance, the device's own engineering and design requirements serve as the ground truth.
- International Standards (ISO, ASTM): For biocompatibility, sterility, and packaging/shelf life, the ground truth is established by the specified ISO and ASTM standards and their acceptance criteria (e.g., non-cytotoxic, SAL of 10$^{-6}$).
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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