(116 days)
Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.
Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.
Depalt Vaginal Speculum is a nonmetal, single use (disposable) medical device used to expose the interior of the vagina. The vaginal speculum may be used with or without the Depalt Lighting System.
Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.
This submission K072762 is for a medical device (Depalt Vaginal Speculum and Depalt Lighting System), not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) does not apply.
The FDA 510(k) submission for this device focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of:
- Intended Use: Visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.
- Technological Characteristics:
- Speculum: Nonmetal, single-use (disposable), made of Polystyrene.
- Lighting System: Provides illumination during procedures and examinations.
- Material: Polystyrene for the speculum.
The substantiation for this type of device typically involves:
- Bench Testing: To ensure mechanical integrity, material compatibility, and light output specifications (for the lighting system). This is often compared against industry standards or the performance of predicate devices.
- Biocompatibility Testing: To ensure the materials used are safe for patient contact.
- Sterilization Validation: If the device is supplied sterile.
- Labeling Review: To ensure appropriate instructions for use and warnings.
Since this is not an AI/ML device, the following points from your request are not applicable:
- A table of acceptance criteria and the reported device performance (in the context of AI metrics).
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The FDA's review for this 510(k) focuses on safety and effectiveness through substantial equivalence, primarily based on the listed technical characteristics and intended use, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy.
§ 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.