(28 days)
The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.
This document is a 510(k) premarket notification for the Bakri Essential Postpartum Balloon, a medical device. It does not describe a study involving an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects cannot be extracted.
The document discusses the substantial equivalence of the Bakri Essential Postpartum Balloon to a predicate device (Bakri Postpartum Balloon, K170622). It focuses on non-clinical performance testing related to packaging modifications and the removal of a syringe from the product set, not on a study proving a device's performance against specific clinical acceptance criteria in the context of an AI/ML system.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance (in the context of an AI/ML device).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
- Whether standalone performance was done for an AI algorithm.
- The 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 "Summary of Non-clinical Performance Testing" section details tests performed for the physical device's packaging and sterilization integrity, with specific acceptance criteria for those tests:
- Pouch Seal Strength Testing: Minimum seal strength shall meet or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15.
- Bubble Leak Testing: Packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11.
- Dye Penetration Testing: No packaging seal may be breached by dye per F1929-15.
- Additional distribution testing followed by functional verification: Device shows no signs of damage after sterilization and simulation distribution.
These criteria and tests relate to the physical integrity and sterility of the packaged device, not a performance study of a diagnostic or therapeutic AI/ML algorithm.
§ 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.