(67 days)
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.
The provided text describes a 510(k) premarket notification for the Bakri Postpartum Balloon. The core of this submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections (2-9 relating to study details) are not explicitly present in the provided documentation, as a different regulatory pathway was taken.
Here's a breakdown of the information that can be extracted and an explanation for the missing elements based on the nature of a 510(k) submission based on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria/Performance Goal: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device, specifically the SOS Bakri Tamponade Balloon Set (K013597).
Reported Device Performance:
| Characteristic | Acceptance Criteria (Substantial Equivalence to SOS Bakri Tamponade Balloon Set K013597) | Reported Device Performance (Bakri Postpartum Balloon) |
|---|---|---|
| Indications for Use | "Temporary control or reduction of postpartum uterine bleeding when conservative management is warranted." (Predicate device's original indication) | "Temporary control or reduction of postpartum uterine bleeding when conservative management is warranted." (No change, but removal of uterine atony as a contraindication implies broader applicability within this indication) |
| Design/Function | "Identical" to predicate device | "Identical in design and function" to the SOS Bakri Tamponade Balloon Set (K013597). Described as an "inflatable tamponade balloon designed and proven to be effective in reducing and controlling postpartum bleeding." |
| Materials | Not explicitly stated for predicate, but "similar" or "identical" expected for equivalence. | Silicone rubber. Biocompatibility testing shown to meet test requirements. |
| Sterility | Predicate device is sterile. | Provided sterile in peel-open pouches. |
| Durability | Not explicitly stated for predicate in this document, but implied safe and effective. | Bench testing has proven the product's durability during simulated use. |
| Use | One time use. | Intended for one time use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this submission relies on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a "test set" for performance evaluation in the way requested. The "testing, gathered data, and the history of the predicate device" refer to the existing data for the already cleared predicate.
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)
This information is not provided for the same reasons as above. No specific "test set" with expert-established ground truth was part of this 510(k) for the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no specific clinical "test set" requiring adjudication for ground truth was used in this 510(k) submission.
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 device is a manual obstetric-gynecologic instrument (balloon), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
6. 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 or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the current device's safety and effectiveness is primarily established through demonstration of substantial equivalence to an already legally marketed and cleared predicate device (SOS Bakri Tamponade Balloon Set K013597). This implies that the predicate device's safety and effectiveness (likely supported by historical data, clinical experience, and potentially older, pre-market clearance studies not detailed here) serves as the basis. The current submission highlights:
- "testing, gathered data, and the history of the predicate device... proves that the Bakri Postpartum Balloon is a safe and effective device."
- Biocompatibility testing results for the specific materials.
- Bench testing for durability.
8. The sample size for the training set
This information is not provided. As this is a 510(k) submission for a physical medical device based on substantial equivalence, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided. No "training set" in the context of machine learning or AI was used. The "ground truth" for the device's overall claims relies on its demonstrated equivalence to the predicate and the predicate's established track record.
§ 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.