(280 days)
The HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as lapacervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.
There are four versions of the subject device. HK-WQ-I and HK-WO-II have a curved central guide rod, while the HK-ZQ-I and HK-ZQ-II have a central guide rod which can be rotated (or "flexed") up or down using a dial on the handle.
Each device is a sterile, disposable, single-patient use device which consists of a manipulator shaft with an inflatable intrauterine balloon at the proximal end. The intrauterine balloon is inflated by liquid via a standard syringe injected through the check valve. The internal injection tip of the manipulator shaft is open to allow direct intrauterine introduction of medicine liquid via the injector port. The device also incorporates a vaginal sealing balloon which is inflated by liquid via a standard syringe injected through the check valve to seal the vagina and maintain pneumoperitoneum. The location of the uterus can be adjusted by the handle.
Each device version can be used with a cervical cup. During use, the open-end of the cup rests on the cervix. There are two versions of the cup- a ceramic version and a polyphenylene sulfite version. For both materials, the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm.
This document is a 510(k) premarket notification for uterine manipulators (HK-WQ-I, HK-WQ-II, HK-ZQ-I, and HK-ZQ-II). As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information (like acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth provenance) is not present in this type of regulatory submission, as these devices are not AI/ML-based.
However, I can extract the information that is available regarding non-clinical performance tests:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it lists the types of non-clinical performance tests conducted to demonstrate that the subject devices perform similarly to their predicate devices and meet safety requirements. The "reported device performance" is implied to be successful, as the conclusion states that the devices are substantially equivalent.
Non-Clinical Performance Tests Conducted:
| Test Category | Specific Tests Performed | Outcome (Implied) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Pass |
| Sensitization (ISO 10993-10:2010) | Pass | |
| Irritation (ISO 10993-10:2010) | Pass | |
| Acute systemic toxicity (ISO 10993-11:2006) | Pass | |
| Pyrogenicity (USP and ISO 10993-11:2006) | Pass | |
| Mechanical Performance | Dimensional specifications (all versions) | Pass |
| (HK-WQ-I, -WQ-II, | Intrauterine balloon tensile and burst strength tests | Pass |
| -ZQ-I, -ZQ-II) | Uterus shaft deflection force test | Pass |
| Movement force test | Pass | |
| Intrauterine balloon inflation cycling | Pass | |
| Mechanical Performance | Vaginal sealing balloon maximum inflation volume test (HK-WQ-II, -ZQ-II only) | Pass |
| (Vaginal Balloon) | Vaginal sealing balloon tensile strength under maximum inflation volume (HK-WQ-II, -ZQ-II) | Pass |
| Vaginal sealing balloon sealing characteristics (HK-WQ-II, -ZQ-II only) | Pass | |
| Vaginal sealing balloon air leakage test (HK-WQ-II, -ZQ-II only) | Pass | |
| Mechanical Performance | Dimensional specifications (cervical cup) | Pass |
| (Cervical Cup) | Structural strength | Pass |
| Tension resistance | Pass | |
| Locking force | Pass | |
| Movement force | Pass | |
| Sterilization | Sterilization validation per ISO 11135:2017 | Pass |
| Shelf Life | Package integrity and mechanical performance testing | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical (laboratory/benchtop) and do not involve human or patient data in the sense of a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are non-clinical performance and safety tests, not studies requiring expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for non-clinical performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual surgical instrument, not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For non-clinical tests, "ground truth" would be the measured physical properties against a standard or specification.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.