(115 days)
VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
VCARE Dx™ uterine manipulator/injector cannula is a sterile, disposable, single-patient use device which consists of a hollow, rigid, insulated, anatomically curved manipulator tube (OD: 5mm; length: 48cm (19") including handle) with an inflatable PVC intrauterine balloon at the proximal end, graduations (cm) along the shaft measuring distance from the proximal end and a molded handle at the distal end for maintaining proper attitude of the uterus. The graduations on the shaft of the VCARE Dx™ can be used as a guide for comparison to a graduated uterine sound, if one is used. The intrauterine balloon is inflated by passing air via a standard syringe (not included) through the distally located pilot balloon/valve assembly. The internal tip of the manipulator tube is open to allow direct intrauterine introduction of dye/contrast media via the injector port on the rear of the handle, when prescribed. VCARE DxTM incorporates a component that seats against the cervix providing a positive stop from over-penetration of the uterine cavity and counter traction with the intrauterine balloon for effective manipulation. The rear portion of the device is secured at its proper depth with a locking mechanism situated at the rear of the main tube and external to the patient.
The provided K093556 document describes a 510(k) submission for the VCARE Dx uterine manipulator/injector cannula. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence rather than explicit performance targets.
Here's an analysis of the document's information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define quantitative "acceptance criteria" for the VCARE Dx in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" were implied to be the performance specifications and functional design of the predicate device, VCARE (K955446). The study aimed to demonstrate that the VCARE Dx performed similarly to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar performance specifications to VCARE (predicate device) | "All results are favorable in establishing substantial equivalence between the design of VCARE Dx and the predicate device VCARE." |
| Similar function and specifications to VCARE (predicate device) | "The design of VCARE Dx is substantially equivalent to VCARE with regards to function and specifications." |
| Effective in manipulating the uterus | (Implied by substantial equivalence to predicate) |
| Effective in injection of fluids during laparoscopic procedures | (Implied by substantial equivalence to predicate) |
| Addressing identified risks (e.g., inadequate device performance) | "Performance Testing (Section 8)" |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications."
- Sample Size: The document does not specify the sample size used for this comparison test.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a performance verification test likely conducted by the manufacturer.
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. Given that the study was a comparison of performance specifications between two devices, it's unlikely that external medical experts were used to "establish ground truth" in the way they would for, say, diagnostic accuracy. The assessment would have been against engineering specifications or functional outputs.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which doesn't appear to be the primary focus of this engineering comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
An MRMC comparative effectiveness study was not performed, nor is it applicable to this device. The VCARE Dx is a physical medical device (uterine manipulator/injector cannula), not an AI algorithm or diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
A standalone performance study in the context of an "algorithm only" or "AI" is not applicable to this device. It is a physical medical device. The "performance verification" was a comparison of the device itself to its predicate.
7. The Type of Ground Truth Used:
For the performance verification, the "ground truth" was effectively the established performance specifications and functional design of the legally marketed predicate device (VCARE). The study aimed to show that VCARE Dx met these same functional and specification standards. It was not a diagnostic device where pathology or outcome data would be the ground truth.
8. The Sample Size for the Training Set:
This is not applicable as the VCARE Dx is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reasons stated above.
§ 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.