(158 days)
The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure.
Indications For Use:
- Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the . mid-pelvis.
- Delay in the second stage associated with borderline cephalopelvic disproportion .
- Fetal distress .
- Shortening of second stage labor for fetal or maternal benefit .
- Prolapse of the umbilical cord when the cervix is fully dilated ●
The purpose of this premarket notification is to add a fluid retention trap option to the current Ameda Disposable Vacuum Assist Cup in order to collect fluids that may be aspirated during the delivery procedure. The fluid retention trap consists of a housing segment that is constructed of high impact polystyrene and a polyurethane foam filter. The fluid retention trap, when used, is connected to the tubing of the device between the vacuum cup and the vacuum pump.
Here's an analysis of the provided text regarding the Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Functional Performance | Fluid Handling Capacity | "Laboratory testing was performed to evaluate fluid handling capacity." | Laboratory Testing |
| Resistance to Air Flow | "Laboratory testing was performed to evaluate...resistance to air flow." | Laboratory Testing | |
| Biocompatibility | Material Biocompatibility | Materials used are "considered biocompatible and appropriate for their intended use." | Assessment based on ISO 10993, G95-1, USP; biomaterial history or in vitro/in vivo evaluations by Hollister or suppliers. |
| Substantial Equivalence | Intended Use | "substantially equivalent in its intended use as a fetal vacuum extractor as described in 21 CFR 884.4340." | Comparison to Predicate Devices |
| Materials | "identical in...materials" to Ameda Dolphin Dispo-Soft Vacuum Extractor (K895700). | Comparison to Predicate Devices | |
| Manufacturing Processes | "identical in...manufacturing processes" to Ameda Dolphin Dispo-Soft Vacuum Extractor (K895700). | Comparison to Predicate Devices | |
| Fluid Collection Capabilities | "include fluid collection capabilities" (compared to Mityvac and Tender Touch predicate devices). | Comparison to Predicate Devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "laboratory testing" and "evaluations" for biocompatibility but does not provide specific sample sizes for these tests.
- Data Provenance: The studies were conducted by Hollister Incorporated and/or its material suppliers. The exact country of origin is not specified beyond "Libertyville, Illinois, USA" for Hollister. The studies described are retrospective in the sense that they are conducted on the device components or the assembled device to demonstrate its performance characteristics. They are not clinical trials involving human subjects to gather new prospective data on efficacy or safety in a clinical setting; rather, they aim to show equivalence to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts for Functional Performance: Not explicitly stated. For laboratory testing, the ground truth would be established by the testing methodology and measurements against predefined specifications. These specifications would likely be derived from industry standards, predicate device performance, or engineering requirements. The "experts" would be the engineers and technicians performing and interpreting these tests, presumably qualified in their respective fields.
- Experts for Biocompatibility: The assessment was "based on principles and guidelines established by various governmental and standard setting organizations, such as: ISO 10993, International Standard Organization (ISO) Standard; General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation; United States Pharmacopeia (USP)." The evaluations were contracted either by Hollister or the suppliers of the materials to "licensed commercial reference laboratories." The qualifications of the personnel at these laboratories would be in toxicology, material science, and regulatory compliance for medical devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated for any of the tests. For laboratory tests, the results would typically be objectively measured and compared to numerical criteria. For biocompatibility, the assessment would be based on established standards and expert interpretation of test results from commercial laboratories. There is no indication of a "2+1" or "3+1" type of expert adjudication process, which is more common in clinical image interpretation studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, there is no mention of an MRMC comparative effectiveness study involving human readers or AI. This submission is for a physical medical device (Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap), not an AI/imaging device. Therefore, the concept of "AI assistance" for human readers does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, this is not an AI/algorithm-based device. The "standalone" performance refers to the device's functional integrity as a physical product (e.g., fluid handling capacity, air flow resistance, biocompatibility) rather than an algorithm's performance. The laboratory tests performed are considered "standalone" in that they assess the device itself without direct human interaction as part of the test subject.
7. Type of Ground Truth Used
- Functional Performance: Ground truth was based on pre-defined engineering specifications, performance metrics (e.g., specific fluid volumes, air pressure differentials) established through internal R&D, and comparison to predicate device characteristics.
- Biocompatibility: Ground truth was based on established international (ISO 10993) and national (U.S. FDA, USP) standards and guidelines for biological safety of medical device materials, as well as historical data for biomaterials.
- Substantial Equivalence: Ground truth for comparison was the characteristics (intended use, materials, manufacturing processes, fluid collection capabilities) of legally marketed predicate devices (Ameda Dolphin Dispo-Soft Vacuum Extractor, Mityvac Extractor Cup System, Tender Touch).
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable in the context of this device and its testing. "Training set" typically refers to the data used to train a machine learning model. This document describes the evaluation of a physical medical device. While Hollister would have internal design and development processes with various iterations and tests that could be loosely considered 'training' for the device's design, it's not a "training set" in the machine learning sense. The laboratory testing and predicate device comparisons serve as the validation of the final design.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML development. The design and development of the device would have involved engineering principles, material science, and adherence to medical device regulations. The "ground truth" for the design validation (analogous to proving performance) was established through laboratory measurements and comparisons to predicate devices and standards.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).