(105 days)
The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.
The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.
The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.
The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.
An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.
This summary describes the acceptance criteria and study information for "The Advance Catheter for HSG and SIS" based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Meets requirements per ISO10993 |
| Flow Rate | Meets set requirements |
| Joints Tensile Strength | Meets set requirements |
| Operational Equivalence | "The Advance Catheter for HSG and SIS" is substantially equivalent to predicate devices with minor differences. |
2. Sample Size and Data Provenance
The submission does not explicitly state sample sizes for tests such as biocompatibility, flow rate, or tensile strength. It refers to "test reports in sections 15 and 18," which are not provided in this excerpt. The tests appear to be non-clinical, laboratory-based performance tests, not human trials. Therefore, data provenance related to human subjects (e.g., country of origin, retrospective/prospective) is not applicable.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not indicate the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The study focused on engineering performance characteristics and substantial equivalence to legally marketed devices.
4. Adjudication Method
Not applicable. The study primarily describes non-clinical performance testing and a comparison to predicate devices, not an assessment requiring expert adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or reported in this submission. This device is an instrument for delivering contrast media, not a diagnostic imaging AI with human-in-the-loop performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
For the non-clinical tests (biocompatibility, flow rate, tensile strength), the "ground truth" was defined by pre-specified engineering requirements and ISO standards (e.g., ISO10993). For the overall device, the "ground truth" for regulatory clearance was substantial equivalence to existing legally marketed devices, demonstrating comparable safety and effectiveness based on similar design, materials, and intended use.
8. Sample Size for Training Set
Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set was Established
Not applicable. As described above, there was no training set in the context of an algorithm.
§ 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.