(345 days)
The ClearView Total is 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.
Clinical Innovations' ClearView Total is a single-use sterile device used for uterine manipulation. Uterine manipulation is essential for laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. Uterine manipulators may be helpful when clinicians perform tubal ligations, diagnostic laparoscopies for evaluating pelvic pain and infertility, treatment of endometriosis, removal of pelvic scars (adhesions) involving the uterus, fallopian tubes and ovaries, treatment of ectopic pregnancy, removal of uterine fibroids, removal of ovarian cysts, removal of ovaries, tubal repair, laparoscopic hysterectomy, laparoscopic repair of pelvic bowel or bladder, sampling of pelvic lymph nodes, laparoscopic bladder suspension procedures for treatment of incontinence, and biopsy of pelvic masses.
The ColpoCup accessory is a plastic cup which is mechanically screwed into the uterine manipulator. The ColpoCup is compatible with typical surgical devices, including harmonics and electrosurgical tools. Three different sizes of ColpoCups will be included with the device; 3.0cm, 3.5cm. and 4.0cm. Each ColpoCup will be a high contrast color in order to provide the surgeon with clear visibility during laparoscopic dissection.
At the base of the ColpoCup, past the tip pivot point, is a pre-attached Occluder constructed of an inflatable balloon and will be included to seal off the vagina and prevent pnuemoperitoneum loss. The Occluder Balloon is connected to a separate inflation valve which is located proximally from the balloon and allows for inflation after placement.
The provided text is a 510(k) Summary for a medical device called the "ClearView Total," a uterine manipulator. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices, but it does not outline specific acceptance criteria or report performance in the format of a clinical study assessing a device against predefined performance metrics.
Instead, the document focuses on demonstrating that the ClearView Total is "substantially equivalent" to existing, legally marketed predicate devices through comparison of indications for use, technical characteristics, and various integrity and biocompatibility tests.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type, training set size) are not applicable or cannot be extracted from this document, as the study described is not a clinical effectiveness study with performance metrics in the way these questions imply for an AI/diagnostic device.
However, I can extract information related to the device integrity and biocompatibility testing that served as the "study" for this submission.
Here's a breakdown of the information available based on your request, with relevant sections marked as "Not Applicable" or "Not Provided" where the document does not contain the specific information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present quantitative acceptance criteria or device performance in the typical format of a clinical study for diagnostic or AI devices. Instead, it states that all tests "met the specified requirements" or "met the appropriate acceptance criteria."
| Acceptance Criteria (Stated as met) | Reported Device Performance |
|---|---|
| Accelerated Age Testing requirements | Met specified requirements |
| Balloon Leak/Burst Testing requirements | Met specified requirements |
| Cup Security and Cup Break requirements | Met specified requirements |
| Cytotoxicity standards | Met appropriate acceptance criteria |
| Intracutaneous Reactivity Irritation standards | Met appropriate acceptance criteria |
| Sensitization standards | Met appropriate acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
This document describes engineering and biocompatibility tests, not a clinical test set with patient data.
- Sample Size: Not specified (refers to device units tested for engineering and biocompatibility).
- Data Provenance: Not applicable (these are laboratory/bench tests on device components/materials).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. (Testing results would likely be determined by laboratory technicians or engineers against predefined test specifications.)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This document describes a submission for a physical medical device, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
- Effect Size of Human Readers with vs. without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This device is a physical surgical instrument, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the engineering tests (Accelerated Age, Balloon Leak/Burst, Cup Security/Break), the "ground truth" would be the pre-defined engineering specifications and performance limits for the device's physical properties. For biocompatibility tests, the "ground truth" would be established by industry standards (e.g., ISO 10993 series) for material safety.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable.
Summary of the Study Description:
The "study" described in the 510(k) summary involves device integrity testing and biocompatibility testing.
- Device Integrity Testing: Included Accelerated Age Testing, Balloon Leak/Burst Testing, and Cup Security and Cup Break tests. The document states that "All device integrity tests for the ClearView Total met the specified requirements." These tests would assess the physical and mechanical performance of the device under various conditions to ensure its structural integrity and functionality.
- Biocompatibility Testing: Included Cytotoxicity, Intracutaneous Reactivity Irritation, and Sensitization tests. The document states that "All testing met the appropriate acceptance criteria." These tests are conducted to ensure that the device materials are safe for contact with human tissue and do not elicit adverse biological reactions.
The purpose of these studies was to support the claim that the ClearView Total is "substantially equivalent" to predicate devices, meaning it is as safe and effective as devices already on the market, without introducing new questions of safety or effectiveness.
§ 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.