(113 days)
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
The provided text describes a submission for a medical device called the Glenveigh Vaginal Repair Balloon Catheter. However, it does not include the detailed information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Type of Device: The Glenveigh Vaginal Repair Balloon Catheter is a physical medical device (an obstetric-gynecologic specialized manual instrument). Your questions (e.g., about test sets, ground truth, experts, MRMC studies, standalone algorithm performance, training sets) are typically relevant for software-as-a-medical-device (SaMD) or devices incorporating AI/ML, which analyze data (like images) to provide diagnostic or prognostic information.
- Nature of the Submission: This document is a 510(k) summary of safety and effectiveness, seeking clearance based on substantial equivalence to a predicate device. For physical devices, substantial equivalence is often established through manufacturing specifications, material biocompatibility, and functional bench testing.
- "Performance Data" Section: The text states, "Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device." This typically refers to engineering tests (e.g., burst pressure, inflation/deflation rates, material strength, biocompatibility), not clinical studies with human readers or AI algorithms evaluating data.
Therefore, based on the provided text, I cannot answer your specific questions relating to acceptance criteria and a study as typically understood for AI/ML-driven medical devices. The document does not contain information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or similar metrics. The "performance data" mentioned refers to functional equivalence testing.
- Sample sizes for test sets or data provenance. No such clinical or dataset-based testing is described.
- Number or qualifications of experts for ground truth. Not applicable in this context.
- Adjudication method. Not applicable.
- MRMC comparative effectiveness study. Not conducted for this type of device according to the document.
- Standalone algorithm performance. No algorithm is described.
- Type of ground truth used. Not applicable.
- Training set size. No training set is applicable.
- How ground truth for the training set was established. Not applicable.
Summary of what is available in the text related to "performance" and "acceptance":
- Device Function: "temporarily blocks the flow of fluids to assist in episiotomy/laceration repair."
- Performance Claim: Bench testing demonstrated the device is "functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness."
- Biocompatibility: "materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993."
- Conclusion: "Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaginal Tamponade Balloon with respect to intended use and technological characteristics."
The "acceptance criteria" for this device would likely be successful completion of these functional and biocompatibility tests, demonstrating equivalence to the predicate device, rather than diagnostic accuracy metrics.
§ 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.