(76 days)
The Dynarex Vaginal Specula is used to expose the interior of the vagina.
Indications For Use: This device is used to expose the interior of the vagina.
The Dynarex vaginal speculum is a non-metal (polystyrene), non-lubricated, hand held device used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
The provided document is a 510(k) summary for the Dynarex Vaginal Speculum. It relies on demonstrating substantial equivalence to a predicate device (Dukal Vaginal Speculum, K020726) rather than presenting a study with explicit acceptance criteria and corresponding performance data. Therefore, many of the requested fields cannot be directly answered as they pertain to a different type of device evaluation (e.g., performance studies for novel devices or AI/software-as-a-medical-device).
Here's the information as it can be extracted from the document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria (based on Predicate) | Reported Device Performance (Dynarex Vaginal Speculum) |
|---|---|---|
| Indications for Use | Used to expose the interior of the vagina. | Used to expose the interior of the vagina. |
| Design | Injection Molded, clear plastic. | Injection Molded, clear plastic. |
| Materials | Polystyrene | Polystyrene |
| Performance | Substantially Equivalent (implies similar functionality to Dukal device) | Hand operated, multi-position |
| Sterility | Non-Sterile | Non-Sterile |
| Mechanical Safety | Substantially Equivalent (implies similar safety features to Dukal device) | Simple thumb adjustable lever action. |
| Lubrication | Non-Lubricated | Non-Lubricated |
| Packaging | Bulk Pack 10/Plastic Bag, and Individually wrapped. | Bulk Pack 10/Plastic Bag, and Individually wrapped. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device relies on substantial equivalence to a predicate, not performance testing with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
5. 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 is a non-AI, manual medical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI, manual medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device (Dukal Vaginal Speculum, K020726), demonstrated through its prior FDA clearance.
8. The sample size for the training set
- Not applicable. This device is not an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.