ORIBRUSH - STANDARD - B002

• K Number: K991593
• Device Name: ORIBRUSH - STANDARD - B002
• Manufacturer: ORIFICE MEDICAL AB
• Date Cleared: 1999-06-29 ( 53 days)
• Product Code: HHT
• Regulation Number: 884.4530
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.

Device Description

Not Found

AI/ML Overview

The provided text {0} and {1} is a 510(k) clearance letter from the FDA for a medical device called "ORIBRUSH™ Cervical Brush Model B002". Unfortunately, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter primarily focuses on:

• Confirmation of Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and performs as safely and effectively as a legally marketed device.
• Regulatory Classification: The device is classified as Class II, under 21 CFR §884.4530/Procode: 85 HHT.
• Marketing Authorization: The letter grants authorization to market the device, subject to general controls and, potentially, additional special controls if applicable.
• Indications for Use: The device is indicated as an "ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR."

Therefore, I cannot provide the requested information in the structured format because the input text does not contain the necessary data points related to:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in the 510(k) submission itself (which is not provided) and summarized in a "Summary of Safety and Effectiveness" document. The FDA clearance letter is a summary of their decision regarding the submission, not a detailed report of the studies performed.

Regulation Number and Section

§ 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.