(90 days)
The ABBI (Air Bubble Based Infuser) is indicated for the following:
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Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (SonoHSG).
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Instillation of saline as a continuous stream of contrast media into the used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).
The Air Bubble-Based Infuser (ABBI™) is a dual-barrel syringe that can be connected to an intrauterine infusion catheter to instill a saline-air mixture as contrast media during sono-hysterosalpingogram (Sono HSG) procedures and saline only during hysterosonography (SIS) procedures. The device has a selector valve that allows the user to select infusion of a saline-air mixture for a Sono HSG procedure or saline alone for a SIS procedure. These procedures are used for the evaluation of the fallopian tube(s) selectively and/or the uterus.
The ABBI™ is labeled for use with the H/S Elliptosphere Catheter Set (K013972).
The device is a single use only and provided sterile using an ethylene oxide sterilization method. The device is intended to be used in a healthcare facility or hospital.
The provided text describes the Air Bubble-Based Infuser (ABBI™) and its substantial equivalence to a predicate device, focusing on non-clinical performance data. It does not contain information about the use of AI, so I cannot provide details on AI-related aspects.
Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence. The "performance" is implicitly stated as "demonstrates that the ABBI™ is substantially equivalent to the proposed predicate device."
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Filling and Infusion Test | Demonstrated substantial equivalence to predicate. |
| Volume Capacity | Demonstrated substantial equivalence to predicate. | |
| Pressure and Vacuum | Demonstrated substantial equivalence to predicate. | |
| Torque Test | Demonstrated substantial equivalence to predicate. | |
| Multi-Fill Performance Test | Demonstrated substantial equivalence to predicate. | |
| Material/Design Integrity | Steam Deformation Test | Demonstrated substantial equivalence to predicate. |
| Feature Evaluation | Demonstrated substantial equivalence to predicate. | |
| Biocompatibility | Cytotoxicity - MEM Elution (ISO 10993-5:2009) | Non-cytotoxic. |
| Irritation Vaginal Irritation Study (ISO 10993-10:2010) | Non-irritating. | |
| Sensitization Guinea Pig Maximization (ISO 10993-10:2010) | Non-sensitizing. | |
| Usability | Summative Usability Assessment | Demonstrated substantial equivalence to predicate. |
| Clinical Performance (Simulated) | Cadaver Device Evaluation Study | Demonstrated substantial equivalence to predicate. |
| Shelf Life | Accelerated Aging Study (functional characteristics & package integrity) | Supports a 1-year shelf life. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for any of the non-clinical tests or the cadaver study. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
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. The studies mentioned are primarily non-clinical device performance and biocompatibility tests, which typically do not involve establishing ground truth by human experts in the same way clinical diagnostic studies would. The "Summative Usability Assessment" might have involved human participants evaluating the device, but the number and qualifications of evaluators are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are typically associated with clinical studies involving interpretation of results, which is not described here.
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 is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance and substantial equivalence to a predicate device, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the tests (filling, volume, pressure, torque, deformation, biocompatibility), the "ground truth" would be established by physical measurements, chemical analyses, and biological responses according to established engineering and ISO standards, rather than expert consensus on diagnostic images or pathology. For the cadaver study, the ground truth would be the direct observation of the device's function within the cadaver.
8. The sample size for the training set:
This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a 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.