(83 days)
The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.
The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.
The new Unicare System™ is a sterile, disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The Unicare System™ consists of the Unicare Manipulator™, a rear Stabilizer™, and a set of interchangeable, forward Collars™.
The Unicare Manipulator™ is a rigid, anatomically curved cannula having at its proximal end a tip for insertion into the uterus to manipulate and maintain the proper attitude of the uterus. The Unicare Manipulator incorporates a sliding tube component with a proximal ball that provides a positive stop from over-penetration of the uterine cavity and counter traction with the tip for manipulation. At the distal end of the device is a handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme distal end of the device is a standard luer port suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the cannula.
The Unicare System also incorporates a set of interchangeable, forward Collars™ and a rear Stabilizer™. The appropriately sized Collar surrounds the cervix, delineates the fornix, and supports and defines the vaginal wall. The rear Stabilizer and a sliding tube are slid along the cannula to adjust the depth of tip insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear Stabilizer and sliding tube components are secured at their proper depth with a locking mechanism situated distal to the sliding tube and external to the patient.
The Unicare Manipulator™ will be offered and sold separately from the Unicare System™. The Unicare Manipulator"™ does not include a rear Stabilizer" or a set of interchangeable, forward Collars", and is therefore indicated only for a subset of procedures of the Unicare System™
This document (K163214) describes a 510(k) submission for the Unicare System & Unicare Manipulator, a uterine manipulator. The submission focuses on demonstrating substantial equivalence to a predicate device (VCARE manufactured by Conmed Corporation, K071907) rather than providing extensive details on a standalone study with human readers or clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Non-cytotoxic |
| Sensitivity | Non-sensitizing |
| Irritability | Non-irritating |
| Systemic Toxicity | Not acutely toxic |
| Non-Clinical Performance Testing: | |
| Mechanical performance (flow rates, strength, applied clinical forces) | Met all acceptance criteria |
| Packaging structural integrity (after transit) | Met all acceptance criteria |
| Sterility | Met all acceptance criteria |
| Accelerated aging (non-clinical performance after aging) | Met all 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 explicitly states: "No clinical testing has been performed in support of this Unicare System™ and Unicare Manipulator™ 510(k) submission." Therefore, there is no test set in the context of clinical data for AI device performance. The testing performed was non-clinical (biocompatibility, mechanical, packaging, sterility, accelerated aging) and involved the physical devices. The sample sizes for these specific non-clinical tests are not detailed beyond "the device was evaluated." Data provenance is not applicable as it was non-clinical lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, no ground truth was established by experts from patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical testing or expert review of clinical data was conducted.
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
No MRMC comparative effectiveness study was done. The submission is for a physical medical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (biocompatibility, mechanical, packaging, sterility, accelerated aging), the "ground truth" would be established by the industry standards and methodologies (e.g., ISO and ASTM standards) that define acceptable performance. For instance, for sterility, the ground truth is "sterile" as determined by ISO 11137 standards. For biocompatibility, it's non-cytotoxic, non-irritating, etc., as per ISO 10993 standards.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained, so no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained, so no training set or ground truth for it was established.
§ 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.