(141 days)
The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.
The Digene Cervical Brush has a truncated cone-shaped brush head composed of bristles joined to a wire shaft; the brush head on the wire shaft is bonded to a plastic handle. The distal end of the wire shaft is embedded in solidified glue. To collect cervical cells, the brush end of the Digene Cervical Brush is inserted 1.0 to 1.5 cm into the cervical os until the longest outer bristles of the brush touch the ectocervix. The brush is rotated three full turns in a counter-clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear or is inserted into a transport tube for use in STD testing.
The provided text describes a 510(k) submission for the "Digene Cervical Brush," a specimen collection device. It focuses on establishing substantial equivalence to a predicate device, the Medscand Cytobrush, rather than demonstrating meeting specific performance criteria through a study with defined acceptance criteria for the device itself.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document, as it's a submission for a collection device, not a diagnostic device with performance claims.
Here's a breakdown of what can be extracted and what information is missing:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not describe performance criteria, sensitivity, specificity, or other typical metrics associated with diagnostic devices. It focuses on equivalence for a collection tool.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical collection brush, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this type of submission.
- The sample size for the training set: Not applicable, as this is not an algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
What is available: The Basis for Substantial Equivalence
The submission argues for substantial equivalence to a predicate device, the Medscand Cytobrush (K832986), based on the following characteristics:
- Intended Use: Both are for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.
- Design: Both have a truncated cone-shaped brush head composed of bristles joined to a wire shaft, with the brush head bonded to a plastic handle.
- Materials: Implied to be similar based on the equivalence claim.
- Manufacturing Processes: Implied to be similar based on the equivalence claim.
- Physical Properties: Implied to be similar based on the equivalence claim.
- Principles of Operation: Both collect cervical cells by insertion into the cervical os, rotation, and withdrawal.
In summary, the "acceptance criteria" for the Digene Cervical Brush were effectively that it demonstrated "substantial equivalence" to the legally marketed Medscand Cytobrush, meaning it raised no new questions of safety or effectiveness, as confirmed by the FDA's decision letter (K971586). The study proving this was a comparison of its characteristics to the predicate device, rather than a clinical performance study with specific endpoints.
§ 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.