(86 days)
FemChec® 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).
FemChec® 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 sterile via EO sterilization and is intended for single-use.
The provided text is a 510(k) summary for the FemChec Controlled Saline-Air Device (FCD-250), which is a medical device and not an AI or software device. Therefore, the questions related to AI/algorithm performance, training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data for a physical medical device.
However, I can extract the acceptance criteria and a summary of the studies performed from the provided text for the FemChec device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Ethylene Oxide Sterilization Validation per ISO 11135-1:2014, AAMI TIR 28:2016, ISO 10993-7:2008 | Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence. |
| Packaging | Visual inspection, Bubble Leak test per ASTM F2096-11, Seal Strength testing per ASTM F88/F88M-15 | Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence. |
| Transportation | Transportation Simulation testing per ASTM D4169-14 | Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence. |
| Biocompatibility | Cytotoxicity per ISO 10993-5:2009, Sensitization ISO 10993-10:2021, Irritation per ISO 10993-10:2021 | Tested to be non-cytotoxic, non-sensitizing, and non-irritating. |
| Bench Performance | Visual Inspection, Functional/Cycle Testing, Saline-Air Quantification (before and after accelerated aging to 12 months real-time aging per ASTM F1980-16) | All predetermined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the studies conducted are non-clinical bench performance and material compatibility studies for a physical device, not a performance study involving a test set of data points or images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable. Ground truth establishment by experts is relevant for AI/software devices requiring interpretation of data (e.g., medical images), which is not the case for this physical medical device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies where multiple readers/experts assess cases, which is not applicable to the non-clinical studies for this physical device.
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 studies for a physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable in the context of AI/software performance. For the described bench tests, the "ground truth" would be established by the specifications and standards (e.g., flow rates, material properties, sterility levels) defined in the test protocols themselves, which are based on recognized international and ASTM standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.
§ 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.