(385 days)
The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.
The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended for collecting cytological materials from the surface of the cervix. This device consists of two components: a white colored head and a pink colored handle. The head contains a brush and a connection portion. The head and handle are physically connected through a male/female connection mechanism. The handle is made of Polypropylene (PP) and the head is made of low density polyethylene (LDPE). This device has a 3-years shelf-life.
The provided documentation is a 510(k) summary for a Disposable Cervical Brush, a medical device used for collecting cervical cells for Pap smear analysis. It outlines the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence.
Based on the provided text, here's a detailed breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating safety and performance through non-clinical testing and comparison to a predicate device. The underlying acceptance criterion for a 510(k) is substantial equivalence to a predicate device, meaning it is as safe and effective as the legally marketed predicate.
The reported performance is primarily derived from meeting established standards for biocompatibility and mechanical integrity, which implicitly demonstrate that the device performs as intended and is safe for its intended use.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Conducted and passed |
| Vaginal irritation | Conducted and passed | |
| Guinea Pig Maximization Sensitization | Conducted and passed | |
| Mechanical Performance | Brush off test | Conducted and passed |
| Joint strength (firm connection) test | Conducted and passed | |
| Bending strength resistance test | Conducted and passed | |
| Tensile strength at the bristle joint test | Conducted and passed | |
| Tensile strength at connection portion of the brush head test | Conducted and passed | |
| Chemistry | Reduction material test | Conducted and passed |
| Heavy metals test | Conducted and passed | |
| Cadmium test | Conducted and passed | |
| pH value test | Conducted and passed | |
| Dissolution tests of brush head and brush handle | Conducted and passed | |
| Substantial Equivalence | Intended Use | Same as predicate (K896065) |
| Structure | Same as predicate | |
| Materials | Same as predicate | |
| Dimensions | Comparable to predicate (minor differences not raising concerns) | |
| Color | Same as predicate |
Study Information
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical (bench) testing for biocompatibility, mechanical performance, and chemistry. It does not mention a "test set" in the context of clinical data, as it's a 510(k) for a Class II manual instrument where clinical studies are often not required if substantial equivalence can be demonstrated through other means.
- For the non-clinical tests, specific sample sizes are not provided, nor is the country of origin of the testing data or whether it was retrospective or prospective. It is implied these were prospective tests conducted to evaluate the device.
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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. The document describes non-clinical testing, not a study involving expert-established ground truth on patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving adjudication of human-interpreted data.
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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 not an AI/software device, and no MRMC study is mentioned. The device is a manual instrument for cell collection.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference standards were established laboratory testing standards and methods for biocompatibility, mechanical properties, and chemical composition. For instance, cytotoxicity tests adhere to recognized protocols to determine the biological response.
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The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established
- Not applicable. As there's no training set, there's no ground truth established for it.
§ 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.