(133 days)
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device. The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.
This document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO. It details the device's indications for use, its description, and a summary of performance and safety data, as well as a substantial equivalence discussion.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., "device must withstand N newtons of force"). Instead, it lists various performance tests and indicates that they were "successfully completed to confirm the subject device met the user requirements for the proposed intended use." The reported device performance is qualitative, confirming that the tests were passed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain system and balloon integrity during "worst" case conditions (Air Leak) | Air Leak Test – inflation of the balloon confirmed system and balloon integrity would be maintained during "worst" case conditions. |
| Balloon integrity when exposed to maximum inflation volume | Balloon destructive testing - Balloon integrity when exposed to maximum inflation volume was successful. |
| Correlation of balloon inflated diameter and infused balloon volume | Repeat inflation/deflation of balloon and correlation of balloon inflated diameter and infused balloon volume were successfully completed. |
| Durability of critical bonds | Tensile Testing of all critical bonds was successfully completed. |
| Durability of entire system | Tensile Testing of entire system was successfully completed. |
| Compatibility with McCartney Tube (for ManipulatOR PRO) | Compatibility of ManipulatOR PRO with McCartney Tube was successfully completed. |
| Tip deflection force | Force required for tip deflection testing was successfully completed. |
| Clamping forces (for ManipulatOR PRO) | Locking forces of clamp on ManipulatOR PRO testing was successfully completed. |
| Ease of movement when clamp is unlocked (for ManipulatOR PRO) | Ease of movement of ManipulatOR PRO when clamp is unlocked testing was successfully completed. |
| Resistance to aging | Accelerated age testing was successfully completed. |
| Packaging integrity | Packaging validation testing was successfully completed. |
| Biocompatibility with direct body materials | Per ISO 10993-1, biocompatibility tests (MEM Elution Cytoxicity, Mucosal (vaginal) Irritation, Guinea Pig Maximization Sensitization) were conducted and confirmed all direct body materials are biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the various performance tests (e.g., number of devices tested for air leak, balloon integrity, etc.). The provenance of the data is from Gynetech Pty Ltd, an Australian company. The studies appear to be prospective bench testing and biocompatibility testing, conducted by the manufacturer to demonstrate device performance. This is not clinical data, but rather engineering and laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data is derived from technical bench tests and biocompatibility testing, not from expert review of data that would require "ground truth" establishment in the traditional sense of clinical studies.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench tests and biocompatibility assessments, not clinical studies involving expert adjudication of findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes technical performance testing and biocompatibility assessment, not a clinical study involving human readers or AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone performance study of an algorithm was not done. This device is a physical medical instrument, not an AI or software device. The listed studies focus on the physical and material performance of the uterine manipulator.
7. Type of Ground Truth Used
The "ground truth" for the performance studies described would be based on engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and established test protocols to determine if the device meets its design requirements. This is not clinical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, and the described studies are not machine learning or AI-based; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
§ 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.