(30 days)
Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
The proposed devices are offered in two configurations, the Bakri Postpartum Balloon (henceforth referred to as Bakri) consisting of a double lumen silicone balloon catheter, a stopcock, and a 60 mL Luer-tip syringe and the Bakri Postpartum Balloon with Rapid Instillation Components (henceforth referred to as Bakri RI) configuration which additionally includes a dual check valve and polymer tubing. The tubing is fitted with a Luer lock-type connector to the dual check valve and a non-vented bag spike with a vented cap that connects to a saline bag (not included in the device).
The balloon catheter common to both configurations is designed as a dual lumen silicone shaft with 500 mL balloon. The proximal end of the catheter has a lighthouse adaptor designed to accept a drainage bag connector and a side arm which is fitted with a Luer Lock-type adaptor to which a stopcock is attached and subsequently a Luer tip syringe or a dual check valve can be connected. The distal end of the catheter has two sideports spaced 180° opposite of each other, and the tip is rounded to a smooth finish. The polymer tubing of the Bakri RI rapid instillation components is 180 cm in length. Both the Bakri and the Bakri RI is supplied sterile and intended for one time use.
This document describes the Cook Incorporated Bakri® Postpartum Balloon and Bakri® Postpartum Balloon with Rapid Instillation Components (K170622). It is a medical device intended to provide temporary control or reduction of postpartum uterine bleeding.
Here's an analysis of the provided text with respect to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Inflated Balloon Reliability, Dimensional Evaluation, and Integrity | When subjected to maximum labeled volume, the inflated balloon and components do not show signs of leakage and/or rupture, and balloon dimensions meet clinical and anatomical requirements. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Tensile Test of the Distal Tip | When subjected to maximum load requirements, the distal tip satisfies the minimum load requirements. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Sideport Drainage and Deflation Reliability | Will drain approximately 200 mL from the sideport in less than or equal to 1 minute and will have less than or equal to 30 mL of water left inside the balloon catheter after 15 minutes of drainage. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Radial Pressure | The balloon can withstand a radial pressure of 100 mm Hg for up to 3 hours without leakage or rupture. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Balloon Inflation Testing | The balloon can be inflated to the minimal volume of 500 mL with the Rapid Instillation Components. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Simulated Use and Leak Test | The device performs as intended and does not leak during normal use. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
| Tensile Testing (Spike/Tubing, MLLA/Tubing, and Tubing) | Withstands normal use forces. | The tests were performed to demonstrate that the modifications met applicable design and performance requirements to support a determination of substantial equivalence. |
Study Proving Device Meets Acceptance Criteria:
The document refers to a series of tests conducted to demonstrate that modifications to the balloon catheter and the addition of rapid instillation components met "applicable design and performance requirements to support a determination of substantial equivalence" to a predicate device (K062438). The document lists several specific laboratory and engineering tests (Inflated Balloon Reliability, Dimensional Evaluation, Integrity, Tensile Test of the Distal Tip, Sideport Drainage and Deflation Reliability, Radial Pressure, Balloon Inflation Testing, Simulated Use and Leak Test, Tensile Testing).
However, the provided text does not include detailed results for each test against the acceptance criteria. It broadly states that the tests were performed and the results support a determination of substantial equivalence. It does not quantify the specific performance values achieved for each test, such as the exact drainage time or the specific load withstood during tensile testing.
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not explicitly stated in the provided text for any of the performance tests.
- Data provenance: Not explicitly stated (e.g., country of origin). The tests are described as "Test Data" conducted by Cook Incorporated, implying in-house testing. The nature of these tests (e.g., mechanical, simulated use) suggests they are laboratory-based rather than involving patient data.
- Retrospective or prospective: These are laboratory/engineering tests, not clinical studies involving patients, so the terms "retrospective" or "prospective" do not directly apply in a clinical data sense. They are likely prospective tests conducted on manufactured device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of tests described. The "ground truth" here is the physical and mechanical properties of the device, measured against engineering specifications and performance requirements, not diagnostic interpretations requiring expert consensus.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or similar expert-driven evaluations. The tests described are objective, quantifiable engineering and performance tests.
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:
This information is not applicable. An MRMC study is for evaluating diagnostic devices, typically involving human readers interpreting images, often with and without AI assistance. This document describes a physical medical device (a postpartum balloon) and its mechanical performance tests, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm or an AI system. It is a physical medical device.
7. The type of ground truth used:
The ground truth for the tests described is based on engineering specifications and performance requirements, derived from the intended use of the device and comparison to a predicate device, rather than expert consensus, pathology, or outcomes data. For example, the "ground truth" for the radial pressure test is 100 mm Hg for 3 hours without leakage.
8. The sample size for the training set:
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The tests are for the physical device itself.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set."
§ 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.