(251 days)
The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).
The uVue™ HSG/SHG Catheter is a 6.2 French polyurethane catheter molded inside a 9.0 French polyurethane integrated catheter as a single piece. The device has a 26 centimeter working length. Along the distal end of the catheter, there is a silicone radiopaque positioner. In addition, distal from the positioner is a 1.5 milliliter silicone balloon. The catheter consists of three lumens: a closed lumen that contains a stainless steel stylet, an open lumen used to inflate the balloon, and an open lumen used to inject diagnostic media into the uterus. The catheter features a proximal fitting of a double lumen polyurethane hub with a polyethylene and polyetherimide stopcock attached. Both the hub and stopcock accept standard Luer lock or Luer slip syringes.
The purpose of the first luer is to allow for inflation of the balloon with saline via a proximally extending inflation line. The purpose of the second luer to allow for installation of diagnostic media into the uterine cavity. A 3 mL syringe will be provided with the catheter as a set.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a Tyvekpolyethylene peel-open pouch with a two year shelf life.
The document provides information on the uVue™ HSG/SHG Catheter, but it primarily focuses on premarket notification for substantial equivalence to a predicate device and engineering performance testing. It does NOT describe a clinical study involving human patients to prove the device meets acceptance criteria related to its clinical effectiveness or accuracy in diagnosis.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement for clinical performance cannot be extracted from this document, as such a study is not described.
However, I can provide information regarding the engineering performance tests that were conducted and their acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Stated as "Requirement") | Reported Device Performance |
|---|---|---|
| Tensile Strength | Tensile force during proper clinical use should not fracture the uVue™ HSG/SHG Catheter materials and bonds. | Predetermined acceptance criteria were met. |
| Dimensional Analysis | Specific product dimensions should be within set tolerances. | Predetermined acceptance criteria were met. |
| Balloon Integrity | Balloons should not burst or leak during nominal inflation and after a predetermined time period at nominal inflation in a water bath. | Predetermined acceptance criteria were met. |
| Balloon Diameter & Max Volume | Balloons, subjected to a desired volume, should achieve a desired diameter while not having any rupture, leakage, or herniation of the entire balloon and/or catheter, or leakage at the hub during placement in a constant temperature bath. Testing continued until maximum burst volume. | Predetermined acceptance criteria were met. |
| Balloon Deflation Reliability | Balloons, subject to a desired volume and subsequently deflated, should achieve a desired diameter. | Predetermined acceptance criteria were met. |
| Buckling Force | (Characterization test, no explicit "acceptance criteria" stated, but peak load data was obtained.) | Peak load data provided. |
| Stylet Puncture Force | Force required to puncture the distal tip of the catheter must be greater than the buckling force. | Predetermined acceptance criteria were met. |
| Biocompatibility | Conforms with ISO 10993-1:2009 for Cytotoxicity, Sensitization, and Irritation. | Predetermined acceptance criteria were met. |
| Shelf Life | Maintains mechanical requirements and sterility following aging for two years. | Predetermined acceptance criteria were met. |
Regarding Clinical Performance Studies:
The document does not describe any clinical study validating the diagnostic performance (e.g., accuracy in visualizing uterine cavity or fallopian tubes) of the uVue™ HSG/SHG Catheter. The testing described is entirely focused on the physical, mechanical, and biological safety aspects of the device as a medical instrument.
Therefore, the following information is not applicable or not available from the provided text, as it pertains to clinical performance which was not described:
- Sample size used for the test set and the data provenance: Not applicable, no clinical test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established.
- Adjudication method for the test set: Not applicable, no clinical test set described.
- 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, this device does not involve AI or human reader interpretation in the context described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, no clinical ground truth established.
- The sample size for the training set: Not applicable, this is a physical medical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.