(173 days)
The ESM-UBT device is intended to provide temporary control of postpartum uterine bleeding when conservative management is warranted.
The Every Second Matters - Uterine Balloon Tamponade ("ESM-UBT") device is a single use product that consists of the kitting of 510(k)-cleared or off-the-shelf ("OTS") class I exempt components. The kit also contains an antiseptic prep pad that is marketed under an OTC monograph and is intended for use as an accessory with and during the assembly of the class I medical device components of the ESM-UBT device:
- Urinary catheter
- Luer lock valve
- Condom
- Syringe
- Elastic O-ring
- Catheter holder
- Antiseptic (povidone iodine) prep pad
The components will not be modified from their packaged state, and the entire kit will be re-labeled as the ESM-UBT device. The device is assembled in an ISO certified clean room using the Foley urinary catheter, Luer lock valve, condom, and a green elastic O-ring. The assembled condom-catheter is inserted into the bleeding uterus through the cervical opening. Upon placement within the uterine cavity, the balloon on the Foley catheter is inflated first with 15 mL of saline. This small balloon helps secure the catheter inside the uterus. One port on the Foley catheter is used for the syringe to inject saline into the small balloon, whereas the other port is used to inflate the condom balloon with saline. This condom balloon should be inflated until tamponade occurs as evidenced by bleeding cessation. The maximum fill volume of 500 mL was verified in bench tests. The device should be fixed to the thigh at the end using the catheter holder.
The provided text is a 510(k) summary for the Every Second Matters-Uterine Balloon Tamponade ("ESM-UBT") device. It describes the device, its intended use, and comparative information with a predicate device. However, it does not explicitly define acceptance criteria in a quantitative manner as typically expected for device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and positive clinical outcomes from peer-reviewed publications.
Here's an analysis based on the provided information, addressing your questions as best as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative acceptance criteria are not presented in a traditional tabular format within this document. The device performance is largely established through a combination of non-clinical (mechanical, biocompatibility) testing and clinical evidence from publications demonstrating safety and effectiveness compared to the predicate and in the intended population.
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| Biocompatibility | Met all specified ISO 10993 standards (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity) and additional tests (Pyrogenicity, Hemolysis Assay). Results demonstrated "the subject lubricant is biocompatible." |
| Mechanical Performance | - Condom Diameter: Verification that the filled condom balloon has an appropriate diameter within the uterus. (Specific diameter values not provided) |
| - Burst Volume: Verification that the device has at least the burst volume of the predicate Bakri balloon. (Specific volume not provided beyond "up to 500 mL") | |
| - Device Integrity/Radial Pressure: Verification that the balloon can withstand a pressure higher than the normal intraluminal pressure of uterine balloon tamponade devices inside the uterus in a simulated system without leakage. (Specific pressure values not provided) | |
| - Deflation Reliability: Verification that the device can be fully deflated and retrieved without rupture. (No specific rupture rate provided) | |
| - Catheter Securement: Verification that the balloon on the Foley catheter can secure the device inside the uterus. (No specific securement metric provided) | |
| - O-ring Tensile Test: Verification that the O-ring maintains a connection between the condom balloon and catheter. (No specific tensile strength metric provided) | |
| Clinical Performance (Effectiveness) | Effective in managing PPH, led to high survival rates and low rates of complications based on peer-reviewed publications. "Bleeding cessation" is mentioned as evidence of tamponade. |
| Clinical Performance (Safety) | All observed deaths were "expected due to the patients and unrelated to the ESM-UBT device." Healthcare workers reported no difficulty, complication, or discomfort during placement. |
| Sterility Justification | PVP-1 application and microbial controls under ISO 4074 (for condoms) are sufficient given the benefit-risk profile for life-threatening PPH. |
| Substantial Equivalence | "As safe and effective as the predicate device" (Bakri Postpartum Balloon, K170622). |
2. Sample Size Used for the Test Set and the Data Provenance
The document references "peer-reviewed publications" for clinical data.
- Sample Size: Over 900 devices have been used based on the collective data from these publications.
- Data Provenance: Retrospective, derived from devices used in India, Tanzania, Kenya, Senegal, Sierra Leone, and Nepal. This suggests a multi-national and real-world setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document states: "Ujenzi assessed the severity, expectedness, and relatedness of each reported death and provided this information to an independent committee for review."
- Number of Experts: An "independent committee" was used. The exact number of experts in this committee is not specified.
- Qualifications of Experts: Not explicitly stated beyond being an "independent committee."
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
For reported deaths, the adjudication involved an "independent committee for review." The specific adjudication method (e.g., how disagreements were resolved) is not detailed. For the broader clinical effectiveness, the peer-reviewed nature of the publications implies some level of expert review, but a formal adjudication method for a test set (like for a diagnostic device) is not described because this is a therapeutic device.
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
- No, an MRMC comparative effectiveness study was not done. This device is a physical therapeutic device (uterine balloon tamponade), not an AI-assisted diagnostic or imaging device that would typically involve "human readers" or AI assistance in that context. The "effect size" mentioned would be irrelevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI program.
7. The Type of Ground Truth Used
For the clinical data, the ground truth was outcomes data (survival rates, complication rates, bleeding cessation) observed in real-world clinical practice, as reported in peer-reviewed publications. The severity and relatedness of deaths were also adjudicated by an independent committee.
8. The Sample Size for the Training Set
No specific "training set" is mentioned as this device is a physical medical device, not a machine learning algorithm. The clinical data cited from "over 900 devices" used across multiple countries served as supporting evidence for its safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The clinical evidence was gathered from real-world usage and documented in peer-reviewed publications.
§ 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.