(91 days)
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.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.