(136 days)
FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.
Here's a breakdown of the acceptance criteria and the studies mentioned for the FemVue MINI Saline-Air Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that "all predetermined acceptance criteria were met" for various tests. Therefore, the table below is constructed by inferring the acceptance criteria from the type of test conducted.
| Acceptance Criterion (Inferred from Test) | Reported Device Performance |
|---|---|
| Sterility (achieves sterility after Ethylene Oxide sterilization) | Met (per ISO 11135:2014, AAMI TIR 28:2016, ISO 10993-7: 2008) |
| Package Integrity (maintains sterility barrier) | Met (per Visual inspection, ASTM F2096-11, ASTM F88/ F88M-23, ASTM F1886/F1886-16) |
| Withstand Transportation (maintains integrity after transport simulation) | Met (per ASTM D4169-22) |
| Biocompatibility (non-cytotoxic, non-sensitizing, non-irritating) | Met (non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993-5: 2009, ISO 10993-10: 2021) |
| Visual Inspection (meets specified visual appearance) | Met (before and after accelerated aging) |
| Functional/Cycle Testing (operates as intended through its lifecycle) | Met (before and after accelerated aging) |
| Saline-Air Quantification (delivers consistent alternating pattern of saline and air) | Met (before and after accelerated aging) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual bench performance tests. It only states that these tests were conducted. It also does not explicitly state the data provenance (e.g., country of origin) or if the studies were retrospective or prospective, though bench testing is inherently prospective.
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. The tests described are primarily physical, chemical, and functional bench tests, rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the bench tests, it's unlikely a formal adjudication method (like 2+1, 3+1) would be applicable. The tests likely have objective pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data for a device, not a diagnostic algorithm that would typically require such a study to assess human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm only) was not done. This device is a manual instrument, not an AI or software algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance studies described, the "ground truth" refers to established engineering standards, material specifications, and functional requirements for a medical device. This is determined by the specific ASTM and ISO standards cited (e.g., ISO 11135 for sterility, ISO 10993 for biocompatibility, ASTM F1980-16 for accelerated aging). The concept of expert consensus, pathology, or outcomes data as ground truth is not applicable to these types of engineering and functional tests.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a hardware product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of device.
§ 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.