(66 days)
The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.
The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.
This is a 510(k) premarket notification for a medical device called the "Uterine ElevatOR PRO with OccludOR Balloon™", not an AI/ML device. Therefore, the request for acceptance criteria and study details related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.
The document describes performance data for a physical medical device, which includes:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that "In all testing, the subject device met the pre-specified acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion and the corresponding reported device performance. It lists the types of tests conducted:
| Test Category | Specific Tests Performed | Reported Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity per ISO 10993-5:2009 |
- Irritation per ISO 10993-10:2010
- Sensitization per ISO 10993-5:2010
- Acute Systemic toxicity per ISO 10993-11:2017
- Pyrogenicity per ISO 10993-11 and USP | "The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours."
"met the pre-specified acceptance criteria." |
| Performance & Mechanical | - Intrauterine balloon integrity & concentric inspection - Intrauterine balloon inflation stability test for a defined time period.
- Intrauterine balloon burst test
- Intrauterine balloon fatigue test
- Intrauterine balloon adhesion strength test
- OccludOR balloon outer diameter inspection & leakage free test
- OccludOR balloon deflation time test
- OccludOR balloon capacity test- reliability/safety
- OccludOR balloon fatigue durability test
- OccludOR balloon burst test
- Vaginal cup air leakage test
- Cervical cup temperature test
- Air inflation valve test
- Dye-injection port compliance & leakage test
- Thumb screw strength test
- Locking force test of vaginal cup
- Ease of movement of vaginal cup along the shaft
- Cervical cup detachment force test
- Cervical cup stopper adhesion strength test
- Device tensile strength
- Handle joint strength
- Tip deflection
- Ultrasonic welding strength | "In all testing, the subject device met the pre-specified acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for any of the tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in full study reports, not a 510(k) summary.
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):
Not applicable, as this is a physical medical device and not an AI/ML device relying on "ground truth" derived from expert consensus. The "truth" for this device's performance is determined by meeting physical and biological specifications through various standard engineering and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical medical device as described.
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, as this is a physical medical device and not an AI/ML device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a physical medical device without an algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for a physical medical device. The "ground truth" here is adherence to engineering specifications and biocompatibility standards.
8. The sample size for the training set:
Not applicable, as this is a physical medical device and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set or AI/ML model for this physical medical 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.